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Study to Compare AMG 510 "Proposed INN Sotorasib" With Docetaxel in Non Small Cell Lung Cancer (NSCLC) (CodeBreak 200).
NCT04303780 · View on ClinicalTrials.gov ↗
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04303780
The ClinicalTrials.gov registry entry for NCT04303780 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 345 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amgen, which has 266 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04303780 reports 20 study locations spanning 8 distinct geographic areas — top geographies include California, Florida, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04303780?
The interventions under investigation include: Docetaxel (DRUG), AMG 510 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04303780?
This trial is sponsored by Amgen, which has 266 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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