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Phase 3 Study of MRTX849 vs Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation

NCT04685135

Description:

This Phase 3 study will evaluate the efficacy of the investigational agent MRTX849 versus docetaxel in patients who have been previously treated for metastatic NSCLC with a KRAS G12C mutation.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Phase 3 Study of MRTX849 vs Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation
  • Official Title: A Randomized Phase 3 Study of MRTX849 Versus Docetaxel in Patients With Previously Treated Non-Small Cell Lung Cancer With KRAS G12C Mutation

Clinical Trial IDs

  • ORG STUDY ID: 849-012
  • NCT ID: NCT04685135

Conditions

  • Metastatic Non Small Cell Lung Cancer
  • Advanced Non Small Cell Lung Cancer

Interventions

DrugSynonymsArms
MRTX849MRTX849
DocetaxelTaxotereDocetaxel

Purpose

This Phase 3 study will evaluate the efficacy of the investigational agent MRTX849 versus docetaxel in patients who have been previously treated for metastatic NSCLC with a KRAS G12C mutation.

Trial Arms

NameTypeDescriptionInterventions
MRTX849Experimental
  • MRTX849
DocetaxelActive Comparator
  • Docetaxel

Eligibility Criteria

        Inclusion Criteria:

          -  Histologically or cytologically confirmed diagnosis of NSCLC with KRAS G12C mutation.

          -  Candidacy to receive treatment with docetaxel.

        Exclusion Criteria:

          -  Prior treatment with an agent targeting KRAS G12C (e.g., AMG 510).

          -  Active brain metastases.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall Survival (OS)
Time Frame:30 months
Safety Issue:
Description:Defined as time from date of randomization to date of death due to any cause.

Secondary Outcome Measures

Measure:Adverse Events
Time Frame:30 Months
Safety Issue:
Description:Defined as number of patients with treatment emergent AEs
Measure:Objective Response Rate (ORR)
Time Frame:30 Months
Safety Issue:
Description:Defined as the percent of patients documented to have a confirmed CR or PR.
Measure:Duration of Response (DOR)
Time Frame:30 Months
Safety Issue:
Description:Defined as the time from date of the first documentation of objective tumor response (CR or PR) to the first documentation of either Progression of Disease (PD) or death due to any cause, whichever occurs first.
Measure:Patient Reported Outcomes (PROs)
Time Frame:30 Months
Safety Issue:
Description:To be assessed by Lung Cancer Symptom Scale (LCSS).
Measure:Quality of LIfe Assessment
Time Frame:30 Months
Safety Issue:
Description:To be assessed by European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L).

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Mirati Therapeutics Inc.

Trial Keywords

  • KRAS G12C
  • Non-small cell lung cancer
  • NSCLC
  • Metastatic Cancer
  • Docetaxel
  • Phase 3 Clinical Trial

Last Updated

April 1, 2021