drugset / Trial / NCT02318368
A Phase 2, Study of Ficlatuzumab Plus Erlotinib vs. Placebo Plus Erlotinib in Subjects With Previously Untreated Metastatic, EGFR-mutated NSCLC and BDX004 Positive Label
RandomizedParallel-groupTriple-blindTreatment
Summary
Phase 2 multicenter, controlled, randomized, double-blind study to evaluate the efficacy and safety of ficlatuzumab versus placebo when administered with erlotinib in subjects with previously untreated metastatic EGFR-mutated NSCLC and BDX004 Positive Label.
Timeline
- Start
- 2014-11
- Primary completion
- 2017-01
- Completion
- 2017-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ficlatuzumab | Monoclonal antibody | 20 mg/kg | Intravenous |
| Background | Erlotinib | Small molecule | 150 mg | Oral |