iTRAP
Research type
Research Study
Full title
Phase I Study in Patients with Tumours Requiring Arginine to Assess ADI-PEG 20 with Atezolizumab, Pemetrexed and Carboplatin (ADIAtezoPemCarbo) (iTRAP Study)
IRAS ID
245036
Contact name
Peter Szlosarek
Contact email
Sponsor organisation
Queen Mary University of London
Eudract number
2018-001033-40
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 0 months, 0 days
Research summary
iTRAP is an open-label, multi-centre, dose escalation study of ADI-PEG 20 in combination with atezolizumab, pemetrexed and carboplatin in patients with advanced non-squamous non-small-cell lung cancer(NSCLC) (stage IIIB/IV). The main purpose is to determine the highest safe dose of ADI-PEG 20 when given in combination with atezolizumab, pemetrexed and carboplatin. Up to 12 patients will be enrolled depending on the occurrence of dose limiting toxicities (DLT). Dose escalation will occur using a 3 + 3 design.
Patients will receive ADI-PEG 20, atezolizumab, pemetrexed and carboplatin for 4 cycles. However, if disease progression occurs within the first 4 cycles, treatment will be stopped at the time it is documented. If after completion of 4 cycles, disease progression has not occurred, patients will continue to receive only ADI-PEG 20 and atezolizumab either individually or together depending on how well the drugs are tolerated for up to a maximum of 2 years. However, if disease progression is documented within that time treatment will be stopped at the time it is documented. Any of the study medications can be stopped at any time if unacceptable toxicity is observed.
REC name
London - Chelsea Research Ethics Committee
REC reference
19/LO/0080
Date of REC Opinion
20 Mar 2019
REC opinion
Further Information Favourable Opinion