Phase 3 Study Comparing MRTX849 (Adagrasib) and Docetaxel for Advanced Non-Small Cell Lung Cancer with KRAS G12C Mutation

Sponsor: Mirati Therapeutics Inc.

Sponsor score: 40

ClinicalTrials ID:NCT04685135

This clinical trial is testing a new drug, MRTX849 (adagrasib), against the standard chemotherapy drug, docetaxel, in patients with advanced non-small cell lung cancer (NSCLC) that has a specific genetic mutation called KRAS G12C.

Patient Parameters

Program Overview

The purpose of this Phase 3 study is to compare the effectiveness of a new investigational drug, MRTX849 (adagrasib), with the standard chemotherapy drug, docetaxel, in patients who have advanced non-small cell lung cancer (NSCLC) with a KRAS G12C mutation. This study is for patients who have already received treatment for their metastatic cancer.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of non-small cell lung cancer (NSCLC) with a KRAS G12C mutation.
  • Be eligible to receive treatment with the chemotherapy drug docetaxel.

Crossover Inclusion Criteria:

  • Show disease progression as defined by specific medical criteria after receiving docetaxel.
  • Have an ECOG performance status score between 0 and 2, indicating full activity or some restriction in physically strenuous activities.

Exclusion Criteria

  • Have previously been treated with any drug targeting the KRAS G12C mutation, such as AMG 510 or Sotorasib.
  • Have active cancer that has spread to the brain.

Crossover Exclusion Criteria:

  • Have received any other systemic cancer treatment after the last dose of docetaxel in the study.

Locations

FACILITYZIPCITYSTATE
Local Institution - 012-89890703CerritosCalifornia
City of Hope - Duarte (Main Campus)91010DuarteCalifornia
Local Institution - 012-898 D91204GlendaleCalifornia
Local Institution - 012-910-A92648Huntington BeachCalifornia
Local Institution - 012-910-C92618IrvineCalifornia
City Of Hope90808Long BeachCalifornia
Local Institution - 012-910-F90813Long BeachCalifornia
Local Institution - 012-910-D92663Newport BeachCalifornia
Local Institution - 012-898 C92705Santa AnaCalifornia
Providence Medical Group - Santa Rosa95403Santa RosaCalifornia

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