A randomized, controlled trial evaluating the efficacy and safety of BTH1677 in combination with bevacizumab, carboplatin, and paclitaxel in first-line treatment of advanced non-small cell lung cancer

Table 1 Patient demographics and disease characteristics at baseline (Safety population)

	BTH1677/ Bevacizumab/Carboplatin/ Paclitaxel (N = 59)	Bevacizumab/ Carboplatin/ Paclitaxel (N = 30)
Age (years)
Median (range)^a	59 (43, 76)	58 (28, 75)
Sex, n (%)
Male	26 (44.1)	14 (46.7)
Female	33 (55.9)	16 (53.3)
Race, n (%)
White	57 (96.6)	30 (100.0)
Black	1 (1.7)	0
Asian or Pacific Islander	1 (1.7)	0
ECOG Performance Status, n (%)
0	31 (52.5)	20 (66.7)
1	28 (47.5)	10 (33.3)
Disease stage at randomization
Stage IIIB	0	0
Stage IV	59 (100.0)	30 (100.0)
Time from initial tumor diagnosis to diagnosis of stage IIIB/IV NSCLC (days)^b
Median (range)	0 (0, 3158)	0 (0, 0)
Time from diagnosis of stage IIIB/IV NSCLC to randomization (days)^c
Median (range)	18 (1, 168)	17.5 (7, 77)
Time from initial tumor diagnosis to randomization (days)^d
Median (range)	20 (1, 3171)	17.5 (7, 77)
Prior cancer treatment, n (%)
Radiotherapy	2 (3.4)	0
Surgery	8 (13.6)	2 (6.7)
Chemotherapy, hormonal, or other^e	2 (3.4)	0

Abbreviations: ECOG Eastern Cooperative Oncology Group, N overall sample size, n number of patients, NSCLC non-small cell lung cancer
^aInclusion criteria restricted patients to 18 to 75 years of age but one 76-year-old patient was inadvertently enrolled in the study
^bTime from initial tumor diagnosis to diagnosis of Stage IIIB/IV NSCLC = Stage IIIB/IV diagnosis date - initial tumor diagnosis date
^cTime from diagnosis of Stage IIIB/IV NSCLC to randomization = Date of randomization - Stage IIIB/IV diagnosis date
^dTime from initial tumor diagnosis to randomization = Date of randomization –initial tumor diagnosis date
^eTwo patients in the BTH1677 arm received prior chemotherapy for lung cancer. Both patients were previous responders and received the prior chemotherapy greater than 6 months prior to enrollment