NCT03684967

Study of Fruquintinib (HMPL-013) in High Risk Patients With Advanced NSCLC

An Open-label Single Arm Multi-center Phase II Study to Assess Fruquintinib in High Risk Patients With Advanced Non-squamous Non-small Cell Lung Cancer

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Hutchison Medipharma Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Fruquintinib administered at 4 mg once daily in cycle 1 and 5 mg once daily in followed cycles (3 weeks on and 1 week off, 4 weeks as 1 cycle) was well tolerated and demonstrated encouraging preliminary clinical antitumor activity in patients with advanced NSCLC in phase II study. This study is aimed to evaluate the efficacy and safety of Fruquintinib in the treatment of high risk patients with advanced NSCLC who is \> 75 years, or Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) = 2, or without systemic chemotherapy, or with at least three lines systemic chemotherapies.

Detailed description

This is an open-label single arm multi-center phase II study to assess the efficacy and safety of Fruquintinib in high risk patients with advanced NSCLC who is \> 75 years, or ECOG PS = 2, or without systemic chemotherapy, or with at least three lines systemic chemotherapies. After checking eligibility criteria, subjects will take Fruquintinib as below: 4 mg once daily in the Cycle 1, administration for 3 weeks followed by 1 week break. 5mg once daily in followed cycles, administration for 3 weeks followed by 1 week break. Primary Efficacy Endpoint: Disease Control Rate (DCR) (According to RECIST Version 1.1). Safety and tolerance will be evaluated by incidence, severity and outcomes of adverse events (AEs) and categorized by severity in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Secondary Efficacy Endpoints: Objective Response Rate (ORR), Duration of Response (DOR), Progression free survival (PFS), Overall Survival (OS) and Quality of Life (QoL).

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	Fruquintinib	Fruquintinib treatment: 4mg in the Cycle 1,administration for 3 weeks followed by 1 week break, and administration every day for the first 21 days.5mg ,administration for 3 weeks followed by 1 week break, and administration every day for the first 21 days

Timeline

• Start date: 2018-05-08
• Primary completion: 2019-09-06
• Completion: 2019-09-06
• First posted: 2018-09-26
• Last updated: 2019-11-19

Locations

1 site across 1 country: China