Spots Global Cancer Trial Database for Immunotherapy With Non-Ablative Radiation in Previously Untreated Patients With Stage IV NSCLC

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Trial Identification

Brief Title: Immunotherapy With Non-Ablative Radiation in Previously Untreated Patients With Stage IV NSCLC

Official Title: A Phase II Trial of Immunotherapy With Non-Ablative Radiation in Previously Untreated Patients With Stage IV NSCLC

Study ID: NCT05691829

Conditions

NSCLC Stage IV

Interventions

Pembrolizumab

Radiation

Chemotherapy

Study Description

Brief Summary: The purpose of this study is to test if low dose radiation, which is routinely used in treating patients with lung cancer for symptom control, can improve the results from the standard treatment with pembrolizumab and chemotherapy. In this study, only individuals who have NSCLC that is advanced (Stage IV), or has come back (recurred), will be able to participate.

Detailed Description: This is a phase II open-label trial of pembrolizumab sequentially following upfront non-ablative focal therapy to up to five distinct metastatic subsites in de novo stage IV Non-Small Cell Lung Cancer (NSCLC). The primary goal of this trial is to evaluate the efficacy defined by time to progression or death with upfront non-ablative focal radiation (RT) to index lesions as a way of enhancing the anti-tumor immune response to pembrolizumab. Adult patients with metastatic NSCLC, with at least 2 measurable lesions and those Patients with metastatic NSCLC who are previously untreated are eligible for the study if they meet all inclusion criteria, and do not satisfy any exclusion criteria. Participants will receive standard of care immunotherapy of Pembrolizumab in addition to non-ablative radiation. The intervention is the low dose fractionation, 4Gy x 5, in the upfront treatment of de novo stage IV NSCLC in up to five distinct subsites of metastatic NSCLC.