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

NCT04303780

CompletedPhase 3

Sponsor: Amgen

Conditions: KRAS p, G12c Mutated /Advanced Metastatic NSCLC

Interventions: AMG 510, Docetaxel

Countries: United States, Australia, Belgium, Brazil, Canada, Denmark, Finland, France

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

Eligibility overview

Sex: ALL

Age: 18 Years to 100 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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
Locations (274)
  • Anaheim, California, United States
  • Duarte, California, United States
  • Long Beach, California, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Sacramento, California, United States
  • Santa Barbara, California, United States
  • Stanford, California, United States
  • Torrance, California, United States
  • Denver, Colorado, United States
  • Norwalk, Connecticut, United States
  • Newark, Delaware, United States
  • Washington D.C., District of Columbia, United States
  • Fort Myers, Florida, United States
  • Hollywood, Florida, United States
  • St. Petersburg, Florida, United States
  • Tallahassee, Florida, United States
  • Atlanta, Georgia, United States
  • Atlanta, Georgia, United States
  • North Chicago, Illinois, United States
  • Fort Wayne, Indiana, United States
  • Shreveport, Louisiana, United States
  • Clinton, Maryland, United States
  • Lowell, Massachusetts, United States
  • Ann Arbor, Michigan, United States
  • Grand Rapids, Michigan, United States
  • Minneapolis, Minnesota, United States
  • Kansas City, Missouri, United States
  • Las Vegas, Nevada, United States
  • Florham Park, New Jersey, United States
  • + 244 more on CT.gov