A Phase II, Study to Determine the Preliminary Efficacy of Novel Combinations of Treatment in Patients with Platinum Refractory Extensive-Stage Small-Cell Lung Cancer

Study identifier:D419QC00002

ClinicalTrials.gov identifier:NCT02937818

EudraCT identifier:2016-001202-42

CTIS identifier:N/A

Study Complete

Official Title

A Phase II, Open-Label, Multi-Arm Study to Determine the Preliminary Efficacy of Novel Combinations of Treatment in Patients with Platinum Refractory Extensive-Stage Small-Cell Lung Cancer

Medical condition

Platinum Refractory Extensive-Stage Small Cell Lung Carcinoma

Phase

Phase 2

Healthy volunteers

Study drug

Durvalumab and Tremelimumab, AZD1775 and carboplatin (CBPT), AZD6738 and olaparib

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 28 Nov 2016

Primary Completion Date: 22 Jun 2020

Study Completion Date: 27 Nov 2023

Study design

Allocation: Non-randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 May 2024 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

(applicable to all arms)
• Adults with histologically or cytologically documented ED SCLC who have demonstrated progressive disease either during first-line platinum-based chemotherapy (platinum refractory) or within 90 days of completing platinum based-chemotherapy (platinum resistant) and have not received further treatment.
• Brain metastases must be asymptomatic or treated and stable off steroids and anti-convulsants for at least 1 month prior to study treatment.
• At least 1 lesion, not previously irradiated, that can be accurately measured at baseline (per RECIST v 1.1 guidelines)
• Life expectancy of at least 8 weeks.
• WHO/ ECOG PS of 0-1 at enrollment.
Inclusion criteria (Arm A specific)
• Body weight >30 kg.
• No prior exposure to immune mediated therapy, excluding therapeutic anticancer vaccines.
Inclusion criteria (Arm B specific)
• Able and willing to swallow oral medication.
Inclusion criteria (Arm C specific)
• Able and willing to swallow oral medication.

Exclusion Criteria

(applicable to all arms):
• Participation in another clinical study, major surgery, radiation therapy within 28 days.
• Any condition that, in the opinion of the Investigator, would interfere with the evaluation of the IP or interpretation of patient safety or study results.
• Uncontrolled intercurrent illness, including but not limited to interstitial lung disease.
• History of another primary malignancy, leptomeningeal carcinomatosis or spinal cord compression.
Exclusion criteria (Arm A specific)
• Active autoimmune disease, including a paraneoplastic syndrome.
• Active or prior documented autoimmune or inflammatory disorders.
• Any unresolved toxicity (CTCAE Grade >2) from previous anticancer therapy.
• Active infection including tuberculosis, HIV, Hepatitis B or C.
Exclusion criteria (Arm B specific)
• Prior exposure to any WEE1 inhibitors.
• Products known to be sensitive to CYP3A4 substrates or CYP3A4 substrates with a narrow therapeutic index, or to be moderate to strong inhibitors/inducers of CYP3A4. Co-administration of rosuvastatin, atorvastatin, simvastatin and lovastatin, aprepitant or fosaprepitant or any herbal preparations. Grapefruit and Seville oranges should be avoided while taking AZD1775.
• Any known hypersensitivity or contraindication to IP or CBDP.
• QTcF > 470 msec or congenital long QT syndrome.
• Any current or within 6 months cardiac diseases NYHA ≥ Class 2: unstable angina pectoris, congestive heart failure, acute MI, conduction abnormality not controlled with pacemaker or medication, significant ventricular or supraventricular arrhythmias.
• A recent history of Torsades de pointes.
Exclusion criteria (Arm C specific)
• Cytotoxic chemotherapy within 21 days of Cycle 1 Day 1 is not permitted
• Previous treatment with a PARP inhibitor (including olaparib) or ATR inhibitor
• Concomitant use of known strong CYP3A inhibitors and moderate CYP3A inhibitors
• Concomitant use of known strong and moderate CYP3A inducers
• Persisting (> 4 weeks) severe pancytopenia due to previous therapy
• Cardiac dysfunction
• Refractory nausea and vomitting, chronic gastrointenstinal diseases or previous significant bowel resection
• Patients with uncontrolled seizures
• Intenstinal obstruction or CTCAE grade 3 or grade 4 GI bleeding within 4 weeks before dosing

Location

Research Site

Miskolc, Hungary, 3529

Location

Research Site

Székesfehérvár, Hungary, 8000

Location

Research Site

Kecskemét, Hungary, 6000

Location

Research Site

Sumy, Ukraine, 40022

Location

Research Site

Ivano-Frankivsk, Ukraine, 76018

Location

Research Site

Dnipro, Ukraine, 49102

Location

Research Site

Valencia, Spain, 46009

Location

Research Site

Sevilla, Spain, 41009

Arms	Assigned Interventions
Experimental: ARM A	Drug: Durvalumab and Tremelimumab Durvalumab + tremelimumab via intravenous (IV) infusion every 4 weeks (q4w), starting on Week 0, for up to a total of 4 months (4 cycles) followed by durvalumab monotherapy via IV infusion q4w, starting on Week 16 until PD, or for other discontinuation criteria.
Experimental: ARM B	Drug: AZD1775 and carboplatin (CBPT) AZD1775 twice daily (oral) for 2.5 days from Day 1 + CBDP area under the curve 5 (Day1) (IV); every 3 weeks.
Experimental: ARM C	Drug: AZD6738 and olaparib AZD6738 once a day (oral) for 7 days from Day 1 + olaparib twice a day(oral) for 28 days from Day 1, every 4 weeks

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was conducted between 28-Nov-2016 and 22-Jun-2020, at 11 study centers in 5 countries (Germany, Hungary, Poland, Spain, and Ukraine).

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants who met the inclusion exclusion criteria were enrolled to the study. All study assessments were performed as per the schedule of assessment.

Reporting Groups

	Description
Arm A: Durvalumab + Tremelimumab (Original Cohort)	Participants received durvalumab 1500 mg + tremelimumab 75 mg via intravenous (IV) infusion every 4 weeks (q4w), starting on Week 0, for up to a total of 4 months (4 cycles) followed by durvalumab monotherapy 1500 mg via IV infusion q4w, starting on Week 16 until confirmed progressive disease (PD), or other discontinuation criteria.
Arm A: Durvalumab + Tremelimumab (Expansion Cohort)	Participants received durvalumab 1500 mg + tremelimumab 75 mg via intravenous (IV) infusion every 4 weeks (q4w), starting on Week 0, for up to a total of 4 months (4 cycles) followed by durvalumab monotherapy 1500 mg via IV infusion q4w, starting on Week 16 until confirmed PD, or other discontinuation criteria.
Arm B: Adavosertib + Carboplatin	Participants orally received adavosertib 225 mg twice daily (BID) for 2.5 days from Day 1 + carboplatin area under the curve (AUC) 5 Day 1 IV, every 3 weeks (q3w).
Arm C: Ceralasertib (AZD6738) + Olaparib	Participants orally received ceralasertib 160 mg once daily (QD) Days 1 to 7 + olaparib 300 mg BID Days 1 to 28, q4w.

Participant Flow: Overall Study

	Arm A: Durvalumab + Tremelimumab (Original Cohort)	Arm A: Durvalumab + Tremelimumab (Expansion Cohort)	Arm B: Adavosertib + Carboplatin	Arm C: Ceralasertib (AZD6738) + Olaparib
STARTED	21	20	10	21
COMPLETED	0	0	0	0
NOT COMPLETED	21	20	10	21
Participants decision	2	1	1	1
Adverse Event	2	4	1	1
Disease progression	17	15	7	19
Condition under investigation worsened	0	0	1	0

Baseline Characteristics

Analysis Population Description -- Explanation of how the number of participants for analysis was determined.

The Full Analysis Set (FAS) included all treated participants.

Reporting Groups

	Description
Arm A: Durvalumab + Tremelimumab (Original Cohort)	Participants received durvalumab 1500 mg + tremelimumab 75 mg via intravenous (IV) infusion every 4 weeks (q4w), starting on Week 0, for up to a total of 4 months (4 cycles) followed by durvalumab monotherapy 1500 mg via IV infusion q4w, starting on Week 16 until confirmed progressive disease (PD), or other discontinuation criteria.
Arm A: Durvalumab + Tremelimumab (Expansion Cohort)	Participants received durvalumab 1500 mg + tremelimumab 75 mg via intravenous (IV) infusion every 4 weeks (q4w), starting on Week 0, for up to a total of 4 months (4 cycles) followed by durvalumab monotherapy 1500 mg via IV infusion q4w, starting on Week 16 until confirmed PD, or other discontinuation criteria.
Arm B: Adavosertib + Carboplatin	Participants orally received adavosertib 225 mg twice daily (BID) for 2.5 days from Day 1 + carboplatin area under the curve (AUC) 5 Day 1 IV, every 3 weeks (q3w).
Arm C: Ceralasertib (AZD6738) + Olaparib	Participants orally received ceralasertib 160 mg once daily (QD) Days 1 to 7 + olaparib 300 mg BID Days 1 to 28, q4w.

