Lung Cancer Clinical Trial
Official title:
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
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.
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).
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