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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: Recruiting Phase 3 study of Non-small Cell Lung Cancer (NSCLC), sponsored by Amgen.
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 272-participant average among 59 other Non-small Cell Lung Cancer (NSCLC) trials with a reported enrollment target (176% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
PFS is defined as the time from randomization until the first documentation of radiologic disease progression or death due to any cause, whichever occurs first. Progression will be based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, per Blinded Independent Central Review (BICR).
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 |
What NCT05920356 shows while recruiting
NCT05920356 is an interventional study that assigns participants to a tested intervention. The registered 750 participants enrollment target is mid-sized for trials with a published cap, above the 272-participant average among 59 other Non-small Cell Lung Cancer (NSCLC) trials with a reported enrollment target (176% higher).
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 names 20 study sites across 12 states, led by 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.
Learn More About Clinical Trials
Similar trials for Non-small Cell Lung Cancer (NSCLC)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05920356's enrollment target sits among peer trials
750 6th of 59 higher than 54 of 59 other Non-small Cell Lung Cancer (NSCLC) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-small Cell Lung Cancer (NSCLC) 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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