OncRef

Clinical Trial: NCT02444741

Pembrolizumab and Stereotactic Body Radiation Therapy or Non-Stereotactic Wide-Field Radiation Therapy in Treating Patients With Non-small Cell Lung Cancer

Status:

COMPLETED

Phase:

Phase 1

Lead Sponsor:M.D. Anderson Cancer Center
Information Provided By:M.D. Anderson Cancer Center
Last Update Posted:2026-05-15

Study Overview

Brief Summary

This randomized phase I/II trial studies the side effects and best dose of pembrolizumab when given together with stereotactic body radiation therapy or non-stereotactic wide-field radiation therapy (conventional radiation therapy) and to see how well they work in treating patients with non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving pembrolizumab together with radiation therapy may kill more tumor cells.

Official Title

Phase I/II Trial of MK-3475 and Hypofractionated Stereotactic Radiation Therapy in Patients With NSCLC

Conditions

Malignant Solid Neoplasm, Metastatic Lung Non-Small Cell Carcinoma, Stage IV Lung Non-Small Cell Cancer AJCC v7

Intervention / Treatment

  • Radiation: 3-Dimensional Conformal Radiation Therapy
  • Radiation: Intensity-Modulated Radiation Therapy
  • Other: Laboratory Biomarker Analysis
  • Biological: Pembrolizumab
  • Radiation: Proton Beam Radiation Therapy
  • Radiation: Radiation Therapy
  • Radiation: Stereotactic Body Radiation Therapy

Other Study ID Numbers

  • 2014-1020
  • NCI-2015-01505
  • 2014-1020

Start Date (Actual)

2015-09-17

Primary Completion Date (Actual)

2026-02-17

Study Completion Date (Actual)

2026-02-17

Enrollment (Actual)

124

Study Type

Interventional

Phase

Phase 1, Phase 2