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BrUOG 397: NEO Rad (LOW): Neoadjuvant Low Dose Stereotactic Body Radiotherapy, Ipilimumab and Nivolumab

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later Jun 2026 → Oct 2026
See other at-risk trials from Brown University

Record History

  1. Primary completion pushed from Jun 2026 to Oct 2026
    • Study completion pushed from Sep 2026 to Dec 2026
    v12
  2. Primary completion pushed from Feb 2026 to Jun 2026
    • Study completion pushed from Apr 2026 to Sep 2026
    v11
  3. Primary completion date: Aug 1, 2025 to Feb 2026
    • Study completion date: Dec 1, 2025 to Apr 2026
    v10
  4. Primary completion date: Feb 1, 2025 to Aug 1, 2025
    • Study completion date: Apr 1, 2025 to Dec 1, 2025
    v9
  5. Primary completion date: Oct 15, 2024 to Feb 1, 2025
    • Study completion date: Jan 2025 to Apr 1, 2025
    v8
Show 6 earlier versionsHide 6 earlier versions
  1. Primary completion date: Apr 15, 2024 to Oct 15, 2024v7
  2. Primary completion date: Dec 2023 to Apr 15, 2024v6
  3. Primary completion date: Dec 2022 to Dec 2023
    • Study completion date: Jan 2024 to Jan 2025
    v5
  4. Primary completion date: Jan 2022 to Dec 2022
    • Study completion date: Jan 2023 to Jan 2024
    v4
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 2021 to Oct 5, 2021
    • Site details revised
    v3
  6. Start date: Jul 2021 to Sep 2021v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04933903
Lead Sponsor Brown University
Collaborators: Bristol-Myers Squibb
Conditions
(from sponsor)		 Non Small Cell Lung Cancer
Related terms Carcinoma, Non-Small-Cell Lung
Enrollment 25 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov