Randomized parallel group phase III trial for patients with NSCLC
Research type
Research Study
Full title
A randomized parallel group phase III trial of OSE2101 as 2nd or 3rd line compared with standard treatment (docetaxel or pemetrexed) in HLA‐A2 positive patients with locally advanced (IIIB) unsuitable for radiotherapy or metastatic (IV) Non‐Small‐Cell Lung Cancer. (OSE2101C301).
IRAS ID
199415
Contact name
David Farrugia
Contact email
Sponsor organisation
OSE Immunotherapeutics
Eudract number
2015-003183-36
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 11 months, 16 days
Research summary
NSCLC is the most frequent type of lung cancer and one of the two main groups of lung cancer (the other group is Small Cell Cancer). NSCLC represents 85-90% of lung cancer cases. There are three common types of NSCLC and they are grouped together because they behave in a similar way and respond to treatment in a different way to small cell lung cancer. The three types are adenocarcinoma, squamous cell carcinoma, and large cell carcinoma.
This study aims to compare a new immunotherapy called OSE2101 and the purpose of the study is to show that OSE2101 is superior to the current usual treatment called standard of care (docetaxel or pemetrexed) in prolonging survival.
The study will be conducted in approximately 70 sites in Europe and USA. A total of 500 patients will participate in the study
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
16/EM/0220
Date of REC Opinion
6 Jul 2016
REC opinion
Further Information Favourable Opinion