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)
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)
Fase: Phase II-III clinical trials
Struttura Principale: Oncologia Medica Toraco-Polmonare
Farmaco: Sotorasib, Pembrolizumab, Carboplatino, Pemetrexed
Patologie: Lung cancer
ClinicalTrials.gov: Read the details about clinical trials
PI: Dr. Giuseppe Lo Russo
This is a study aimed at evaluating the efficacy and safety of sotorasib in combination with carboplatin and pemetrexed compared to pembrolizumab in combination with carboplatin and pemetrexed in subjects with stage IV or stage IIIB/C advanced non-squamous NSCLC, negative for PD-L1 and positive for the p.G12C mutation of KRAS.
The study includes 4 periods:
1) pre-screening
2) screening,
3) treatment within one of the 2 groups:
- Experimental: Sotorasib + Carboplatin + Pemetrexed
- Control: Pembrolizumab + Carboplatin + Pemetrexed
4) post-treatment
Last update: 20/05/2025