Table 1. Active clinical trials involving SBRT and immunotherapy in metastatic lung cancer.
| NCT number | Title (study drug if not in title) | Recruitment | Study endpoint | Phase | Enrollment |
|---|---|---|---|---|---|
| NCT02239900 | Ipilimumab and Stereotactic Body Radiation Therapy (SBRT) in Advanced Solid Tumors | MD Anderson, Houston, TX; recruiting 120 | Safety, irRC response rate | 1–2 | Active, closed to enrollment |
| NCT02444741 | Pembrolizumab and Stereotactic Body Radiation Therapy (SBRT) in Patients With Non-Small Cell Lung Cancer (NSCLC) | MD Anderson, Houston, TX; recruiting 104 | Safety, irRC response rate, PFS | 1–2 | Open |
| NCT02839265 | FLT3 Ligand Immunotherapy and Stereotactic Radiotherapy for Advanced Non-small Cell Lung Cancer (FLT3) | Albert Einstein, NYC, NY; recruiting 29 | 4-month PFS | 2 | Open |
| NCT03168464 | Radiation and Immune Checkpoints Blockade in Metastatic NSCLC (nivolumab/ipilimumab) | Cornell, NYC, NY; recruiting 45 | Response rate, PFS, OS | 1–2 | |
| NCT03275597 | Phase Ib Study of Stereotactic Body Radiotherapy (SBRT) in Oligometastatic Non-small Lung Cancer (NSCLC) With Dual Immune Checkpoint Inhibition (durvalumab/tremelimumab) | University of Wisconsin, Madison; recruiting 21 | Safety, PFS, OS | 1 | Open |
| NCT03223155 | Evaluate Concurrent Or Sequential Ipilimumab, Nivolumab, and Stereotactic Body Radiotherapy in Patients With Stage IV Non-Small Cell Lung Cancer | University of Chicago, IL; recruiting 80 | Safety, response rate | 1 | Open |
| NCT03313804 | Priming Immunotherapy in Advanced Disease With Radiation (any checkpoint inhibitor) | University of Kentucky, Lexington; recruiting 57 | 6-month PFS | 2 | Open |
| NCT03035890 | Hypofractionated Radiation Therapy to Improve Immunotherapy Response in Non-Small Cell Lung Cancer (nivolumab, pembrolizumab, or atezolizumab) | West Virginia University; recruiting 33 | Response rate, OS, PFS, QoL | 1 | |
| NCT02831933 | Trial of Stereotactic Body Radiation and Gene Therapy Before Nivolumab for Metastatic Non-Small Cell Lung Carcinoma (ENSIGN) | Methodist Hospital, Houston, TX; recruiting 29 | Response rate, PFS, OS | 2 | Open |
| NCT03224871 | A Pilot Study of Interlesional IL-2 and RT in Patients With NSCLC (nivolumab/pembrolizumab) | University of California, Davis; recruiting 30 | Safety, DFS | 1 | Open |
| NCT03158883 | Avelumab and Stereotactic Ablative Radiotherapy in Non-responding and Progressing NSCLC Patients | University of California, Davis; recruiting 26 | Response rate, PFS, OS, irRC | 1 | Open |
| NCT03176173 | Radical-Dose Image Guided Radiation Therapy in Treating Patients With Metastatic Non-small Cell Lung Cancer Undergoing Immunotherapy (nivolumab, pembrolizumab, or atezolizumab) | Stanford University, CA; recruiting 85 | PFS, OS, ctDNA changes | 2 | Open |
| NCT03050060 | Image Guided Hypofractionated Radiation Therapy, Nelfinavir Mesylate, Pembrolizumab, Nivolumab and Atezolizumab in Treating Patients With Advanced Melanoma, Lung, or Kidney Cancer | University of Washington, Seattle; recruiting 120 | Response rate, PFS, OS | 2 | Open |
| NCT02623595 | A Study of SBRT in Combination With rhGM-CSF for Stage IV NSCLC Patients Who Failed in Second-line Chemotherapy | Wuhan University, China; recruiting 60 | Abscopal effect rate, OS, PFS | 2 | Open |
| NCT03509584 | Phase I Multicenter Trial Combining Nivolumab, Ipilimumab and Hypo-fractionated Radiotherapy for Pretreated Advanced Stage Non-small Cell Lung Cancer Patients | France; recruiting 24 | Safety | 1 | Not yet open |
DFS, disease free survival; irRC, immune related response criteria; PFS, progression free survival; OS, overall survival; QoL, quality of life; ctDNA, circulating tumor DNA.