NCT03035890

Hypofractionated Radiation Therapy to Improve Immunotherapy Response in Non-Small Cell Lung Cancer

Use of Response-Adapted Hypofractionated Radiation Therapy to Potentiate the Systemic Immune Response to Checkpoint Inhibitors in Non-Small Cell Lung Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: West Virginia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study includes the additional use of radiation therapy in combination immunotherapy in order to determine whether the radiation may improve the response of non-small cell lung cancer to immunotherapy and to monitor any side effects.

Detailed description

Preclinical data suggest that radiation therapy may be uniquely suited to combine with immune checkpoint inhibitors, since radiation can disrupt a tumor's physical barriers to T-cell infiltration and augment antigen presentation, thus serving as an "in situ personalized vaccine" to activate the immune system and potentially enhance the systemic response. The rationale for this study is to determine the safety and efficacy of combined immune checkpoint inhibitors and radiation therapy in metastatic non-small cell lung cancer patients.

Conditions

• Non Small Cell Lung Cancer Metastatic

Interventions

Type	Name	Description
RADIATION	Radiation	Radiation therapy will be administered in 3 or 5 fractions over 3-10 days, at a recommended dose of 8-15 Gy per fraction for 3 total fractions (total dose 24-45 Gy) or 6-10 Gy per fraction for 5 total fractions (total dose 30-50 Gy)
DRUG	Immuno-Therapeutic Agent	Immune checkpoint inhibitors that are FDA approved for use in patients with metastatic NSCLC will be acceptable for use concurrently with radiotherapy in this trial. The choice of agents will be at the treating medical oncologist's discretion, and include: * Nivolumab 240mg or 3 mg/kg once every 2 weeks (14 day cycle) * Pembrolizumab 200mg or 2 mg/kg once every 3 weeks (21 day cycle) * Atezolizumab 1200 mg once every 3 weeks (21 day cycle) These agents should be continued per standard of care until either disease progression or unacceptable toxicity.

Timeline

• Start date: 2017-01-23
• Primary completion: 2022-06-30
• Completion: 2022-06-30
• First posted: 2017-01-30
• Last updated: 2025-04-01
• Results posted: 2025-04-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study