EMR100070-005: Avelumab vs platinum-based doublet in first line NSCLC
Research type
Research Study
Full title
A Phase III, open-label, multicenter trial of avelumab (MSB0010718C) versus platinum-based doublet as a first-line treatment of recurrent or Stage IV PD-L1+ non–small-cell lung cancer
IRAS ID
190004
Contact name
Pieter Postmus
Contact email
Sponsor organisation
Merck KGaA
Eudract number
2015-001537-24
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
IND Number, IND 122898
Duration of Study in the UK
6 years, 10 months, 31 days
Research summary
The research study is testing the investigational drug, MSB0010718C for treatment of patients with recurrent (has returned after treatment) or Stage 4 (the cancer has spread) non-small cell lung cancer (NSCLC). MSB0010718C belongs to a group of drugs called anti-PDL1 (programmed death ligand 1) antibodies. This type of drug is considered to work by regulating the immune process in the body (or the cells that attack the body).\n\nThe main purpose of this study is to find out if MSB0010718C is better at stopping the growth and spread (progression) of PD-L1 positive NSCLC compared to standard combination of chemotherapy in patients that have not had chemotherapy before.\n\nTherefore, half of the patients will be chosen randomly to receive MSB0010718C intravenously (into the vein) every 2 weeks until disease progression or unacceptable toxicity. The other half will receive the Investigator’s choice of combination chemotherapy intravenously every 3 weeks until disease progression or unacceptable toxicity up to 6 cycles. 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.\n\nApproximately 420 patients worldwide will be enrolled; this includes about 16 UK patients. The research is anticipated to last until 2022 including a 5 year follow-up period. \n\t\nPost treatment follow-up will consist of an End-of-treatment visit 4 weeks after the last treatment administration, a Safety follow-up visit 12 weeks after the last administration and follow-up for disease progression or survival for up to 5 years after the last patient receives the last dose of MSB0010718C.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
15/NW/0917
Date of REC Opinion
29 Jan 2016
REC opinion
Further Information Favourable Opinion