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

Stage IV Small Cell Lung Cancer Clinical Trial

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)

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Carcinoma
• Stage IV Small Cell Lung Cancer

• NCT number: NCT03223155
• Study type: Interventional
• Source: University of Chicago
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: September 7, 2017
• Completion date: December 2027