Parikh AB, et al. - Researchers in this single-arm phase II trial evaluated the use of metformin with chemotherapy in advanced non-small cell lung cancer (NSCLC). Findings showed that for advanced NSCLC, adding metformin to chemotherapy was safe but did not significantly improve clinical outcomes compared to historical phase III controls.

Methods

• Patients were administered carboplatin AUC 5 + pemetrexed 500 mg/m² IV every 21 days for 4 cycles.
• Patients achieving at least stable disease were administered maintenance pemetrexed until progression or toxicity.
• In this study, patients received metformin at 1000 mg/day for week 1, 1500 mg/day for week 2, then 2000 mg/day thereafter, in divided doses.
• Progression-free survival (PFS) was assessed as the primary endpoint.
• Secondary endpoints included overall survival (OS), objective response rate (ORR), disease control rate (DCR), duration of response (DOR), and adverse events (AE).
• Researchers tested tumor tissue for LKB1/STK11 mutations, and assessed non-fasting serum insulin levels longitudinally.

Results

• Out of 50 planned patients, researchers included 14 patients.
• ORR of 23% and median PFS of 3.9 months were observed.
• Median OS of 11.7 months was evident.
• They identified no LKB1/STK11 mutations.
• Fatigue (42.9%), anemia, and nausea (28.6% each) were identified as the most common AE.
• In this study, the most common grade III AE identified was nausea (14.3%).
• They noticed no grade IV AE.
• Metformin treatment was provided for a mean duration of 5.6 months.