Tactical
Research type
Research Study
Full title
Targeted stromal cells expressing TRAIL as a therapy for lung cancer
IRAS ID
228124
Contact name
Sam Janes
Contact email
Sponsor organisation
University College London
Eudract number
2015-005526-18
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 4 months, 1 days
Research summary
Over 45,000 people are diagnosed with lung cancer in the UK per year. It is the leading cause of cancer death worldwide, responsible for over 35,000 deaths per year in the UK. 80% of patients are diagnosed with non-small cell lung cancer (NSCLC) and of these approximately 40% have adenocarcinoma. Over 70% present with metastatic disease which cannot be cured with chemotherapy or radiotherapy. Novel therapies are needed.
Mesenchymal stromal cells (MSCs) have the ability to travel to tumour sites. We have isolated MSCs from umbilical cords and genetically modified them to express a protein called TRAIL (TNF-related apoptosis inducing ligand) which kills multiple cancer types when tested on cells in the laboratory and in animal models. We want to use these modified MSCs (MSCTRAIL) as a treatment in patients with metastatic lung adenocarcinoma.
The aim of the study is to evaluate the safety and anti-tumour activity of MSCTRAIL in addition to chemotherapy in NSCLC in a Phase I/II clinical trial.
Phase I will assess the safety and determine the recommended Phase II dose (RP2D) of MSCTRAIL in combination with pemetrexed/cisplatin chemotherapy. We will treat between 6 and 12 patients in phase I.
The second phase of the study will compare MSCTRAIL (at RP2D) and pemetrexed/cisplatin chemotherapy versus placebo and pemetrexed/cisplatin. Patients will be randomised 1:1 between the intervention and control arm. This is a double blind trial, where patients and the clinical team (with the exception of the nurse administering the therapy) will not know whether they are receiving MSCTRAIL or a placebo. Phase II will include 46 patients. The primary outcome will be tumour response rate at 12 weeks.REC name
London - West London & GTAC Research Ethics Committee
REC reference
18/LO/0009
Date of REC Opinion
20 Mar 2018
REC opinion
Further Information Favourable Opinion