BrUOG 397: NEO Rad (LOW): Neoadjuvant Low Dose Stereotactic Body Radiotherapy, Ipilimumab and Nivolumab
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ClinicalTrials.gov Identifier: NCT04933903 |
Recruitment Status :
Recruiting
First Posted : June 22, 2021
Last Update Posted : April 5, 2024
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Sponsor:
Brown University
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Brown University
Tracking Information | |||||||
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First Submitted Date ICMJE | October 15, 2020 | ||||||
First Posted Date ICMJE | June 22, 2021 | ||||||
Last Update Posted Date | April 5, 2024 | ||||||
Actual Study Start Date ICMJE | October 5, 2021 | ||||||
Estimated Primary Completion Date | April 15, 2024 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Number of Patients with a Pathologic Response [ Time Frame: From beginning of study treatment to approximately day 49-63 on study. ] Assess Pathologic Response (major pathologic response and complete pathologic response) following neoadjuvant low dose SBRT, Ipilimumab and Nivolumab.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: Beginning of study treatment through 90 days post study treatment completion. ] Assess safety and operative morbidity following neoadjuvant low dose SBRT, Ipilimumab and Nivolumab and surgery.
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | BrUOG 397: NEO Rad (LOW): Neoadjuvant Low Dose Stereotactic Body Radiotherapy, Ipilimumab and Nivolumab | ||||||
Official Title ICMJE | BrUOG 397: NEO Rad (LOW): Neoadjuvant Low Dose Stereotactic Body Radiotherapy, Ipilimumab and Nivolumab for Patients With Resectable Stage IB - III Non-Small Cell Lung Cancer | ||||||
Brief 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. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 2 | ||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Non Small Cell Lung Cancer | ||||||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: Protocol Therapy
Ipilimumab: 1mg/kg IV day 1. Nivolumab: 3mg/kg IV days 1, 15, 29. SBRT delivered as 1-2 fractions to the gross primary tumor and nodal disease following day 1 infusion and completed by day 3 (7Gy x 1; 4Gy x 2).
Interventions:
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Recruiting | ||||||
Estimated Enrollment ICMJE |
25 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | January 2025 | ||||||
Estimated Primary Completion Date | April 15, 2024 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT04933903 | ||||||
Other Study ID Numbers ICMJE | BrUOG 397 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||||
Current Responsible Party | Brown University | ||||||
Original Responsible Party | Same as current | ||||||
Current Study Sponsor ICMJE | Brown University | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
Collaborators ICMJE | Bristol-Myers Squibb | ||||||
Investigators ICMJE |
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PRS Account | Brown University | ||||||
Verification Date | April 2024 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |