Study to Compare AMG 510 "Proposed INN Sotorasib" With Docetaxel in Non Small Cell Lung Cancer (NSCLC) (CodeBreak 200).

• Status: Active, not recruiting
• Trial end date: 2026-04-27
• Target enrollment: 0
• Participant gender: All

Summary

A Phase 3 Study to Compare AMG 510 with Docetaxel in Non Small Cell Lung Cancer (NSCLC) subjects with KRAS p. G12c mutation

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Docetaxel

Criteria

Inclusion Criteria:

• Men or women greater than or equal to 18 years old.

• ECOG ≤ 1

• Pathologically documented, previously treated, locally-advanced and unresectable or metastatic NSCLC with KRAS p.G12C mutation confirmed through central testing or have documentation of KRAS p.G12C mutation through Amgen Study 20190294 prior to enrollment

Exclusion Criteria:

• Active brain metastases

• Myocardial infarction within 6 months of study day 1

• Gastrointestinal (GI) tract disease causing the inability to take oral medication