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

Sponsor
Queen Mary University of London
Study ID
NCT03498222
Phase
PHASE1
Status
Withdrawn

Conditions

  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab — DRUG
    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).
  • Pemetrexed — DRUG
    Administered at a fixed dose of 500mg/m2 by IV infusion every 3 weeks.
  • Carboplatin — DRUG
    Administered at a fixed dose of AUC5 by IV infusion every 3 weeks.
  • ADI PEG20 — DRUG
    Administered by intramuscular (IM) injection to patients once weekly.

Study Details

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.

Key Dates

Start date
Jun 1, 2018
Status verified
Feb 2020
Primary completion
Jan 31, 2020
Completion
Dec 31, 2021

Study Design

Enrollment
0 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Level -1
    Atezolizumab 1200mg Pemetrexed 500mg/m2 Carboplatin AUC5 ADI PEG20 9mg/m2
  • Experimental: Dose Level 1
    Atezolizumab 1200mg Pemetrexed 500mg/m2 Carboplatin AUC5 ADI PEG20 18mg/m2
  • Experimental: Dose Level 2
    Atezolizumab 1200mg Pemetrexed 500mg/m2 Carboplatin AUC5 ADI PEG20 36mg/m2

Primary Outcome Measure

Occurrence of dose limiting toxicities [ Time Frame: First 21 days of treatment ]

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