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)

Brief description of study

The purpose of the study is to determine the anti-tumor effect (safety and tolerability) of sotorasib monotherapy in subjects with metastatic non-small cell lung cancer (NSCLC). We also want to find out the pharmacokinetics (PK) of sotorasib following administration as an oral tablet formulation. The study drug sotorasib is investigational, which means that it has not been approved by the U.S Food and Drug Administration (FDA), the health authority that gives approval for new medicines to be prescribed in the United States, but the FDA has given its permission to test this combination in the current trial.

Clinical Study Identifier: s19-01962
ClinicalTrials.gov Identifier: NCT04933695

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