Last updated on January 2020

A Randomized Two Arm Phase II Trial of Pembrolizumab Alone or Sequentially Following Single Fraction Non-ablative Radiation to One of the Target Lesions in Previously Treated Patients With Stage IV NSCLC


Brief description of study

This study looks at patients with advanced lung cancer. Participants in this study will be randomized into two groups. The first group will have radiation plus a drug (pembrolizumab). The second group will have only the drug (pembrolizumab). Tumors of participants will be measured to see if the addition of radiation changes the growth of the tumor compared to the drug alone.

Detailed Study Description

This is a Phase 2 randomized two arm phase II trial of pembrolizumab alone or sequentially following focal radiation to one of the target lesions, in previously treated patients with stage IV Non-Small Cell Lung Cancer (NSCLC). The primary goal of this trial is to compare the efficacy of focal radiation (RT) to an index lesion as a way of enhancing the anti-tumor immune response to pembrolizumab to that of pembrolizumab alone. The primary efficacy endpoint is overall RECIST-defined response outside the radiation field. To accomplish this goal 66 patients will be randomized 2:1 (stratified by histology (squamous versus non-squamous) and refractory versus non-refractory disease) to radiation plus pembrolizumab or pembrolizumab only, respectively.

Primary Objective: To determine the tumor responses outside the radiation field (abscopal effect) after radiation followed by pembrolizumab in metastatic NSCLC.

Secondary Objectives:

  1. To determine the progression-free and overall survival in patients with NSCLC receiving pembrolizumab, who receive Single Fraction Radiation Therapy (SFRT)
  2. To determine the safety and toxicity of the combination of SFRT and pembrolizumab
  3. To examine potential predictive biomarkers in tumor samples and peripheral blood in patients treated with pembrolizumab and SFRT
  4. To determine the local control of SFRT in the radiated lesion, when SFRT is given with pembrolizumab
  5. To evaluate the induction of a T-cell response in patients with metastatic NSCLC treated with radiation and the effect of radiation

Clinical Study Identifier: NCT02658097

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