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

Completed · Phase 2

Conditions studied: Metastatic Nonsmall Cell Lung Cancer, Non Small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT03825510

Run by

Crozer-Keystone Health System

People needed

3

Starts

2017-04-28

Expected to finish

2022-03-08

Last updated by the study team

2023-03-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• ANC ≥ 1.5 x 109/L
• Hemoglobin ≥9.0 g/dL
• 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.

You may not qualify if…

• 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.

Where it is running

• Philadelphia CyberKnife — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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