MedTrace Logo

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

NCT03498222 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2020-02-25

No results posted yet for this study

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.

Conditions

  • Carcinoma, Non-Small-Cell Lung

Interventions

DRUG

Atezolizumab

Administered at a fixed dose of 1200 mg (equivalent to an average body weight-based dose of 15mg/kg) by intravenous (IV) infusion every 3 weeks (21 days).

DRUG

Pemetrexed

Administered at a fixed dose of 500mg/m2 by IV infusion every 3 weeks.

DRUG

Carboplatin

Administered at a fixed dose of AUC5 by IV infusion every 3 weeks.

DRUG

ADI PEG20

Administered by intramuscular (IM) injection to patients once weekly.

Sponsors & Collaborators

  • Polaris Group

    collaborator INDUSTRY

  • Hoffmann-La Roche

    collaborator INDUSTRY

  • Queen Mary University of London

    lead OTHER

Principal Investigators

  • Peter Szlosarek · Queen Mary University of London

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2020-01-31
Completion
2021-12-31
FDA Drug
Yes

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03498222 on ClinicalTrials.gov