This phase II trial studies how well radical-dose image guided radiation therapy works in treating patients with stage I-IV non-small cell lung cancer 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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03176173.
PRIMARY OBJECTIVE:
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.
EXPLORATORY 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) in the absence of disease progression or unacceptable toxicity, 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.
Lead OrganizationStanford Cancer Institute Palo Alto
Principal InvestigatorMichael Gensheimer