Table 1.
Clinical characteristics of patients enrolled in the dose escalation cohort of the PEMBIB phase 1b trial
| DL1 Nintedanib 150 mg bid N = 6 |
DL2 Nintedanib 200 mg bid N = 6 |
Total N = 12 |
|
|---|---|---|---|
| Sex | |||
| Male | 3 (50%) | 3 (50%) | 6 (50%) |
| Female | 3 (50%) | 3 (50%) | 6 (50%) |
| Age, Median (range) | 62 (43–74) | 49 (40–67) | 59 (40–74) |
| ECOG PS | |||
| 0 | 3 (50%) | 4 (67%) | 7 (58%) |
| 1 | 3 (50%) | 2 (33%) | 5 (42%) |
| Breast cancer | 0 | 1 (17%) | 1 (8%) |
| Cervical cancer | 2 (33%) | 0 | 2 (17%) |
| Colorectal carcinoma dMMR | 1 (17%) | 0 | 1 (8%) |
| Gastric carcinoma | 1 (17%) | 0 | 1 (8%) |
| Renal clear cell carcinoma | 1 (17%) | 0 | 1 (8%) |
| Caecal neuroendocrine carcinoma | 0 | 1 (17%) | 1 (8%) |
| Peritoneal mesothelioma | 0 | 1 (17%) | 1 (8%) |
| Pleural mesothelioma | 0 | 1 (17%) | 1 (8%) |
| Thymic carcinoma | 0 | 2 (33%) | 2 (17%) |
| Nasopharyngeal undifferenciated carcinoma | 1 (17%) | 0 | 1 (8%) |
| Median previous lines of treatment | 2 (1–5) | 1.5 (1–2) | 2 (1–5) |
| Lung Immune Prognostic Index (LIPI) | |||
| Good | 6 (100%) | 2 (33%) | 8 (67%) |
| Intermediate | 0 | 4 (67%) | 4 (33%) |
| Poor | 0 | 0 | 0 |
| GRIm-score | |||
| 0–1 | 6 (100%) | 3 (50%) | 9 (75%) |
| 2–3 | 0 | 3 (50%) | 3 (25%) |
| Median Neutrophil (.103/mm3) (range) | 4.45 (3.6–6.1) | 3.75 (2–5.4) | 4.2 (2.5–6.1) |
| Median Lymphocytes (.103/mm3) (range) | 1.4 (1.2–3.2) | 1.1 (0.6–1.4) | 1.2 (0.6–3.2) |
| Median Albumin (g/L) (range) | 40 (36–44) | 42.5 (35–50) | 40.5 (35–50) |
| Median LDH UI/L (range) | 186 (147–245) | 288 (154–550) | 208 (147–550) |
| Median CRP (mg/L) (range) | 11.1 (5.9–68.2) | 17.3 (4.9–49.8) | 11.1 (4.9–68.2) |