Table 5 Ongoing trials for evaluating combination strategies of checkpoints inhibitor in advanced NSCLC with brain metastasis
From: Achievements and futures of immune checkpoint inhibitors in non-small cell lung cancer
Identifier | Title | Phase | Population | Arms | Primary endpoint | Secondary endpoint | Status | Primary completion |
|---|---|---|---|---|---|---|---|---|
NCT02978404 | Combining radiosurgery and nivolumab in the treatment of brain metastases | II | Stage IV NSCLC or ccRCC with brain metastasis | Nivolumab (240 mg IV q2 week or 480 mg IV q4 week) and Radiosurgery [15–20 Gray (Gy) in 1 fraction] | Intracranial PFS | Treated brain lesions control rate, OS, PFS, neurocognitive function, toxicity and etc | Recruiting | 1-Jun-21 |
NCT02858869 | Pembrolizumab and stereotactic radiosurgery for melanoma or non-small cell lung cancer brain metastases | I | NSCLC or melanoma with brain metastasis | Arm A (pembrolizumab, SRS 6Â Gy) | Proportion of dose limiting toxicities | ORR, OS, rate of local recurrence and etc | Recruiting | 1-Oct-20 |
Arm B (pembrolizumab, SRS 9Â Gy) | ||||||||
Arm C (pembrolizumab, SRS 18–21 Gy) | ||||||||
NCT02696993 | Nivolumab and radiation therapy with or without ipilimumab in treating patients with brain metastases from non-small cell lung cancer | I/II | Stage IV NSCLC with brain metastasis | Arm A (nivolumab, SRS) | RP2D and Intracranial PFS | Neurocognitive changes | Recruiting | 31-Dec-20 |
Arm B (nivolumab, WBRT) | ||||||||
Arm C (nivolumab, ipilimumab, SRS) | ||||||||
Arm D (nivolumab, ipilimumab, WBRT) | ||||||||
NCT02681549 | Pembrolizumab plus bevacizumab for treatment of brain metastases in metastatic melanoma or non-small cell lung cancer | II | NSCLC or melanoma with brain metastasis | Pembrolizumab plus bevacizumab | BMRR | ORR, PFS, safety and toxicity, biomarkers for efficacy prediction | Recruiting | 1-May-21 |