Study identifier:D6186C00001
ClinicalTrials.gov identifier:NCT03944772
EudraCT identifier:2018-003974-29
CTIS identifier:2023-504624-25-00
A biomarker-directed Phase 2 Platform Study in Patients with Advanced Non-Small Lung Cancer whose Disease Has Progressed on First-Line Osimertinib Therapy.
Non-small Cell Lung Cancer
Phase 2
No
Osimertinib, Savolitinib, Gefitinib, Necitumumab, Durvalumab, Carboplatin, Pemetrexed, Alectinib, Selpercatinib, Selumetinib, Etoposide, Cisplatin, Datopotamab deruxtecan
All
247
Interventional
18 Years - 130 Years
Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Dec 2024 by AstraZeneca
AstraZeneca
-
Phase 2 Platform Study in Patients with Advanced Non-Small Lung Cancer who progressed on First-Line Osimertinib Therapy. This study is modular in design, allowing evaluation of the efficacy, safety and tolerability of multiple study treatments.
This is an open-label, multicentre, multi-drug, biomarker-directed Phase 2 platform study in patients with advanced non-small cell lung cancer (NSCLC) harbouring an epidermal growth factor receptor (EGFR)-sensitizing mutation whose disease has progressed on first-line monotherapy with osimertinib.Treatment options for these patients are limited. Novel treatments for these patients are urgently required. This study is modular in design, allowing evaluation of the efficacy, safety and tolerability of multiple study treatments.
Location
Location
New York, NY, United States, 10017
Location
Seoul, Republic of Korea, 03722
Location
seoul, Republic of Korea, 06351
Location
Houston, TX, United States, 77030
Location
Seoul, Republic of Korea, 05505
Location
Seongnam-si, Republic of Korea, 13620
Location
Fukuoka-shi, Japan, 812-8582
Location
Osaka-shi, Japan, 541-8567
Arms | Assigned Interventions |
---|---|
Experimental: Module 1: Osimertinib + Savolitinib The patients in this group will receive osimertinib taken in combination with savolitinib | Drug: Osimertinib Osimertinib given orally at 80 mg once daily Other Name: TAGRISSO Drug: Savolitinib Savolitinib will be given orally at 300 mg or 600mg once daily |
Experimental: Module 2: Osimertinib + Gefitinib The patients in this group will receive osimertinib taken in combination with gefitinib | Drug: Osimertinib Osimertinib given orally at 80 mg once daily Other Name: TAGRISSO Drug: Gefitinib Gefitinib given orally at 250 mg once daily Other Name: Iressa |
Experimental: Module 3: Osimertinib + Necitumumab The patients in this group will receive osimertinib taken in combination with necitumumab | Drug: Osimertinib Osimertinib given orally at 80 mg once daily Other Name: TAGRISSO Drug: Necitumumab Necitumumab given IV at 800 mg on Day 1 and Day 8 of every 3-week cycle Other Name: Portrazza |
Experimental: Module 4: Carboplatin + Pemetrexed + Durvalumab) The patients in this group will receive platinum-containing doublet (carboplatin + pemetrexed) taken in combination with durvalumab. | Drug: Durvalumab Durvalumab given IV at 1500 mg on Day 1 of every cycle Other Name: IMFINZI Drug: Carboplatin Carboplatin given IV on Day 1 of every 21-day cycle for up to 6 cycles Drug: Pemetrexed Pemetrexed given IV at 500 mg/m2 body BSA on Day 1 of every cycle |
No Intervention: Observational Cohort: No study drug Patients in this group will not receive study treatment but receive further anticancer care (Standard of Care therapy or other experimental therapies) or supportive care, as clinically indicated, in accordance with local practice. With Group C, the aim is to understand the clinical course and/or outcome for the overall clinical population after progression on first-line monotherapy with osimertinib. | - |
Experimental: Module 5: Osimertinib + Alectinib The patients in this group will receive osimertinib taken in combination with alectinib | Drug: Osimertinib Osimertinib given orally at 80 mg once daily Other Name: TAGRISSO Drug: Alectinib Alectinib given orally at 600mg twice daily and for Japanese patients at 300mg twice daily. Other Name: Alecensa |
Experimental: Module 6: Osimertinib + Selpercatinib The patients in this group will receive osimertinib taken in combination with selpercatinib | Drug: Osimertinib Osimertinib given orally at 80 mg once daily Other Name: TAGRISSO Drug: Selpercatinib Selpercatinib given orally at 160mg twice daily Other Name: Loxo-292, Retevmo, Retsevmo |
Experimental: Module 7: Etoposide + Durvalumab + Carboplatin or Cisplatin The patients in this group will receive platinum-containing doublet (etoposide + carboplatin or cisplatin) taken in combination with durvalumab. | Drug: Durvalumab Durvalumab given IV at 1500 mg on Day 1 of every cycle Other Name: IMFINZI Drug: Carboplatin Carboplatin given IV on Day 1 of every 21-day cycle for up to 6 cycles Drug: Etoposide Etoposide 80-100 mg/m2 given IV on day 1, 2 and 3 of every 21-day cycle for up to 4 cycles. Drug: Cisplatin Cisplatin 75-80 mg/m2 given IV on days 1 of each cycle |
Experimental: Module 8: Osimertinib + Pemetrexed + Carboplatin or Cisplatin. The patients in this group will receive Osimertinib plus platinum-containing doublet (pemetrexed + carboplatin or cisplatin). | Drug: Osimertinib Osimertinib given orally at 80 mg once daily Other Name: TAGRISSO Drug: Carboplatin Carboplatin given IV on Day 1 of every 21-day cycle for up to 6 cycles Drug: Pemetrexed Pemetrexed given IV at 500 mg/m2 body BSA on Day 1 of every cycle Drug: Cisplatin Cisplatin 75-80 mg/m2 given IV on days 1 of each cycle |
Experimental: Module 9: Osimertinib + Selumetinib The patients in this group will receive osimertinib taken in combination with selumetinib | Drug: Osimertinib Osimertinib given orally at 80 mg once daily Other Name: TAGRISSO Drug: Selumetinib Selumetinib given orally at 75 mg twice daily for 4 days, followed by 3 days off treatment Other Name: Koselugo |
Experimental: Module 10: Osimertinib + datopotamab deruxtecan The patients in this group will receive osimertinib taken in combination with datopotamab deruxtecan. | Drug: Osimertinib Osimertinib given orally at 80 mg once daily Other Name: TAGRISSO Drug: Datopotamab deruxtecan Datopotamab deruxtecan given IV at 4 or 6 mg/kg on Day 1 of every 3-week cycle. Other Name: Datopotamab deruxtecan Other Name: DS 1062a |
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