A Study of Famitinib in Patients With Advanced Non-squamous and Non-Small Cell Lung Cancer (NSCLC)
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|ClinicalTrials.gov Identifier: NCT02356991|
Recruitment Status : Active, not recruiting
First Posted : February 6, 2015
Last Update Posted : January 18, 2019
Famitinib is a tyrosin-inhibitor agent targeting at c-Kit, VEGFR2, PDGFR, VEGFR3, Flt1 and Flt3. Phase I study has shown that the toxicity is manageable.
The purpose of this study is to evaluate the efficacy and safety profile of Famitinib in patients with Advanced Non-squamous and Non-Small Cell Lung Cancer (NSCLC).
|Condition or disease||Intervention/treatment||Phase|
|Non-Small Cell Lung Cancer (NSCLC)||Drug: Famitinib Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||137 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Randomized,Double-Blind, Placebo-Controlled, Multicenter, Phase II Study of Famitinib in Patients With Advanced Non-squamous and Non-Small Cell Lung Cancer (NSCLC)|
|Actual Study Start Date :||December 2014|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||June 2019|
Famitinib 25 mg qd p.o., 4 weeks per cycle.The treatment continued until disease progression or intolerable toxicity happened or patients withdrawal of consent.
Placebo Comparator: Placebo
Placebo 25 mg qd p.o., 4 weeks per cycle.The treatment continued until disease progression or intolerable toxicity happened or patients withdrawal of consent.
- Progress free survival (PFS) [ Time Frame: 1.5 years ]
- Overall Survival (OS) [ Time Frame: 2 years ]
- Objective Response Rate (ORR) [ Time Frame: 1 years ]
- Disease Control Rate (DCR) [ Time Frame: 1 years ]
- Quality of Life [ Time Frame: 28-day cycle visit until disease progress ]
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): NCT02356991
|Cancer Hospital of Guangzhou Sun Yat-sen University|
|Guangzhou, Guangdong, China, 510060|
|Tongji University Affiliated Shanghai Pulmonary Hospital|
|Shanghai, China, 200433|
|Principal Investigator:||Li Zhang, M.D.||Cancer Hospital of Guangzhou Sun Yat-sen University|