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Closed (no longer recruiting)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

Clinical summary

Summary

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

Conditions

This trial is treating patients with non-small cell lung cancer.

Cancer

Lung Cancers Lung cancer

Age

People18 - 100

Phase

III

Trial Acronym

CodeBreak 200

More information

Trial Identifiers

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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

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.

Ask your doctor if this trial could be right for you.

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Closed hospitals

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Cancer Council Victoria would like to acknowledge the traditional custodians of the land on which we live and work. We would also like to pay respect to the elders past and present and extend that respect to all other Aboriginal people.