NCT05318443

A Study Exploring Efficacy of SIBP04 in Subjects With Non-squamous Non-small Cell Lung Cancer

A Randomized, Double-blind, Parallel-controlled Study Comparing the Efficacy and Safety of Recombinant Anti-VEGF Humanized Monoclonal Antibody Injection (SIBP04) and Bevacizumab Injection (Avastin) in Combination With Paclitaxel and Carboplatin Respectively in Patients With Advanced, Metastatic or Recurrent Non-squamous Non-small Cell Lung Cancer.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 512 (actual)
• Sponsor: Shanghai Institute Of Biological Products · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This trial is a randomized, double-blind, parallel-controlled, multicenter phase III clinical study. To evaluate the clinical efficacy of SIBP04 in patients with locally advanced, metastatic or recurrent non-squamous non-small cell lung cancer.

Detailed description

This trial is a randomized, double-blind, parallel-controlled, multicenter phase III clinical study. The study was divided into three stages: screening stage, treatment stage (combined chemotherapy stage, single drug maintenance treatment stage, visit after treatment) and follow-up stage (survival follow-up after disease progression). To evaluate the safety, tolerability, pharmacokinetics and clinical efficacy of SIBP04 in patients with locally advanced, metastatic or recurrent non-squamous non-small cell lung cancer.

Conditions

• Non-squamous Non-small-cell Lung Cancer

Interventions

Type	Name	Description
DRUG	SIBP04	SIBP04, 15mg/kg, intravenous infusion, the first intravenous infusion 90min (+10min), 3 weeks/cycle, administered on the first day of each treatment cycle.
DRUG	Avastin	Avastin, 15mg/kg, intravenous infusion, the first intravenous infusion 90min (+10min), 3 weeks/cycle, administered on the first day of each treatment cycle.
DRUG	Paclitaxel	Paclitaxel, 175mg/m2, intravenous infusion, every 3 weeks/cycle, administered on the first day of each treatment cycle.
DRUG	Carboplatin	Carboplatin, AUC=5.0, (upper limit 800mg), intravenous infusion, 3 weeks/cycle, administered on the first day of each treatment cycle.

Timeline

• Start date: 2020-04-17
• Primary completion: 2022-12-26
• Completion: 2023-01-12
• First posted: 2022-04-08
• Last updated: 2023-12-27

Locations

1 site across 1 country: China