Targeted Stem Cells Expressing TRAIL as a Therapy for Lung Cancer
Status:
Recruiting
Trial end date:
2025-09-01
Target enrollment:
Participant gender:
Summary
The aim of the study is to evaluate the safety and anti-tumour activity of MSCTRAIL in
addition to chemotherapy in metastatic Non-small cell lung cancer (NSCLC) patients in a Phase
I/II clinical trial.
In the phase I study, patients will receive cisplatin and pemetrexed on day one followed by
MSCTRAIL cells on day 2. This constitutes one cycle of treatment. Each patient will receive 3
cycles of treatment at 21 day intervals. The aim of phase 1 is to estimate the recommended
Phase II dose (RP2D) of MSCTRAIL in combination with pemetrexed/cisplatin chemotherapy.
During the phase II study patients will be randomised to either the intervention or the
control arm of the study. All patients in both arms will receive cisplatin and pemetrexed on
day one of treatment. Patients randomised to the intervention arm will receive the
recommended dose of MSCTRAIL from Phase I on day 2 whilst those in the control arm will
receive a placebo. As this is a double blind trial both patients and the clinical team will
not know whether they are receiving MSCTRAIL or a placebo product. The aim of phase 2 is to
assess tolerability and preliminary efficacy of MSCTRAIL in combination with
pemetrexed/cisplatin chemotherapy.