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, Danvatirsen, Oleclumab, MEDI5752, Pemetrexed, Carboplatin, Gemcitabine, Cisplatin, Nab-paclitaxel, AZD2936
Sex
All
Actual Enrollment
175
Study type
Interventional
Age
18 Years - 130 Years
Date
Study Start Date: 27 Dec 2018
Primary Completion Date: 23 May 2023
Estimated Study Completion Date: 26 Mar 2026
Study design
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verification:
Verified 01 Oct 2024 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
