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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 6 Gy) Proportion of dose limiting toxicities ORR, OS, rate of local recurrence and etc Recruiting 1-Oct-20
Arm B (pembrolizumab, SRS 9 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
  1. Systematic immunotherapy has been an important part for advanced NSCLC, but the efficacy in CNSs metastasis patients is still under exploring
  2. RP2D recommended phase 2 dose, BMRR, brain metastasis response rate, SRS stereotactic radiosurgery, WBRT whole-brain radiotherapy