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NCT03223155 · ClinicalTrials.gov registry record · Phase 1
Concurrent or Sequential Immunotherapy and Radiation Therapy in Patients With Metastatic Lung Cancer
A Phase 1 study of Stage IV Small Cell Lung Cancer, sponsored by University of Chicago.
- Active
- Registry status
- Phase 1
- Development phase
- 78
- Enrollment target
- 1
- Study location
NCT03223155: Active Phase 1 study of Stage IV Small Cell Lung Cancer, sponsored by University of Chicago.
NCT03223155 is a Phase 1 study of Stage IV Small Cell Lung Cancer that is active but no longer recruiting, run by University of Chicago. The registered enrollment target is 78 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03223155, a Phase 1 study of Stage IV Small Cell Lung Cancer, is active but no longer recruiting, sponsored by University of Chicago.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 78 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
To determine the recommended SBRT dose to various metastatic locations in patients with stage IV NSCLC when delivered prior to or concurrently with nivolumab and ipilimumab.
Conditions Studied
Interventions
- DRUG Nivolumab
- DRUG Ipilimumab
- RADIATION Stereotactic body radiation therapy
Study Locations (1)
Illinois
- University of Chicago - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2017-09-07 |
| Est. Completion | 2027-12 |
| Phase | Phase 1 |
What the registry record for NCT03223155 still lists
NCT03223155 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% higher).
The record links to 1 condition, with Stage IV Small Cell Lung Cancer appearing as the primary indexed condition, and to 3 interventions - of which Nivolumab is the first listed.
NCT03223155 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT03223155 about?
NCT03223155 is a clinical study titled "Concurrent or Sequential Immunotherapy and Radiation Therapy in Patients With Metastatic Lung Cancer". 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 le...
What is the current status of trial NCT03223155?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 78 participants. The study started on 2017-09-07. Estimated completion is 2027-12.
What conditions does trial NCT03223155 study?
This clinical trial studies the following conditions: Stage IV Small Cell Lung Cancer.
What interventions are being tested in trial NCT03223155?
The interventions under investigation include: Nivolumab (DRUG), Ipilimumab (DRUG), Stereotactic body radiation therapy (RADIATION).
Who is sponsoring clinical trial NCT03223155?
This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03223155 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03223155's enrollment target sits among peer trials
78 697th of 2000 higher than 1,298 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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