表 2.
NSCLC新辅助免疫治疗临床试验
Trials of neoadjuvant immunotherapy for NSCLC
| n | Stage | Surgical resection | Regimen | MPR | pCR | ORR | Potential predictor | Pathological downstage | > 3 TRAEs | Survival | ||
| PET：positron emission tomography; TRAE：Treatment-related adverse events | ||||||||||||
| ICI+S | NCT02259621[11] | 22 | Ⅰ-Ⅲa | 21 R0:20 |
Nivolumab*2+S | 9(45%) | 2 (10%) | 2 (10%) | TMB | 8 (40%) | 1 (5%) | 18 mon_RFS: 73% |
| ChiCTR-OIC-17013726[41] | 49 | Ia–Ⅲb | 37 | Sintilimab+S | 15 (40%) | 6 (16%) | 8 (20%) | PET-CT SUV downregulate > 30% | 14 (29%) | 4 (10%) | NA | |
| LCMC3 (NCT02927301) [13] | 101 /180 |
Ib-Ⅲa | 90 | Atezolizumab*2 +S |
15 (18%) | 4 (5%) | NA | NA | NA | 4 (4%) | NA | |
| IONESCO | 46 | Ib-Ⅲa | 44 R0:41 |
Durvalumab*3+S | 8 (17%) | 3 (7%) | 4 (9%) | 1yr_RFS: 78.2%; 1yr_OS: 89.1% |
||||
| PRINCEPS (NCT02994576) | 30 | Ⅰ-Ⅲa | 30 R0:29 |
Atezolizumab*1 +S |
4 (13%) | 0 | 2 (7%) | PD-L1 | NA | NA | ||
| NEOSTAR (NCT03158129) [15] | 23 | Ⅰ-Ⅲa | 21 | Nivolumab+S | 4 (17%) | 2 (9%) | NA | NA | NA | 1 death | NA | |
| (nivol+ipi) +S |
21 | 16 | (Nivolumab+ Ipilimumab)+S |
6 (29%) | 4 21%) | |||||||
| (ICI+CT) +S |
NCT01820754 (TOP1201) [20] | 24 | Ib-Ⅲa | 13 | CT*1+(Ipilimumab +CT)*2+S |
NA | NA | 14 (58%) | NA | NA | 11 (46%) | mOS: 29.2 mon |
| NCT02716038[18] | 30 | Ib-Ⅲa | 29 R0:26 |
(Atezolizumab +CT)*2+S |
17 (57%) | 10 (33%) | 19 (63%) | NA | 19 (63%) | 15 (50%) | mDFS: 17.9 mon | |
| SAKK 16/14 (NCT02572843)[19] | 68 | Ⅲa (N2) | 55 | (CT*3+Durvalumab*2) +S |
33 (60%) | 10(18%) | NA | NA | 37 (67%) | 59 (88%) | 1yr_EFS: 73.3% | |
| NADIM (NCT03081689) [34] | 46 | Ⅲa (N2) | 41 | (Nivolumab+CT)+S | 34 (83%) | 26 (63%) | 35 (76%) | PD-L1 | 29 (63%) | 16 (34%) | 2yr_PFS: 77.1%;
2yr_OS: 89.9% |
|