Table 1.
Landmark trials of radiotherapy combined with PD-1/PD-L1 inhibitors for the treatment of NSCLC
| NCT number | Patients | Tumor stage | PD-1/PD-L1 inhibitor | Radiotherapy planning | Treatment schedule | Outcomes | Reference | |||
|---|---|---|---|---|---|---|---|---|---|---|
| ORR | PFS (months) | OS (months) | AE (3-5) | |||||||
| NCT01295827 | 97 | Stage IV advanced |
Pembrolizumab 10 mg/kg q2w or 10 mg/kg q3w or 2 mg/kg q2w |
Previously received any radiotherapy | Pembrolizumab with a history of radiotherapy vs pembrolizumab alone | NR | mPFS 4.4 vs. 2.1; p = 0.019 | mOS 10.7 vs. 5.3; p = 0.026 | Treatment-related pulmonary toxicity 13% vs. 1% | 58 |
| NCT02343952 | 92 | Stage III | Pembrolizumab 200 mg q3w for up to 1 year | 59–66.6 Gy radiotherapy | Concurrent chemoradiation with consolidation pembrolizumab | NR | mPFS 15.4 m 12, 18, and 24-month PFS were 59.9%, 49.5%, and 45.4% respectively | Estimates of 12 and 24-months OS were 80.5% and 68.7% respectively | G ≥ 2 pneumonitis 17.2%; G3-4 pneumonitis 5.4%, no other G3/4 toxicities exceeded 5% | 59 |
| NCT02125461 | 709 | Stage III | Durvalumab 10 mg/kg q2w for up to 12 months | Previously definitive chemoradiotherapy | Durvalumab + previous chemoradiotherapy vs placebo + previous chemoradiotherapy | 28.4% vs. 16.0%; p < 0.001 | mPFS 16.8 vs. 5.6; p < 0.001 | mOS 23.2 vs. 14.6; p < 0.001 | 29.9% vs. 26.1% | 60 |
| NCT02621398 | 21 | Stage III | Pembrolizumab 200 mg q3w or 100 mg q3w | Concurrent chemoradiotherapy (60 Gy in 30 fractions) | Pembrolizumab + concurrent chemoradiotherapy | NR | mPFS with at least 1 dose of pembrolizumab 18.7 m; mPFS with at least 2 doses of pembrolizumab 21 m | mOS 29.4 m | NR | 62 |
| NCT02608385 | 79 | Advanced Solid Tumors | Pembrolizumab 200 mg q3w | SBRT 30 to 50 Gy in 3 to 5 fractions | Pembrolizumab + multisite SBRT | 13.2% | mPFS 3.1 m | mOS 9.6 m | DLT rate 9.7% | 29 |
| NCT02492568 | 92 | Advanced | Pembrolizumab 200 mg/kg q3w | 24 Gy in 3 fractions | Pembrolizumab alone vs. pembrolizumab + SBRT | 18% vs. 36%; p = 0.07 | mPFS 1.9 vs 6.6; p = 0.19 | mOS 7.6 vs. 15.9; p = 0.16 | NR | 63 |
ORR overall response rate, mPFS median progression-free survival, mOS median overall survival, AE adverse effect, DLT dose-limiting toxicity