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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

Status
Active
Cancer Type
Lung Cancer
Trial Phase
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT04933695
Protocol IDs
20190288 (primary)
NCI-2021-12590
2021-002638-18
Study Sponsor
Amgen, Inc.

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.

Eligibility

  1. Adult (= or > 18 years old) with NSCLC
  2. Untreated Stage IV metastatic disease. Participants who received adjuvant or neoadjuvant anti-tumor therapy are eligible if the adjuvant/neoadjuvant therapy was completed greater than 12 months prior to the development of metastatic stage IV disease
  3. Pathologically documented metastatic NSCLC with KRAS G12C mutation (local confirmation)
  4. Programmed death-ligand 1 (PD-L1) TPS Score < 1% and/or serine/threonine kinase 11 (STK11) co-mutation (local confirmation)
  5. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
  6. No active brain metastases
  7. Measurable disease per investigator interpretation using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
**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.
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Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.