Baseline Measures

	Arm A: Durvalumab + Tremelimumab (Original Cohort)	Arm A: Durvalumab + Tremelimumab (Expansion Cohort)	Arm B: Adavosertib + Carboplatin	Arm C: Ceralasertib (AZD6738) + Olaparib	Total
Number of Participants [units: Participants]	21	20	10	21	72
Age, Customized [units: Participants]
< 50	2	0	1	2	5
≥ 50 to < 65	13	12	5	12	42
≥ 65 to < 75	6	6	3	5	20
≥ 75 to < 80	0	2	1	2	5
≥ 80	0	0	0	0	0
Sex: Female, Male [units: Participants]
Female	6	4	2	7	19
Male	15	16	8	14	53
Race (NIH/OMB) [units: Participants]
American Indian or Alaska Native	0	0	0	0	0
Asian	0	0	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0	0	0
Black or African American	0	0	0	0	0
White	21	20	10	21	72
More than one race	0	0	0	0	0
Unknown or Not Reported	0	0	0	0	0
Ethnicity (NIH/OMB) [units: Participants]
Hispanic or Latino	0	1	0	0	1
Not Hispanic or Latino	21	19	10	21	71
Unknown or Not Reported	0	0	0	0	0

Outcome Measures

1. Primary Outcome Measure: Number of Participants With Overall Response [ Time Frame: Until disease progression [PD] (Up to 3.5 Years) ]

Measure Type	Primary
Measure Name	Number of Participants With Overall Response
Measure Description	Overall Response Rate (ORR) using Investigator assessments according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. ORR was defined as the number (percentage) of participants with a confirmed Complete Response (CR) or confirmed Partial Response (PR) and was estimated for each treatment arm with corresponding 2-sided 95% exact confidence intervals (CIs). A confirmed response of CR/PR meant that a response of CR/PR was recorded at one visit and confirmed by repeat imaging, preferably at the next regularly scheduled imaging visit, and not less than 4 weeks after the visit when the response was first observed, with no evidence of progression between the initial and CR/PR confirmation visit.
Time Frame	Until disease progression [PD] (Up to 3.5 Years)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The FAS included all treated participants.

Reporting Groups

	Description
Arm A: Durvalumab + Tremelimumab (Original Cohort)	Participants received durvalumab 1500 mg + tremelimumab 75 mg via intravenous (IV) infusion every 4 weeks (q4w), starting on Week 0, for up to a total of 4 months (4 cycles) followed by durvalumab monotherapy 1500 mg via IV infusion q4w, starting on Week 16 until confirmed progressive disease (PD), or other discontinuation criteria.
Arm A: Durvalumab + Tremelimumab (Expansion Cohort)	Participants received durvalumab 1500 mg + tremelimumab 75 mg via intravenous (IV) infusion every 4 weeks (q4w), starting on Week 0, for up to a total of 4 months (4 cycles) followed by durvalumab monotherapy 1500 mg via IV infusion q4w, starting on Week 16 until confirmed PD, or other discontinuation criteria.
Arm B: Adavosertib + Carboplatin	Participants orally received adavosertib 225 mg twice daily (BID) for 2.5 days from Day 1 + carboplatin area under the curve (AUC) 5 Day 1 IV, every 3 weeks (q3w).
Arm C: Ceralasertib (AZD6738) + Olaparib	Participants orally received ceralasertib 160 mg once daily (QD) Days 1 to 7 + olaparib 300 mg BID Days 1 to 28, q4w.

Measured Values

	Arm A: Durvalumab + Tremelimumab (Original Cohort)	Arm A: Durvalumab + Tremelimumab (Expansion Cohort)	Arm B: Adavosertib + Carboplatin	Arm C: Ceralasertib (AZD6738) + Olaparib
Number of Participants Analyzed [units:participants]	21	20	10	21
Number of Participants With Overall Response [units: Participants]	2	1	0	1

No statistical analysis provided for Number of Participants With Overall Response

2. Secondary Outcome Measure: Duration of Response (DoR) [ Time Frame: Until disease progression or data cut-off or Death (Up to 3.5 Years) ]

Measure Type	Secondary
Measure Name	Duration of Response (DoR)
Measure Description	The DoR was defined as the time from the date of first documented response (which was subsequently confirmed) CR/PR until the date of documented progression, or death in the absence of disease progression. The DoR in participants with confirmed objective response are reported.
Time Frame	Until disease progression or data cut-off or Death (Up to 3.5 Years)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The FAS included all treated participants.

Reporting Groups

	Description
Arm A: Durvalumab + Tremelimumab (Original Cohort)	Participants received durvalumab 1500 mg + tremelimumab 75 mg via intravenous (IV) infusion every 4 weeks (q4w), starting on Week 0, for up to a total of 4 months (4 cycles) followed by durvalumab monotherapy 1500 mg via IV infusion q4w, starting on Week 16 until confirmed progressive disease (PD), or other discontinuation criteria.
Arm A: Durvalumab + Tremelimumab (Expansion Cohort)	Participants received durvalumab 1500 mg + tremelimumab 75 mg via intravenous (IV) infusion every 4 weeks (q4w), starting on Week 0, for up to a total of 4 months (4 cycles) followed by durvalumab monotherapy 1500 mg via IV infusion q4w, starting on Week 16 until confirmed PD, or other discontinuation criteria.
Arm B: Adavosertib + Carboplatin	Participants orally received adavosertib 225 mg twice daily (BID) for 2.5 days from Day 1 + carboplatin area under the curve (AUC) 5 Day 1 IV, every 3 weeks (q3w).
Arm C: Ceralasertib (AZD6738) + Olaparib	Participants orally received ceralasertib 160 mg once daily (QD) Days 1 to 7 + olaparib 300 mg BID Days 1 to 28, q4w.

Measured Values

	Arm A: Durvalumab + Tremelimumab (Original Cohort)	Arm A: Durvalumab + Tremelimumab (Expansion Cohort)	Arm B: Adavosertib + Carboplatin	Arm C: Ceralasertib (AZD6738) + Olaparib
Number of Participants Analyzed [units:participants]	2	1	0	1
Duration of Response (DoR) [units: Months] Median (Full Range)	NA (1.5 to NA) ^[1]	3 (3 to 3)		8.5 (8.5 to 8.5)

No statistical analysis provided for Duration of Response (DoR)

3. Secondary Outcome Measure: Percentage of Participants With Disease Control at 12 Weeks [ Time Frame: At 12 Weeks ]

Measure Type	Secondary
Measure Name	Percentage of Participants With Disease Control at 12 Weeks
Measure Description	The disease control rate (DCR) at 12 weeks was defined as the percentage of participants who had a best objective response of CR or PR in the first 13 weeks or who had demonstrated stable disease (SD) for a minimum interval of 11 weeks following the start of study treatment. The DCR was determined programmatically based on RECIST 1.1 using site Investigator data and all data up until the first progression event.
Time Frame	At 12 Weeks
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The FAS included all treated participants.

Reporting Groups

	Description
Arm A: Durvalumab + Tremelimumab (Original Cohort)	Participants received durvalumab 1500 mg + tremelimumab 75 mg via intravenous (IV) infusion every 4 weeks (q4w), starting on Week 0, for up to a total of 4 months (4 cycles) followed by durvalumab monotherapy 1500 mg via IV infusion q4w, starting on Week 16 until confirmed progressive disease (PD), or other discontinuation criteria.
Arm A: Durvalumab + Tremelimumab (Expansion Cohort)	Participants received durvalumab 1500 mg + tremelimumab 75 mg via intravenous (IV) infusion every 4 weeks (q4w), starting on Week 0, for up to a total of 4 months (4 cycles) followed by durvalumab monotherapy 1500 mg via IV infusion q4w, starting on Week 16 until confirmed PD, or other discontinuation criteria.
Arm B: Adavosertib + Carboplatin	Participants orally received adavosertib 225 mg twice daily (BID) for 2.5 days from Day 1 + carboplatin area under the curve (AUC) 5 Day 1 IV, every 3 weeks (q3w).
Arm C: Ceralasertib (AZD6738) + Olaparib	Participants orally received ceralasertib 160 mg once daily (QD) Days 1 to 7 + olaparib 300 mg BID Days 1 to 28, q4w.

