A Phase 3 Study Comparing Sotorasib Plus Platinum Doublet Chemotherapy Versus Pembrolizumab Plus Platinum Doublet Chemotherapy as Front-Line Therapy in Stage IV or Advanced Stage IIIBC Nonsquamous Non-Small Cell Lung Cancer Negative for PD-L1 and Positive for KRAS p.G12C

What this Trial Is About

Researchers are studying two combination treatments as front-line therapies for adults with stage IV or advanced stage IIIBC nonsquamous non-small cell lung cancer NSCLC that carries a KRAS p.G12C mutation and is negative for PD-L1. This phase 3 trial compares progression-free survival and overall survival in participants receiving either sotorasib with platinum doublet chemotherapy or pembrolizumab with platinum doublet chemotherapy. The goal is to evaluate which treatment combination may better manage this specific lung cancer type. Participants receive one of two treatment combinations sotorasib taken orally with carboplatin and pemetrexed, or pembrolizumab given intravenously with carboplatin and pemetrexed. These therapies are administered as front-line treatments. The study is randomized and open-label, meaning participants are assigned to a treatment group by chance and both participants and researchers know which treatment is given. During the study, participants will be monitored regularly for disease progression and survival over approximately 2.5 years. Additional assessments include quality-of-life questionnaires focusing on symptoms like dyspnea, cough, and chest pain, as well as physical function and global health status up to week 12. Safety is evaluated by tracking adverse events, vital signs, and laboratory test changes throughout the study, which may last up to about 5.5 years including follow-up. Participants receive care under medical supervision while contributing to important research on lung cancer treatment.

A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)