Table 1. Ongoing studies incorporating RT and immunotherapy in SCLC.
Agent | Phase | Endpoint | Patients (n) | Details | NCT |
---|---|---|---|---|---|
Ipilimumab + nivolumab | II | Primary: OS; secondary: ORR, PFS, toxicity | LS-SCLC [260] | Open label, randomized to chemoradiation and PCI followed by either observation vs. induction ipilimumab + nivolumab ×4 and maintenance nivolumab | NCT02046733 |
Pembrolizumab | I | Primary: MTD; secondary: PFS | A: LS-SCLC [9]; B: ES-SCLC [80] | A: open label dose escalation of pembrolizumab with concurrent chemoradiation (platinum/etoposide ×4, 150 cGy BID to 45 Gy) followed by maintenance pembrolizumab; B: platinum/etoposide chemotherapy for up to 6 cycles followed by consolidative thoracic RT 300 cGY daily to 45 Gy, with concurrent pembrolizumab for cycle 3 and onward followed by maintenance pembrolizumab | NCT02402920 |
Tremelimumab + durvalumab | II | Primary: PFS; secondary: irRR, OS | Recurrent SCLC [20] | Open label, randomized to tremelimumab + durvalumab with or without SBRT immediately preceding immunotherapy | NCT02701400 |
SCLC, small cell lung cancer; OS, overall survival; ORR, objective response rate; PFS, progression-free survival; MTD, maximum tolerated dose; LS-SCLC, limited stage disease; ES-SCLC, extensive stage disease; PCI, prophylactic cranial irradiation; BID, twice daily; SBRT, stereotactic body radiation therapy; NCT, National Clinical Trials number.