Adagrasib + Pembrolizumab for Non-Small Cell Lung Cancer
Recruiting at 341 trial locations
Fl
BC
Overseen ByBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Mirati Therapeutics Inc.
Pivotal Trial (Near Approval)
Prior Safety Data
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?
This is a trial to evaluate the efficacy, safety, and tolerability of adagrasib plus pembrolizumab plus platinum-doublet chemotherapy versus placebo plus pembrolizumab plus platinum-doublet chemotherapy in participants with previously untreated, locally advanced or metastatic NSCLC with KRAS G12C mutation
Eligibility Criteria
This trial is for adults with advanced non-squamous non-small cell lung cancer that has a specific mutation (KRAS G12C) and haven't been treated before. Participants should be fit enough for chemotherapy, but those with certain health conditions or previous treatments are excluded.Inclusion Criteria
I have brain metastases smaller than 20 mm and don't need immediate treatment.
My non-squamous NSCLC has a KRAS G12C mutation.
My cancer can be measured on scans.
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Exclusion Criteria
Other protocol-defined Inclusion/Exclusion criteria apply
I haven't had serious heart problems in the last 6 months.
I have been treated with drugs targeting the KRAS G12C mutation.
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Treatment Details
Interventions
- Adagrasib (Small Molecule Inhibitor)
- Pembrolizumab (Monoclonal Antibody)
- Platinum-doublet Chemotherapy (Chemotherapy)
Trial OverviewThe study tests if adding Adagrasib to the standard treatment of Pembrolizumab plus platinum-based chemo (like Cisplatin or Carboplatin) is better than using a placebo with the standard treatment in patients with this type of lung cancer.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: AdagrasibExperimental Treatment5 Interventions
Group II: PlaceboPlacebo Group5 Interventions
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mirati Therapeutics Inc.
Lead Sponsor
Trials
73
Recruited
8,900+
Dr. Charles M. Baum
Mirati Therapeutics Inc.
Chief Executive Officer since 2023
MD, PhD
Dr. Joseph Leveque
Mirati Therapeutics Inc.
Chief Medical Officer since 2021
MD