HomeTrialNCT04303780
NCT04303780Phase 3ACTIVE NOT RECRUITING

Study to Compare AMG 510 "Proposed INN Sotorasib" With Docetaxel in Non Small Cell Lung Cancer (NSCLC) (CodeBreak 200).

Study Summary

A Phase 3 Study to Compare AMG 510 with Docetaxel in Non Small Cell Lung Cancer (NSCLC) subjects with KRAS p. G12c mutation

Interventions / Drugs
View on ClinicalTrials.gov ↗
Study Details
Enrollment345 participants
Primary Completion
Lead SponsorAmgen
Data Retrieved2026-04-13 18:29:34.157130+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

Enrollment is complete. The trial is in its follow-up or data collection phase — a readout may occur on or near the primary completion date.

Enrolled: 345 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.

Not financial advice. BiotechSign data is sourced from ClinicalTrials.gov, SEC EDGAR, and other public databases for research and informational purposes only. It does not constitute investment recommendations. Always do your own due diligence before making investment decisions.