Brief Summary
This is a trial to evaluate the efficacy, safety, and tolerability of adagrasib plus pembrolizumab plus platinum-doublet chemotherapya cancer treatment that uses drugs to kill or slow the growth of cancer cells, while minimising damage to healthy cells versus placebo plus pembrolizumab plus platinum-doublet chemotherapy in participants with previously untreated, locally advancedat a late stage, far along or metastatic NSCLC with KRAS G12C mutation
Intervention / Treatment
- Drug: Adagrasib
- Drug: Pembrolizumab
- Drug: Carboplatin
- Drug: Pemetrexed
- Drug: Placebo
- Drug: Cisplatin
Inclusion Criteria:
- Histologically or cytologically confirmed diagnosisthe process of identifying a disease based on signs and symptoms, patient history and medical test results of non-squamous NSCLC with evidence of KRAS G12C mutation via tumor tissuea group of cells that work together to perform a function and/or circulating tumor deoxyribonucleic acid (ctDNA).
- Locally advanced or metastatic disease.
- Measurable disease via computed tomography (CT) or magnetic resonance imagingtests that create detailed images of areas inside the body (MRI) per RECIST v1.1 criteria of at least 1 lesion.
- No prior systemic anti-cancer therapy given for advanced or metastatic disease.
- Not a candidate for definitive therapy (eg, chemoradiation or complete surgical resectionsurgical removal of tissue or part/all of an organ).
- Participants with brain metastases are eligible for enrollment, including those with untreated brain metastases. Brain metastases must be asymptomatic and not in need of immediate local therapy. Any untreated brain metastases must be ≤ 20 mm in diameter.
- Any PD-L1 expression (0 to 100%) as determined by VENTANA PD-L1 (SP263) assay, Agilent PD-L1 IHC 22C3 pharmDx, or Agilent PD-L1 IHC 28-8 pharmDx.