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NCT05920356 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study of Non-small Cell Lung Cancer (NSCLC), sponsored by Amgen.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 750
- Enrollment target
- 20
- Study locations
NCT05920356 is a Phase 3 study of Non-small Cell Lung Cancer (NSCLC) that is actively recruiting participants, run by Amgen. The registered enrollment target is 750 participants, above the 276-participant average among 58 other Non-small Cell Lung Cancer (NSCLC) trials with a reported enrollment target (172% higher). The trial reports 20 study locations across 12 states.
The verdict
NCT05920356, a Phase 3 study of Non-small Cell Lung Cancer (NSCLC), is actively recruiting participants, sponsored by Amgen.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 750 participants
- Enrollment target
- 20
- Study locations
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 Studied
Interventions
- DRUG Pembrolizumab
- DRUG Sotorasib
Study Locations (20)
Tennessee
- University of Tennessee Medical Center Knoxville - Knoxville
- Regional One Health - Memphis
- Sarah Cannon Research Institute - Nashville
- United States Oncology Regulatory Affairs Corporate Office - Nashville
Illinois
- University of Illinois Chicago - Chicago
- Illinois Cancer Specialists - Niles
North Carolina
- Duke University - Durham
- FirstHealth Cancer Center - Pinehurst
Pennsylvania
- Alliance Cancer Specialists - Media - Media
- University of Pittsburgh Medical Center - Pittsburgh
Texas
- University of Texas MD Anderson Cancer Center - Houston
- US Oncology Research Investigational Products Center - Irving
Buenos Aires
- Hospital Britanico de Buenos Aires - CABA
- Instituto Alexander Fleming - Capital Federal
California
- Sansum Clinic - Santa Barbara
Delaware
- Medical Oncology Hematology Consultants Helen F Graham Cancer Center - Newark
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 750 participants |
| Start Date | 2023-11-16 |
| Est. Completion | 2031-06-30 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05920356
The ClinicalTrials.gov registry entry for NCT05920356 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 750 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 276-participant average among 58 other Non-small Cell Lung Cancer (NSCLC) trials with a reported enrollment target (172% higher). The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Non-small Cell Lung Cancer (NSCLC) appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT05920356 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Tennessee, Illinois, North Carolina.
Frequently Asked Questions
What is clinical trial NCT05920356 about?
NCT05920356 is a clinical study titled "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)". 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.
What is the current status of trial NCT05920356?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 750 participants. The study started on 2023-11-16. Estimated completion is 2031-06-30.
What conditions does trial NCT05920356 study?
This clinical trial studies the following conditions: Non-small Cell Lung Cancer (NSCLC).
What interventions are being tested in trial NCT05920356?
The interventions under investigation include: Pembrolizumab (DRUG), Sotorasib (DRUG).
Who is sponsoring clinical trial NCT05920356?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05920356 being conducted?
This trial has 20 study locations across California, Delaware, Illinois, Kentucky, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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