A study of novel anti-cancer agents in patients with previously untreated NSCLC - MAGELLAN
Study identifier:D933IC00001
ClinicalTrials.gov identifier:NCT03819465
EudraCT identifier:2018-001748-74
CTIS identifier:N/A
Recruitment Complete
Official Title
A Phase IB, Open-Label, Multi-Center Study to Determine the Efficacy and Safety of Durvalumab and/or Novel Oncology Therapies, With or Without Chemotherapy, for First-Line Stage IV Non-Small Cell Lung Cancer (NSCLC) (MAGELLAN)
Medical condition
Metastatic Non-Small Cell Lung Cancer (NSCLC)
Phase
Phase 1
Healthy volunteers
No
Study drug
Durvalumab, Durvalumab, Durvalumab, Durvalumab, Durvalumab, Durvalumab, Danvatirsen, Danvatirsen, Oleclumab, Oleclumab, MEDI5752, MEDI5752, Pemetrexed, Pemetrexed, Pemetrexed, Pemetrexed, Carboplatin, Carboplatin, Carboplatin, Carboplatin, Gemcitabine, Gemcitabine, Gemcitabine, Cisplatin, Cisplatin, Cisplatin, Cisplatin, Nab-paclitaxel, Nab-paclitaxel, Nab-paclitaxel, AZD2936, AZD2936
Sex
All
Actual enrollment
175
Study type
Interventional
Age
18 Years - 130 Years
Date
Study Start Date: 27 Dec 2018
Estimated Primary Completion Date: 23 May 2023
Estimated Study Completion Date: 23 May 2023
Study design
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verification:
Verified 01 May 2023 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: A1 Durvalumab | Drug: Durvalumab Durvalumab IV Cohort A: Every 4 weeks (q4w) Cohort B: Every 3 weeks (q3w) for the first 4 cycles, then every 4 weeks (q4w) starting at Cycle 5 Day 1 Other Name: MEDI4736 |
| Experimental: A2 Durvalumab + danvatirsen | Drug: Durvalumab Durvalumab IV Cohort A: Every 4 weeks (q4w) Cohort B: Every 3 weeks (q3w) for the first 4 cycles, then every 4 weeks (q4w) starting at Cycle 5 Day 1 Other Name: MEDI4736 Drug: Danvatirsen Danvatirsen IV Loading dose Cycle 1 Day 1, Cycle 1 Day 3, and Cycle 1 Day 5 then once a week (q1w) starting at Cycle 1 Day 8 Other Name: AZD9150 |
| Experimental: A3 Durvalumab + oleclumab | Drug: Durvalumab Durvalumab IV Cohort A: Every 4 weeks (q4w) Cohort B: Every 3 weeks (q3w) for the first 4 cycles, then every 4 weeks (q4w) starting at Cycle 5 Day 1 Other Name: MEDI4736 Drug: Oleclumab Oleclumab IV Cohort A: Every 2 weeks (q2w) for first 2 cycles, then every 4 weeks (q4w) starting at Cycle 3 Day 1 Cohort B: Every 3 weeks (q3w) for the first 4 cycles, then every 4 weeks (q4w) starting at Cycle 5 Day 1 Other Name: MEDI9447 |
| Experimental: A4 MEDI5752 | Drug: MEDI5752 MEDI5752 IV Every 3 weeks (q3w) Other Name: MEDI5752 |
| Experimental: B1 Durvalumab + Investigator’s choice of chemotherapy | Drug: Durvalumab Durvalumab IV Cohort A: Every 4 weeks (q4w) Cohort B: Every 3 weeks (q3w) for the first 4 cycles, then every 4 weeks (q4w) starting at Cycle 5 Day 1 Other Name: MEDI4736 Drug: Pemetrexed Pemetrexed IV Day 1 of each 21-day cycle Arm B1: Day 1 of each 21-day cycle for the first 4 cycles then either every 3 weeks (q3w) or every 4 weeks (q4w) (per investigator discretion) thereafter Arm B2 and B3: Day 1 of each 21-day cycle for the first 4 cycles then Day 1 of each 28-day cycle (q4w) thereafter Arm B5: Day 1 of each 21-day cycle throughout the study Drug: Carboplatin Carboplatin IV Day 1 of each 21-day cycle Drug: Gemcitabine Gemcitabine IV Days 1 and 8 of each 21-day cycle Drug: Cisplatin Cisplatin IV Day 1 of each 21-day cycle Drug: Nab-paclitaxel Nab-paclitaxel IV Days 1, 8, and 15 of each 21-day cycle |
