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 UCLA UCSF
Dates
study started
estimated completion

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 Carcinoma, Non-Small-Cell Lung Docetaxel 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

  • Research Site accepting new patients
    Los Angeles California 90095-1772 United States
  • Research Site accepting new patients
    Los Angeles California 90095 United States
  • Research Site accepting new patients
    San Francisco California 94143 United States
  • Research Site accepting new patients
    Santa Monica California 90404 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Amgen
ID
NCT04303780
Phase
Phase 3
Study Type
Interventional
Last Updated