drugset / Trial / NCT04416035

A Study to Compare the Similarity in Efficacy and Safety Between TRS003 and China-approved Bevacizumab® in NSCLC

NCT04416035 ↗

Phase 3 Unknown 608 enrolled Zhejiang Teruisi Pharmaceutical Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a double-blind Phase 3 clinical trial evaluating the efficacy and safety of TRS003 and paclitaxel-carboplatin versus China-approved bevacizumab and paclitaxel-carboplatin in patients with unresectable, locally advanced, or metastatic non-squamous non-small cell lung cancer (NSCLC). Approximately 608 patients will be enrolled in this study from America, Europe, and Asia. Patients who sign the informed consent and meet the inclusion criteria, will be randomized (1:1) to receive either TRS003 in combination with paclitaxel and carboplatin or China-approved bevacizumab in combination with paclitaxel and carboplatin for 4 to 6 cycles.

Timeline

Start
2020-08-17
Primary completion
2021-10-21
Completion
2021-11-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bevacizumab Monoclonal antibody 15 mg/kg Intravenous
Subject TRS003 Unknown 15 mg/kg Intravenous
Background Carboplatin Small molecule 6 unknown Intravenous
Background Paclitaxel Small molecule 200 mg/m2 Intravenous