| Experimental: B2 Durvalumab + Investigator's choice of chemotherapy + danvatirsen | Drug: Durvalumab Durvalumab IV Cohort A: Every 4 weeks (q4w) Cohort B: Every 3 weeks (q3w) for the first 4 cycles, then every 4 weeks (q4w) starting at Cycle 5 Day 1 Other Name: MEDI4736 Drug: Danvatirsen Danvatirsen IV Loading dose Cycle 1 Day 1, Cycle 1 Day 3, and Cycle 1 Day 5 then once a week (q1w) starting at Cycle 1 Day 8 Other Name: AZD9150 Drug: Pemetrexed Pemetrexed IV Day 1 of each 21-day cycle Arm B1: Day 1 of each 21-day cycle for the first 4 cycles then either every 3 weeks (q3w) or every 4 weeks (q4w) (per investigator discretion) thereafter Arm B2 and B3: Day 1 of each 21-day cycle for the first 4 cycles then Day 1 of each 28-day cycle (q4w) thereafter Arm B5: Day 1 of each 21-day cycle throughout the study Drug: Carboplatin Carboplatin IV Day 1 of each 21-day cycle Drug: Gemcitabine Gemcitabine IV Days 1 and 8 of each 21-day cycle Drug: Cisplatin Cisplatin IV Day 1 of each 21-day cycle Drug: Nab-paclitaxel Nab-paclitaxel IV Days 1, 8, and 15 of each 21-day cycle |
| Experimental: B3 Durvalumab + investigator's choice of chemotherapy + oleclumab | Drug: Durvalumab Durvalumab IV Cohort A: Every 4 weeks (q4w) Cohort B: Every 3 weeks (q3w) for the first 4 cycles, then every 4 weeks (q4w) starting at Cycle 5 Day 1 Other Name: MEDI4736 Drug: Oleclumab Oleclumab IV Cohort A: Every 2 weeks (q2w) for first 2 cycles, then every 4 weeks (q4w) starting at Cycle 3 Day 1 Cohort B: Every 3 weeks (q3w) for the first 4 cycles, then every 4 weeks (q4w) starting at Cycle 5 Day 1 Other Name: MEDI9447 Drug: Pemetrexed Pemetrexed IV Day 1 of each 21-day cycle Arm B1: Day 1 of each 21-day cycle for the first 4 cycles then either every 3 weeks (q3w) or every 4 weeks (q4w) (per investigator discretion) thereafter Arm B2 and B3: Day 1 of each 21-day cycle for the first 4 cycles then Day 1 of each 28-day cycle (q4w) thereafter Arm B5: Day 1 of each 21-day cycle throughout the study Drug: Carboplatin Carboplatin IV Day 1 of each 21-day cycle Drug: Gemcitabine Gemcitabine IV Days 1 and 8 of each 21-day cycle Drug: Cisplatin Cisplatin IV Day 1 of each 21-day cycle Drug: Nab-paclitaxel Nab-paclitaxel IV Days 1, 8, and 15 of each 21-day cycle |
| Experimental: B4 MEDI5752 | Drug: MEDI5752 MEDI5752 IV Every 3 weeks (q3w) Other Name: MEDI5752 |
| Experimental: A5 AZD2936 | Drug: AZD2936 AZD2936 IV Other Name: AZD2936 |
| Experimental: B5 AZD2936 + chemotherapy | Drug: Pemetrexed Pemetrexed IV Day 1 of each 21-day cycle Arm B1: Day 1 of each 21-day cycle for the first 4 cycles then either every 3 weeks (q3w) or every 4 weeks (q4w) (per investigator discretion) thereafter Arm B2 and B3: Day 1 of each 21-day cycle for the first 4 cycles then Day 1 of each 28-day cycle (q4w) thereafter Arm B5: Day 1 of each 21-day cycle throughout the study Drug: Carboplatin Carboplatin IV Day 1 of each 21-day cycle Drug: Cisplatin Cisplatin IV Day 1 of each 21-day cycle Drug: AZD2936 AZD2936 IV Other Name: AZD2936 |
Contacts
Investigators
Principal Investigator
Sandip Patel
UCSD Morres Cancer Center
