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Lung-MAP 2015 — biomarker-driven master protocol

One-paragraph summary

Lung-MAP (SWOG S1400) was designed as a national biomarker-driven master protocol for previously treated advanced squamous lung cancer. A common screening platform assigned patients to parallel genotype-matched substudies, with a non-match option for people lacking an actionable assignment. The design sought to reduce screening waste, share infrastructure, open and close arms efficiently, and make a genomically fragmented disease experimentally tractable.

Design logic

Conventional problem Lung-MAP response
Each rare target requires a separate screening trial One molecular-screening protocol feeds multiple arms
Repeated biopsies and consent consume time/tissue Common infrastructure and shared eligibility
Control standards evolve Modular substudy replacement and amendment
Biomarker-negative patients are stranded Non-match immunotherapy/standard pathway
Negative studies disappear Protocol-level record preserves arm history

Key contributions

  • Established feasibility of a large public–private master protocol in community and academic sites.
  • Centered LUSC at a time when most precision-oncology infrastructure favored adenocarcinoma.
  • Made biomarker prevalence, screen failure, tissue adequacy, and assignment rate explicit operational outcomes.
  • Created reusable governance for multiple sponsors and assays.

Limitations and lessons

  • A platform improves testing efficiency; it cannot make a weak target biologically valid.
  • Rare subgroups still accrue slowly, and target definitions can change during the study.
  • A common control may age as immunotherapy and other standards change.
  • Expansion beyond a purely squamous population improves reach but can dilute histology-specific inference.
  • Molecular assignment is only the first attrition point: clinical decline, travel, organ function, prior therapy, and cohort slots determine actual treatment.

Why it matters

Lung-MAP is the field's answer to the TCGA problem: many plausible, low-frequency alterations and no dominant driver. Its durable contribution may be experimental infrastructure and the disciplined documentation of negative target programs as much as any individual positive substudy.

Cited by wiki pages

  • Overview
  • Failed and frontier targets
  • Clinical-trials landscape

Verified citation

Herbst RS, et al. Lung Master Protocol (Lung-MAP)—a biomarker-driven protocol for accelerating development of therapies for squamous cell lung cancer: SWOG S1400. Clin Cancer Res. 2015;21:1514–1524. [PMID 25680375](https://pubmed.ncbi.nlm.nih.gov/25680375/){target="_blank" rel="noopener"}