Unresectable Stage IIIA/IIIB Non-small Cell Lung Cancer (NSCLC)
Part of paid clinical trials in Chicago, Illinois.
- Sponsor
- Greg Durm, MD
- Study ID
- NCT03285321
- Phase
- PHASE2
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Nivolumab — DRUG480mg
- Nivolumab — DRUG240mg
- Ipilimumab — DRUG1mg/kg
Study Details
This study is an open label, multicenter, randomized phase II trial of consolidation immunotherapy with either nivolumab alone or the combination of nivolumab and ipilimumab following concurrent chemoradiation in patients with unresectable stage III NSCLC.
Key Dates
- Start date
- Sep 15, 2017
- Status verified
- Dec 2025
- Primary completion
- Oct 13, 2023
- Completion
- Feb 6, 2024
Study Design
- Enrollment
- 105 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Arm 1Nivolumab 480mg IV every 4 weeks for up to 6 cycles
- Experimental: Arm 2Nivolumab 240mg IV every 2 weeks PLUS Ipilimumab 1mg/kg IV every 6 weeks for up to 4 cycles (12 doses Nivolumab and 4 doses of Ipilimumab)
Primary Outcome Measure
Progression Free Survival (PFS) at 18-month [ Time Frame: 18 months ]
Locations (12)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Rush University Medical Center | Chicago | Illinois | 60612 | - |
| University of Illinois Cancer Center | Chicago | Illinois | 60612 | - |
| Indiana University | Indianapolis | Indiana | 46202 | - |
| University of Louisville James Graham Brown Cancer Center | Louisville | Kentucky | 40202 | - |
| Johns Hopkins Sidney Kimmel Comprehensive | Baltimore | Maryland | 21287 | - |
| Karmanos Cancer Center (Wayne State University) | Detroit | Michigan | 48201 | - |
| Michigan State University | Lansing | Michigan | 48910 | - |
| University of Minnesota | Minneapolis | Minnesota | 55455 | - |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | - |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08903 | - |
| Penn State Cancer Institute | Hershey | Pennsylvania | 17033 | - |
| University of Wisconsin | Madison | Wisconsin | 53705 | - |
Related coverage on Hipa.ai
- Nivolumab Alone vs. Nivolumab/Ipilimumab for NSCLC Shows Similar PFSNivolumab · Mar 11, 2025 · ClinicalTrials.gov
Find similar trials in Chicago, IL
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Rush University Medical Center· Chicago, ILUniversity of Illinois Cancer Center· Chicago, ILIndiana University· Indianapolis, INUniversity of Louisville James Graham Brown Cancer Center· Louisville, KYJohns Hopkins Sidney Kimmel Comprehensive· Baltimore, MDKarmanos Cancer Center (Wayne State University)· Detroit, MI
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