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NCT05920356Phase 3RECRUITING

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)

Study 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.

Conditions
Non-Small Cell Lung Cancer (NSCLC)
Interventions / Drugs
SotorasibPembrolizumab
View on ClinicalTrials.gov ↗
Sponsor
AMGN
Amgen Inc
Biologics
F35/100
Study Details
Enrollment750 participants
Primary Completion—
Lead SponsorAmgen
Data Retrieved2026-04-13 18:29:34.157264+00:00
What This Trial Means for Biotech Investors
Trial Phase Context

Phase 3 trials are pivotal studies with large patient populations (hundreds to thousands) designed to prove efficacy and safety for FDA submission. A successful Phase 3 readout is typically the last major hurdle before a New Drug Application (NDA) or BLA filing.

Status & Expected Data

Currently recruiting: the trial is enrolling patients. A data readout is not expected until after enrollment closes and the follow-up period is complete.

Enrolled: 750 participants
Sponsor Catalyst Profile

Amgen Inc (AMGN) is the sponsoring company for this trial. BiotechSign currently grades this company F (35/100) based on composite catalyst signals across its full pipeline. This trial is one data point in that overall catalyst picture.

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