Status:
COMPLETED
Immunotherapy SBRT Sensitization of the Programmed Death-1 (PD-1) Effect
Lead Sponsor:
Crozer-Keystone Health System
Collaborating Sponsors:
Saint Peters University Hospital
Community Medical Center, Toms River, NJ
Conditions:
Metastatic Nonsmall Cell Lung Cancer
Non Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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)...
Detailed Description
Blockade of the PD-1/PD-L1 T-cell checkpoint pathway is an effective and well tolerated approach to stimulating the immune response which is a critical option in the treatment of metastatic NSCLC. How...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 28 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 8 2022
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT03825510
Start Date
April 28 2017
End Date
March 8 2022
Last Update
March 6 2023
Active Locations (1)
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1
Philadelphia CyberKnife
Philadelphia, Pennsylvania, United States, 19083