Clinical Trials

Sponsor: Amgen Inc.

Sponsor Study ID: 20190288

Study Title: 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)

NCT Number: NCT04933695

Phase: II

Protocol Type: Treatment

Age Group: Adult

Disease Sites: Lung

Study Objectives: The main objective of this study is to evaluate the tumor objective response rate (ORR) of sotorasib assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria in participants who receive sotorasib at either Dose A or a Dose B whose tumors are programmed death-ligand 1 (PD-L1) Tumor Proportion Score (TPS) < 1% and/or harbor a serine/threonine kinase 11 (STK11) co-mutation, in a subgroup of subjects with PD-L1 < 1% and in a subgroup of subjects with STK11 co-mutation.

For more information about the trial above please contact the study team:

Trial opened at the following institutions: Medical University of South Carolina

Study Documents
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