Status:
ACTIVE_NOT_RECRUITING
Study to Compare AMG 510 "Proposed INN Sotorasib" With Docetaxel in Non Small Cell Lung Cancer (NSCLC) (CodeBreak 200).
Lead Sponsor:
Amgen
Conditions:
KRAS p, G12c Mutated /Advanced Metastatic NSCLC
Eligibility:
All Genders
18-100 years
Phase:
PHASE3
Brief Summary
A Phase 3 Study to Compare AMG 510 with Docetaxel in Non Small Cell Lung Cancer (NSCLC) subjects with KRAS p. G12c mutation
Eligibility Criteria
Inclusion
- 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
- Active brain metastases
- Myocardial infarction within 6 months of study day 1
- Gastrointestinal (GI) tract disease causing the inability to take oral medication
Key Trial Info
Start Date :
June 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 25 2026
Estimated Enrollment :
345 Patients enrolled
Trial Details
Trial ID
NCT04303780
Start Date
June 4 2020
End Date
February 25 2026
Last Update
October 14 2025
Active Locations (274)
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1
Pacific Cancer Medical Center Inc
Anaheim, California, United States, 92801
2
City of Hope National Medical Center
Duarte, California, United States, 91010
3
Pacific Shores Medical Group Long Beach
Long Beach, California, United States, 90813
4
University of California Los Angeles
Los Angeles, California, United States, 90095-1772