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A Study of Sotorasib (AMG 510) in Participants With Stage IV NSCLC Whose Tumors Harbor a KRAS p.G12C Mutation in Need of First-line Treatment


Active: No
Cancer Type: Lung Cancer NCT ID: NCT04933695
Trial Phases: Phase II Protocol IDs: 20190288 (primary)
NCI-2021-12590
2021-002638-18
Eligibility: 18 Years and older, Male and Female Study Type: Treatment
Study Sponsor: Amgen, Inc.
NCI Full Details: http://clinicaltrials.gov/show/NCT04933695

Summary

The main objective of this study is to evaluate the tumor objective response rate (ORR)
assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria in
participants who receive sotorasib at either 960 mg daily or 240 mg daily 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 participants with PD-L1 < 1%
and in a subgroup of participants with STK11 co-mutation.
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.