S1400, "Phase II/III Biomarker-Driven Master Protocol for Second Line Therapy of Squamous Cell Lung Cancer (Screening Step) Lung-MAP Sub-Study” (CTRC #14-0036)
Sherri Cervantez M.D.
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About This Study
This is a prospective, multi-sub-study randomized Phase 11/111 master registration protocol, in which patients with advanced stage lung SCCA (2d line therapy), are randomized to biomarker driven targeted therapy (TT) or SoC as shown in the schema. Each sub-study is defined by a genotypically defined alteration (biomarker) in the tumor and a drug (or drug combination) that targets it. Each sub-study will function autonomously and will open and close independently of the other sub-studies. The candidate drugs must have demonstrated biologic activity against the target associated with a proposed predictive biomarker(s). Drug combinations in the experimental arm will be allowed in appropriate settings and where appropriate the control arm may consist of FDA approved targeted therapy such as erlotinib. Archival formalin-fixed paraffin embedded (FFPE) tumor will be screened by a broad analytically validated testing next generation sequencing (NGS) platform centrally to establish eligibility within 10-14 days. This platform will be supplemented by individual immune-histochemical (IHC) protein assays performed in a CLIA setting as necessitated by the specific experimental agent used. Core needle biopsies for fresh tumor tissue may be necessary when archival tumor tissue is not available or on a drug-biomarker-specific basis.