drugset / Trial / NCT02083679
Sym004 in Subjects With Stage IV Non-small Cell Lung Cancer
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is a multi-center, open-label, Phase 1b, dose escalation trial of Sym004 administered in combination with 1 of 3 platinum-doublets in subjects with Stage IV Non-Small Cell Lung Cancer (NSCLC). The sponsor decided to discontinue the development of Sym004. Also the decision was made to discontinue the development of Sym004 in NSCLC indication. The decision to discontinue Sym004 in NSCLC was not related to any safety or efficacy findings regarding Sym004. As a result of the early discontinuation of the trial during the dose escalation part, the expansion cohort will no longer be performed hence the pre-specified secondary endpoints are not analyzed and were removed from the protocol based on protocol amendment 2 dated 31 March 2015.
Timeline
- Start
- 2014-07
- Primary completion
- 2015-08
- Completion
- 2015-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sym004 | Monoclonal antibody | 6 mg/kg | Intravenous |
| Subject | Sym004 | Monoclonal antibody | 12 mg/kg | Intravenous |
| Background | Carboplatin | Small molecule | 6 unknown | Intravenous |
| Background | Cisplatin | Other / unclassified | 75 mg/m2 | Intravenous |
| Background | Gemcitabine | Small molecule | 1250 mg/m2 | Intravenous |
| Background | Paclitaxel | Small molecule | 225 mg/m2 | Intravenous |
| Background | Pemetrexed | Small molecule | 500 mg/m2 | Intravenous |