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晚期肺鳞癌免疫治疗的Ⅱ/Ⅲ期临床研究
Phase Ⅱ/Ⅲ clinical trials of immunotherapy for advanced lung squamous cell carcinoma
| Clinical trial | Phase | Patients with SqCLC (%) | Screening criteria of PD-L1 expression | Study design | Control group [mOS (95%CI) (mon)] | Experimental group [mOS (95%CI) (mon)] | HR (95%CI; P) |
| -: not reported; mon: months; SqCLC: squamous cell lung cancer; PD-L1: programmed death-ligand 1; mOS: median overall survival; TPS: tumor proportion score; TC: tumor cells; IC: tumor-infiltrating immune cells; ITT: intention-to-treat; NE: not estimable. | |||||||
| Second-line treatment for advanced SqCLC | |||||||
| CheckMate 017[38] | Ⅲ | 100 | - | Nivolumab vs Docetaxel | 6.0 (5.1-7.3) | 9.2 (7.3-12.6) | 0.59 (0.44-0.79, P < 0.001) |
| CheckMate 078[39] | Ⅲ | 39-40 | - | Nivolumab vs Docetaxel | 7.9 (5.9-11.4) | 12.3 (9.5-14.6) | 0.61 (0.42-0.89) |
| KEYNOTE-010[40] | Ⅱ/Ⅲ | ≈24 | - | Pembrolizumab vs Docetaxel | - | - | 0.74 (0.50-1.09) |
| POPLAR[42] | Ⅱ | 34 | - | Atezolizumab vs Docetaxel | 8.6 | 10.1 | 0.80 (0.49-1.30) |
| OAK[41] | Ⅲ | 26 | - | Atezolizumab vs Docetaxel | 7.7 (6.3-8.9) | 8.9 (7.4-12.8) | 0.73 (0.54-0.98, P=0.038, 3) |
| JAVELIN Lung 200[37] | Ⅲ | 30-35 | - | Avelumab vs Docetaxel | 7.5 (5.9-10.6) | 10.6 (8.8-18.5) | 0.70 (0.48-1.01) |
| First-line monotherapy for advanced SqCLC | |||||||
| KEYNOTE-042[44] | Ⅲ | 36-39 | TPS≥1% | Pembrolizumab vs chemotherapy | - | - | 0.75 (0.60-0.93) |
| KEYNOTE-024[43] | Ⅲ | 17-18 | TPS≥50% | Pembrolizumab vs chemotherapy | - | - | 0.35 (0.17-0.71) |
| CheckMate 026[45] | Ⅲ | 24 | ≥1% | Nivoluamb vs chemotherapy | 10.2 | 10.5 | 0.82 (0.54-1.24) |
| MYSTIC[46, 47] | Ⅲ | 32 | TC ≥25% | Durvalumab/Durvalumab+Tre-melizumab vs chemotherapy | - | - | 0.89 (0.57-1.37) |
| First-line combination therapy for advanced SqCLC | |||||||
| KEYNOTE-407[48] | Ⅲ | 100 | - | Carboplatin+Paclitaxel/nab-Paclitaxel±Pembrolizumab | 11.6 (10.1-13.7) | 17.1 (14.4-19.9) | 0.71 (0.58-0.88) |
| IMpower131[49] | Ⅲ | 100 | - | Carboplatin+nab-Paclitaxel±Atezolizumab | ITT (n=340) 13.5 (12.2-15.1) TC3/IC3 n=44 10.2 (7.1-17.5) |
ITT (n=343) 14.2 (12.3-16.8) TC3/IC3 n=47 23.4 (17.8-NE) |
0.88 (0.73-1.05, P=0.158, 1) 0.48 (0.29-0.81) |
| CheckMate 227[51] | Ⅲ | 28-30 | - | Nivoluamb+Ipilimumab vs chemotherapy | 9.2 | 15.0 | 0.62 |