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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: Active

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 molecular testing

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
San Francisco
UCSF Medical Center-Mission Bay
Status: APPROVED
Contact: UCSF Clinical Trials
Phone: 877-827-3222

Trial Phase Phase III

Trial Type Treatment

Lead Organization
Amgen, Inc.

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