Table 1.
Baseline characteristics in the ITT population
| Characteristic | Serplulimab plus CF group (n = 368) | Placebo plus CF group (n = 183) |
|---|---|---|
| Age (years) | ||
| Median (IQR) | 64 (57–68) | 64 (57–68) |
| <65 | 199 (54%) | 98 (54%) |
| ≥65 | 169 (46%) | 85 (46%) |
| Sex | ||
| Male | 317 (86%) | 153 (84%) |
| Female | 51 (14%) | 30 (16%) |
| ECOG performance status | ||
| 0 | 93 (25%) | 53 (29%) |
| 1 | 275 (75%) | 130 (71%) |
| Disease statusa | ||
| Locally advanced | 46 (13%) | 29 (16%) |
| Distantly metastatic | 322 (88%) | 154 (84%) |
| Number of organs with metastases | ||
| 1 | 184 (50%) | 104 (57%) |
| ≥2 | 184 (50%) | 79 (43%) |
| Sites of metastases | ||
| Lymph node | 365 (99%) | 182 (99%) |
| Lung | 96 (26%) | 42 (23%) |
| Liver | 71 (19%) | 32 (17%) |
| Bone | 48 (13%) | 15 (8%) |
| PD-L1 expression | ||
| 1 ≤ CPS < 10 | 206 (56%) | 104 (57%) |
| CPS ≥ 10 | 162 (44%) | 79 (43%) |
| Smoking status | ||
| Current or former smoker | 232 (63%) | 115 (63%) |
| Never smoked | 136 (37%) | 68 (37%) |
Data are presented as n (%) unless otherwise stated. Sex was recorded by the investigators according to the identity information provided by the patients. CF, cisplatin and 5-FU.
aPercentages may not add up to 100% owing to rounding.