Palo Alto, California 94304

  • Small Cell Lung Cancer

Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: - Has metastatic non-small cell lung cancer (NSCLC) - Has been receiving anti-PD-1 or anti-PD-L1 immunotherapy for at least four weeks - Has had restaging imaging after initiation of immunotherapy, at least 4 weeks after pre-immunotherapy baseline imaging; computed tomography (CT) or positron emission tomography (PET)/CT of at least chest/upper abdomen must be performed within 4 weeks prior to registration; for patients with history of brain metastases, brain magnetic resonance imaging (MRI) or CT is required within 4 weeks of registration; for other patients brain MRI or CT is required within 12 weeks of registration - Is expected by the treating medical oncologist to continue on immunotherapy for at least three more months; imaging must show response, stable disease, or modest progression as determined by the treating medical oncologist; if there is modest progression, the patient must be clinically stable in terms of performance status and overall disease-related symptoms - Has at least one extracranial tumor safely treatable with radical-dose radiation therapy - Eastern Cooperative Oncology Group (ECOG) performance status 0-2 - Has the ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: - Untreated brain metastases, if not planned to be treated in this course of radiation therapy - Pregnancy or women of childbearing potential not willing/able to use contraception during protocol treatment


NCT ID:

NCT03176173


Primary Contact:

Principal Investigator
Michael Gensheimer
Stanford University

Kim Nguyen
Phone: 650) 497-8966
Email: nknguyen@stanford.edu


Backup Contact:

N/A


Location Contact:

Palo Alto, California 94304
United States

Kim Nguyen
Phone: 650-497-8966
Email: nknguyen@stanford.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 18, 2021

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