SAS (N=69) | EAS (N=62) | |
Age | 58.0 (33.0, 76.0) | 58.0 (33.0, 76.0) |
BMI, kg/m2 | 23.2 (16.5, 30.8) | 23.1 (16.5, 30.8) |
Sex, n (%) | ||
Male | 38 (55.1) | 33 (53.2) |
Female | 31 (44.9) | 29 (46.8) |
Ethnicity | 69 (100) | 62 (100) |
Chinese | 69 (100) | 62 (100) |
ECOG PS | ||
0 | 3 (4.3) | 3 (4.8) |
1 | 66 (95.7) | 59 (95.2) |
Smoking status | ||
Current or former smokers | 20 (29.0) | 17 (27.4) |
Never smoked | 49 (71.0) | 45 (72.6) |
Tumor histology | ||
Adenocarcinoma | 68 (98.6) | 61 (98.4) |
NSCLC not otherwise specified | 1 (1.4) | 1 (1.6) |
Site of metastasis | ||
Liver | 8 (11.6) | 5 (8.1) |
CNS | 13 (18.8) | 11 (17.7) |
Bone | 24 (34.8) | 22 (35.5) |
Disease stage | ||
IIIB | 2 (2.9) | 2 (3.2) |
IV | 67 (97.1) | 60 (96.8) |
Prior EGFR mutation type | ||
Exon 19 deletion | 39 (56.5) | 35 (56.5) |
Exon 21 L858R | 28 (40.6) | 26 (41.9) |
Others* | 2 (2.9) | 1 (1.6) |
EGFR T790M mutation | ||
Positive | 20 (29.0) | 18 (29.0) |
Negative/unknown | 49 (71.0) | 44 (71.0) |
Prior antitumor treatment | ||
Neoadjuvant/adjuvant | 10 (14.5) | 8 (12.9) |
1L systematic therapy | 65 (94.2) | 59 (95.2) |
2L systematic therapy | 32 (46.4) | 29 (46.8) |
Prior EGFR TKI treatment | ||
First/second G TKI | 26 (37.7) | 23 (37.1) |
Third G TKI | 9 (13.0) | 7 (11.3) |
First/second G TKI+ third G TKI | 34 (49.3) | 32 (51.6) |
Prior anti-angiogenesis treatment | ||
Yes | 22 (31.9) | 18 (29.0) |
No | 47 (68.1) | 44 (71.0) |
Prior systematic chemotherapy† | ||
Yes | 12 (17.4) | 11 (17.7) |
No | 57 (82.6) | 51 (82.3) |
Data are the median (range) and n (%).
*Others including patients with G719X or L861Q mutation.
†Patients received prior monotherapy or limited courses of doublet chemotherapy for advanced NSCLC.
CNS, central nervous system; EAS, efficacy analysis set; ECOG PS, Eastern Cooperative Oncology Group performance status; EGFR, epidermal growth factor receptor; G, generation; 1L, first line; 2L, second line; NSCLC, non-small cell lung cancer; SAS, safety analysis set; TKI, tyrosine kinase inhibitor.