NCT04933695

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

A Phase 2, Multicenter, Open-label Study of Sotorasib (AMG 510) in Subjects With Stage IV NSCLC Whose Tumors Harbor a KRAS G12C Mutation in Need of First-line Treatment (CodeBreaK 201)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Sotorasib	Oral tablet

Timeline

• Start date: 2022-01-28
• Primary completion: 2025-05-27
• Completion: 2025-05-27
• First posted: 2021-06-22
• Last updated: 2025-10-22

Locations

67 sites across 10 countries: United States, Belgium, Denmark, France, Germany, Italy, Netherlands, Spain, Sweden, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study