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Table 1 Baseline demographics and disease characteristics of the 437 patients with advanced non-small cell lung cancer who were enrolled in the ALTER0303 trial

From: China National Medical Products Administration approval summary: anlotinib for the treatment of advanced non-small cell lung cancer after two lines of chemotherapy

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%)
  1. ECOG, Eastern Cooperative Oncology Group; PS, performance status; EGFR, epidermal growth factor receptor; ALK, anaplastic lymphoma kinase; TKI, tyrosine kinase inhibitor
  2. aEGFR mutations include Exon 19 deletion and Exon 21 Leu858Arg. Pre-TKI use include: gefitinib, erlotinib, acotenib, afatinib and AZD9291