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NCT04303780 · ClinicalTrials.gov registry record · Phase 3
Study to Compare AMG 510 "Proposed INN Sotorasib" With Docetaxel in Non Small Cell Lung Cancer (NSCLC) (CodeBreak 200).
A Phase 3 study of KRAS p, G12c Mutated /Advanced Metastatic NSCLC, sponsored by Amgen.
- Active
- Registry status
- Phase 3
- Development phase
- 345
- Enrollment target
- 20
- Study locations
NCT04303780: Active Phase 3 study of KRAS p, G12c Mutated /Advanced Metastatic NSCLC, sponsored by Amgen.
NCT04303780 is a Phase 3 study of KRAS p, G12c Mutated /Advanced Metastatic NSCLC that is active but no longer recruiting, run by Amgen. The registered enrollment target is 345 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (55% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04303780, a Phase 3 study of KRAS p, G12c Mutated /Advanced Metastatic NSCLC, is active but no longer recruiting, sponsored by Amgen.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 345 participants
- Enrollment target
- 20
- Study locations
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
Primary Outcome
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
Conditions Studied
Interventions
- DRUG Docetaxel
- DRUG AMG 510
Study Locations (20)
California
- Pacific Cancer Medical Center Inc - Anaheim
- City of Hope National Medical Center - Duarte
- Pacific Shores Medical Group Long Beach - Long Beach
- University of California Los Angeles - Los Angeles
- University of California Los Angeles - Los Angeles
- University of California at Davis Medical Center - Sacramento
- Ridley Tree Cancer Center - Santa Barbara
- University of California San Francisco Mission Hall - Stanford
- Harbor University of California Los Angeles Medical Center - Torrance
Florida
- Florida Cancer Specialists - Fort Myers - Fort Myers
- Memorial Regional Hospital - Hollywood
- Florida Cancer Specialists Research North - St. Petersburg
- Florida Cancer Specialists Research Panhandle - Tallahassee
Georgia
- Emory University - Atlanta
- Northside Hospital, Incorporated - Atlanta
Colorado
- Rocky Mountain Cancer Centers - Denver
Connecticut
- Danbury Hospital - Norwalk
Delaware
- Medical Oncology Hematology Consultants Helen F Graham Cancer Center - Newark
District of Columbia
- Washington Cancer Institute at MedStar Washington Hospital - Washington D.C.
Illinois
- Affiliated Oncologists, LLC - North Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 345 participants |
| Start Date | 2020-06-04 |
| Est. Completion | 2026-02-25 |
| Phase | Phase 3 |
What the registry record for NCT04303780 still lists
NCT04303780 is an interventional study that assigns participants to a tested intervention. The registered 345 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (55% lower).
The record links to 1 condition, with KRAS p, G12c Mutated /Advanced Metastatic NSCLC appearing as the primary indexed condition, and to 2 interventions - of which Docetaxel is the first listed.
NCT04303780 names 20 study sites across 8 states, led by California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT04303780 about?
NCT04303780 is a clinical study titled "Study to Compare AMG 510 "Proposed INN Sotorasib" With Docetaxel in Non Small Cell Lung Cancer (NSCLC) (CodeBreak 200).". A Phase 3 Study to Compare AMG 510 with Docetaxel in Non Small Cell Lung Cancer (NSCLC) subjects with KRAS p. G12c mutation
What is the current status of trial NCT04303780?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 345 participants. The study started on 2020-06-04. Estimated completion is 2026-02-25.
What conditions does trial NCT04303780 study?
This clinical trial studies the following conditions: KRAS p, G12c Mutated /Advanced Metastatic NSCLC.
What interventions are being tested in trial NCT04303780?
The interventions under investigation include: Docetaxel (DRUG), AMG 510 (DRUG).
Who is sponsoring clinical trial NCT04303780?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04303780 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, Delaware, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04303780's enrollment target sits among peer trials
345 1050th of 2000 higher than 951 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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