NCT02083679

Sym004 in Subjects With Stage IV Non-small Cell Lung Cancer

A Phase Ib, Open-label, Dose Escalation Trial Investigating Different Doses and Schedules of Sym004 in Combination With Platinum-doublets in Subjects With Stage IV Non-small Cell Lung Cancer

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: EMD Serono · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Carcinoma, Non-Small-Cell Lung

Interventions

Type	Name	Description
DRUG	Part 1: Sym004 6 mg/kg + Cisplatin/Gemcitabine	Sym004 will be administered as an intravenous infusion at a dose of 6 mg/kg weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject meets any of the criteria for subject withdrawal, or withdrawal from the investigational medicinal product (IMP) in combination with platinum-doublet chemotherapy regimen of cisplatin/gemcitabine (cisplatin 75 mg/m\^2 on Day 1 plus gemcitabine 1250 mg/m\^2 on Days 1 and 8 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
DRUG	Part 1: Sym004 6 mg/kg + Cisplatin/Pemetrexed	Sym004 will be administered as an intravenous infusion at a dose 6 mg/kg weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject meets any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of cisplatin/pemetrexed (cisplatin 75 mg/m\^2 plus pemetrexed 500 mg/m\^2 on Day 1 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
DRUG	Part 1: Sym004 6 mg/kg + Carboplatin/Paclitaxel	Sym004 will be administered as an intravenous infusion at a dose 6 mg/kg weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject meets any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of carboplatin/paclitaxel (carboplatin area under the concentration-time curve (AUC) = 6 milligram per millilitre per minute \[mg/mL/min\] plus paclitaxel 225 mg/m\^2 on Day 1 of 3-Week cycle intravenously for a maximum of 6 treatment cycles).
DRUG	Part 1: Sym004 6/12 mg/kg + Carboplatin/Paclitaxel	Sym004 will be administered as an intravenous infusion at a dose 6 mg/kg on Day 1 and 12 mg/kg on Day 8 of a 3-Week cycle until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject meets any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of carboplatin/paclitaxel (carboplatin AUC = 6 mg/mL/min plus paclitaxel 225 mg/m\^2 on Day 1 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).

Timeline

• Start date: 2014-07-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2014-03-11
• Last updated: 2016-10-25
• Results posted: 2016-10-25

Locations

2 sites across 2 countries: United States, Germany