Divarasib / Pembrolizumab / Carboplatin · Phase 3 Trial

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

ClinicalTrials.gov · September 8, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a Phase 3 registration for a planned randomized trial comparing divarasib plus pembrolizumab versus chemotherapy plus pembrolizumab in untreated KRAS G12C-mutated advanced non-squamous NSCLC. The trial is currently recruiting and no efficacy or safety results are available in this registry record.

What was studied

Phase 3, Interventional, Randomized, Parallel, Open label, Treatment purpose. Non-Small Cell Lung Cancer, KRAS G12C Lung Cancer; age from 18 Years. Intervention: Divarasib + Pembrolizumab. Compared with: Pembrolizumab + Pemetrexed + Carboplatin or Cisplatin — Active Comparator. n = 600. 280 sites across 28 countries.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

Results from this trial, when available, may inform first-line treatment selection for KRAS G12C-mutated NSCLC. Currently, no efficacy or safety data can guide clinical decision-making from this registry record.

Plain-language summary

This is a clinical trial registry record describing a Phase 3 study that is currently recruiting with no results posted; it documents planned design and endpoints only.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Progression-Free Survival (PFS) (assessed at Up to approximately 5 years); Overall Survival (OS) (assessed at Up to approximately 5 years)

DesignPhase 3, Interventional, Randomized, Parallel, Open label, Treatment purpose

PopulationNon-Small Cell Lung Cancer, KRAS G12C Lung Cancer; age from 18 Years

Sample size600

InterventionDivarasib + Pembrolizumab

ComparatorPembrolizumab + Pemetrexed + Carboplatin or Cisplatin — Active Comparator

Setting280 sites across 28 countries

Reported figures

Quoted from the source exactly as published.

Planned enrollment600

PhasePhase 3

Primary endpoint 1Progression-Free Survival, up to approximately 5 years

Primary endpoint 2Overall Survival, up to approximately 5 years

Clinical bottom line

Caveats

No results reported; this is a study registration only.
Recruitment status is RECRUITING; trial is not yet complete.
No randomization method, blinding strategy, or statistical analysis plan provided in registry record.
Comparator arm includes choice of carboplatin or cisplatin; specific allocation method not stated.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

strong

Phase 3 randomized controlled trial comparing two active treatment arms.

Directness

strong

Primary endpoints are PFS and OS in treatment-naïve KRAS G12C-mutated advanced NSCLC.

Consistency

insufficient

No results reported; consistency cannot be assessed from registry record alone.

Risk of bias

insufficient

Study methods (blinding, allocation concealment) not detailed in registry record.

Sample adequacy

moderate

Planned enrollment 600 participants; adequate for Phase 3 but not yet reached.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT06793215). This is a study registration, not published results. Lead sponsor: Hoffmann-La Roche. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 600 participants (ESTIMATED). Conditions: Non-Small Cell Lung Cancer, KRAS G12C Lung Cancer. Interventions: DRUG: Divarasib; DRUG: Pembrolizumab; DRUG: Pemetrexed; DRUG: Carboplatin; DRUG: Cisplatin. Primary outcome measures: Progression-Free Survival (PFS) , Up to approximately 5 years; Overall Survival (OS) , Up to approximately 5 years. Brief summary: 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).

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

DivarasibPembrolizumabCarboplatinNCT06793215KRAS G12C Lung CancerPemetrexedNon Small Cell Lung CancerHoffmann-La Roche