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

PHASE1TerminatedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

July 31, 2014

Primary Completion Date

August 31, 2015

Study Completion Date

August 31, 2015

Conditions
Carcinoma, Non-Small-Cell Lung
Interventions
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).

Trial Locations (2)

Unknown

Please Contact U.S. Medical Information Located in, Rockland

Please contact the Merck KGaA Communication Center located in, Darmstadt

Sponsors

Lead Sponsor

All Listed Sponsors
lead

EMD Serono

INDUSTRY

NCT02083679 - Sym004 in Subjects With Stage IV Non-small Cell Lung Cancer | Biotech Hunter | Biotech Hunter