Table 1. Patient Characteristics.
| Variable | No. (%) | ||
|---|---|---|---|
| Nivolumab plus ipilimumab (n = 125) | Nivolumab (n = 127) | Total (N = 252) | |
| Age, median (range), y | 67.5 (41.8-83.4) | 68.1 (48.6-90.3) | 67.5 (41.8-90.3) |
| Men | 83 (66) | 86 (68) | 169 (67) |
| Women | 42 (34) | 41 (32) | 83 (33) |
| Race/ethnicity | |||
| White | 102 (82) | 104 (82) | 206 (82) |
| Black | 17 (14) | 16 (13) | 33 (13) |
| Asian | 0 | 4 (3) | 4 (2) |
| Pacific Islander | 0 | 1 (1) | 1 (0.4) |
| Native American | 1 (1) | 2 (2) | 3 (1) |
| Multiracial | 1 (1) | 0 | 1 (0.4) |
| Unknown | 4 (3) | 0 | 4 (2) |
| Hispanic | 2 (2) | 1 (1) | 3 (1) |
| Unknown | 3 (2) | 0 | 3 (1) |
| No. of prior systemic therapies for stage IV or recurrent disease | |||
| 0a | 35 (28) | 35 (28) | 70 (28) |
| 1 | 73 (58) | 77 (61) | 150 (60) |
| 2 | 6 (5) | 7 (6) | 13 (5) |
| ≥3 | 3 (2) | 1 (1) | 4 (1) |
| Unknown | 8 (6) | 7 (6) | 15 (6) |
| Zubrod performance score | |||
| 0 | 36 (29) | 35 (28) | 71 (28) |
| 1 | 89 (71) | 92 (72) | 181 (72) |
| Weight loss in past 6 mo | |||
| <5% | 86 (69) | 93 (73) | 179 (71) |
| 5% to <10% | 25 (20) | 18 (14) | 43 (17) |
| 10% to <20% | 13 (10) | 13 (10) | 26 (10) |
| ≥20% | 1 (1) | 3 (2) | 4 (2) |
| Smoking status | |||
| Current | 48 (38) | 54 (43) | 102 (40) |
| Former | 75 (60) | 72 (57) | 147 (58) |
| Never | 2 (2) | 1 (1) | 3 (1) |
| Brain metastases at baseline | 8 (6) | 12 (9) | 20 (8) |
| Liver metastases at baseline | 23 (18) | 30 (24) | 53 (21) |
| Prior radiation therapy | |||
| Localized radiation | 36 (29) | 49 (39) | 85 (34) |
| Radiation with curative intent | 41 (33) | 45 (35) | 86 (34) |
a
Includes patients who received systemic therapy for stage I to III non–small cell lung cancer within 1 y of S1400I treatment.