Measured Values

	Arm A: Durvalumab + Tremelimumab (Original Cohort)	Arm A: Durvalumab + Tremelimumab (Expansion Cohort)	Arm B: Adavosertib + Carboplatin	Arm C: Ceralasertib (AZD6738) + Olaparib
Number of Participants Analyzed [units:participants]	21	20	10	21
Percentage of Participants With Disease Control at 12 Weeks [units: Percentage of Participants]	38.1	15.0	30.0	38.1

No statistical analysis provided for Percentage of Participants With Disease Control at 12 Weeks

4. Secondary Outcome Measure: Time to Response (TTR) [ Time Frame: Until disease progression or data cut-off or Death (Up to 3.5 Years) ]

Measure Type	Secondary
Measure Name	Time to Response (TTR)
Measure Description	The TTR (per RECIST 1.1 as assessed by the Investigator) was defined as the time from the date of first dose until the first date of documented response.
Time Frame	Until disease progression or data cut-off or Death (Up to 3.5 Years)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The FAS included all treated participants.

Reporting Groups

	Description
Arm A: Durvalumab + Tremelimumab (Original Cohort)	Participants received durvalumab 1500 mg + tremelimumab 75 mg via intravenous (IV) infusion every 4 weeks (q4w), starting on Week 0, for up to a total of 4 months (4 cycles) followed by durvalumab monotherapy 1500 mg via IV infusion q4w, starting on Week 16 until confirmed progressive disease (PD), or other discontinuation criteria.
Arm A: Durvalumab + Tremelimumab (Expansion Cohort)	Participants received durvalumab 1500 mg + tremelimumab 75 mg via intravenous (IV) infusion every 4 weeks (q4w), starting on Week 0, for up to a total of 4 months (4 cycles) followed by durvalumab monotherapy 1500 mg via IV infusion q4w, starting on Week 16 until confirmed PD, or other discontinuation criteria.
Arm B: Adavosertib + Carboplatin	Participants orally received adavosertib 225 mg twice daily (BID) for 2.5 days from Day 1 + carboplatin area under the curve (AUC) 5 Day 1 IV, every 3 weeks (q3w).
Arm C: Ceralasertib (AZD6738) + Olaparib	Participants orally received ceralasertib 160 mg once daily (QD) Days 1 to 7 + olaparib 300 mg BID Days 1 to 28, q4w.

Measured Values

	Arm A: Durvalumab + Tremelimumab (Original Cohort)	Arm A: Durvalumab + Tremelimumab (Expansion Cohort)	Arm B: Adavosertib + Carboplatin	Arm C: Ceralasertib (AZD6738) + Olaparib
Number of Participants Analyzed [units:participants]	2	1	0	1
Time to Response (TTR) [units: Months] Median (Full Range)	1.8 (1.7 to 1.8)	1.8 (1.8 to 1.8)		1.7 (1.7 to 1.7)

No statistical analysis provided for Time to Response (TTR)

5. Secondary Outcome Measure: Progression Free Survival (PFS) [ Time Frame: Until disease progression or data cut-off or Death (Up to 3.5 Years) ]

Measure Type	Secondary
Measure Name	Progression Free Survival (PFS)
Measure Description	The PFS (per RECIST 1.1 according to the Investigator’s assessment) was defined as the time from the date of the first dose of study treatment until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdrew from allocated therapy or received another anti-cancer therapy prior to progression.
Time Frame	Until disease progression or data cut-off or Death (Up to 3.5 Years)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The FAS included all treated participants.

Reporting Groups

	Description
Arm A: Durvalumab + Tremelimumab (Original Cohort)	Participants received durvalumab 1500 mg + tremelimumab 75 mg via intravenous (IV) infusion every 4 weeks (q4w), starting on Week 0, for up to a total of 4 months (4 cycles) followed by durvalumab monotherapy 1500 mg via IV infusion q4w, starting on Week 16 until confirmed progressive disease (PD), or other discontinuation criteria.
Arm A: Durvalumab + Tremelimumab (Expansion Cohort)	Participants received durvalumab 1500 mg + tremelimumab 75 mg via intravenous (IV) infusion every 4 weeks (q4w), starting on Week 0, for up to a total of 4 months (4 cycles) followed by durvalumab monotherapy 1500 mg via IV infusion q4w, starting on Week 16 until confirmed PD, or other discontinuation criteria.
Arm B: Adavosertib + Carboplatin	Participants orally received adavosertib 225 mg twice daily (BID) for 2.5 days from Day 1 + carboplatin area under the curve (AUC) 5 Day 1 IV, every 3 weeks (q3w).
Arm C: Ceralasertib (AZD6738) + Olaparib	Participants orally received ceralasertib 160 mg once daily (QD) Days 1 to 7 + olaparib 300 mg BID Days 1 to 28, q4w.

Measured Values

	Arm A: Durvalumab + Tremelimumab (Original Cohort)	Arm A: Durvalumab + Tremelimumab (Expansion Cohort)	Arm B: Adavosertib + Carboplatin	Arm C: Ceralasertib (AZD6738) + Olaparib
Number of Participants Analyzed [units:participants]	21	20	10	21
Progression Free Survival (PFS) [units: Months] Median (95% Confidence Interval)	1.91 (1.77 to 4.34)	1.77 (1.02 to 2.20)	2.60 (0.56 to 4.83)	2.92 (1.81 to 4.53)

No statistical analysis provided for Progression Free Survival (PFS)

6. Secondary Outcome Measure: Overall Survival (OS) [ Time Frame: Until disease progression or data cut-off or Death (Up to 3.5 Years) ]

Measure Type	Secondary
Measure Name	Overall Survival (OS)
Measure Description	The OS was defined as the time from the date of the first dose of study treatment until death due to any cause.
Time Frame	Until disease progression or data cut-off or Death (Up to 3.5 Years)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The FAS included all treated participants.

Reporting Groups

	Description
Arm A: Durvalumab + Tremelimumab (Original Cohort)	Participants received durvalumab 1500 mg + tremelimumab 75 mg via intravenous (IV) infusion every 4 weeks (q4w), starting on Week 0, for up to a total of 4 months (4 cycles) followed by durvalumab monotherapy 1500 mg via IV infusion q4w, starting on Week 16 until confirmed progressive disease (PD), or other discontinuation criteria.
Arm A: Durvalumab + Tremelimumab (Expansion Cohort)	Participants received durvalumab 1500 mg + tremelimumab 75 mg via intravenous (IV) infusion every 4 weeks (q4w), starting on Week 0, for up to a total of 4 months (4 cycles) followed by durvalumab monotherapy 1500 mg via IV infusion q4w, starting on Week 16 until confirmed PD, or other discontinuation criteria.
Arm B: Adavosertib + Carboplatin	Participants orally received adavosertib 225 mg twice daily (BID) for 2.5 days from Day 1 + carboplatin area under the curve (AUC) 5 Day 1 IV, every 3 weeks (q3w).
Arm C: Ceralasertib (AZD6738) + Olaparib	Participants orally received ceralasertib 160 mg once daily (QD) Days 1 to 7 + olaparib 300 mg BID Days 1 to 28, q4w.

Measured Values

	Arm A: Durvalumab + Tremelimumab (Original Cohort)	Arm A: Durvalumab + Tremelimumab (Expansion Cohort)	Arm B: Adavosertib + Carboplatin	Arm C: Ceralasertib (AZD6738) + Olaparib
Number of Participants Analyzed [units:participants]	21	20	10	21
Overall Survival (OS) [units: Months] Median (95% Confidence Interval)	5.95 (1.91 to 10.61)	3.37 (1.91 to 7.66)	4.67 (0.56 to 5.98)	7.56 (4.21 to 12.58)

No statistical analysis provided for Overall Survival (OS)

7. Secondary Outcome Measure: Time to maximum concentration (tmax) [ Time Frame: Cycle 1 (each cycle was 28 days in length) Day 1 (post-dose) ]

Measure Type	Secondary
Measure Name	Time to maximum concentration (tmax)
Measure Description	Time to maximum concentration for ceralasertib and olaparib are reported.
Time Frame	Cycle 1 (each cycle was 28 days in length) Day 1 (post-dose)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Pharmacokinetic Analysis Set: all participants who received at least 1 dose of study treatment and had post-dose data available, excluding those who had a deviation considered by the sponsor to have a potential impact on the interpretation of the pharmacokinetic analyses.

Reporting Groups

	Description
Ceralasertib (AZD6738)	Participants orally received ceralasertib 160 mg once daily (QD) Days 1 to 7 + olaparib 300 mg BID Days 1 to 28, q4w.
Olaparib	Participants orally received ceralasertib 160 mg once daily (QD) Days 1 to 7 + olaparib 300 mg BID Days 1 to 28, q4w.

