表 5.
ICIs二线治疗晚期NSCLC临床研究结果汇总
Summary of results from phase Ⅲ clinical trials of ICIs as second-line therapy for advanced NSCLC
| 治疗模式 | 病理学类型 | 研究 | 样本量 | PD-L1表达 | 治疗组 | mOS（mon） | 生存率 | mPFS（mon） | ORR |
| Doc：多西他赛；*主要研究终点。临床研究释义详见附录。 | |||||||||
| 单药 | 非鳞癌 & 鳞癌 | KEYNOTE- 010[45, 46] | 1, 033 | ≥50% | 帕博利珠单抗vs Doc | *16.9 vs 8.2 (HR=0.55) |
25.0% vs 8.2% (5年) | *5.3 vs 4.2 (HR=0.57) |
33.1% vs 9.2% |
| 442 | ≥1% | *11.8 vs 8.4 (HR=0.70) |
15.6% vs 6.5% (5年) | *4.0 vs 4.1 (HR=0.84) |
21.2% vs 9.6% | ||||
| OAK[47, 48] | 1, 225 | / | 阿替利珠单抗vs Doc | *13.3 vs 9.8 (HR=0.78) |
16% vs 9% (4年) | 2.8 vs 4.0 (HR=0.95) |
14% vs 13% | ||
| CheckMate 078[49, 50] | 504 | / | 纳武利尤单抗vs Doc | *11.9 vs 9.5 (HR=0.75) |
19% vs 12% (3年) | 2.8 vs 2.8 (HR=0.78) |
18% vs 4% | ||
| 鳞癌 | CheckMate 017[51, 52] | 272 | / | 纳武利尤单抗vs Doc | *9.2 vs 6.0 (HR=0.62) |
12.3% vs 3.6% (5年) | 3.5 vs 2.8 (HR=0.62) |
20% vs 9% | |
| 非鳞癌 | CheckMate 057[52, 53] | 582 | / | 纳武利尤单抗vs Doc | *12.2 vs 9.5 (HR=0.70) |
14.0% vs 2.1% (5年) | 2.3 vs 4.2 (HR=0.92) |
19% vs 12% | |