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Concurrent or Sequential Immunotherapy and Radiation Therapy in Patients With Metastatic Lung Cancer

NCT03223155 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2026-03-04

No results posted yet for this 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.

Conditions

  • Stage IV Small Cell Lung Cancer

Interventions

DRUG

Nivolumab

Patients in Sequential Arm will begin treatment with nivolumab (given with ipilimumab) between 1-7 days after completion of SBRT. Patients in Concurrent arm will begin treatment with nivolumab (given with ipilimumab) first and will continue treatment within 2 weeks, after completion of SBRT to 2-4 sites. In both arms, patients will receive treatment with nivolumab 3 mg/kg as a 30-minute infusion +/- 10 minutes every 2 weeks for a maximum of 24 months. Patients will receive treatment on days 1, 15, and 29 of each 6 week cycle.

DRUG

Ipilimumab

Patients in Sequential Arm will begin treatment with ipilimumab (given with nivolumab) between 1-7 days after completion of SBRT. Patients in Concurrent arm will begin treatment with ipilimumab (given with nivolumab) first and will continue treatment within 2 weeks, after completion of SBRT to 2-4 sites. In both arms, patients will receive treatment with ipilimumab 1 mg/kg as a 30-minute +/- 10 minutes infusion every 6 weeks for a maximum of 24 months. Patients will receive treatment on day 1 of each 6 week cycle.

RADIATION

Stereotactic body radiation therapy

All patients will receive 3 or 5 fractions of radiation as determined by the location of the lesions to be irradiated. There should be a minimum of 40 hours between treatments for an individual lesion. However, a patient may receive radiation for different lesions on consecutive days. Starting dose depends on metastasis locations.

Sponsors & Collaborators

  • University of Chicago

    lead OTHER

Principal Investigators

  • Steven Chmura, MD, PhD · University of Chicago

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-07
Primary Completion
2026-12-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03223155 on ClinicalTrials.gov