Clinical trial · Interventional
Immunotherapy SBRT Sensitization of the Programmed Death-1 (PD-1) Effect
A Prospective Trail of Immunotherapy and Stereotactic Body Radiotherapy (SBRT) for the Treatment of Metastatic Lung Cancer: SBRT Sensitization of the Programmed Death-1 (PD-1) Effect
NCT03825510CI-TRIAL-00064450I-SABRcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Nonsmall Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stereotactic Body Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment Arm
- interventionNames
- Radiation: Stereotactic Body Radiotherapy
Primary outcomes (2)
- measure
- Overall Survival
- timeFrame
- 24 months
- description
- Determine overall survival in patients receiving SBRT and immunotherapy as compared to landmark trials of patients receiving immunotherapy alone (Checkmate 057, Keynote 024)
- measure
- Acute Toxicity: Radiation pnuemonitis measured using NCI CTCAE version 4.0
- timeFrame
- 0-15 weeks
- description
- Determine excess/unexpected toxicity that cannot be attributed to routine radiation therapy or immunotherapy side effects.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.