NCT03851445

Lung-MAP: A Master Screening Protocol for Previously-Treated Non-Small Cell Lung Cancer

Recruiting now Phase 2, PHASE3 Last updated 5 December 2025

What this trial tests

Phase 2, PHASE3 trial testing Screening Platform in Previously Treated Non-Small Cell Lung Cancer in 10,000 participants. Currently enrolling.

Timeline

6 February 2019

Primary endpoint
28 January 2029

28 January 2029

Quick facts

Lead sponsor	SWOG Cancer Research Network
Phase	Phase 2, PHASE3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	screening
Enrollment	10,000
Start date	6 February 2019
Primary completion	28 January 2029
Estimated completion	28 January 2029
Sites	1201 locations across United States

Drugs / interventions tested

• Screening Platform — full drug profile →

Conditions studied

• Previously Treated Non-Small Cell Lung Cancer — all drugs for Previously Treated Non-Small Cell Lung Cancer →

Sponsor

SWOG Cancer Research Network

Who can join

18 and older, any sex, with Previously Treated Non-Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This screening and multi-sub-study randomized phase II/III trial will establish a method for genomic screening of similar large cancer populations followed by assigning and accruing simultaneously to a multi-sub-study hybrid Master Protocol (Lung-MAP). The type of cancer trait (biomarker) will determine to which sub-study, within this protocol, a participant will be assigned to compare new targeted cancer therapy, designed to block the growth and spread of cancer, or combinations to standard of care therapy with the ultimate goal of being able to approve new targeted therapies in this setting. In addition, the protocol includes non-match sub-studies which will include all screened patients not eligible for any of the biomarker-driven sub-studies.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Phase II Randomized Study of Ramucirumab and Pembrolizumab Versus Standard of Care in Advanced Non-Small-Cell Lung Cancer Previously Treated With Immunotherapy-Lung-MAP S1800A.
   Reckamp KL, Redman MW, Dragnev KH, Minichiello K, et al · · 2022 · cited 173× · PMID 35658002 · DOI 10.1200/jco.22.00912
2. An overview of precision oncology basket and umbrella trials for clinicians.
   Park JJH, Hsu G, Siden EG, Thorlund K, et al · · 2020 · cited 144× · PMID 32031692 · DOI 10.3322/caac.21600
3. National Cancer Institute Basket/Umbrella Clinical Trials: MATCH, LungMAP, and Beyond.
   Chen AP, Eljanne M, Harris L, Malik S, et al · · 2019 · cited 18× · PMID 31335391 · DOI 10.1097/ppo.0000000000000389
4. Design and analysis of umbrella trials: Where do we stand?
   Ouma LO, Wason JMS, Zheng H, Wilson N, et al · · 2022 · cited 16× · PMID 36313987 · DOI 10.3389/fmed.2022.1037439
5. Moving Beyond the Momentum: Innovative Approaches to Clinical Trial Implementation.
   Eng C, Chen EY, Rogers J, Lewis M, et al · · 2021 · cited 8× · PMID 33534616 · DOI 10.1200/op.20.00701
6. Approach for reporting master protocol study designs on ClinicalTrials.gov: qualitative analysis.
   Williams RJ, Dobbins HD, Tse T, Chon SD, et al · · 2022 · cited 4× · PMID 35688481 · DOI 10.1136/bmj-2021-067745
7. Clinical benefits of precision medicine in treating solid cancers: European Society of Medical Oncology-Magnitude of Clinical Benefit Scale score-based analysis.
   Hibino Y, Ito M, Satake T, Kondo S. · · 2021 · cited 4× · PMID 34118770 · DOI 10.1016/j.esmoop.2021.100187
8. Representativeness of Patients Enrolled in the Lung Cancer Master Protocol (Lung-MAP).
   Vaidya R, Unger JM, Qian L, Qian L, et al · · 2023 · cited 2× · PMID 37677122 · DOI 10.1200/po.23.00218