Sotorasib / Pembrolizumab / Non Small Cell Lung Cancer (NSCLC) · Phase 3 Trial

A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)

ClinicalTrials.gov · September 11, 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 registered Phase 3 trial comparing sotorasib plus platinum doublet chemotherapy against pembrolizumab plus platinum doublet chemotherapy in front-line stage IIIB/C-IV nonsquamous NSCLC. No results have been posted in this registry record; the trial is currently recruiting. The study is designed to compare hard endpoints (PFS and OS) over approximately 2.5 years of follow-up.

What was studied

Phase 3, Interventional, Randomized, Parallel, Open label, Treatment purpose. Non-Small Cell Lung Cancer (NSCLC); age from 18 Years; to 100 Years. Intervention: Sotorasib combined with carboplatin and pemetrexed. Compared with: Pembrolizumab combined with carboplatin and pemetrexed — Active Comparator. n = 750. 418 sites across 38 countries.

Key findings

Safety

No efficacy or safety data are available for evaluation.

Who this may help

This trial, when results become available, will directly inform first-line treatment choice in advanced nonsquamous NSCLC. Until results are posted, this record serves to document the planned comparison and endpoints only.

Plain-language summary

This is an active Phase 3 trial registration with no results posted; the study design and planned endpoints are described but no outcome data are available.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Progression-free Survival (PFS) (assessed at Approximately 2.5 years); Overall Survival (OS) (assessed at Approximately 2.5 years)

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

PopulationNon-Small Cell Lung Cancer (NSCLC); age from 18 Years; to 100 Years

Sample size750

InterventionSotorasib combined with carboplatin and pemetrexed

ComparatorPembrolizumab combined with carboplatin and pemetrexed — Active Comparator

Setting418 sites across 38 countries

Reported figures

Quoted from the source exactly as published.

Planned enrollment750

Primary endpoint 1Progression-free Survival (PFS)

Primary endpoint 2Overall Survival (OS)

Follow-up durationApproximately 2.5 years

Clinical bottom line

Caveats

No results are posted in this registry record; trial is still recruiting.
Blinding status, allocation concealment method, and statistical analysis plan are not described in the registry entry.
No efficacy or safety data are available for evaluation.
Actual follow-up duration and final enrollment number are not yet reported.

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 interventions.

Directness

strong

Hard clinical endpoints (PFS, OS) in front-line advanced NSCLC setting.

Consistency

insufficient

No results reported; cannot assess consistency with other evidence.

Risk of bias

insufficient

Registry record does not describe blinding, allocation concealment, or analysis plan.

Sample adequacy

moderate

Planned enrollment 750 participants; adequate for Phase 3 but not yet enrolled.

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 (NCT05920356). This is a study registration, not published results. Lead sponsor: Amgen. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 750 participants (ESTIMATED). Conditions: Non-Small Cell Lung Cancer (NSCLC). Interventions: DRUG: Sotorasib; DRUG: Pembrolizumab. Primary outcome measures: Progression-free Survival (PFS) , Approximately 2.5 years; Overall Survival (OS) , Approximately 2.5 years. Brief summary: The primary objectives are to compare progression-free survival (PFS) and overall survival (OS) in participants who receive sotorasib with platinum doublet chemotherapy versus participants who receive pembrolizumab with platinum doublet chemotherapy.

Follow from this

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

NCT05920356AmgenSotorasibPembrolizumabNon Small Cell Lung Cancer (NSCLC)