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No longer recruiting (closed or complete)Last updated: 11 June 2024

KRYSTAL-12: This study is evaluating how effective targeted therapy (called adagrasib) is compared to chemotherapy (called docetaxel) in people with previously treated metastatic non-small cell lung cancer with a KRAS G12C mutationA Randomized Phase 3 Study of MRTX849 Versus Docetaxel in Patients With Previously Treated Non-Small Cell Lung Cancer With KRAS G12C Mutation

Trial purpose

Medical clipboardCancer treatment

Tumor type

Lung Cancers Lung cancer

Age

People18+

Trial acronym

KRYSTAL-12

Clinical summary

Summary

Eligible participants will be randomly allocated to one of two treatment arms. In Arm 1 (Experimental), participants will receive adagrasib. In Arm 2 (Active Comparator), participants will receive docetaxel.

Conditions

This trial is treating people with metastatic non-small cell lung cancer with a KRAS G12C mutation

Eligibility

Inclusion

  • Histologically or cytologically confirmed diagnosis of NSCLC with KRAS G12C mutation.
  • Candidacy to receive treatment with docetaxel.

Crossover Inclusion Criteria:

  • Evidence of RECIST 1.1 defined disease progression on docetaxel per BICR
  • ECOG performance status 0-2

Exclusion

  • Prior treatment with an agent targeting KRAS G12C (e.g., AMG 510, Sotorasib).
  • Active brain metastases.

Crossover Exclusion Criteria:

  • Receipt of any other systemic anti-cancer therapy after last administration of docetaxel on the study.

Inclusion

  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
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

Mirati Therapeutics Inc.

Scientific Title

A Randomized Phase 3 Study of MRTX849 Versus Docetaxel in Patients With Previously Treated Non-Small Cell Lung Cancer With KRAS G12C Mutation

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