Clinical Trial: NCT03223155
Concurrent or Sequential Immunotherapy and Radiation Therapy in Patients With Metastatic Lung Cancer
Status:
ACTIVE NOT RECRUITINGPhase:
Phase 1| Lead Sponsor: | University of Chicago |
| Information Provided By: | University of Chicago |
| Last Update Posted: | 2026-03-04 |
Study Overview
Brief Summary
Trial Design
- Patients with stage IV non-small cell lung cancer are randomized to nivolumab/ipilimumab plus either sequential or concurrent stereotactic body radiotherapy (SBRT).
- The primary endpoint is the phase I safety endpoint of SBRT dose for each body site.
- The same starting SBRT dose levels are used in each arm. If two or more patients experience a dose-limiting toxicity (DLT) at the starting dose level, then the reduced dose level will be used (Section 7.1-Page 72).
- DLT is defined as any grade ≥3 toxicity possibly, likely, or definitely related to SBRT plus nivolumab/ipilimumab (the combination and not the individual components).
- Irradiated metastases will be grouped into one of five locations, which have different SBRT doses, and the DLTs will be attributed to the relevant organ system.
- The starting and decreased SBRT dose levels are found in Table 2 (Page 20).
- SBRT will be delivered in 3-5 fractions over the course of 1-1.5 weeks.
- Patients in the sequential arm will begin immunotherapy between 1-7 days after completion of SBRT
- Given the accrual data for IRB15-1130, the investigators anticipate that approximately 1/3 of patients will contribute metastasis to 2 locations. Since there are 2 arms, and 5 metastasis locations with 6 patients per location for the starting dose level, this translates to 40 patients for the starting dose level, and another 40 patients should each of the 5 locations require de-escalation to the lower dose level.
- Secondary endpoints include comparisons of efficacy and toxicity between the arms, as well as interrogation of changes in the immune microenvironment induced by the two approaches.
Official Title
A Randomized Phase I Trial to Evaluate Concurrent Or Sequential Ipilimumab, Nivolumab, and Stereotactic Body Radiotherapy in Patients With Stage IV Non-Small Cell Lung Cancer (COSINR Study)
Conditions
Stage IV Small Cell Lung Cancer
Intervention / Treatment
- Drug: Nivolumab
- Drug: Ipilimumab
- Radiation: Stereotactic body radiation therapy
Other Study ID Numbers
- IRB17-0547
Start Date (Actual)
2017-09-07
Primary Completion Date (Estimated)
2026-12
Study Completion Date (Estimated)
2027-12
Enrollment (Actual)
78
Study Type
Interventional
Phase
Phase 1
| Lead Sponsor: | University of Chicago |
| Information Provided By: | University of Chicago |
| Last Update Posted: | 2026-03-04 |
Study Overview
Brief Summary
Trial Design
- Patients with stage IV non-small cell lung cancer are randomized to nivolumab/ipilimumab plus either sequential or concurrent stereotactic body radiotherapy (SBRT).
- The primary endpoint is the phase I safety endpoint of SBRT dose for each body site.
- The same starting SBRT dose levels are used in each arm. If two or more patients experience a dose-limiting toxicity (DLT) at the starting dose level, then the reduced dose level will be used (Section 7.1-Page 72).
- DLT is defined as any grade ≥3 toxicity possibly, likely, or definitely related to SBRT plus nivolumab/ipilimumab (the combination and not the individual components).
- Irradiated metastases will be grouped into one of five locations, which have different SBRT doses, and the DLTs will be attributed to the relevant organ system.
- The starting and decreased SBRT dose levels are found in Table 2 (Page 20).
- SBRT will be delivered in 3-5 fractions over the course of 1-1.5 weeks.
- Patients in the sequential arm will begin immunotherapy between 1-7 days after completion of SBRT
- Given the accrual data for IRB15-1130, the investigators anticipate that approximately 1/3 of patients will contribute metastasis to 2 locations. Since there are 2 arms, and 5 metastasis locations with 6 patients per location for the starting dose level, this translates to 40 patients for the starting dose level, and another 40 patients should each of the 5 locations require de-escalation to the lower dose level.
- Secondary endpoints include comparisons of efficacy and toxicity between the arms, as well as interrogation of changes in the immune microenvironment induced by the two approaches.
Official Title
A Randomized Phase I Trial to Evaluate Concurrent Or Sequential Ipilimumab, Nivolumab, and Stereotactic Body Radiotherapy in Patients With Stage IV Non-Small Cell Lung Cancer (COSINR Study)
Conditions
Stage IV Small Cell Lung Cancer
Intervention / Treatment
- Drug: Nivolumab
- Drug: Ipilimumab
- Radiation: Stereotactic body radiation therapy
Other Study ID Numbers
- IRB17-0547
Start Date (Actual)
2017-09-07
Primary Completion Date (Estimated)
2026-12
Study Completion Date (Estimated)
2027-12
Enrollment (Actual)
78
Study Type
Interventional
Phase
Phase 1