Measured Values

	Ceralasertib (AZD6738)	Olaparib
Number of Participants Analyzed [units:participants]	21	21
Time to maximum concentration (tmax) [units: Hour] Median (Full Range)	1.250 (1.00 to 6.08)	1.800 (1.00 to 6.08)

No statistical analysis provided for Time to maximum concentration (tmax)

8. Secondary Outcome Measure: Maximum concentration (Cmax) [ Time Frame: Cycle 1 (each cycle was 28 days in length) Day 1 (post-dose) ]

Measure Type	Secondary
Measure Name	Maximum concentration (Cmax)
Measure Description	Maximum concentration for ceralasertib and olaparib are reported.
Time Frame	Cycle 1 (each cycle was 28 days in length) Day 1 (post-dose)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Pharmacokinetic Analysis Set: all participants who received at least 1 dose of study treatment and had post-dose data available, excluding those who had a deviation considered by the sponsor to have a potential impact on the interpretation of the pharmacokinetic analyses.

Reporting Groups

	Description
Ceralasertib (AZD6738)	Participants orally received ceralasertib 160 mg once daily (QD) Days 1 to 7 + olaparib 300 mg BID Days 1 to 28, q4w.
Olaparib	Participants orally received ceralasertib 160 mg once daily (QD) Days 1 to 7 + olaparib 300 mg BID Days 1 to 28, q4w.

Measured Values

	Ceralasertib (AZD6738)	Olaparib
Number of Participants Analyzed [units:participants]	21	21
Maximum concentration (Cmax) [units: µg/mL] Geometric Mean (Geometric Coefficient of Variation)	4.215 (27.7129%)	6.558 (39.9411%)

No statistical analysis provided for Maximum concentration (Cmax)

9. Secondary Outcome Measure: Partial area under the concentration-time curve (AUC0-6) [ Time Frame: Cycle 1 (each cycle was 28 days in length) Day 1 (post-dose) and Cycle 1 Day 7 (pre-dose and post-dose) ]

Measure Type	Secondary
Measure Name	Partial area under the concentration-time curve (AUC0-6)
Measure Description	Partial area under the concentration-time curve for ceralasertib and olaparib are reported.
Time Frame	Cycle 1 (each cycle was 28 days in length) Day 1 (post-dose) and Cycle 1 Day 7 (pre-dose and post-dose)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Pharmacokinetic Analysis Set: all participants who received at least 1 dose of study treatment and had post-dose data available, excluding those who had a deviation considered by the sponsor to have a potential impact on the interpretation of the pharmacokinetic analyses. Here, number analyzed in each row signifies only participants with available data that were analyzed for that specified time point.

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

Pharmacokinetic Analysis Set: all participants who received at least 1 dose of study treatment and had post-dose data available, excluding those who had a deviation considered by the sponsor to have a potential impact on the interpretation of the pharmacokinetic analyses. Here, number analyzed in each row signifies only participants with available data that were analyzed for that specified time point.

Reporting Groups

	Description
Ceralasertib (AZD6738)	Participants orally received ceralasertib 160 mg once daily (QD) Days 1 to 7 + olaparib 300 mg BID Days 1 to 28, q4w.
Olaparib	Participants orally received ceralasertib 160 mg once daily (QD) Days 1 to 7 + olaparib 300 mg BID Days 1 to 28, q4w.

Measured Values

	Ceralasertib (AZD6738)	Olaparib
Number of Participants Analyzed [units:participants]	20	21
Partial area under the concentration-time curve (AUC0-6) [units: h*µg/mL] Geometric Mean (Geometric Coefficient of Variation)
Cycle 1, Day 1	18.346 (34.6952%)	26.356 (42.2963%)
Cycle 1, Day 7	23.666 (23.9202%)	42.016 (33.7599%)

No statistical analysis provided for Partial area under the concentration-time curve (AUC0-6)

10. Secondary Outcome Measure: Area under the concentration-time curve from time zero to the last measurable concentration (AUC0-t) [ Time Frame: Cycle 1 (each cycle was 28 days in length) Day 1 (post-dose) and Cycle 1 Day 7 (pre-dose and post-dose) ]

Measure Type	Secondary
Measure Name	Area under the concentration-time curve from time zero to the last measurable concentration (AUC0-t)
Measure Description	Area under the concentration-time curve from time zero to the last measurable concentration for Ceralasertib and Olaparib are reported.
Time Frame	Cycle 1 (each cycle was 28 days in length) Day 1 (post-dose) and Cycle 1 Day 7 (pre-dose and post-dose)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Pharmacokinetic Analysis Set: all participants who received at least 1 dose of study treatment and had post-dose data available, excluding those who had a deviation considered by the sponsor to have a potential impact on the interpretation of the pharmacokinetic analyses. Here, number analyzed in each row signifies only participants with available data that were analyzed for that specified time point.

Reporting Groups

	Description
Ceralasertib (AZD6738)	Participants orally received ceralasertib 160 mg once daily (QD) Days 1 to 7 + olaparib 300 mg BID Days 1 to 28, q4w.
Olaparib	Participants orally received ceralasertib 160 mg once daily (QD) Days 1 to 7 + olaparib 300 mg BID Days 1 to 28, q4w.

Measured Values

	Ceralasertib (AZD6738)	Olaparib
Number of Participants Analyzed [units:participants]	21	21
Area under the concentration-time curve from time zero to the last measurable concentration (AUC0-t) [units: h*µg/mL] Geometric Mean (Geometric Coefficient of Variation)
Cycle 1, Day 1	18.575 (34.5074%)	26.973 (41.4461%)
Cycle 1, Day 7	24.061 (23.0923%)	62.535 (42.4552%)

No statistical analysis provided for Area under the concentration-time curve from time zero to the last measurable concentration (AUC0-t)

11. Secondary Outcome Measure: Time to maximum concentration at steady state (tmax,ss) [ Time Frame: Cycle 1 (each cycle was 28 days in length) Day 7 (pre-dose and post-dose) ]

Measure Type	Secondary
Measure Name	Time to maximum concentration at steady state (tmax,ss)
Measure Description	Time to maximum concentration at steady state for Ceralasertib and Olaparib are reported.
Time Frame	Cycle 1 (each cycle was 28 days in length) Day 7 (pre-dose and post-dose)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Pharmacokinetic Analysis Set: all participants who received at least 1 dose of study treatment and had post-dose data available, excluding those who had a deviation considered by the sponsor to have a potential impact on the interpretation of the pharmacokinetic analyses.

Reporting Groups

	Description
Ceralasertib (AZD6738)	Participants orally received ceralasertib 160 mg once daily (QD) Days 1 to 7 + olaparib 300 mg BID Days 1 to 28, q4w.
Olaparib	Participants orally received ceralasertib 160 mg once daily (QD) Days 1 to 7 + olaparib 300 mg BID Days 1 to 28, q4w.

Measured Values

	Ceralasertib (AZD6738)	Olaparib
Number of Participants Analyzed [units:participants]	10	10
Time to maximum concentration at steady state (tmax,ss) [units: Hour] Median (Full Range)	1.875 (0.63 to 6.08)	2.708 (0.63 to 4.50)

No statistical analysis provided for Time to maximum concentration at steady state (tmax,ss)

12. Secondary Outcome Measure: Maximum concentration at steady state (Cmax,ss) [ Time Frame: Cycle 1 (each cycle was 28 days in length) Day 7 (pre-dose and post-dose) ]

Measure Type	Secondary
Measure Name	Maximum concentration at steady state (Cmax,ss)
Measure Description	Maximum concentration at steady state for Ceralasertib and Olaparib are reported.
Time Frame	Cycle 1 (each cycle was 28 days in length) Day 7 (pre-dose and post-dose)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Pharmacokinetic Analysis Set: all participants who received at least 1 dose of study treatment and had post-dose data available, excluding those who had a deviation considered by the sponsor to have a potential impact on the interpretation of the pharmacokinetic analyses.

Reporting Groups

	Description
Ceralasertib (AZD6738)	Participants orally received ceralasertib 160 mg once daily (QD) Days 1 to 7 + olaparib 300 mg BID Days 1 to 28, q4w.
Olaparib	Participants orally received ceralasertib 160 mg once daily (QD) Days 1 to 7 + olaparib 300 mg BID Days 1 to 28, q4w.

