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

Completed · Phase 3

Conditions studied: KRAS p, G12c Mutated /Advanced Metastatic NSCLC

In brief

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

Key facts

Study ID

NCT04303780

Run by

Amgen

People needed

345

Starts

2020-06-04

Expected to finish

2026-06-24

Last updated by the study team

2026-07-22

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Active brain metastases
• Myocardial infarction within 6 months of study day 1
• Gastrointestinal (GI) tract disease causing the inability to take oral medication

Where it is running

• City of Hope National Medical Center — Duarte, California, United States
• Pacific Shores Medical Group Long Beach — Long Beach, California, United States
• University of California Los Angeles — Los Angeles, California, United States
• University of California Los Angeles — Los Angeles, California, United States
• University of California at Davis Medical Center — Sacramento, California, United States
• Ridley Tree Cancer Center — Santa Barbara, California, United States
• University of California San Francisco Mission Hall — Stanford, California, United States
• Harbor University of California Los Angeles Medical Center — Torrance, California, United States
• Rocky Mountain Cancer Centers — Denver, Colorado, United States
• Danbury Hospital — Norwalk, Connecticut, United States
• Medical Oncology Hematology Consultants Helen F Graham Cancer Center — Newark, Delaware, United States
• Washington Cancer Institute at MedStar Washington Hospital — Washington D.C., District of Columbia, United States
• Florida Cancer Specialists - Fort Myers — Fort Myers, Florida, United States
• Memorial Regional Hospital — Hollywood, Florida, United States
• Florida Cancer Specialists Research North — St. Petersburg, Florida, United States
• Florida Cancer Specialists Research Panhandle — Tallahassee, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Northside Hospital, Incorporated — Atlanta, Georgia, United States
• Affiliated Oncologists, LLC — North Chicago, Illinois, United States
• Fort Wayne Medical Oncology and Hematology — Fort Wayne, Indiana, United States
• Willis Knighton Cancer Center — Shreveport, Louisiana, United States
• Maryland Oncology Hematology PA — Clinton, Maryland, United States
• New York Cancer and Blood Specialists — Lowell, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Pacific Cancer Medical Center Inc — Anaheim, California, United States

Full record on ClinicalTrials.gov

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