NCT03498222

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

Phase I Study in Patients With Tumours Requiring Arginine to Assess ADI-PEG 20 With Atezolizumab, Pemetrexed and Carboplatin (ADIAtezoPemCarbo) (iTRAP Study)

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Queen Mary University of London · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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 NSCLC (stage IIIB/IV). Patients will initially receive 4 cycles of ADI PEG20 in combination with atezolizumab, pemetrexed and carboplatin unless there is documented disease progression or unacceptable toxicities. On completion of 4 cycles and in the absence of disease progression requiring other therapeutic interventions, patients may receive additional cycles of ADI PEG20 and/or atezolizumab and/or pemetrexed for up to a maximum of 2 years at the discretion of the treating physician. Dose escalation will occur using a 3 + 3 design. The trial will start at dose level 1, which represents 100% of the recommended dose of carboplatin (AUC5) and pemetrexed (500mg/m2) when given as a combination, 100% of the atezolizumab recommended dose (1200mg) and 50% of the recommended single agent dose of ADI PEG20 (18mg/m2). ADI PEG20 doses will be increased according to pre-planned dose escalations. If the maximum tolerated dose (MTD) is reached with the first 6 patients, up to an additional 6 patients will be enrolled at the MTD. The MTD is defined as the dose level below that at which 2/3 or ≥3/6 patients experience a dose limiting toxicity (DLT). The maximum administered dose (MAD) may also equal the MTD if dose escalation is stopped before two DLTs are observed at a given dose level due to the expectation that higher dose levels would be too toxic to administer to patients or the maximum planned dose level has been achieved. The MTD will be determined following review of all the relevant toxicity data by the Safety Review Committee (SRC). If dose level 1 equals the MAD then dose level -1 may be investigated with a 50% reduction in ADI PEG20 (9mg/m2) along with atezolizumab 1200mg, carboplatin AUC5, and pemetrexed 500mg/m2.

Conditions

• Carcinoma, Non-Small-Cell Lung

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-06-01
• Primary completion: 2020-01-31
• Completion: 2021-12-31
• First posted: 2018-04-13
• Last updated: 2020-02-25

Regulatory

• FDA-regulated drug study