drugset / Trial / NCT02191891
Xentuzumab (BI 836845) Plus Afatinib in Patients With Epidermal Growth Factor Receptor (EGFR) Mutant Non-small Cell Lung Cancer (NSCLC)
Non-randomizedSingle-groupOpen-labelTreatment
Summary
Part A: To determine the maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) of Xentuzumab (BI 836845) in combination with afatinib in patients with non-small cell lung cancer with progression following prior treatment (EGFR TKI or platinum-based chemotherapy). Part B: To evaluate the early anti-tumour activity of Xentuzumab (BI 836845) in combination with afatinib in patients with EGFR mutant non-small cell lung cancer with progression following prior irreversible EGFR TKIs. Part A and B: To evaluate the safety and pharmacokinetics of BI 836845 in combination with afatinib in patients with non-small cell lung cancer
Timeline
- Start
- 2014-10-21
- Primary completion
- 2018-04-18
- Completion
- 2018-04-18
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Afatinib | Small molecule | 20 mg | Oral |
| Subject | Afatinib | Small molecule | 30 mg | Oral |
| Subject | Afatinib | Small molecule | 40 mg | Oral |
| Subject | Xentuzumab | Monoclonal antibody | 1000 mg | Intravenous |