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

Phase 3

Active, not recruiting

• Conditions: KRAS p, G12c Mutated /Advanced Metastatic NSCLC
• Interventions: Drug: AMG 510; Drug: Docetaxel

• Registration Number: NCT04303780
• Lead Sponsor: Amgen

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-05
• Study First Submitted QC: 2020-03-09
• Study First Posted: 2020-03-11
• Study Start: 2020-06-04
• Primary Completion: 2022-08-02
• Results First Submitted: 2023-04-17
• Results First Submitted QC: 2023-04-17
• Results First Posted: 2023-05-10
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-01
• Last Update Posted: 2025-07-10
• Study Completion: 2026-02-25

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 345

Inclusion Criteria

• Men or women greater than or equal to 18 years old.
• ECOG ≤ 1
• Pathologically documented, previously treated, locally-advanced and unresectable or metastatic NSCLC with KRAS p.G12C mutation confirmed through central testing or have documentation of KRAS p.G12C mutation through Amgen Study 20190294 prior to enrollment

Exclusion Criteria

• Active brain metastases
• Myocardial infarction within 6 months of study day 1
• Gastrointestinal (GI) tract disease causing the inability to take oral medication

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AMG 510	AMG 510	-
Docetaxel	Docetaxel	-

Primary Outcome Measures

Name	Time	Method
Progression-free Survival (PFS)	Baseline up to primary analysis data cut-off date (02 August 2022); max time on study as of primary analysis data cut off was 24.3 months	PFS was defined as the time from randomization (baseline) until disease progression or death from any cause, whichever occurred first for all participants. Progression was based on blinded independent central review (BICR) of disease response per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).; As pre-specified in the statistical analysis plan, for participants who crossed over from docetaxel to AMG 510, the participant's response post first progression or post crossover was not used for the primary analyses. Data are presented per original treatment randomized.

Trial Locations

Locations (272)

Pacific Cancer Medical Center Inc; 🇺🇸 Anaheim, California, United States

City of Hope National Medical Center; 🇺🇸 Duarte, California, United States

Pacific Shores Medical Group Long Beach; 🇺🇸 Long Beach, California, United States

University of California Los Angeles; 🇺🇸 Los Angeles, California, United States

University of California at Davis Medical Center; 🇺🇸 Sacramento, California, United States

Ridley Tree Cancer Center; 🇺🇸 Santa Barbara, California, United States

University of California San Francisco Mission Hall; 🇺🇸 Stanford, California, United States

Harbor University of California Los Angeles Medical Center; 🇺🇸 Torrance, California, United States

Rocky Mountain Cancer Centers; 🇺🇸 Denver, Colorado, United States

Danbury Hospital; 🇺🇸 Norwalk, Connecticut, United States

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