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Trial NCT04613596

Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7

Phase
Phase 2/3
Sponsor
Mirati Therapeutics Inc.
Conditions
Advanced Non-Small Cell Lung Cancer; Metastatic Non-Small Cell Lung Cancer
Ages
18+ years
View on ClinicalTrials.gov ↗

Eligibility criteria

Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).

Inclusion Criteria: * Phase 2: Histologically confirmed diagnosis of unresectable or metastatic NSCLC with KRAS G12C mutation and any PD-L1 TPS * Phase 3: Histologically confirmed diagnosis of unresectable or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS>=50% * Phase 3: Presence of measurable disease per RECIST1.1 * Phase 3: CNS Inclusion - Based on screening brain imaging, patients must have one of the following: 1. No evidence of brain metastases 2. Untreated brain metastases not needing immediate local therapy 3. Previously treated brain metastases not needing immediate local therapy Exclusion Criteria: * Phase 2 and Phase 3: Prior systemic treatment for locally advanced or metastatic NSCLC including chemotherapy, immune checkpoint inhibitor therapy, or a therapy targeting KRAS G12C mutation (e.g., AMG 510). * Phase 2: Active brain metastases * Phase 3: Patients with known central nervous system (CNS) lesions must not have any of the following: 1. Any untreated brain lesions > 2.0 cm in sizeBrain metastases 2. Any brainstem lesions 3. Ongoing use of systemic corticosteroids for control of symptoms of brain lesions at a total daily dose of > 10 mg of prednisone (or equivalent) prior to randomization. 4. Have poorly controlled (> 1/week) generalized or complex partial seizures, or manifest neurologic progression due to brain lesions notwithstanding CNS-directed therapy * Phase 3: Radiation to the lung > 30 Gy within 6 months prior to the first dose of study treatment

Restrictions found (1)

  • Brain metastasesOutrightexclusion

    untreated brain lesion > 2.0 cm

    Show in the text

Recruiting in Massachusetts

  • Dana-Farber Cancer Institute · Boston, Suffolk County
  • Dana-Farber Cancer Institute at St. Elizabeths Medical Center · Brighton, Suffolk County
  • Brigham and Womens/Mass General Health Care Center at Foxborough · Foxborough, Norfolk County
  • Dana-Farber Cancer Institute - Merrimack Valley · Methuen, Essex County
  • Dana-Farber Brigham and Womens Cancer Center at Milford Regional · Milford, Worcester County
  • Dana-Farber Brigham Cancer Center at South Shore Health · South Weymouth, Norfolk County