NCT03867175

Immunotherapy With or Without SBRT in Patients With Stage IV Non-small Cell Lung Cancer

A Randomized Trial of Consolidative Immunotherapy With vs Without Thoracic Radiotherapy and / or Stereotactic Body Radiation Therapy (SBRT) After First-Line Systemic Therapy for Metastatic NSCLC

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase III trial studies immunotherapy and stereotactic body radiation therapy to see how well it works compared with immunotherapy alone after first-line systemic therapy (therapy that goes throughout the body) in treating patients with stage IV 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. 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 immunotherapy with stereotactic body radiation therapy may work better than immunotherapy alone in treating patients with non-small cell lung cancer.

Detailed description

PRIMARY OBJECTIVES: I. To compare progression-free survival of patients randomized to radiation and consolidative immunotherapy against those receiving consolidative immunotherapy alone. SECONDARY OBJECTIVES: I. To estimate overall survival in all patients and will compare overall survival of those randomized to radiation and consolidative immunotherapy against those receiving consolidative immunotherapy alone. II. In patients receiving radiation, to describe the rate of in-field local control and rate of out-of-field disease progression with serial imaging. III. In patients not receiving radiation, describe progression at known sites of disease after first line systemic therapy and rate of development of new metastases with serial imaging. IV. To evaluate toxicity associated with radiation followed by consolidative immunotherapy. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients undergo 3-10 treatments of stereotactic body radiation therapy (SBRT). Patients also receive pembrolizumab intravenously (IV) over 30 minutes every 3-4 weeks for 1 year at the discretion of the treating physician. ARM II: Patients receive pembrolizumab IV over 30 minutes every 3-4 weeks for 1 year at the discretion of the treating physician. After completion of study treatment, patients are followed up at 1 month, every 3 months for 1 year, every 6 months for the next 2 years, and then annually for 2 years.

Conditions

• Metastatic Lung Cancer
• Stage IV Lung Cancer

Interventions

Type	Name	Description
RADIATION	Stereotactic Body Radiation Therapy	Patients undergo 3-10 treatments of stereotactic body radiation therapy (SBRT)
BIOLOGICAL	Pembrolizumab	Patients undergo 3-10 treatments of SBRT. Patients also receive pembrolizumab IV over 30 minutes every 3-4 weeks for 1 year at the discretion of the treating physician.

Timeline

• Start date: 2019-06-24
• Primary completion: 2025-04-21
• Completion: 2025-04-21
• First posted: 2019-03-07
• Last updated: 2025-06-13
• Results posted: 2025-06-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study