Table 1.
Patient Baseline Demographic and Disease Characteristics in the Intention-to-Treat Population
| Characteristics | Pembrolizumab Plus Chemotherapy n = 65 | Placebo Plus Chemotherapy n = 60 |
|---|---|---|
| Age, y | ||
| Median (range) | 63.0 (31‒76) | 63.0 (39‒78) |
| Men, n (%) | 62 (95.4) | 57 (95.0) |
| ECOG PS, n (%) | ||
| 0 | 20 (30.8) | 11 (18.3) |
| 1 | 45 (69.2) | 49 (81.7) |
| Smoking status, n (%) | ||
| Current or former | 60 (92.3) | 54 (90.0) |
| Never | 5 (7.7) | 6 (10.0) |
| Histology, n (%) | ||
| Squamous | 64 (98.5) | 60 (100.0) |
| Adenosquamous | 1 (1.5) | 0 |
| Brain metastases, n (%) | 1 (1.5) | 3 (5.0) |
| PD-L1 TPS, n (%) | ||
| <1% | 25 (38.5) | 23 (38.3) |
| ≥1% | 37 (56.9) | 35 (58.3) |
| 1%–49% | 15 (23.1) | 20 (33.3) |
| ≥50% | 22 (33.8) | 15 (25.0) |
| Could not be evaluated | 3 (4.6) | 2 (3.3) |
| Taxane chemotherapy | ||
| Paclitaxel | 65 (100.0) | 60 (100.0) |
| Previous therapy, n (%) | ||
| Neoadjuvant or adjuvant therapy | 3 (4.6) | 2 (3.3) |
| Thoracic radiotherapy | 1 (1.5) | 1 (1.7) |
ECOG PS, Eastern Cooperative Oncology Group performance status; PD-L1, programmed death ligand 1; TPS, tumor proportion score.