Table 1: Baseline characteristics of the intention-to-treat primary population.
| Atezolizumab (n=425) | Docetaxel (n=425) | Overall (N=850) | |
|---|---|---|---|
| Age (years) | |||
| Median (range) | 63·0 (33·0–82·0) | 64·0 (34·0–85·0) | 64·0 (33·0–85·0) |
| Age ≥65 years | 190 (45%) | 207 (49%) | 397 (47%) |
| Sex | |||
| Male | 261 (61%) | 259 (61%) | 520 (61%) |
| Female | 164 (39%) | 166 (39%) | 330 (39%) |
| Race | |||
| White | 302 (71%) | 296 (70%) | 598 (70%) |
| Asian | 85 (20%) | 95 (22%) | 180 (21%) |
| Black | 5 (1%) | 11 (3%) | 16 (2%) |
| Other* | 13 (3%) | 9 (2%) | 22 (3%) |
| Unknown | 20 (5%) | 14 (3%) | 34 (4%) |
| ECOG performance status | |||
| 0 | 155 (36%) | 160 (38%) | 315 (37%) |
| 1 | 270 (64%) | 265 (62%) | 535 (63%) |
| Tobacco use history | |||
| Never | 84 (20%) | 72 (17%) | 156 (18%) |
| Current | 59 (14%) | 67 (16%) | 126 (15%) |
| Previous | 282 (66%) | 286 (67%) | 568 (67%) |
| EGFR mutation | |||
| Positive | 42 (10%) | 43 (10%) | 85 (10%) |
| Negative | 318 (75%) | 310 (73%) | 628 (74%) |
| Unknown | 65 (15%) | 72 (17%) | 137 (16%) |
| EML4-ALK translocation | |||
| Positive | 2 (<1%) | 0 | 2 (<1%) |
| Negative | 223 (52%) | 201(47%) | 424 (50%) |
| Unknown | 200(47%) | 224 (53%) | 424 (50%) |
| KRAS mutation | |||
| Positive | 26 (6%) | 33 (8%) | 59 (7%) |
| Negative | 99 (23%) | 104 (24%) | 203 (24%) |
| Unknown | 300 (71%) | 288 (68%) | 588 (69%) |
| Histology | |||
| Non-squamous | 313 (74%) | 315 (74%) | 628 (74%) |
| Squamous | 112 (26%) | 110 (26%) | 222 (26%) |
| PD-L1 subgroups | |||
| TC3 or IC3 | 72 (17%) | 65 (15%) | 137 (16%) |
| TC2/3 or IC2/3 | 129 (30%) | 136 (32%) | 265 (31%) |
| TC1/2/3 or IC1/2/3† | 241 (57%) | 222 (52%) | 463 (54%) |
| TC0 and IC0 | 180 (42%) | 199 (47%) | 379 (45%) |
| Number of previous therapies in the locally advanced or metastatic setting | |||
| 1 | 320 (75%) | 320 (75%) | 640 (75%) |
| 2 | 105 (25%) | 105 (25%) | 210 (25%) |
Data are median (range) and n (%), unless otherwise indicated. ECOG=Eastern Cooperative Oncology Group. IC=tumour-infiltrating immune cell. PD-L1=programmed death-ligand 1. TC=tumour cell.
*
Other includes American Indian, Alaska native, Hawaiian native, other Pacific Islander, other, and multiple.
†
Tumour tissue for eight patients was not evaluable for TC1/2/3 or IC1/2/3.