NCT03176173

Radical RADiotherapy and Immunotherapy for Metastatic CAncer of the Lung (RRADICAL)

Radical-Dose Image Guided Radiation Therapy in Treating Patients With Metastatic Non-small Cell Lung Cancer Undergoing Immunotherapy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well radical-dose image guided radiation therapy works in treating patients with non-small cell lung cancer that has spread to other places in the body who are undergoing immunotherapy. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving radical-dose image guided radiation therapy to patients with non-small cell lung cancer may help to improve response to immunotherapy anti-cancer treatment.

Detailed description

PRIMARY OBJECTIVES: I. Determine if progression-free survival at 24 weeks with this treatment combination is improved compared to historical controls who received immunotherapy without radiation therapy. SECONDARY OBJECTIVES: I. Assess acute (0-6 months) and late (\> 6 months) grade 3-5 toxicity. II. Assess overall survival. III. Correlate circulating tumor deoxyribonucleic acid (DNA) (ratio of post-radiation therapy \[RT\] to pre-RT level) with radiographic response. IV. Correlate immune markers in peripheral blood with radiographic response. TERTIARY OBJECTIVES: I. Analyze progression-free survival with immune-related response criteria. II. Measure time to discontinuation of study immunotherapy agent. III. Assess patterns of progression. OUTLINE: Patients are assigned to 1 of 2 arms. ARM I: Patients undergo radical-dose image guided radiation therapy daily for up to 10 days (within 2 weeks) while undergoing standard of care immunotherapy. Arm II: Patients who decline to undergo radiation therapy receive standard of care immunotherapy. After completion of study treatment, patients are followed up at 30 days and every 6 months thereafter.

Conditions

• Stage IV Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
RADIATION	Image-guided Radiation Therapy	Ablative treatment as 50 Gy in 5 or 10 fractions. Non-ablative treatment as 27 Gy in 3 fractions, or 40 Gy in 10 fractions.
DRUG	Immunotherapy (physician's choice for standard of care immunotherapy)	Continue regular medical care immunotherapy. Other than being an anti-PD-1 or anti-PD-L1 immunotherapy, the agent, dose, and schedule is not specified by protocol.

Timeline

• Start date: 2017-06-28
• Primary completion: 2021-11-24
• Completion: 2025-01-31
• First posted: 2017-06-05
• Last updated: 2025-11-05
• Results posted: 2025-11-05

Locations

1 site across 1 country: United States