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An Open Label, Randomized Study of Neoadjuvant Nivolumab and Chemotherapy, With or Without Sub-ablative Stereotactic Body Radiation Therapy, for Resectable Stage IIA to IIIB Non-small Cell Lung Cancer

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from Montefiore Medical Center

Record History

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  1. Eligibility criteria expanded, about 37 words
    • Secondary endpoints: details revised at 2 of 2 entries
    • Study description expanded, about 12 words
  2. Primary endpoint(s) modified
    • Results posted: Aug 27, 2026
    • Collaborators: 3 to 4
    v9
  3. Primary endpoint revisedv8 Show 9 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 52 to confirmed 17
    • Study sites: 1 to 4
    • Primary completion date changed from estimate of Jul 2025 to Jul 1, 2025
    • Study completion date: Jul 2025 to May 2030
    • Secondary endpoints: details revised at 2 of 2 entries
    • Study description revised
    • Collaborators: 1 to 3
    • Eligibility criteria expanded, about 2 words
  4. Study completion date: Aug 2027 to Jul 2025v7
  5. Start date changed from estimate of Jan 17, 2023 to Jan 25, 2023v6
Show 4 earlier versionsHide 4 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Nov 2022 to Jan 17, 2023
    • Study sites: 0 to 1
    v5
  2. Start date: Sep 2022 to Nov 2022v4
  3. Start date: Aug 2022 to Sep 2022v3
  4. Enrollment target: 60 to 52v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
An open label, randomized study of neoadjuvant nivolumab and chemotherapy, with or without sub-ablative stereotactic body radiation therapy, for resectable stage IIA to IIIB non-small cell lung cancer
Trial Details
NCT Number NCT05500092
Lead Sponsor Montefiore Medical Center
Collaborators: Bristol-Myers Squibb, Penn State University, Washington University School of Medicine, American Cancer Society, Inc.
Conditions
(from sponsor)		 Resectable Stage IIA to IIIB Non-small Cell Lung Cancer
Enrollment 17 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov