Table. Baseline Characteristics of Patients in the ITT Population.
| Characteristic | Patients, No. (%) | |
|---|---|---|
| Ensartinib (n = 143) | Crizotinib (n = 147) | |
| Age, median (range), y | 54 (25-86) | 53 (26-90) |
| >65 y | 24 (16.8) | 23 (15.6) |
| Sex | ||
| Male | 72 (50.3) | 77 (52.4) |
| Female | 71 (49.7) | 70 (47.6) |
| Race and ethnicity | ||
| Non-Asiana | 66 (46.2) | 63 (42.9) |
| Asian | 77 (53.8) | 84 (57.1) |
| ECOG performance status | ||
| 0 or 1 | 136 (95.1) | 139/146 (95.2) |
| 2 | 7 (4.9) | 7/146 (4.8) |
| History of tobacco use | ||
| Never smoked | 85 (59.4) | 94 (63.9) |
| Current or former smoker | 58 (40.6) | 53 (36.1) |
| Stage of disease | ||
| IIIB | 13 (9.1) | 10 (6.8) |
| IV | 130 (90.9) | 137 (93.2) |
| ALK status assessed centrallyb | 121 (84.6) | 126 (85.7) |
| Brain metastases at baselinec | 47 (32.9) | 57 (38.8) |
| Previous radiotherapy to brain | 7 (4.9) | 7 (4.8) |
| Previous chemotherapy | 34 (23.8) | 42 (28.6) |
Abbreviations: ALK, anaplastic lymphoma kinase gene; ECOG, Eastern Cooperative Oncology Group; ITT, intent-to-treat.
a
Non-Asian patients included White (ensartinib, 63 [44.1%]; crizotinib, 57 [38.8%]), Black or African American (ensartinib, 1 [0.7%]; crizotinib, 3 [2.0%]), and other (ensartinib, 3 [2.1%]; crizotinib, 4 [2.7%]).
b
ALK positivity assessed by the Abbott fluorescence in situ hybridization assay.
c
The presence of brain metastases was assessed by a blinded independent review committee.