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A Phase 2, Multicenter, Open-label Study of Sotorasib (AMG 510) in Subjects with Stage IV NSCLC Whose Tumors Harbor a KRASG12C Mutation in Need of First-Line Treatment (CodeBreaK 201)

Approved WMOWill not start

Primary- To evaluate the tumor objective response rate (ORR) assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria in subjects who receive sotorasib at either 960 mg daily (QD) or 240 mg QD whose tumors are PD-L1 Tumor…

A Phase 1b, Master Protocol Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Sotorasib (AMG 510) in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)

Approved WMORecruiting

This study has been transitioned to CTIS with ID 2023-506794-35-00 check the CTIS register for the current data. - Primary Objective:To evaluate the safety and tolerability of investigational regimens of sotorasib in adult subjects with KRAS p.G12C…