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NCT04317534 · ClinicalTrials.gov registry record · Phase 2
Adjuvant Pembrolizumab vs Observation Following Curative Resection for Stage I Non-small Cell Lung Cancer (NSCLC) With Primary Tumors Between 1-4 cm
A Phase 2 study of NSCLC, Stage I, sponsored by Greg Durm, MD.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 244
- Enrollment target
- 13
- Study locations
NCT04317534 is a Phase 2 study of NSCLC, Stage I that is actively recruiting participants, run by Greg Durm, MD. The registered enrollment target is 244 participants. The trial reports 13 study locations across 12 states.
The verdict
NCT04317534, a Phase 2 study of NSCLC, Stage I, is actively recruiting participants, sponsored by Greg Durm, MD.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 244 participants
- Enrollment target
- 13
- Study locations
Study Summary
A randomized trial of adjuvant Pembrolizumab following surgical resection versus observation following surgical resection in patients with stage I non-small cell lung cancer (NSCLC) with primary tumors between 1-4 cm. Patients will be randomized (1:1) 4-12 weeks following surgery to either: * Arm A: Pembrolizumab 400 mg every 6 weeks × 9 cycles * Arm B: Observation Stratification factors will include: PD-L1 TPS (\<50% vs. ≥50%), and tumor size (1-2 cm vs. \>2-4 cm)
Conditions Studied
Interventions
- DRUG Pembrolizumab
Study Locations (13)
Virginia
- University of Virginia Health System - Charlottesville
- Virginia Commonwealth University - Richmond
Florida
- Moffit Cancer Center - Tampa
Illinois
- University of Illinois Cancer Center - Chicago
Indiana
- Indiana University Melvin and Bren Simon Cancer Center - Indianapolis
Iowa
- University of Iowa Hospitals and Clinics - Iowa City
Minnesota
- University of Minnesota - Minneapolis
Nebraska
- University of Nebraska Medical Center - Omaha
New Jersey
- Rutgers Cancer Institute of New Jersey - New Brunswick
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 244 participants |
| Start Date | 2020-05-05 |
| Est. Completion | 2029-04-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04317534
The ClinicalTrials.gov registry entry for NCT04317534 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 244 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Greg Durm, MD, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with NSCLC, Stage I appearing as the primary indexed condition, and to 1 intervention - of which Pembrolizumab is the first listed.
NCT04317534 reports 13 study locations spanning 12 distinct geographic areas - top geographies include Virginia, Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT04317534 about?
NCT04317534 is a clinical study titled "Adjuvant Pembrolizumab vs Observation Following Curative Resection for Stage I Non-small Cell Lung Cancer (NSCLC) With Primary Tumors Between 1-4 cm". A randomized trial of adjuvant Pembrolizumab following surgical resection versus observation following surgical resection in patients with stage I non-small cell lung cancer (NSCLC) with primary tumors between 1-4 cm. Patients will be randomized (1:1) 4-12 weeks following surgery to either: * Arm ...
What is the current status of trial NCT04317534?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 244 participants. The study started on 2020-05-05. Estimated completion is 2029-04-01.
What conditions does trial NCT04317534 study?
This clinical trial studies the following conditions: NSCLC, Stage I.
What interventions are being tested in trial NCT04317534?
The interventions under investigation include: Pembrolizumab (DRUG).
Who is sponsoring clinical trial NCT04317534?
This trial is sponsored by Greg Durm, MD, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04317534 being conducted?
This trial has 13 study locations across Florida, Illinois, Indiana, Iowa, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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