EMR100070-004: Phase III study of avelumab vs docetaxel in NSCLC
Research type
Research Study
Full title
A Phase III open-label, multicenter trial of avelumab (MSB0010718C) versus docetaxel in subjects with non-small cell lung cancer that has progressed after a platinum-containing doublet
IRAS ID
173661
Contact name
Nicola Louise Steele
Contact email
Sponsor organisation
Merck KGaA
Eudract number
2014-005060-15
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
pIND 122898, IND Number
Duration of Study in the UK
1 years, 2 months, 17 days
Research summary
The research study is testing the investigational drug, avelumab (MSB0010718C) for treatment of non-small cell lung cancer (NSCLC). Avelumab belongs to a group of drugs called anti-PDL1 (programmed death ligand 1) antibodies. They are considered to work by regulating the immune process in the body (or the cells that attack the body) that is thought to cause NSCLC.
The main purpose of this study is to demonstrate superiority with regard to overall survival of avelumab versus docetaxel in subjects with PD-L1 positive NSCLC after failure of combination chemotherapy. Doxetaxel is approved by health authorities for prolonging overall survival.
Therefore, half of the subjects will be chosen randomly to receive avelumab intravenously (into the vein) every 2 weeks and the other half will receive doxetaxel intravenously every 3 weeks. Assessments include medical history, demographic data, subject reported outcomes/quality of life questionnaires, physical examination, vital signs, echocardiogram (ECG), urine and blood tests, tumour assessments (CT/MRI scans) and a possible tumour biopsy to test the PD-L1 status. The PD-L1 status will be measured using a PD-L1 assay test which is an investigational device that is under development and not currently approved by any regulatory health agency for commercial use.
Approximately 650 subjects worldwide will be enrolled; this includes about 19 UK subjects. The research is anticipated to last until 2021 including a 5 year follow-up period. Treatment for all subjects will continue until disease progression (unless if in the Investigator’s opinion, the subject will benefit from continued treatment), unacceptable toxicity, or discontinuation.
Post treatment follow-up will consist of an End-of-treatment visit 4 weeks after the last treatment administration, a long-term follow-up visit 12 weeks after the last administration and follow-up for safety, disease progression or survival for up to 5 years after the last subject receives the last dose of avelumab.
REC name
West of Scotland REC 1
REC reference
15/WS/0121
Date of REC Opinion
27 Jul 2015
REC opinion
Further Information Favourable Opinion