NCT02691299

A Phase III Clinical Trial of Fruquintinib in Patients With Advanced Non-small Cell Lung Cancer

A Randomized, Double-blind, Placebo-controlled, Multi-center Phase III Clinical Trial in Patients With Advanced Non-squamous Non-small Cell Lung Cancer Treated With Fruquintinib

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 527 (actual)
• Sponsor: Hutchison Medipharma Limited · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Fruquintinib/Placebo 5 mg, QD, orally administered under fasting conditions for 3 consecutive weeks followed by one-week off to evaluate the survival benefit of patients with advanced non-squamous NSCLC treated with Fruquintinib.

Detailed description

This is a randomized, double-blind, placebo-controlled, multi-center Phase III clinical trial in patients with advanced non-squamous non-small cell lung cancer (NSCLC) treated with Fruquintinib who failed 2 lines of systemic chemotherapy or with non-tolerable toxicities. Approximately 521 subjects will be randomized to Fruquintinib group or placebo group at a ratio of 2:1. Patients in the two groups can receive supportive treatment. Randomization will be stratified by EGFR gene status (mutant vs. wild type) and history of treatment by VEGF inhibitors (yes vs no) . All subjects will receive study treatment in 4-week cycles: Fruquintinib/placebo for 3 consecutive weeks, and then one week off. Tumor assessment will be performed every 4 weeks in the first 2 cycles, and every 8 weeks since the 3rd cycle, until disease progression or death. Subsequent anti-neoplastic treatment and survival status will be followed up after disease progression.

Conditions

• NSCLC

Interventions

Type	Name	Description
DRUG	Fruquintinib	Fruquintinib is a capsule in the form of 5mg and 1mg, orally once daily. 3 weeks on/1 week off
DRUG	Placebo	Placebo is a capsule in the form of 5mg and 1mg, orally once daily. 3 weeks on/1 week off

Timeline

• Start date: 2015-12-09
• Primary completion: 2018-09-21
• Completion: 2018-11-16
• First posted: 2016-02-25
• Last updated: 2019-02-12

Locations

11 sites across 1 country: China