Table 1 Patient baseline characteristics
Characteristic | Total (n=64) | Dose-escalation phase (n=26) | Dose-expansion phase (n=38) |
|---|---|---|---|
Age, years | |||
 Mean (SD) | 51.3 (9.1) | 51.4 (8.5) | 51.2 (9.6) |
Sex, n (%) | |||
 Male | 32 (50.0) | 15 (57.7) | 17 (44.7) |
 Female | 32 (50.0) | 11 (42.3) | 21 (55.3) |
Tumor histology, n (%) | |||
 Adenocarcinoma | 62 (96.9) | 26 (100.0) | 36 (94.7) |
 Others | 2 (3.1) | 0 (0.0) | 2 (5.3) |
ALK-testing method | |||
 IHC | 30 (46.9) | 10 (38.5) | 20 (52.6) |
 FISH | 24 (37.5) | 12 (46.2) | 12 (31.6) |
 PCR | 9 (14.0) | 3 (11.5) | 6 (15.8) |
 NGS | 1 (1.6) | 1 (3.8) | 0 (0.0) |
ECOG PS, n (%) | |||
 0 | 48 (75.0) | 19 (73.1) | 29 (76.3) |
 1 | 16 (25.0) | 7 (26.9) | 9 (23.7) |
Smoking status, n (%) | |||
 Presence | 19 (29.7) | 12 (46.2) | 7 (18.4) |
 Absence | 45 (70.3) | 14 (53.8) | 31 (81.6) |
Prior chemotherapy, n (%) | |||
 None | 13 (20.3) | 2 (7.7) | 11 (28.9) |
 One regimen | 30 (46.9) | 13 (50.0) | 17 (44.7) |
 Two regimens | 15 (23.4) | 7 (26.9) | 8 (21.1) |
 Three or more regimens | 6 (9.4) | 4 (15.4) | 2 (5.3) |
Prior ALK TKIs, n (%) | |||
 ALK TKI-naïve | 41 (64.1) | 14 (53.8) | 27 (71.1) |
 Received crizotinib previously | 23 (35.9) | 12 (46.2) | 11 (28.9) |