drugset / Trial / NCT03169335

Efficacy and Safety of QL1101 and Avastin® Respectively Combined With Paclitaxel and Carboplatin in the First-line Treatment of Non-squamous Non-small Cell Lung Cancer

NCT03169335

Phase 3 Completed 535 enrolled Qilu Pharmaceutical Co., Ltd.
RandomizedParallel-groupDouble-blindTreatment

Summary

The objective of this study is to assess the similarity between QL1101 and Avastin® respectively combined with chemotherapy in terms of efficacy and safety in patients with non-squamous non-small cell lung cancer. The study intends to include first-line patients with non-squamous non-small cell lung cancer, and uses QL1101 combined with basic chemotherapy CP (paclitaxel + carboplatin). The regimen is consistent with the usage and dosage of Avastin® at home and abroad indicated for the treatment of non-squamous non-small cell lung cancer.

Timeline

Start
2017-03-28
Primary completion
2018-06-23
Completion
2018-07-13

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bevacizumab Monoclonal antibody 15 mg/kg
Subject QL1101 Unknown 15 mg/kg
Background Carboplatin Small molecule 5 unknown Intravenous
Background Paclitaxel Small molecule 175 mg/m2 Intravenous