A Clinical Trial of Fruquintinib in Patients With Advanced Non-small Cell Lung Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02590965|
Recruitment Status : Completed
First Posted : October 29, 2015
Last Update Posted : February 13, 2020
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer||Drug: Fruquintinib Drug: Placebo||Phase 2|
Approximately 90 subjects will be randomized to Fruquintinib plus best supportive care or placebo plus best supportive care at a 2:1 ratio.
Randomization will be stratified by EGFR (epidermal growth factor receptor) gene status: mutant vs. wild type vs. unknown.
All subjects will receive Fruquintinib/placebo for consecutive 3 weeks, followed by one-week rest. A treatment cycle consists of 4 weeks. Tumor assessment will be performed every 4 weeks in the first 3 cycles, and every 8 weeks since the 4th cycle, until disease progression. Further treatment and survival follow-up after progression will be recorded.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||91 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomized, Double-blind, Placebo-controlled, Multi-center Phase II Clinical Trial to Evaluate the Efficacy and Safety of Fruquintinib Plus Best Supportive Care in Patients With Advanced Non-squamous Non-small Cell Lung Cancer|
|Actual Study Start Date :||May 29, 2014|
|Actual Primary Completion Date :||August 7, 2015|
|Actual Study Completion Date :||February 10, 2017|
Placebo Comparator: Control Group
Placebo is a capsule in the form of 1mg and 5 mg, orally, once daily, 3 weeks on/1week off with best supportive care.
Placebo is a capsule in the form of 1mg and 5mg, orally, once daily, 3 weeks on/1 week off
Other Name: HMPL-013-placebo
Experimental: Treatment Group
The subjects will receive oral Fruquintinib at fasting state 5mg+best supportive care, once daily for the first 3 consecutive weeks and dose holiday for 1 week according to their dose regimens until the occurrence of disease progression, unacceptable toxicity, or withdrawal of consent
After checking eligibility criteria, subjects will be randomized into Fruquintinib plus best supportive care group (treatment group) or placebo plus best supportive care group (control group) in a ration of 2:1.
Other Name: HMPL-013
- Progressive free survival (PFS) [ Time Frame: measured every 4 weeks at first 2 cycles and every 8 weeks since the third cycle from randomization to disease progression, assessed up to one year ]To compare the Progressive Free Survival (PFS) of Fruquintinib plus best supportive care (BSC) versus placebo plus BSC in patients advanced non-squamous NSCLC patients who failed to standard second-line chemotherapy according to RECIST 1.1
- Objective response rate (ORR) [ Time Frame: measured every 4 weeks at first 2 cycles and every 8 weeks since the third cycle from randomization to disease progression, assessed up to one year ]To evaluate objective response rate (ORR) in the two groups according to RECIST 1.1
- Disease control rate (DCR) [ Time Frame: measured every 4 weeks at first 2 cycles and every 8 weeks since the third cycle from randomization to disease progression, assessed up to one year ]To evaluate disease control rate (DCR) in the two groups according to RECIST 1.1
- Overall survival (OS) [ Time Frame: every 2 months from randomization to death, assessed up to one year ]To evaluate overall survival (OS) in the two groups
- safety and tolerability by incidence, severity and outcome of adverse events [ Time Frame: From randomization to 30 days after last dose ]To evaluate the safety and tolerability in the two groups by incidence, severity and outcomes of AEs and categorized by severity in accordance with the NCI CTC AE Version 4.0.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02590965
|307 Hospital of PLA|
|Beijing, Beijing, China, 100071|
|Beijing Cancer Hospital|
|Beijing, Beijing, China, 100142|
|Beijing Chest Hospital|
|Beijing, Beijing, China, 101149|
|Xi Nan Hospital, Third Military Medical University|
|Chongqing, Chongqing, China, 400038|
|Guangdong General Hospital|
|Guangzhou, Guangdong, China, 510080|
|Nantong Tumor Hospital|
|Nantong, Jiangsu, China, 226000|
|The First Hospital of Jilin University|
|Changchun, Jilin, China, 130021|
|Linyi Tumor Hospital|
|Linyi, Shandong, China, 276001|
|The Cancer Hospital of Fudan University|
|Shanghai, Shanghai, China, 200000|
|Shanghai Chest Hospital|
|Shanghai, Shanghai, China, 200030|
|West China Hospital|
|Chengdu, Sichuan, China, 610041|
|The First Affiliated Hosptial of College of Medicine, Zhejiang University|
|Hangzhou, Zhejiang, China, 310003|