Share Icon Health Study Area: Cardiovascular Disease Chevron Icon Health Study Area: Genitourinary For Patients Health Study Area: Lung Cancer Page Icon Phone Icon For Caregivers Health Study Area: AutoImmune Disease Health Study Area: Melanoma Location Icon Print YouTube Icon For Parents Health Study Area: Lung Cancer Print Created with Sketch. Help Icon Green Check Icon Search Icon Instagram Created with sketchtool. Direction Arrow Icon Error Icon For Parents Health Study Area: Blood Cancer Help Icon Health Study Area: NASH Gender Both Bookmark Icon Health Study Area: Melanoma Created with Sketch. Glossary Print Health Study Area: Blood Cancer Health Study Area: Genitourinary Health Study Area: Gastrointestinal Cancer Mobile Menu Icon Created with Sketch. Health Study Area: Cardiovascular Disease Health Study Area: Women's Cancer Communities Map Icon Created with Sketch. For Caregivers Health Study Area: Fibrosis Health Study Area: AutoImmune Disease FAQs Health Study Area: Head and Neck Cancer Created with Sketch. For Clinicians Chevron Right Icon Gender Female Health Study Area: Breast Cancer Direction Arrow Icon Gender Both Right Arrow Icon LinkedIn Icon Green Check Icon Gender Male Health Study Area: Fibrosis For Patients Twitter Icon Email Icon Facebook Icon Health Study Area: Gastrointestinal Cancer Health Study Area: Head and Neck Cancer For Clinicians External Link Icon
Søg Study Connect

Recruiting

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 - CA239-0009

Opdateret: 16 november, 2024   |   ClinicalTrials.gov

Udskriftsvenligt sammendrag

OVERVEJER DU DETTE FORSØG?
Udskriv denne side og forsøgsvejledningen som en hjælp til at tale med din læge.
Brug vejledningen til forsøgsdeltagere for at finde rundt i processen for deltagelse i et klinisk forsøg. Forstå de vigtigste faktorer, der skal overvejes, før du beslutter dig, og find spørgsmål, du kan stille dit sundhedsteam.

Forsøgsdetaljer

  • Phase 2/Phase 3

    Fase

  • Køn

  • 18+

    Aldersinterval

  • 265

    Beliggenhed(er)

  • Recruiting

Behandlingsmuligheder

Forsøgsgrene
TILDELT INTERVENTION
Experimental: Phase 2 Cohort 1a: PD-L1 TPS <1%
Drug: Adagrasib
Experimental: Phase 2 Cohort 1b: PD-L1 TPS <1%
Drug: Adagrasib
Experimental: Phase 2 Cohort 2: PD-L1 TPS ≥1%
Drug: Adagrasib
Experimental: Phase 3 Cohort 3 Investigational Arm
Drug: Adagrasib
Active Comparator: Phase 3 Cohort 4 Comparator Arm
Drug: Pembrolizumab

Primære egnethedskriterier

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 evaluable or measurable disease per RECIST - 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 > 1.0 cm in size 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

Hvis du vil rapportere en bivirkning, kan du indberette direkte til Lægemiddelstyrelsen via hjemmesiden www.meldenbivirkning.dk
Vi anbefaler at du også kontakter BMS for at rapportere bivirkninger.
Bivirkninger og andre rapporterbare begivenheder er defineret her
Rapporter bivirkninger eller klager over produktkvalitet: Medicinsk information

466-DK-2200001