Study identifier:D419QC00002
ClinicalTrials.gov identifier:NCT02937818
EudraCT identifier:2016-001202-42
CTIS identifier:N/A
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
Platinum Refractory Extensive-Stage Small Cell Lung Carcinoma
Phase 2
No
Durvalumab and Tremelimumab, AZD1775 and carboplatin (CBPT), AZD6738 and olaparib
All
72
Interventional
18 Years - 130 Years
Allocation: Non-randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verified 01 May 2024 by AstraZeneca
AstraZeneca
-
Study design This is a Phase II, open-label, multi-drug, multi-center, multi-arm, signal-searching study in patients with extensive-stage small-cell lung cancer (SCLC) who have refractory or resistant disease from prior platinum-based chemotherapy.
This study is modular in design, allowing evaluation of the preliminary efficacy, safety, tolerability, and immunogenicity of novel combinations of immunotherapies and/or deoxyribonucleic acid (DNA) damage repair inhibitors in patients with platinum refractory or resistant extensive-stage-disease SCLC. Patients who have progressive disease (PD) during first-line platinum-based chemotherapy (platinum refractory) or PD within 90 days after completing first-line platinum-based chemotherapy (platinum resistant) will be enrolled to the study. The primary objective of the study is to assess the preliminary efficacy of each treatment arm based on objective response rate (ORR). This study consists of a number of arms (sub-studies), each evaluating the efficacy, safety, and tolerability of a specific agent or combination. This study was initially open with 2 arms (Arms A and B), and additional arms may open, provided there is compelling rationale for the combination and safe and tolerable doses and schedules have been determined from ongoing Phase I studies. There are 2 pre-defined arms: A. Durvalumab + tremelimumab followed by durvalumab monotherapy B. AZD1775 + carboplatin (CBDP) Further arm was added in amendment 3: C. AZD6738 + olaparib Amendment #4 was updated with possibility to allow expansion of any arm, to a total of 40 eligible subjects, based on Review Committee assessment of data from the first 20 subjects (from Stage 1 and Stage 2). Currently Arm A will enroll 20 additional patients into expansion.
Location
Location
Miskolc, Hungary, 3529
Location
Székesfehérvár, Hungary, 8000
Location
Kecskemét, Hungary, 6000
Location
Sumy, Ukraine, 40022
Location
Ivano-Frankivsk, Ukraine, 76018
Location
Dnipro, Ukraine, 49102
Location
Valencia, Spain, 46009
Location
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 |
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