Table 1

Patient demographics and baseline characteristics

Cohort A1*
Cohort AOverallECOG PS 2Asymptomatic untreated brain metastases
(N=391)(N=198)†(n=139)‡(n=49)§
Age, years
Median (range)65.0 (26–89)67.0 (39–90)67.0 (39–90)64.0 (40–78)
<75 years, n (%)331 (84.7)157 (79.3)108 (77.7)48 (98.0)
≥75 years, n (%)60 (15.3)41 (20.7)31 (22.3)1 (2.0)
Sex, n (%)
Male236 (60.4)127 (64.1)90 (64.7)28 (57.1)
Female155 (39.6)71 (35.9)49 (35.3)21 (42.9)
Race, n (%)
White379 (96.9)194 (98.0)138 (99.3)46 (93.9)
Black6 (1.5)3 (1.5)1 (0.7)3 (6.1)
Other5 (1.3)1 (0.5)00
Not reported1 (0.3)000
Region, n (%)
North America121 (30.9)24 (12.1)17 (12.2)5 (10.2)
Europe270 (69.1)144 (72.7)100 (71.9)41 (83.7)
Other030 (15.2)22 (15.8)3 (6.1)
ECOG PS, n (%)
0171 (43.7)18 (9.1)0 (0)15 (30.6)
1217 (55.5)50 (25.3)10 (7.2)30 (61.2)
23 (0.8)130 (65.7)129 (92.8)4 (8.2)
Smoking status, n (%)
Never smoker32 (8.2)17 (8.6)13 (9.4)6 (12.2)
Former/current smoker357 (91.3)177 (89.4)123 (88.5)42 (85.7)
Unknown2 (0.5)4 (2.0)3 (2.2)1 (2.0)
Disease stage, n (%)
IV344 (88.0)185 (93.4)130 (93.5)49 (100.0)
Recurrent47 (12.0)13 (6.6)9 (6.5)0
Histology, n (%)
Non-squamous281 (71.9)139 (70.2)88 (63.3)45 (91.8)
Adenocarcinoma268 (68.5)127 (64.1)80 (57.6)41 (83.7)
Large cell6 (1.5)5 (2.5)4 (2.9)0
Bronchoalveolar1 (0.3)000
Other6 (1.5)7 (3.5)4 (2.9)4 (8.2)
Squamous110 (28.1)59 (29.8)51 (36.7)4 (8.2)
Tumor PD-L1 expression, n (%)¶
Evaluable357 (91.3)171 (86.4)119 (85.6)43 (87.8)
≥1%176 (49.3)76 (44.4)52 (43.7)20 (46.5)
<1%181 (50.7)95 (55.6)67 (56.3)23 (53.5)
≥50%65 (18.2)32 (18.7)22 (18.5)8 (18.6)
EGFR mutation status, n (%)
Positive8 (2.0)**2 (1.0)**1 (0.7)**1 (2.0)**
Not detected279 (71.4)129 (65.2)83 (59.7)40 (81.6)
Not reported104 (26.6)67 (33.8)55 (39.6)8 (16.3)
  • *Patients belonging to multiple subgroups are included in each of the subgroups.

  • †Includes all special populations: ECOG PS 2, untreated brain metastases, renal impairment, hepatic impairment, and positive HIV status.

  • ‡Includes five patients with untreated brain metastases, one with renal impairment, and three with hepatic impairment.

  • §Includes five patients with ECOG PS 2 and one patient with positive HIV status.

  • ¶Assessed on tumor tissue collected prior to treatment initiation, as described in the online supplemental methods, and calculated as a percentage of evaluable patients.

  • **Of the eight EGFR mutations in cohort A, three were sensitizing; neither of the two EGFR mutations in cohort A1 was sensitizing.

  • ECOG PS, Eastern Cooperative Oncology Group performance status; EGFR, epidermal growth factor receptor; PD-L1, programmed death ligand 1.