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

Trial Status: Closed to Accrual

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

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

California

Duarte
City of Hope Comprehensive Cancer Center
Status: IN_REVIEW
Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: IN_REVIEW
Contact: Lia Etheridge
Phone: 310-825-7174
Sacramento
University of California Davis Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
San Francisco
UCSF Medical Center-Mission Bay
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: UCSF Clinical Trials
Phone: 877-827-3222

District of Columbia

Washington
MedStar Washington Hospital Center
Status: ACTIVE

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: ACTIVE

Michigan

Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: ACTIVE

New York

Bronx
Montefiore Medical Center-Weiler Hospital
Status: ACTIVE

North Carolina

Winston-Salem
Wake Forest University Health Sciences
Status: CLOSED_TO_ACCRUAL

Texas

Houston
M D Anderson Cancer Center
Status: APPROVED

Trial Phase Phase III

Trial Type Treatment

Lead Organization
Amgen, Inc.

  • Primary ID 20190009
  • Secondary IDs NCI-2020-02976, 2019-003582-18, 2019‐003582‐18
  • Clinicaltrials.gov ID NCT04303780