Full Title
A Phase 3, Multicenter, Randomized, Open-label Study Evaluating Efficacy of Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Subjects With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers, Negative for PD-L1, and Positive for KRAS p.G12C (CodeBreaK 202)Purpose
Researchers want to see if adding sotorasib to standard therapy improves the treatment of lung cancer. The people in this study have advanced non-small cell lung cancer (NSCLC) with a G12C mutation in the KRAS gene.
Sotorasib is designed to block the KRASG12C protein and slow the growth of cancer cells. It is taken orally (by mouth).
Doctors routinely treat NSCLC with KRASG12C mutations using platinum-based chemotherapy (carboplatin and pemetrexed) plus pembrolizumab immunotherapy. These medications are given intravenously (by vein). Doctors hope that giving sotorasib with platinum-based chemotherapy works better than the standard treatment.
If you join this study, you will be randomly assigned to get one of these treatments:
- Sotorasib plus carboplatin and pemetrexed
- Standard treatment with pembrolizumab plus carboplatin and pemetrexed
Who Can Join
To join this study, there are a few conditions. You must:
- Have advanced NSCLC that has the KRASG12C mutation and has not yet been treated with chemotherapy.
- Have not received anti-cancer treatment for at least 6 months before the lung cancer spread.
- Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
- Be age 18 or older.
Contact
For more information or to see if you can join this study, please call Dr. Kathryn Arbour’s office at 646-608-3792.