S1400: Phase II/III Biomarker-Driven Master Protocol for Second Line Therapy of Squamous Cell Lung Cancer
The purpose of this study screening step is to perform tests on genes and proteins produced by genes in your tumor sample for certain features that investigational targeted agents used in this study are specifically designed to work against. Then the purpose is to assign you to a treatment sub-study that is chosen based on the results (genes and proteins called “biomarkers”) of this genetic testing on your tumor sample. These study related “research tests” will be done in a special lab. The system of assigning a treatment sub-study based on biomarker testing of cancer is investigational; in squamous cell lung cancer patients, we don’t know whether testing can identify patients who will or will not benefit from treatment. The purpose of the treatment part of this study is to compare the effects, good and bad, of these investigational agents to the usual approach to treating your type of cancer.
Study phase: II
Study phase (if other): III
Basic eligibility criteria:
Please contact the study coordinator for additional eligibility information.
Patients must have pathologically proven squamous cell carcinoma (SCCA) cancer of the lung confirmed by tumor biopsy and/or fine-needle aspiration.
Patients must have progressed after receiving a platinum-based chemotherapy regimen.
Patients must have adequate tumor tissue available,
Patients must not have a known EGFR mutation or ALK fusion.
Patients must be ? 18 years of age.
Patients must be willing to provide prior smoking history
Primary disease category: Cancer
Sponsor: Southwest Oncology Group (SWOG)
Protocol number: S1400
Projected enrollment dates: April 2015 to May 2022
Official study title: S1400: Phase II/III Biomarker-Driven Master Protocol for Second Line Therapy of Squamous Cell Lung Cancer