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Randomized Phase II Trial of Concurrent Chemoradiotherapy +/- Metformin HCL in Locally Advanced NSCLC

Primary Objective To determine whether MET added to chemoradiotherapy can improve progression-free survival (PFS) in patients with locally advanced NSCLC Secondary Objectives Determine the effects of MET on overall survival (OS), time to local-regional progression (LRP), and time to distant metastasis (DM); Evaluate the effect of MET on chemoradiotherapy toxicity (CTCAE, v. 4) within 1 year of completion of all treatment; Collect biospecimens to develop biomarkers of MET activity: Investigate potential serum biomarkers of MET response: serum MET levels, insulin and lipid levels; Evaluate MET activity on peripheral blood cells (in a subset of patients); Investigate potential tumor biomarkers of MET response: tumor NSCLC histology and tumor mutational status (TP53, STK11 [LKB], K-RAS).

Primary Objective To determine whether MET added to chemoradiotherapy can improve progression-free survival (PFS) in patients with locally advanced NSCLC Secondary Objectives Determine the effects of MET on overall survival (OS), time to local-regional progression (LRP), and time to distant metastasis (DM); Evaluate the effect of MET on chemoradiotherapy toxicity (CTCAE, v. 4) within 1 year of completion of all treatment; Collect biospecimens to develop biomarkers of MET activity: Investigate potential serum biomarkers of MET response: serum MET levels, insulin and lipid levels; Evaluate MET activity on peripheral blood cells (in a subset of patients); Investigate potential tumor biomarkers of MET response: tumor NSCLC histology and tumor mutational status (TP53, STK11 [LKB], K-RAS).