|
Characteristic
|
Placebo arm [cases (%)]
|
Anlotinib arm [cases (%)]
|
|---|
|
Total
|
143
|
294
|
|---|
|
Gender
|
|
Male
|
97 (67.8)
|
188 (63.9)
|
|
Female
|
46 (32.2)
|
106 (36.1)
|
|
Smoking status
|
|
Never smoked
|
66 (46.2)
|
151 (51.4)
|
|
Light ex-smoker
|
67 (46.9)
|
130 (44.2)
|
|
Current smoker
|
10 (7.0)
|
13 (4.4)
|
|
Baseline ECOG PS
|
|
0
|
22 (15.4)
|
59 (20.1)
|
|
1
|
120 (83.9)
|
233 (79.3)
|
|
2
|
1 (0.7)
|
2 (0.7)
|
|
Pathologic type
|
|
Adenocarcinoma
|
108 (75.5)
|
228 (77.6)
|
|
Squamous or adenosquamous cell carcinoma
|
33 (23.1)
|
53 (18.0)
|
|
Other types
|
2 (1.4)
|
13 (4.4)
|
|
Clinical stage at screening
|
|
IIIB
|
7 (4.9)
|
15 (5.1)
|
|
IV
|
136 (95.1)
|
277 (94.2)
|
|
Others
|
0
|
2 (0.7)
|
|
Number of metastatic site
|
|
≤ 3
|
81 (56.6)
|
171 (58.2)
|
|
> 3
|
62 (43.4)
|
123 (41.8)
|
|
Surgery history
|
91 (63.6)
|
153 (52.0)
|
|
Pre-chemotherapy
|
|
Two lines
|
78 (54.5)
|
167 (56.8)
|
|
Three lines or more
|
65 (45.5)
|
123 (41.8)
|
|
After first line
|
0
|
4 (1.4)
|
|
EGFR mutation statusa
|
|
Wild-type
|
98 (68.5)
|
201 (68.4)
|
|
Sensitive mutation
|
45 (31.5)
|
93 (31.6)
|
|
ALK status
|
|
Positive
|
2 (1.4)
|
5 (1.7)
|
|
Negative
|
136 (95.1)
|
277 (94.2)
|
|
Unknown
|
5 (3.5)
|
12 (4.1)
|
|
Pre-TKI usea in EGFR mutation patient
|
42 (93%)
|
91 (98%)
|
- ECOG, Eastern Cooperative Oncology Group; PS, performance status; EGFR, epidermal growth factor receptor; ALK, anaplastic lymphoma kinase; TKI, tyrosine kinase inhibitor
- aEGFR mutations include Exon 19 deletion and Exon 21 Leu858Arg. Pre-TKI use include: gefitinib, erlotinib, acotenib, afatinib and AZD9291
