S1400: Lung-MAP, the Lung Master Protocol, coming soon
Lung-MAP Launch in San Francisco
An S1400 kickoff training session will take place at the spring group meeting in San Francisco on Friday, May 2, 6:00-7:30 pm, featuring brief presentations by study chairs, statisticians, data management staff, and more. This session will fulfill the training requirement you'll need to meet before you can enroll patients to S1400; you can attend in-person or complete the module online later. You'll leave the San Francisco session with the knowledge and tools to generate excitement about launching Lung-MAP at your institution!
Lung-MAP 101 (PDF)
SWOG S1400 -- the Lung Master Protocol, or Lung-MAP -- is expected to activate this spring. Given the trial framework and the unprecedented scope of collaboration behind it, this will be a landmark study from the day it launches.
Lung-MAP is a large scale, phase II/III screening/clinical registration protocol that will genomically screen patients with advanced stage lung squamous cell cancer moving to second-line therapy, and will use the screening results to direct each patient to the most appropriate one of five (or more) sub-studies. Patients on each sub-study will be randomized to either standard of care (docetaxel or erlotinib) or biomarker-driven targeted therapy with an investigational agent.
Each Lung-MAP sub-study is designed around a genotypically defined alteration in the tumor and a drug that targets it. Each sub-study will function autonomously, will open and close independently, and will be independently powered for overall survival (OS) with an interim analysis for progression-free survival (PFS) to determine whether to proceed from Phase II into Phase III. When an endpoint for a sub-study is met, that drug-biomarker specific combination may proceed to FDA for approval review of the new drug with its matching companion diagnostic. When an endpoint is not met, that sub-study will be closed and another modular sub-study of a different agent will be initiated.
SWOG's Lung-MAP partners
- National Cancer Institute's National Clinical Trials Network
- Foundation for the National Institutes of Health
- Friends of Cancer Research
- Foundation Medicine
- multiple lung cancer advocacy organizations
Patients with tumors that do not match a drug-biomarker combination will be assigned to a "non-match" sub-study and randomized to either treatment with a designated "non-match" drug (initially an immunotherapy agent targeting PD-L1) or standard of care.
Central genomic screening testing will be performed on archival fresh frozen paraffin-embedded (FFPE) tumor to establish biomarker status within 10-14 days of screening. S1400's five sub-studies are designed to accrue a total of 400-800 patients (from 500-1,000 screened) per year over at least two years.
Lung-MAP is the result of an unprecedented public-private collaboration between government, non-profit, and for-profit organizations. If this Master Protocol strategy is successful, it could serve as a prototype for drug registration in other settings.
An S1400 kickoff training session will take place at the spring group meeting in San Francisco on Friday, May 2, 6:00-7:30 pm, featuring brief presentations by study chairs, statisticians, data management staff, and more. You'll leave the session with the knowledge and tools to generate excitement about launching Lung-MAP at your institution.