Table 1.

Characteristics at Baseline of All the Patients Who Underwent Randomization.^*

Characteristic	Nivolumab (N = 271)	Chemotherapy (N=270)	Total (N = 541)
Age — yr
Median	63	65	64
Range	32–89	29–87	29–89
Age ≥75 yr — no. (%)	30 (11)	32 (12)	62 (11)
Female sex — no. (%)	87 (32)	122 (45)	209 (39)
Disease stage — no. (%)
Stage IV	255 (94)	244 (90)	499 (92)
Recurrent	16 (6)	25 (9)	41 (8)
Not reported	0	1 (<1)	1 (<1)
ECOG performance-status score — no. (%)†
0	85 (31)	93 (34)	178 (33)
1	183 (68)	174 (64)	357 (66)
≥2	2 (1)	3 (1)	5 (1)
Not reported	1 (<1)	0	1 (<1)
Smoking status — no. (%)
Never smoked	30 (11)	29 (11)	59 (11)
Former smoker	186 (69)	182 (67)	368 (68)
Current smoker	52 (19)	55 (20)	107 (20)
Unknown	3 (1)	4 (1)	7 (1)
Previous systemic therapy — no. (%)
Adjuvant	22 (8)	25 (9)	47 (9)
Neoadjuvant	5 (2)	4 (1)	9 (2)
Previous radiotherapy — no. (%)	102 (38)	107 (40)	209 (39)
Tumor histologic findings — no. (%)
Squamous-cell carcinoma	66 (24)	64 (24)	130 (24)
Nonsquamous-cell carcinoma	205 (76)	206 (76)	411 (76)
Selected site of metastatic lesions — no. (%)
Brain	33 (12)	36 (13)	69 (13)
Liver	54 (20)	36 (13)	90 (17)
Sum of target-lesion diameters — mm
Median	82	68	76
Range	(14–218)	(15–272)	(14–272)
PD-L1 expression level — no. (%)
≥5%	208 (77)	210 (78)	418 (77)
≥50%	88 (32)	126 (47)	214 (40)

^*PD-L1 denotes programmed death ligand 1.

^†The Eastern Cooperative Oncology Group (ECOG) performance-status score is assessed on a 5-point scale, with higher numbers indicating greater disability. Patients were required to have an ECOG performance-status score of 0 or 1 during screening. However, at baseline the score had worsened to 2 in five patients and was not reported in one patient.