Study ID: S1400
Phase 2/3 biomarker-driven master protocol for previously treated squamous cell lung cancer (LUNG-MAP)
This screening and multi-sub-study will establish a method for genomic screening of similar large cancer populations followed by assigning and accruing simultaneously to a multi-sub-study hybrid protocol. The participant’s type of cancer trait (biomarker) will determine to which sub-study, within this protocol, he or she will be assigned. The researchers’ intent is to compare new targeted cancer therapy designed to block the growth and spread of cancer, or combinations to standard-of-care therapy.
In addition, the protocol includes a non-match sub-study that 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.
- Mixed histologies are not allowed.
- Must have received at least one line of systemic therapy for any stage of disease (stages I-IV). One of these lines of therapy must have been a platinum-based chemo regimen and must have progressed following the most recent line of therapy. Stage I-III patients who received platinum-based chemo progression must have occurred within one year from receiving that therapy.
- Must have received at least one dose of cycle 1 of a first-line platinum-based chemotherapy regimen for stage IV disease. Patients are eligible upon receiving cycle 1, day 1 infusion.
- Patients with known EGFR mutations or ALK fusions are not eligible.
- Must have adequate tumor tissue (>20% tumor cells and > 0.2mm tumor volume).
- PS 0-1 within 28 days to registration.
To centrally test tumor for targeted therapy; will be eligible for one of the treatment studies (S1400- B, -C,–D, or –I).
- Must have been diagnosed with squamous cell lung cancer
- Must have previously received at least one line of systemic therapy for any stage of squamous cell lung cancer