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

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

78

Participants

Timeline

Start Date

September 7, 2017

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2027

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.

Trial Locations (1)

60637

University of Chicago, Chicago

All Listed Sponsors
lead

University of Chicago

OTHER