This study is in progress, not accepting new patients

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

a study on Non-Small Cell Lung Cancer Lung Cancer

Summary

Eligibility
for people ages 18-100 (full criteria)
Location
at Stanford, California and other locations
Dates
study started
completion around

Description

Summary

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

Official Title

A Phase 3 Multicenter, Randomized, Open Label, Active-controlled, Study of AMG 510 Versus Docetaxel for the Treatment of Previously Treated Locally Advanced and Unresectable or Metastatic NSCLC Subjects With Mutated KRAS p.G12C

Keywords

KRAS p, G12c Mutated /Advanced Metastatic NSCLC, Non-Small-Cell Lung Carcinoma, Docetaxel, Sotorasib, AMG 510

Eligibility

You can join if…

Open to people ages 18-100

  • 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 CAN'T join if...

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

Locations

  • UCSF Mission Hall
    Stanford California 94305 United States
  • University of California at Davis Medical Center
    Sacramento California 95817 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Amgen
Links
AmgenTrials clinical trials website
ID
NCT04303780
Phase
Phase 3 research study
Study Type
Interventional
Participants
About 345 people participating
Last Updated