Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Phase 2 study of NSCLC, Stage I, sponsored by Greg Durm, MD.
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, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% higher). The trial reports 13 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
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)
Primary Outcome
To evaluate whether the addition of adjuvant Pembrolizumab following surgical resection improves disease free survival compared with observation following surgical resection in patients with stage I non-small cell lung cancer (NSCLC) that is between 1-4 cm in size, regardless of PD-L1 TPS score. Median Disease Free Survival (DFS) will be reported.
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 |
What NCT04317534 shows while recruiting
NCT04317534 is an interventional study that assigns participants to a tested intervention. The registered 244 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% higher).
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 lists 13 locations in 12 states (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.
Learn More About Clinical Trials
Similar trials for NSCLC, Stage I
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 NCT04317534's enrollment target sits among peer trials
244 235th of 2000 higher than 1,765 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02227251 · 244 participants · Phase 2
Selinexor (KPT-330) in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
- NCT04683250 · 244 participants · Phase 1
Study of RET Inhibitor TAS0953/HM06 in Patients With Advanced Solid Tumors With RET Gene Abnormalities
- NCT04686305 · 244 participants · Phase 1
Phase Ib Study of the Safety of T-DXd and Immunotherapy Agents With and Without Chemotherapy in Advanced or Metastatic HER2+, Non-squamous NSCLC
- NCT05703269 · 244 participants · NA
Comparing Single vs Multiple Dose Radiation for Cancer Patients With Brain Metastasis and Receiving Immunotherapy
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI