Patient demographics and baseline characteristics
| Characteristic | N=156 |
| Age | |
| Median (range), years | 69.5 (41 to 90) |
| <65, n (%) | 51 (32.7) |
| ≥65, n (%) | 105 (67.3) |
| Sex, n (%) | |
| Male | 83 (53.2) |
| Female | 73 (46.8) |
| Geographic region, n (%) | |
| North America | 127 (81.4) |
| Europe | 25 (16.0) |
| Asia | 4 (2.6) |
| Race, n (%) | |
| White | 124 (79.5) |
| Black or African American | 12 (7.7) |
| Asian | 6 (3.8) |
| Other | 14 (9.0) |
| ECOG PS, n (%) | |
| 0 | 46 (29.5) |
| 1 | 108 (69.2) |
| 2* | 2 (1.3) |
| Smoking status, n (%) | |
| Never used | 17 (10.9) |
| Regular user | 29 (18.6) |
| Occasional user | 2 (1.3) |
| Former user | 108 (69.2) |
| Time since first diagnosis, median (range), months | 2.0 (0.02 to 143.5) |
| Time since diagnosis of metastatic disease, median (range), months† | 1.5 (0.2 to 92.0) |
| Tumor histology, n (%) | |
| Squamous cell carcinoma | 46 (29.5) |
| Non-squamous cell carcinoma | 110 (70.5) |
| EGFR mutation status, n (%) | |
| Wild type | 137 (87.8) |
| Mutant‡ | 1 (0.6) |
| Unknown | 18 (11.5) |
| ALK mutation status, n (%) | |
| Wild type | 140 (89.7) |
| Mutant | 0 |
| Unknown | 16 (10.3) |
| KRAS mutation status, n (%) | |
| Wild type | 6 (3.8) |
| Mutant | 10 (6.4) |
| Unknown | 140 (89.7) |
| PD-L1 expression ≥1% of tumor cells, n (%) | |
| Positive | 88 (56.4) |
| Negative | 23 (14.7) |
| Not evaluable§ | 45 (28.8) |
| PD-L1 expression ≥50% of tumor cells, n (%) | |
| Positive | 53 (34.0) |
| Negative | 58 (37.2) |
| Not evaluable§ | 45 (28.8) |
| PD-L1 expression ≥80% of tumor cells, n (%) | |
| Positive | 38 (24.4) |
| Negative | 73 (46.8) |
| Not evaluable§ | 45 (28.8) |
*Both patients had an ECOG PS of 1 at baseline, which had increased to 2 at the first dose of study treatment.
†Data missing for six patients.
‡This patient was permitted to enroll following discussions between the investigator and the sponsor based on expected resistance to available tyrosine kinase inhibitor therapy.
§Reasons for PD-L1 expression not being evaluable included tumor sample containing insufficient tumor cells (<100), non-evaluable sample type (eg, cytology specimen), and no tumor tissue available for analysis.
ALK, anaplastic lymphoma kinase; ECOG PS, Eastern Cooperative Oncology Group performance status; EGFR, epidermal growth factor receptor; PD-L1, programmed death ligand-1.