Measured Values

	Ceralasertib (AZD6738)	Olaparib
Number of Participants Analyzed [units:participants]	10	10
Maximum concentration at steady state (Cmax,ss) [units: µg/mL] Geometric Mean (Geometric Coefficient of Variation)	5.176 (23.4058%)	9.189 (30.4888%)

No statistical analysis provided for Maximum concentration at steady state (Cmax,ss)

13. Secondary Outcome Measure: Minimum concentration at steady state (Cmin,ss) [ Time Frame: Cycle 1 (each cycle was 28 days in length) Day 7 (pre-dose and post-dose) ]

Measure Type	Secondary
Measure Name	Minimum concentration at steady state (Cmin,ss)
Measure Description	Minimum concentration at steady state for Ceralasertib and Olaparib are reported.
Time Frame	Cycle 1 (each cycle was 28 days in length) Day 7 (pre-dose and post-dose)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Pharmacokinetic Analysis Set: all participants who received at least 1 dose of study treatment and had post-dose data available, excluding those who had a deviation considered by the sponsor to have a potential impact on the interpretation of the pharmacokinetic analyses.

Reporting Groups

	Description
Ceralasertib (AZD6738)	Participants orally received ceralasertib 160 mg once daily (QD) Days 1 to 7 + olaparib 300 mg BID Days 1 to 28, q4w.
Olaparib	Participants orally received ceralasertib 160 mg once daily (QD) Days 1 to 7 + olaparib 300 mg BID Days 1 to 28, q4w.

Measured Values

	Ceralasertib (AZD6738)	Olaparib
Number of Participants Analyzed [units:participants]	10	10
Minimum concentration at steady state (Cmin,ss) [units: µg/mL] Geometric Mean (Geometric Coefficient of Variation)	1.119 (55.9070%)	2.376 (61.8191%)

No statistical analysis provided for Minimum concentration at steady state (Cmin,ss)

14. Secondary Outcome Measure: Area under the concentration-time curve at steady state (AUCss) [ Time Frame: Cycle 1 (each cycle was 28 days in length) Day 7 (pre-dose and post-dose) ]

Measure Type	Secondary
Measure Name	Area under the concentration-time curve at steady state (AUCss)
Measure Description	Area under the concentration-time curve at steady state at steady state for Ceralasertib and Olaparib are reported.
Time Frame	Cycle 1 (each cycle was 28 days in length) Day 7 (pre-dose and post-dose)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Pharmacokinetic Analysis Set: all participants who received at least 1 dose of study treatment and had post-dose data available, excluding those who had a deviation considered by the sponsor to have a potential impact on the interpretation of the pharmacokinetic analyses.

Reporting Groups

	Description
Ceralasertib (AZD6738)	Participants orally received ceralasertib 160 mg once daily (QD) Days 1 to 7 + olaparib 300 mg BID Days 1 to 28, q4w.
Olaparib	Participants orally received ceralasertib 160 mg once daily (QD) Days 1 to 7 + olaparib 300 mg BID Days 1 to 28, q4w.

Measured Values

	Ceralasertib (AZD6738)	Olaparib
Number of Participants Analyzed [units:participants]	10	9
Area under the concentration-time curve at steady state (AUCss) [units: h*µg/mL] Geometric Mean (Geometric Coefficient of Variation)	NA (NA%)^[1]	67.929 (37.4297%)

No statistical analysis provided for Area under the concentration-time curve at steady state (AUCss)

15. Secondary Outcome Measure: Apparent clearance of drug at steady state at steady state (CLss/F) [ Time Frame: Cycle 1 (each cycle was 28 days in length) Day 7 (pre-dose and post-dose) ]

Measure Type	Secondary
Measure Name	Apparent clearance of drug at steady state at steady state (CLss/F)
Measure Description	Area under the concentration-time curve at steady state at steady state for Ceralasertib and Olaparib are reported.
Time Frame	Cycle 1 (each cycle was 28 days in length) Day 7 (pre-dose and post-dose)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Pharmacokinetic Analysis Set: all participants who received at least 1 dose of study treatment and had post-dose data available, excluding those who had a deviation considered by the sponsor to have a potential impact on the interpretation of the pharmacokinetic analyses.

Reporting Groups

	Description
Ceralasertib (AZD6738)	Participants orally received ceralasertib 160 mg once daily (QD) Days 1 to 7 + olaparib 300 mg BID Days 1 to 28, q4w.
Olaparib	Participants orally received ceralasertib 160 mg once daily (QD) Days 1 to 7 + olaparib 300 mg BID Days 1 to 28, q4w.

Measured Values

	Ceralasertib (AZD6738)	Olaparib
Number of Participants Analyzed [units:participants]	10	9
Apparent clearance of drug at steady state at steady state (CLss/F) [units: Litre/hour] Geometric Mean (Geometric Coefficient of Variation)	NA (NA%)^[1]	4.416 (42.3171%)

No statistical analysis provided for Apparent clearance of drug at steady state at steady state (CLss/F)

16. Secondary Outcome Measure: Serum concentrations of Durvalumab and Tremelimumab [ Time Frame: Durvalumab: Cycle 1 (each cycle was 4 weeks) Day 1(post-dose); Cycle 2 Day 1(pre-dose); Cycle 5 Day 1 (pre-dose); Tremelimumab: Cycle 1 (each cycle was 4 weeks) Day 1 (post-dose); Cycle 2 Day 1 (pre-dose); Cycle 5 Day 1 (No dose); Cycle 7 Day 1 (No dose) ]

Measure Type	Secondary
Measure Name	Serum concentrations of Durvalumab and Tremelimumab
Measure Description	Serum concentrations of Durvalumab and Tremelimumab are reported.
Time Frame	Durvalumab: Cycle 1 (each cycle was 4 weeks) Day 1(post-dose); Cycle 2 Day 1(pre-dose); Cycle 5 Day 1 (pre-dose); Tremelimumab: Cycle 1 (each cycle was 4 weeks) Day 1 (post-dose); Cycle 2 Day 1 (pre-dose); Cycle 5 Day 1 (No dose); Cycle 7 Day 1 (No dose)
Safety Issue?	No

Population Description

Reporting Groups

	Description
Arm A: Durvalumab + Tremelimumab (Original Cohort)	Participants received durvalumab 1500 mg + tremelimumab 75 mg via intravenous (IV) infusion every 4 weeks (q4w), starting on Week 0, for up to a total of 4 months (4 cycles) followed by durvalumab monotherapy 1500 mg via IV infusion q4w, starting on Week 16 until confirmed progressive disease (PD), or other discontinuation criteria.

Measured Values

	Arm A: Durvalumab + Tremelimumab (Original Cohort)
Number of Participants Analyzed [units:participants]	21
Serum concentrations of Durvalumab and Tremelimumab [units: μg/mL] Geometric Mean (Geometric Coefficient of Variation)
Durvalumab: Cycle 1 Day 1 (Post-dose)	391.192 (23.5990%)
Durvalumab: Cycle 2 Day 1 (Pre-dose)	55.590 (53.0745%)
Durvalumab: Cycle 5 Day 1 (Pre-dose)	116.846 (51.0036%)
Tremelimumab: Cycle 1 Day 1 (Post-dose)	18.299 (20.8181%)
Tremelimumab: Cycle 2 Day 1 (Pre-dose)	2.650 (53.1007%)
Tremelimumab: Cycle 5 Day 1 (No dose)	5.005 (38.3784%)
Tremelimumab: Cycle 7 Day 1 (No dose)	0.784 (66.3469%)

No statistical analysis provided for Serum concentrations of Durvalumab and Tremelimumab

17. Secondary Outcome Measure: Plasma concentrations of Adavosertib and Carboplatin [ Time Frame: Adavosertib: Cycle 1 (each cycle was 21 days) Day 3 (pre-dose and post-dose); Cycle 3 Day 3 (pre-dose and post-dose); Carboplatin: Cycle 1 (each cycle was 21 days) Day 1 (post-dose) ]

Measure Type	Secondary
Measure Name	Plasma concentrations of Adavosertib and Carboplatin
Measure Description	Plasma concentrations of Adavosertib and Carboplatin are reported.
Time Frame	Adavosertib: Cycle 1 (each cycle was 21 days) Day 3 (pre-dose and post-dose); Cycle 3 Day 3 (pre-dose and post-dose); Carboplatin: Cycle 1 (each cycle was 21 days) Day 1 (post-dose)
Safety Issue?	No

Population Description

Reporting Groups

	Description
Arm B: Adavosertib + Carboplatin	Participants orally received adavosertib 225 mg twice daily (BID) for 2.5 days from Day 1 + carboplatin area under the curve (AUC) 5 Day 1 IV, every 3 weeks (q3w).

