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No longer recruiting (closed or complete)Last updated: 2 February 2024

CodeBreak 200: This phase III trial is comparing a new cancer drug with a standard form of chemotherapy for the treatment of non-small cell lung cancerA 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

Trial purpose

Medical clipboardCancer treatment

Tumor type

Lung Cancers Lung cancer

Age

People18 - 100

Trial acronym

CodeBreak 200

Clinical summary

Summary

Eligible patients will be randomised to receive AMG 510 or docetaxel over a 21-day cycle.

Conditions

This trial is treating people with non-small cell lung cancer

Eligibility

Inclusion

  • 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

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

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

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No longer recruiting (closed or complete) hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

AMGEN

Scientific 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

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