CompletedPhase 3NCT04303780
Official study title

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

Study summary

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

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedAMG 510 and Docetaxel

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · KRAS · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 22, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 3

Interventional

Where is it offered?274 U.S. locations

Locations may change over time.

Who runs it?Amgen

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 3
Sponsor
Amgen
Interventions being studied
Drug: AMG 510; Drug: Docetaxel
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
Reasons someone may not be able to joinExclusion criteria
  • Active brain metastases
  • Myocardial infarction within 6 months of study day 1
  • Gastrointestinal (GI) tract disease causing the inability to take oral medication

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Pacific Cancer Medical Center IncAnaheim, California
  • City of Hope National Medical CenterDuarte, California
  • Pacific Shores Medical Group Long BeachLong Beach, California
  • University of California Los AngelesLos Angeles, California
  • University of California Los AngelesLos Angeles, California
  • University of California at Davis Medical CenterSacramento, California
  • Ridley Tree Cancer CenterSanta Barbara, California
  • University of California San Francisco Mission HallStanford, California
  • Harbor University of California Los Angeles Medical CenterTorrance, California
  • Rocky Mountain Cancer CentersDenver, Colorado
  • Danbury HospitalNorwalk, Connecticut
  • Medical Oncology Hematology Consultants Helen F Graham Cancer CenterNewark, Delaware

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 22, 2026. Always confirm current availability with the study team.

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