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NCT04933903 · ClinicalTrials.gov registry record · Phase 2
BrUOG 397: NEO Rad (LOW): Neoadjuvant Low Dose Stereotactic Body Radiotherapy, Ipilimumab and Nivolumab
A Phase 2 study of Non-Small Cell Lung Cancer, sponsored by Brown University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT04933903: Recruiting Phase 2 study of Non-Small Cell Lung Cancer, sponsored by Brown University.
NCT04933903 is a Phase 2 study of Non-Small Cell Lung Cancer that is actively recruiting participants, run by Brown University. The registered enrollment target is 25 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04933903, a Phase 2 study of Non-Small Cell Lung Cancer, is actively recruiting participants, sponsored by Brown University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study Summary
This single-arm phase 2 study will enroll patients with resectable and operable stage IB - III non-small cell lung cancer and treat them with pre-operative ipilimumab + nivolumab plus low-dose stereotactic body radiation therapy (SBRT) delivered concurrently. Only patients who proceed to surgery will be evaluable for the primary endpoint. The primary efficacy outcome measurement will be pathologic response (including Major Pathologic Response (MPR), and Complete Pathologic Response (CPR)). Secondary outcome measures include safety, and exploratory biomarkers of immune response in pre- and post-operative blood and tissue. A two-stage design will stop the study if fewer than 3 of the first 9 evaluable patients do not achieve MPR. An early stopping rule for safety will stop the study if more than 12 patients are enrolled to find the first 9 evaluable patients.
Primary Outcome
Assess Pathologic Response (major pathologic response and complete pathologic response) following neoadjuvant low dose SBRT, Ipilimumab and Nivolumab.
Conditions Studied
Interventions
- DRUG Nivolumab
- DRUG Ipilimumab
- RADIATION SBRT
Study Locations (1)
Rhode Island
- Rhode Island Hospital - Providence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2021-10-05 |
| Est. Completion | 2026-04 |
| Phase | Phase 2 |
What NCT04933903 shows while recruiting
NCT04933903 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 3 interventions - of which Nivolumab is the first listed.
NCT04933903 reports a single indexed study location in Rhode Island.
Frequently Asked Questions
What is clinical trial NCT04933903 about?
NCT04933903 is a clinical study titled "BrUOG 397: NEO Rad (LOW): Neoadjuvant Low Dose Stereotactic Body Radiotherapy, Ipilimumab and Nivolumab". This single-arm phase 2 study will enroll patients with resectable and operable stage IB - III non-small cell lung cancer and treat them with pre-operative ipilimumab + nivolumab plus low-dose stereotactic body radiation therapy (SBRT) delivered concurrently. Only patients who proceed to surgery wil...
What is the current status of trial NCT04933903?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2021-10-05. Estimated completion is 2026-04.
What conditions does trial NCT04933903 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer.
What interventions are being tested in trial NCT04933903?
The interventions under investigation include: Nivolumab (DRUG), Ipilimumab (DRUG), SBRT (RADIATION).
Who is sponsoring clinical trial NCT04933903?
This trial is sponsored by Brown University, which has 231 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04933903 being conducted?
This trial has 1 study location across Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Non-Small Cell Lung Cancer
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 NCT04933903's enrollment target sits among peer trials
25 406th of 454 higher than 46 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer 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.
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