A Study of Novel Anti-cancer Agents in Patients With Previously Untreated NSCLC
MAGELLAN
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)
2 other identifiers
interventional
175
9 countries
41
Brief Summary
This study is designed 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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Dec 2018
Longer than P75 for phase_1
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 13, 2018
CompletedStudy Start
First participant enrolled
December 27, 2018
CompletedFirst Posted
Study publicly available on registry
January 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 23, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 26, 2026
CompletedFebruary 11, 2026
February 1, 2026
4.4 years
December 13, 2018
February 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assessment of AEs by CTCAE v5.0
Assessment of safety and tolerability of each treatment arm
From informed consent until the safety follow-up visit 3 months after the last dose of study drug, or until the final data cut-off (DCO) date, whichever is earlier.
Secondary Outcomes (6)
Objective Response Rate (ORR)
Tumor assessments every 6-9 weeks until week 48-54, then every 12 or 18 weeks, depending on treatment arm until the earliest of radiological progression, death, withdrawal of consent, or final DCO (approximately 4 months after last patient randomized).
Duration of Response (DoR)
Tumor assessments every 6-9 weeks until week 48-54, then every 12 or 18 weeks, depending on treatment arm until the earliest of radiological progression, death, withdrawal of consent, or final DCO (approximately 4 months after last patient randomized).
Progression Free Survival (PFS)
Tumor assessments every 6-9 weeks until week 48-54, then every 12/18 weeks based on arm until progression, death, withdrawal or final DCO. Further PFS data will be collected until 6 months after last patient dosed or final DCO
Overall Survival (OS)
OS data will be collected until death, 6 months after last patient dosed, or the final DCO date, whichever is earlier.
Blood concentration of durvalumab and novel oncology therapies
From Cycle 1 Day 1 until Cycle 6/7 Day 1 (21-28-day cycles) depending on arm, then every 3 cycles (except for Arms A5 & B5), at end of treatment (Arms A4 & B4, A5 & B5 only), and until 3 months following treatment discontinuation, or the final DCO date.
- +1 more secondary outcomes
Study Arms (10)
A1
EXPERIMENTALDurvalumab
A2
EXPERIMENTALDurvalumab + danvatirsen
A3
EXPERIMENTALDurvalumab + oleclumab
A4
EXPERIMENTALMEDI5752
B1
EXPERIMENTALDurvalumab + Investigator's choice of chemotherapy
B2
EXPERIMENTALDurvalumab + Investigator's choice of chemotherapy + danvatirsen
B3
EXPERIMENTALDurvalumab + investigator's choice of chemotherapy + oleclumab
B4
EXPERIMENTALMEDI5752
A5
EXPERIMENTALAZD2936
B5
EXPERIMENTALAZD2936 + chemotherapy
Interventions
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
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
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
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
Eligibility Criteria
You may qualify if:
- Histologically or cytologically documented Stage IV NSCLC not amenable to curative surgery or radiation
- No prior chemotherapy or any other systemic therapy for metastatic NSCLC
- Prior platinum-containing adjuvant, neoadjuvant, or definitive chemoradiation for advanced disease are eligible, if progression has occurred \>12 months from end of last therapy
- Known tumor PD-L1 status
- Tumors that lack activating EGFR mutations and ALK fusions or documented local test result for any other known genomic alteration for which a targeted therapy is approved in first line per local standard of care
- WHO/ECOG status at 0 or 1 at enrollment
- Life expectancy of at least 12 weeks
- Troponin I or T ≤ ULN (per institutional guidelines)
You may not qualify if:
- Active or prior documented autoimmune or inflammatory disorders
- History of active primary immunodeficiency
- Any prior chemotherapy or any other systemic therapy for metastatic NSCLC
- Untreated CNS metastases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (41)
Research Site
Iowa City, Iowa, 52242, United States
Research Site
Pittsburgh, Pennsylvania, 15212, United States
Research Site
Nashville, Tennessee, 37203, United States
Research Site
Salzburg, 5020, Austria
Research Site
Vienna, 1140, Austria
Research Site
Edegem, 2650, Belgium
Research Site
Bialystok, 15-027, Poland
Research Site
Bydgoszcz, 85-796, Poland
Research Site
Gdansk, 80-214, Poland
Research Site
Grudziądz, 86-300, Poland
Research Site
Lodz, 90-302, Poland
Research Site
Olsztyn, 10-357, Poland
Research Site
Tomaszów Mazowiecki, 97-200, Poland
Research Site
Warsaw, 02-781, Poland
Research Site
Wroclaw, 53-413, Poland
Research Site
Krasnoyarsk, 660133, Russia
Research Site
Moscow, 115478, Russia
Research Site
Saint Petersburg, 191014, Russia
Research Site
Saint Petersburg, 197758, Russia
Research Site
Cheongju-si, 28644, South Korea
Research Site
Seoul, 03722, South Korea
Research Site
Seoul, 05505, South Korea
Research Site
Seoul, 06351, South Korea
Research Site
Seoul, 110-744, South Korea
Research Site
Barcelona, 08025, Spain
Research Site
Barcelona, 8003, Spain
Research Site
Madrid, 28034, Spain
Research Site
Madrid, 28041, Spain
Research Site
Seville, 41013, Spain
Research Site
Kaohsiung City, 807, Taiwan
Research Site
Taichung, 402, Taiwan
Research Site
Taichung, 40705, Taiwan
Research Site
Tainan, 70403, Taiwan
Research Site
Taipei, 10002, Taiwan
Research Site
Taipei, 112, Taiwan
Research Site
Taipei, 235, Taiwan
Research Site
Taoyuan District, 333, Taiwan
Research Site
Bangkok, 10330, Thailand
Research Site
Bangkok, 10700, Thailand
Research Site
Chiang Mai, 50200, Thailand
Research Site
Hat Yai, 90110, Thailand
Related Publications (1)
Cho BC, Charoentum C, Kim DW, Yang CT, Dziadziuszko R, Geater SL, Mann H, Afshar-Imani B, Lyfar P, Yang JC, Patel SP. MAGELLAN arms B1 and B3: Durvalumab plus chemotherapy with and without oleclumab in treatment-naive metastatic non-small-cell lung cancer. Lung Cancer. 2026 Jan;211:108834. doi: 10.1016/j.lungcan.2025.108834. Epub 2025 Nov 7.
PMID: 41380462DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sandip Patel, MD
UCSD Morres Cancer Center
- PRINCIPAL INVESTIGATOR
Chih-Hsin Yang, MD
National Taiwan University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 13, 2018
First Posted
January 28, 2019
Study Start
December 27, 2018
Primary Completion
May 23, 2023
Study Completion
March 26, 2026
Last Updated
February 11, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.