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Lung CancerOpen to EnrollmentPhase 2

LUNG: NSCLC: 1st Line: KRAS G12C mt: KRYSTAL-7

A Phase 2 Trial of MRTX849 in Combination With Pembrolizumab in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation

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Study snapshot

Title
Mirati 847-007 (Lung 1st Line G12C)
Malignancy
Non small cell lung cancer (NSCLC)
Stage
Stage 4
Disease setting
Metastatic/Palliative
Line of therapy
1st Line
Investigational agent
MRTX849 (adagrasib), Pembrolizumab
Drug class
KRAS G12C inhibitor, PD-1 inhibitor
Principal investigator
Jason Porter, MD
Sponsor
Mirati Therapeutics Inc.
Intervention arm
MRTX849 (adegrasib) + pembrolizumab
Path
Non-small cell lung cancer, KRAS G12C mutation
Randomized
No
ClinicalTrials.gov ID
NCT04613596

Eligibility and objectives

Key eligibility criteria details

  • Histologically confirmed diagnosis of metastatic or unresectable NSCLC (squamous or nonsquamous) not a candidate for definitive therapy
  • KRAS G12C mutation
  • Known PD-L1 status (can enroll regardless of level)
  • 1st line- no prior treatment for metastatic NSCLC
    • OK to have had radiosensitizing chemo >1 year prior
  • ECOG PS 0-1
  • Measurable disease
  • No active CNS mets
  • No XRT to the lungs within 6 months prior to first dose of study treatment
  • No known autimmune disease

Objective

  • Primary Outcome
    • ORR
  • Secondary Outcomes
    • Safety Tolerability
    • DOR
    • PK

Treatment details

LUNG: NSCLC: 1st Line: KRAS G12C mt: KRYSTAL-7 — West Cancer Center