OncRef

Clinical Trial: NCT03110978

Stereotactic Body Radiation Therapy With or Without Nivolumab in Treating Patients With Stage I-IIA or Recurrent Non-small Cell Lung Cancer

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 2

Lead Sponsor:M.D. Anderson Cancer Center
Information Provided By:M.D. Anderson Cancer Center
Last Update Posted:2026-06-22

Study Overview

Brief Summary

This phase II trial studies how well stereotactic body radiation therapy with or without nivolumab works in treating patients with stage I-IIA non-small cell lung cancer or cancer that has come back. 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. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving stereotactic body radiation therapy and nivolumab may work better at treating non-small cell lung cancer.

Official Title

Phase II Randomized Clinical Trials Comparing Immunotherapy Plus Stereotactic Ablative Radiotherapy (I-SABR) Versus SABR Alone for Stage I, Selected Stage IIa, or Isolated Lung Parenchymal Recurrent Non-Small Cell Lung Cancer: I-SABR

Conditions

Lung Atypical Carcinoid Tumor, Lung Neuroendocrine Neoplasm, Lung Non-Small Cell Squamous Carcinoma, Minimally Invasive Lung Adenocarcinoma, Neuroendocrine Carcinoma, Recurrent Lung Adenocarcinoma, Recurrent Lung Large Cell Carcinoma, Recurrent Lung Non-Small Cell Carcinoma, Stage I Lung Cancer AJCC v8, Stage IA1 Lung Cancer AJCC v8, Stage IA2 Lung Cancer AJCC v8, Stage IA3 Lung Cancer AJCC v8, Stage IB Lung Cancer AJCC v8, Stage IIA Lung Cancer AJCC v8

Intervention / Treatment

  • Biological: Nivolumab
  • Radiation: Stereotactic Body Radiation Therapy

Other Study ID Numbers

  • 2016-0737
  • NCI-2018-01212
  • 2016-0737

Start Date (Actual)

2017-06-26

Primary Completion Date (Estimated)

2028-06-30

Study Completion Date (Estimated)

2028-06-30

Enrollment (Actual)

140

Study Type

Interventional

Phase

Phase 2