Measured Values

	Arm B: Adavosertib + Carboplatin
Number of Participants Analyzed [units:participants]	10
Plasma concentrations of Adavosertib and Carboplatin [units: nM] Geometric Mean (Geometric Coefficient of Variation)
Adavosertib: Cycle 1 Day 3 (Pre-dose)	551.489 (41.5823%)
Adavosertib: Cycle 1 Day 3 (Post-dose)	728.342 (62.3968%)
Adavosertib: Cycle 3 Day 3 (Pre-dose)	606.571 (46.7716%)
Adavosertib: Cycle 3 Day 3 (Post-dose)	805.270 (68.0275%)
Carboplatin: Cycle 1 Day 1 (Post-dose)	12834.615 (27.5493%)

No statistical analysis provided for Plasma concentrations of Adavosertib and Carboplatin

18. Secondary Outcome Measure: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Day 1 until disease progression, and follow-up visit (Up to 3.5 Years) ]

Measure Type	Secondary
Measure Name	Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measure Description	An AE is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. SAE is an AE that results in any untoward medical occurrence that results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, or is a significant medical event.
Time Frame	Day 1 until disease progression, and follow-up visit (Up to 3.5 Years)
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The FAS included all treated participants.

Reporting Groups

	Description
Arm A: Durvalumab + Tremelimumab (Original Cohort)	Participants received durvalumab 1500 mg + tremelimumab 75 mg via intravenous (IV) infusion every 4 weeks (q4w), starting on Week 0, for up to a total of 4 months (4 cycles) followed by durvalumab monotherapy 1500 mg via IV infusion q4w, starting on Week 16 until confirmed progressive disease (PD), or other discontinuation criteria.
Arm A: Durvalumab + Tremelimumab (Expansion Cohort)	Participants received durvalumab 1500 mg + tremelimumab 75 mg via intravenous (IV) infusion every 4 weeks (q4w), starting on Week 0, for up to a total of 4 months (4 cycles) followed by durvalumab monotherapy 1500 mg via IV infusion q4w, starting on Week 16 until confirmed PD, or other discontinuation criteria.
Arm B: Adavosertib + Carboplatin	Participants orally received adavosertib 225 mg twice daily (BID) for 2.5 days from Day 1 + carboplatin area under the curve (AUC) 5 Day 1 IV, every 3 weeks (q3w).
Arm C: Ceralasertib (AZD6738) + Olaparib	Participants orally received ceralasertib 160 mg once daily (QD) Days 1 to 7 + olaparib 300 mg BID Days 1 to 28, q4w.

Measured Values

	Arm A: Durvalumab + Tremelimumab (Original Cohort)	Arm A: Durvalumab + Tremelimumab (Expansion Cohort)	Arm B: Adavosertib + Carboplatin	Arm C: Ceralasertib (AZD6738) + Olaparib
Number of Participants Analyzed [units:participants]	21	20	10	21
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [units: Participants]
Any AE	16	17	8	18
Any AE causally related to any study treatment	10	9	8	16
Any AE with outcome = death	1	0	1	1
Any SAE	6	8	4	7
Any AE leading to discontinuation of any study treatment	2	4	1	1

No statistical analysis provided for Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

Serious Adverse Events

Time Frame	Day 1 until disease progression, and follow-up visit (Up to 3.5 Years)
Additional Description	No text entered.

Reporting Groups

	Description
Arm A: Durvalumab + Tremelimumab (Original Cohort)	Participants received durvalumab 1500 mg + tremelimumab 75 mg via intravenous (IV) infusion every 4 weeks (q4w), starting on Week 0, for up to a total of 4 months (4 cycles) followed by durvalumab monotherapy 1500 mg via IV infusion q4w, starting on Week 16 until confirmed progressive disease (PD), or other discontinuation criteria.
Arm A: Durvalumab + Tremelimumab (Expansion Cohort)	Participants received durvalumab 1500 mg + tremelimumab 75 mg via intravenous (IV) infusion every 4 weeks (q4w), starting on Week 0, for up to a total of 4 months (4 cycles) followed by durvalumab monotherapy 1500 mg via IV infusion q4w, starting on Week 16 until confirmed PD, or other discontinuation criteria.
Arm B: Adavosertib + Carboplatin	Participants orally received adavosertib 225 mg twice daily (BID) for 2.5 days from Day 1 + carboplatin area under the curve (AUC) 5 Day 1 IV, every 3 weeks (q3w).
Arm C: Ceralasertib (AZD6738) + Olaparib	Participants orally received ceralasertib 160 mg once daily (QD) Days 1 to 7 + olaparib 300 mg BID Days 1 to 28, q4w.

Serious Adverse Events

Arm A: Durvalumab + Tremelimumab (Original Cohort)

Arm A: Durvalumab + Tremelimumab (Expansion Cohort)

Arm B: Adavosertib + Carboplatin

Arm C: Ceralasertib (AZD6738) + Olaparib

Total, serious adverse events

# participants affected / at risk

6/21 (28.57%)

8/20 (40.00%)

4/10 (40.00%)

7/21 (33.33%)

Infections and infestations

Gastroenteritis¹

# participants affected / at risk

0/21 (0.00%)

1/20 (5.00%)

0/10 (0.00%)

0/21 (0.00%)

# events

Infections and infestations

Pneumonia¹

# participants affected / at risk

0/21 (0.00%)

1/20 (5.00%)

0/10 (0.00%)

1/21 (4.76%)

# events

Blood and lymphatic system disorders

Anaemia¹

# participants affected / at risk

0/21 (0.00%)

1/20 (5.00%)

0/10 (0.00%)

4/21 (19.05%)

# events

Blood and lymphatic system disorders

Febrile neutropenia¹

# participants affected / at risk

0/21 (0.00%)

1/20 (5.00%)

0/10 (0.00%)

0/21 (0.00%)

# events

Blood and lymphatic system disorders

Thrombocytopenia¹

# participants affected / at risk

0/21 (0.00%)

1/20 (5.00%)

0/10 (0.00%)

1/21 (4.76%)

# events

Metabolism and nutrition disorders

Hypokalaemia¹

# participants affected / at risk

0/21 (0.00%)

1/20 (5.00%)

0/10 (0.00%)

0/21 (0.00%)

# events

Nervous system disorders

Myasthenic syndrome¹

# participants affected / at risk

1/21 (4.76%)

0/20 (0.00%)

0/10 (0.00%)

0/21 (0.00%)

# events

Nervous system disorders

Peripheral sensory neuropathy¹

# participants affected / at risk

1/21 (4.76%)

0/20 (0.00%)

0/10 (0.00%)

0/21 (0.00%)

# events

Gastrointestinal disorders

Abdominal pain¹

# participants affected / at risk

1/21 (4.76%)

0/20 (0.00%)

0/10 (0.00%)

0/21 (0.00%)

# events

Gastrointestinal disorders

Colitis¹

# participants affected / at risk

0/21 (0.00%)

1/20 (5.00%)

0/10 (0.00%)

0/21 (0.00%)

# events

Gastrointestinal disorders

Diarrhoea¹

# participants affected / at risk

2/21 (9.52%)

1/20 (5.00%)

1/10 (10.00%)

0/21 (0.00%)

# events

Gastrointestinal disorders

Enterocolitis haemorrhagic¹

# participants affected / at risk

1/21 (4.76%)

0/20 (0.00%)

0/10 (0.00%)

0/21 (0.00%)

# events

Gastrointestinal disorders

Pancreatitis¹

# participants affected / at risk

0/21 (0.00%)

1/20 (5.00%)

0/10 (0.00%)

0/21 (0.00%)

# events

Investigations

Hepatic enzyme increased¹

# participants affected / at risk

0/21 (0.00%)

1/20 (5.00%)

0/10 (0.00%)

0/21 (0.00%)

# events

Injury, poisoning and procedural complications

Burns third degree¹

# participants affected / at risk

0/21 (0.00%)

1/20 (5.00%)

0/10 (0.00%)

0/21 (0.00%)

# events

Injury, poisoning and procedural complications

Femoral neck fracture¹

# participants affected / at risk

1/21 (4.76%)

0/20 (0.00%)

0/10 (0.00%)

0/21 (0.00%)

# events

Injury, poisoning and procedural complications

Femur fracture¹

# participants affected / at risk

0/21 (0.00%)

1/20 (5.00%)

0/10 (0.00%)

0/21 (0.00%)

# events

Injury, poisoning and procedural complications

Toxicity to various agents¹

# participants affected / at risk

1/21 (4.76%)

0/20 (0.00%)

1/10 (10.00%)

0/21 (0.00%)

# events

Blood and lymphatic system disorders

Haematotoxicity¹

# participants affected / at risk

0/21 (0.00%)

0/20 (0.00%)

1/10 (10.00%)

0/21 (0.00%)

# events

Blood and lymphatic system disorders

Pancytopenia¹

# participants affected / at risk

0/21 (0.00%)

0/20 (0.00%)

1/10 (10.00%)

0/21 (0.00%)

