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Gregory J. Riely, MD, PhD


CodeBreaK 201 Focuses on Sotorasib in First-Line Treatment of Stage IV NSCLC

By: Julia Fiederlein
Posted: Friday, July 15, 2022

Kathryn Cecilia Arbour, MD, of Memorial Sloan Kettering Cancer Center, New York, and colleagues are conducting the phase II CodeBreaK 201 trial to evaluate the efficacy and safety of first-line treatment with the small molecule KRAS G12C inhibitor sotorasib in patients with non–small cell lung cancer (NSCLC) whose tumors harbor KRAS G12C mutation and who may experience suboptimal outcomes with chemoimmunotherapy. The design of this global, open-label study was presented during the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract TPS9150).

“Sotorasib…is approved for the treatment of patients with locally advanced or metastatic KRAS G12C–mutated NSCLC following the failure of at least one prior line of systemic therapy,” the investigators commented. “[It] has previously demonstrated robust antitumor activity in subgroups of [patients with] KRAS G12C–mutant NSCLC who had a PD-L1 tumor proportion score [of less than] 1% and/or STK11 co-mutations.”

Approximately 170 patients with untreated KRAS G12C–mutated metastatic NSCLC who have a PD-L1 tumor proportion score of less than 1% and/or STK11 co-mutations will be administered 960 or 240 mg of sotorasib daily. They will be stratified based on their STK11 mutation status. Enrollment began in January 2022 and is ongoing.

Objective response was identified as the primary endpoint. The time to response, duration of response, disease control, progression-free survival, overall survival, safety and tolerability, and pharmacokinetic profile will be assessed as secondary endpoints.

Disclosure: For full disclosures of the study authors, visit

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