Table 1 Baseline patient characteristics
Phase I | Phase II | ||||
|---|---|---|---|---|---|
Dalotuzumab 5 mg/kg plus erlotinib cohort 1 | Dalotuzumab 10 mg/kg plus erlotinib cohort 2 | Erlotinib | Dalotuzumab plus erlotinib | ||
n =4 | n =16 | n =38 | n =37 | ||
Gender | Gender | ||||
Male | 4 (100%) | 14 (87.6%) | Male | 28 (73.7%) | 27 (73%) |
Female | 0 (0%) | 2 (12.5%) | Female | 10 (26.3%) | 10 (27%) |
Age (years) | Age (years) | ||||
Mean | 53.8 | 61.9 | Mean | 58.5 | 61.9 |
SD | 3.9 | 7.7 | SD | 10.4 | 7.83 |
Median | 53.5 | 62.0 | Median | 59.0 | 62.0 |
Range | 50 to 58 | 50 to 72 | Range | 36 to 80 | 45 to 77 |
Race | Race | ||||
Caucasian | 4 (100%) | 16 (100%) | Caucasian | 36 (94.7%) | 37 (100%) |
Asian | 0 (0%) | 0 (0%) | Asian | 2 (5.3%) | 0 (0%) |
ECOG performance status | ECOG performance status | ||||
0 | 4 (100%) | 5 (31.4%) | 0 | 13 (34.2%) | 11 (29.7%) |
1 | 0 (0%) | 11 (68.8%) | 1 | 24 (63.2%) | 24 (64.9%) |
2 | 0 (0%) | 0 (0%) | 2 | 1 (2.6%) | 2 (5.5%) |
Stage | Stage | ||||
IIIB | 1 (25%) | 2 (12.5%) | IIIB | 9 (23.7%) | 4 (10.8%) |
IV | 3 (75%) | 14 (87.5%) | IV | 29 (76.3%) | 33 (89.2%) |
Smoking history | Smoking history | ||||
Current smoker | 1 (25%) | 5 (31.1%) | Current smoker | 7 (18.4%) | 12 (32.4%) |
Former smoker | 3 (75%) | 7 (43.8%) | Former smoker | 20 (52.6%) | 21 (56.8%) |
Never smoker | 0 (0%) | 4 (25%) | Never smoker | 11 (28.9%) | 4 (10.8%) |
Previous therapies | Previous treatments | ||||
Mean | 1.5 | 1.5 | First-line only | 20 (52.6%) | 27 (72.9%) |
Median | 1 | 1.5 | First- and second-line | 18 (47.4%) | 10 (27.02%) |
Range | 1 to 3 | 1 to 3 | Prior platinum-containing regimen | 38 (100%) | 35 (94.6%) |
Previous diagnosis of diabetes | 0 (0%) | 4 (25%) | Previous diagnosis of diabetes | 4 (10.4%) | 2 (5.4%) |
Previous treatments for diabetes | 0 (0%) | 4 (25%) | Previous treatments for diabetes | 4 (10.4%) | 2 (5.4%) |
Glimepiridine | 1 (2.6%) | 0 (0%) | |||
Glyburide | 0 (0%) | 1 (6.2%) | Glyburide | 1 (2.6%) | 0 (0%) |
Insulin | 0 (0%) | 1 (6.2%) | Insulin | 0 (0%) | 1 (2.7%) |
Metformin | 0 (0%) | 1 (6.2%) | Metformin | 1 (2.6%) | 1 (2.7%) |
Rapaglinide | 0 (0%) | 1 (6.2%) | Pioglitazone | 1 (2.6%) | 0 (0%) |
Histology | Histology | ||||
Adenocarcinoma | 1 (25%) | 5 (31.3%) | Adenocarcinoma | 15 (39.5%) | 14 (37.8%) |
Squamous cell carcinoma | 3 (75%) | 4 (25%) | Squamous cell carcinoma | 6 (15.8%) | 11 (29.7%) |
Large cell carcinoma | 0 (0%) | 1 (6.3%) | Large cell carcinoma | 0 (0%) | 1 (2.7%) |
Not otherwise specified | 0 (0%) | 6 (37.5%) | Not otherwise specified | 17 (44.7%) | 11 (29.7%) |