# events

Infections and infestations

Urinary tract infection¹

# participants affected / at risk

0/21 (0.00%)

0/20 (0.00%)

0/10 (0.00%)

1/21 (4.76%)

# events

General disorders

Asthenia¹

# participants affected / at risk

0/21 (0.00%)

0/20 (0.00%)

0/10 (0.00%)

1/21 (4.76%)

# events

General disorders

Pyrexia¹

# participants affected / at risk

0/21 (0.00%)

0/20 (0.00%)

0/10 (0.00%)

1/21 (4.76%)

# events

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA version 23.0

Other Adverse Events

Time Frame	Day 1 until disease progression, and follow-up visit (Up to 3.5 Years)
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	5%

Reporting Groups

	Description
Arm A: Durvalumab + Tremelimumab (Original Cohort)	Participants received durvalumab 1500 mg + tremelimumab 75 mg via intravenous (IV) infusion every 4 weeks (q4w), starting on Week 0, for up to a total of 4 months (4 cycles) followed by durvalumab monotherapy 1500 mg via IV infusion q4w, starting on Week 16 until confirmed progressive disease (PD), or other discontinuation criteria.
Arm A: Durvalumab + Tremelimumab (Expansion Cohort)	Participants received durvalumab 1500 mg + tremelimumab 75 mg via intravenous (IV) infusion every 4 weeks (q4w), starting on Week 0, for up to a total of 4 months (4 cycles) followed by durvalumab monotherapy 1500 mg via IV infusion q4w, starting on Week 16 until confirmed PD, or other discontinuation criteria.
Arm B: Adavosertib + Carboplatin	Participants orally received adavosertib 225 mg twice daily (BID) for 2.5 days from Day 1 + carboplatin area under the curve (AUC) 5 Day 1 IV, every 3 weeks (q3w).
Arm C: Ceralasertib (AZD6738) + Olaparib	Participants orally received ceralasertib 160 mg once daily (QD) Days 1 to 7 + olaparib 300 mg BID Days 1 to 28, q4w.

Other Adverse Events

Arm A: Durvalumab + Tremelimumab (Original Cohort)

Arm A: Durvalumab + Tremelimumab (Expansion Cohort)

Arm B: Adavosertib + Carboplatin

Arm C: Ceralasertib (AZD6738) + Olaparib

Total, other (not including serious) adverse events

# participants affected / at risk

14/21 (66.67%)

16/20 (80.00%)

8/10 (80.00%)

13/21 (61.90%)

Blood and lymphatic system disorders

Anaemia¹

# participants affected / at risk

1/21 (4.76%)

1/20 (5.00%)

3/10 (30.00%)

11/21 (52.38%)

# events

Respiratory, thoracic and mediastinal disorders

Cough¹

# participants affected / at risk

3/21 (14.29%)

4/20 (20.00%)

0/10 (0.00%)

1/21 (4.76%)

# events

Gastrointestinal disorders

Diarrhoea¹

# participants affected / at risk

2/21 (9.52%)

3/20 (15.00%)

7/10 (70.00%)

1/21 (4.76%)

# events

Respiratory, thoracic and mediastinal disorders

Dyspnoea¹

# participants affected / at risk

6/21 (28.57%)

0/20 (0.00%)

0/10 (0.00%)

2/21 (9.52%)

# events

General disorders

Fatigue¹

# participants affected / at risk

5/21 (23.81%)

1/20 (5.00%)

3/10 (30.00%)

1/21 (4.76%)

# events

Metabolism and nutrition disorders

Decreased appetite¹

# participants affected / at risk

1/21 (4.76%)

3/20 (15.00%)

2/10 (20.00%)

1/21 (4.76%)

# events

Endocrine disorders

Hyperthyroidism¹

# participants affected / at risk

2/21 (9.52%)

2/20 (10.00%)

0/10 (0.00%)

0/21 (0.00%)

# events

Endocrine disorders

Hypothyroidism¹

# participants affected / at risk

1/21 (4.76%)

3/20 (15.00%)

0/10 (0.00%)

0/21 (0.00%)

# events

Psychiatric disorders

Insomnia¹

# participants affected / at risk

0/21 (0.00%)

4/20 (20.00%)

0/10 (0.00%)

1/21 (4.76%)

# events

General disorders

Asthenia¹

# participants affected / at risk

1/21 (4.76%)

2/20 (10.00%)

3/10 (30.00%)

1/21 (4.76%)

# events

Infections and infestations

Nasopharyngitis¹

# participants affected / at risk

1/21 (4.76%)

2/20 (10.00%)

0/10 (0.00%)

0/21 (0.00%)

# events

Gastrointestinal disorders

Nausea¹

# participants affected / at risk

0/21 (0.00%)

3/20 (15.00%)

6/10 (60.00%)

3/21 (14.29%)

# events

Musculoskeletal and connective tissue disorders

Pain in extremity¹

# participants affected / at risk

2/21 (9.52%)

1/20 (5.00%)

0/10 (0.00%)

0/21 (0.00%)

# events

Skin and subcutaneous tissue disorders

Rash¹

# participants affected / at risk

3/21 (14.29%)

0/20 (0.00%)

0/10 (0.00%)

0/21 (0.00%)

# events

Blood and lymphatic system disorders

Thrombocytopenia¹

# participants affected / at risk

0/21 (0.00%)

1/20 (5.00%)

7/10 (70.00%)

1/21 (4.76%)

# events

Blood and lymphatic system disorders

Neutropenia¹

# participants affected / at risk

0/21 (0.00%)

2/20 (10.00%)

3/10 (30.00%)

0/21 (0.00%)

# events

Gastrointestinal disorders

Vomiting¹

# participants affected / at risk

0/21 (0.00%)

1/20 (5.00%)

3/10 (30.00%)

3/21 (14.29%)

# events

Nervous system disorders

Headache¹

# participants affected / at risk

1/21 (4.76%)

1/20 (5.00%)

2/10 (20.00%)

0/21 (0.00%)

# events

Psychiatric disorders

Anxiety¹

# participants affected / at risk

0/21 (0.00%)

0/20 (0.00%)

1/10 (10.00%)

0/21 (0.00%)

# events

Investigations

Blood creatinine increased¹

# participants affected / at risk

0/21 (0.00%)

0/20 (0.00%)

1/10 (10.00%)

0/21 (0.00%)

# events

Psychiatric disorders

Depressed mood¹

# participants affected / at risk

0/21 (0.00%)

0/20 (0.00%)

1/10 (10.00%)

1/21 (4.76%)

# events

Gastrointestinal disorders

Gastrooesophageal reflux disease¹

# participants affected / at risk

0/21 (0.00%)

0/20 (0.00%)

1/10 (10.00%)

0/21 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Groin pain¹

# participants affected / at risk

0/21 (0.00%)

0/20 (0.00%)

1/10 (10.00%)

0/21 (0.00%)

# events

Hepatobiliary disorders

Hyperbilirubinaemia¹

# participants affected / at risk

0/21 (0.00%)

0/20 (0.00%)

1/10 (10.00%)

0/21 (0.00%)

# events

Metabolism and nutrition disorders

Hyperchloraemia¹

# participants affected / at risk

0/21 (0.00%)

0/20 (0.00%)

1/10 (10.00%)

0/21 (0.00%)

# events

Metabolism and nutrition disorders

Hyperglycaemia¹

# participants affected / at risk

1/21 (4.76%)

1/20 (5.00%)

1/10 (10.00%)

0/21 (0.00%)

# events

Metabolism and nutrition disorders

Hypomagnesaemia¹

# participants affected / at risk

0/21 (0.00%)

1/20 (5.00%)

1/10 (10.00%)

0/21 (0.00%)

# events

Blood and lymphatic system disorders

Leukopenia¹

# participants affected / at risk

0/21 (0.00%)

0/20 (0.00%)

1/10 (10.00%)

0/21 (0.00%)

# events

Nervous system disorders

Lumbosacral radiculopathy¹

# participants affected / at risk

0/21 (0.00%)

0/20 (0.00%)

1/10 (10.00%)

0/21 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Muscular weakness¹

# participants affected / at risk

0/21 (0.00%)

0/20 (0.00%)

1/10 (10.00%)

0/21 (0.00%)

# events

Renal and urinary disorders

Nephritis¹

# participants affected / at risk

0/21 (0.00%)

0/20 (0.00%)

1/10 (10.00%)

0/21 (0.00%)

# events

Nervous system disorders

Peripheral sensory neuropathy¹

# participants affected / at risk

0/21 (0.00%)

0/20 (0.00%)

1/10 (10.00%)

0/21 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Productive cough¹

# participants affected / at risk

0/21 (0.00%)

0/20 (0.00%)

1/10 (10.00%)

0/21 (0.00%)

