Radiation and Immune Checkpoints Blockade in Metastatic NSCLC (BMS # CA209-632)

Non Small Cell Lung Cancer Metastatic Clinical Trial

Official title: Radiation and Immune Checkpoints Blockade in Metastatic NSCLC (BMS # CA209-632)

Status Terminated

Clinical Trial Summary

NSCLC patients with metastatic disease who have failed at least one prior treatment and have a minimum of two metastatic lesions (at least one measurable), are eligible if they have an ECOG Performance Status of 0-1. Patients will receive on Day 1, ipilimumab (every 6 weeks) concurrently with radiation (6Gy x 5 fractions). Nivolumab (every 2 weeks) will be given in addition to ipilimumab on day 22.

Clinical Trial Description

NSCLC patients with metastatic disease who have failed at least one prior treatment and have a minimum of two metastatic lesions (at least one measurable), are eligible if they have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.

Non-ablative radiotherapy (6GyX5) is directed to one lesion during a first immunotherapy treatment with Ipilimumab 3 mg/kg (± 24hrs from first RT dose). On day 22 the combined treatment of ipilimumab plus nivolumab will start (nivolumab 240mg q 2 weeks, ipilimumab 1mg/kg q 6 weeks), and administered until evidence of progression.

Patients are re-imaged at Week 9 (day 70 ± 7) to evaluate for response (defined as an objective response by RECIST of the measurable metastatic sites outside the radiation field). This response will be evaluated assessing clinical and positron emission computed tomography (PET/CT) responses in the non-irradiated measurable metastatic sites using RECIST 1.1. ;

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non Small Cell Lung Cancer Metastatic

• NCT number: NCT03168464
• Study type: Interventional
• Source: Weill Medical College of Cornell University
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: October 9, 2017
• Completion date: March 11, 2022