Clinical Trials
Sponsor:
Sponsor Study ID:
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:
Adults
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.
Study Documents
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