# events

General disorders

Pyrexia¹

# participants affected / at risk

0/21 (0.00%)

1/20 (5.00%)

1/10 (10.00%)

3/21 (14.29%)

# events

Infections and infestations

Respiratory tract infection viral¹

# participants affected / at risk

2/21 (9.52%)

0/20 (0.00%)

1/10 (10.00%)

0/21 (0.00%)

# events

Injury, poisoning and procedural complications

Rib fracture¹

# participants affected / at risk

0/21 (0.00%)

0/20 (0.00%)

1/10 (10.00%)

0/21 (0.00%)

# events

Nervous system disorders

Somnolence¹

# participants affected / at risk

0/21 (0.00%)

1/20 (5.00%)

1/10 (10.00%)

0/21 (0.00%)

# events

Injury, poisoning and procedural complications

Fall¹

# participants affected / at risk

0/21 (0.00%)

1/20 (5.00%)

0/10 (0.00%)

0/21 (0.00%)

# events

Investigations

Platelet count decreased¹

# participants affected / at risk

0/21 (0.00%)

0/20 (0.00%)

0/10 (0.00%)

2/21 (9.52%)

# events

Musculoskeletal and connective tissue disorders

Musculoskeletal pain¹

# participants affected / at risk

0/21 (0.00%)

2/20 (10.00%)

0/10 (0.00%)

2/21 (9.52%)

# events

Respiratory, thoracic and mediastinal disorders

Pleural effusion¹

# participants affected / at risk

2/21 (9.52%)

0/20 (0.00%)

0/10 (0.00%)

0/21 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Dysphonia¹

# participants affected / at risk

1/21 (4.76%)

1/20 (5.00%)

0/10 (0.00%)

1/21 (4.76%)

# events

Respiratory, thoracic and mediastinal disorders

Bronchial hyperreactivity¹

# participants affected / at risk

0/21 (0.00%)

1/20 (5.00%)

0/10 (0.00%)

0/21 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Dry throat¹

# participants affected / at risk

0/21 (0.00%)

1/20 (5.00%)

0/10 (0.00%)

0/21 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Epistaxis¹

# participants affected / at risk

0/21 (0.00%)

1/20 (5.00%)

0/10 (0.00%)

0/21 (0.00%)

# events

Infections and infestations

Bronchitis¹

# participants affected / at risk

2/21 (9.52%)

0/20 (0.00%)

0/10 (0.00%)

1/21 (4.76%)

# events

Respiratory, thoracic and mediastinal disorders

Influenza¹

# participants affected / at risk

2/21 (9.52%)

0/20 (0.00%)

0/10 (0.00%)

0/21 (0.00%)

# events

Infections and infestations

Conjunctivitis¹

# participants affected / at risk

0/21 (0.00%)

1/20 (5.00%)

0/10 (0.00%)

0/21 (0.00%)

# events

Infections and infestations

Oral candidiasis¹

# participants affected / at risk

0/21 (0.00%)

2/20 (10.00%)

0/10 (0.00%)

0/21 (0.00%)

# events

Infections and infestations

Influenza¹

# participants affected / at risk

2/21 (9.52%)

0/20 (0.00%)

0/10 (0.00%)

0/21 (0.00%)

# events

Infections and infestations

Gastroenteritis¹

# participants affected / at risk

0/21 (0.00%)

1/20 (5.00%)

0/10 (0.00%)

0/21 (0.00%)

# events

General disorders

Pain¹

# participants affected / at risk

0/21 (0.00%)

1/20 (5.00%)

0/10 (0.00%)

0/21 (0.00%)

# events

Metabolism and nutrition disorders

Type 2 diabetes mellitus¹

# participants affected / at risk

2/21 (9.52%)

0/20 (0.00%)

0/10 (0.00%)

0/21 (0.00%)

# events

Metabolism and nutrition disorders

Hyponatraemia¹

# participants affected / at risk

0/21 (0.00%)

2/20 (10.00%)

0/10 (0.00%)

0/21 (0.00%)

# events

Metabolism and nutrition disorders

Hypophosphataemia¹

# participants affected / at risk

0/21 (0.00%)

1/20 (5.00%)

0/10 (0.00%)

0/21 (0.00%)

# events

Gastrointestinal disorders

Constipation¹

# participants affected / at risk

1/21 (4.76%)

1/20 (5.00%)

0/10 (0.00%)

1/21 (4.76%)

# events

Gastrointestinal disorders

Abdominal pain¹

# participants affected / at risk

0/21 (0.00%)

1/20 (5.00%)

0/10 (0.00%)

1/21 (4.76%)

# events

Gastrointestinal disorders

Dry mouth¹

# participants affected / at risk

0/21 (0.00%)

1/20 (5.00%)

0/10 (0.00%)

0/21 (0.00%)

# events

Gastrointestinal disorders

Dysphagia¹

# participants affected / at risk

0/21 (0.00%)

1/20 (5.00%)

0/10 (0.00%)

0/21 (0.00%)

# events

Skin and subcutaneous tissue disorders

Pruritus¹

# participants affected / at risk

2/21 (9.52%)

0/20 (0.00%)

0/10 (0.00%)

0/21 (0.00%)

# events

Skin and subcutaneous tissue disorders

Skin induration¹

# participants affected / at risk

0/21 (0.00%)

1/20 (5.00%)

0/10 (0.00%)

0/21 (0.00%)

# events

Nervous system disorders

Peripheral motor neuropathy¹

# participants affected / at risk

2/21 (9.52%)

0/20 (0.00%)

0/10 (0.00%)

0/21 (0.00%)

# events

Nervous system disorders

Peripheral sensorimotor neuropathy¹

# participants affected / at risk

0/21 (0.00%)

1/20 (5.00%)

0/10 (0.00%)

0/21 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Arthralgia¹

# participants affected / at risk

1/21 (4.76%)

1/20 (5.00%)

0/10 (0.00%)

0/21 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Osteoarthritis¹

# participants affected / at risk

0/21 (0.00%)

1/20 (5.00%)

0/10 (0.00%)

0/21 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Psoriatic arthropathy¹

# participants affected / at risk

0/21 (0.00%)

1/20 (5.00%)

0/10 (0.00%)

0/21 (0.00%)

# events

Blood and lymphatic system disorders

Febrile neutropenia¹

# participants affected / at risk

0/21 (0.00%)

1/20 (5.00%)

0/10 (0.00%)

0/21 (0.00%)

# events

Investigations

Lipase increased¹

# participants affected / at risk

1/21 (4.76%)

1/20 (5.00%)

0/10 (0.00%)

0/21 (0.00%)

# events

Investigations

Blood lactate dehydrogenase increased¹

# participants affected / at risk

0/21 (0.00%)

1/20 (5.00%)

0/10 (0.00%)

0/21 (0.00%)

# events

Investigations

Blood pressure increased¹

# participants affected / at risk

0/21 (0.00%)

1/20 (5.00%)

0/10 (0.00%)

0/21 (0.00%)

# events

Psychiatric disorders

Confusional state¹

# participants affected / at risk

0/21 (0.00%)

1/20 (5.00%)

0/10 (0.00%)

0/21 (0.00%)

# events

Psychiatric disorders

Depression¹

# participants affected / at risk

0/21 (0.00%)

1/20 (5.00%)

0/10 (0.00%)

0/21 (0.00%)

# events

Eye disorders

Cataract¹

# participants affected / at risk

0/21 (0.00%)

1/20 (5.00%)

0/10 (0.00%)

0/21 (0.00%)

# events

Ear and labyrinth disorders

Vertigo¹

# participants affected / at risk

0/21 (0.00%)

1/20 (5.00%)

0/10 (0.00%)

0/21 (0.00%)

# events

Vascular disorders

Hypertension¹

# participants affected / at risk

0/21 (0.00%)

1/20 (5.00%)

0/10 (0.00%)

0/21 (0.00%)

# events

Renal and urinary disorders

Urinary hesitation¹

# participants affected / at risk

0/21 (0.00%)

1/20 (5.00%)

0/10 (0.00%)

0/21 (0.00%)

# events

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA version 23.0

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days . The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Study results are Sponsor’s intellectual property and PIs cannot present or publish results without prior Sponsor approval.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact

Name/Title:	Global Clinical Lead
Organization:	AstraZeneca Clinical Study Information Center
Phone	1-877-240-9479
E-mail:	[email protected]

Documents available

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CSR Synopsis
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Trial Results Summaries
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Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Contact Backup

AstraZeneca Cancer Study Locator Service

1-877-400-4656

AstraZeneca@emergingmed.com

Investigators

Principal Investigator

Haiyi Jiang

AstraZeneca

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

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CSR Synopsis

Trial Results Summaries

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