Codebreak 202: This study is comparing the effectiveness of targeted therapy versus immunotherapy when given in addition to platinum chemotherapy in people with advanced non-small cell lung cancer who have not had prior treatment for their advanced diseaseA 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

Trial purpose

Cancer treatment

Tumor type

Lung cancer

Age

18 - 100

Trial acronym

Codebreak 202

Summary

You may be eligible for this study if you have non-squamous stage IV or advanced stage IIIB or IIIC non-small cell lung cancer with a KRAS p. G12C mutation, and negative PD-L1 expression. You should not have received any prior systemic anti-cancer treatment for your advanced or metastatic disease. Prior treatment for your cancer in an earlier stage is permitted.

Eligible participants will be randomly allocated (by chance) to one of two treatment arms. 

In Arm 1 (Experimental), participants will receive targeted therapy (called sotorasib) in combination with platinum chemotherapy (carboplatin and pemetrexed). 

In Arm 2 (Active Comparator), participants will receive immunotherapy (called pembrolizumab) in combination with platinum chemotherapy (carboplatin and pemetrexed). 

Conditions

This trial is treating people with non-squamous non-small cell lung cancer with KRAS p.G12c mutation and negative PD-L1 expression