drugset
drugset / Trial / NCT03498222

Study in Patients With Tumours Requiring Arginine to Assess ADI-PEG 20 With Atezolizumab, Pemetrexed and Carboplatin

NCT03498222 ↗

Phase 1 Withdrawn Queen Mary University of London Hoffmann-La Roche · collabPolaris Group · collab
Non-randomizedSequentialOpen-labelTreatment

Summary

iTRAP is an open-label, multi-centre, dose escalation study of ADI PEG20 in combination with atezolizumab, pemetrexed and carboplatin in patients with advanced non-squamous non-small cell lung carcinoma (NSCLC) - stage IIIB/IV.

Timeline

Start
2018-06-01
Primary completion
2020-01-31
Completion
2021-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Pegargiminase Protein / enzyme biologic 9 mg/m2 Intramuscular
Subject Pegargiminase Protein / enzyme biologic 18 mg/m2 Intramuscular
Subject Pegargiminase Protein / enzyme biologic 36 mg/m2 Intramuscular
Background Atezolizumab Monoclonal antibody 1200 mg Intravenous
Background Carboplatin Small molecule — Intravenous
Background Pemetrexed Small molecule 500 mg/m2 Intravenous

Indications

non-small cell lung carcinoma