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Clinical Trial Details

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Brief Title Lung-MAP: Biomarker-Targeted Second-Line Therapy in Treating Patients With Recurrent Stage IV Squamous Cell Lung Cancer
Official Title A Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer (Lung-MAP)
Principal Investigator Vokes, Everett
Brief Summary 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" (S1400). 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 a "non-match" sub-study which will include all screened patients not eligible for any of the biomarker-driven sub-studies. This sub-study will compare a non-match therapy to standard of care also with the goal of approval.
Gender Both
Ages 18 Years
Enrollment 10000
Accepts Healthy Volunteers No
Lead Sponsor Southwest Oncology GroupOther
Collaborator National Cancer Institute (NCI)NIH
Study Design Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Study Phase Phase 2/Phase 3
Study Type Interventional
Contact Name Francisco Robert
Contact Phone 1-855-702-8222 (adult trials) or 1-773-702-6808 (pediatric trials)
Condition Recurrent Squamous Cell Lung Carcinoma
Detail for Health Professional (on clinicaltrials.gov)
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