CompletedPhase 2NCT03825510

Immunotherapy SBRT Sensitization of the Programmed Death-1 (PD-1) Effect

The purpose of this study is to determine efficacy, safety of Stereotactic Body Radiotherapy (SBRT) in combination with immunotherapy in participants with metastatic non-small cell lung cancer (NSCLC) who are eligible for an immunotherapy agent.

Checked against the public recordLast updated Mar 6, 2023 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 2
U.S. locations1
SponsorCrozer-Keystone Health System
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Crozer-Keystone Health System
Interventions being studied
Radiation: Stereotactic Body Radiotherapy
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Inclusion Criteria: * Histologically or cytologically confirmed Stage IV NSCLC according to the 7th AJCC staging manual. * Eligible for an immunotherapy agent. Patients who progress after drug therapy (3 months) for ALK, EGFR or ROS mutation positive lung cancer are eligible. * At least 2 lesions that are safely amenable to SBRT. ECOG \<=2. * At least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria for response assessment or at least 1 lesion with FDG avidity and CT correlate that can be monitored for PET-CT response by SUV Max increase or decrease. * Normal Hepatic and renal function. * Bone marrow reserve: 1. ANC ≥ 1.5 x 109/L 2. Hemoglobin ≥9.0 g/dL 3. Platelet count ≥75 x 109/L * Ability to comply with follow-up visits and evaluations, treatment planning and studies and other study related procedures and visits. * Ability to sign informed consent. Exclusion Criteria: * Patients with active CNS metastases * Active, known or suspected auto-immune disease. * Patients with medical conditions that require systemic immunosuppression. * Patients with a history of interstitial lung disease. * Prior treatment with immune checkpoint inhibitors/immonotherapy. * Other active malignancy requiring intervention. * Prior lung radiation, with the only metastatic targets in the lungs. * Unresolved toxicity from prior chemotherapy or anti-cancer treatment. * Current or prior enrollment in clinical trial with an investigational drug within 4 weeks. * Pregnancy or positive pregnancy test.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Philadelphia CyberKnifePhiladelphia, Pennsylvania

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 6, 2023. Always confirm current availability with the study team.

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