A Study Evaluating the Efficacy and Safety of Divarasib and Pembrolizumab Versus Pembrolizumab and Pemetrexed and Carboplatin or Cisplatin in Participants With Previously Untreated, KRAS G12C-Mutated, Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer

Conditions

• KRAS G12C Lung Cancer
• Non-Small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Divarasib — DRUG
  Divarasib will be administered orally QD
• Pembrolizumab — DRUG
  Pembrolizumab will be administered via IV infusion Q3W
• Pemetrexed — DRUG
  Pemetrexed will be administered via IV infusion Q3W
• Carboplatin — DRUG
  Carboplatin will be administered via IV infusion Q3W
• Cisplatin — DRUG
  Cisplatin will be administered via IV infusion Q3W

Study Details

The purpose of this study is to evaluate the efficacy and safety of divarasib and pembrolizumab compared with pembrolizumab and pemetrexed and carboplatin or cisplatin, for the first-line treatment of adult participants with KRAS G12C-mutated, advanced or metastatic non squamous non-small cell lung cancer (NSCLC).

Key Dates

Start date

Oct 24, 2025

Status verified

Jun 2026

Primary completion

Nov 30, 2028

Completion

Oct 31, 2030

Study Design

Enrollment

600 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Divarasib + Pembrolizumab
  Participants will receive divarasib orally, once daily (QD) and pembrolizumab via intravenous (IV) infusion every 3 weeks (Q3W)
• Active Comparator: Pembrolizumab + Pemetrexed + Carboplatin or Cisplatin
  Participants will receive pembrolizumab, pemetrexed and carboplatin or cisplatin via IV infusion Q3W

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: Up to approximately 5 years ]

Central Contacts

• Reference Study ID Number: CO45042 https://forpatients.roche.com/
  888-662-6728 (U.S. and Canada)
  [email protected]
• Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry

Locations (50)

Find similar trials in Anchorage, AK

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