Phase II Clinical Study of Intermittent High Dose of Icotinib in Combination With Docetaxel to Treat Lung Cancer
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|ClinicalTrials.gov Identifier: NCT02191059|
Recruitment Status : Unknown
Verified July 2014 by Zhehai Wang, Shandong Cancer Hospital and Institute.
Recruitment status was: Not yet recruiting
First Posted : July 15, 2014
Last Update Posted : July 31, 2014
- There is as yet no optimal treatment regimen for patients with epidermal growth factor receptor (EGFR) gene wild type non-small-cell lung cancer (NSCLC) .
- Icotinib is a new type of small molecule EGFR TKI, developed and patented by Zhejiang BetaPharma Co., Ltd.(Hangzhou, Zhejiang, China, Patent No. WO2003082830). It has the similar anti-tumor activity with gefitinib, erlotinib. Pre-clinical studies showed icotinib could significantly inhibit the EGFR tyrosine kinase activity. Notably, anti-tumor activities were observed in patients with advanced NSCLC.
- In this study, we will evaluate the efficiency of intermittent high dose of Icotinib in combination with Docetaxel as second-line treatment for NSCLC patients with wild type EGFR. The overall response rate(ORR),progression free survival(PFS) ,overall survival(OS) and health related quality of life(HRQoL) will be monitored.
|Condition or disease||Intervention/treatment||Phase|
|Non Small Cell Lung Cancer||Drug: Icotinib Drug: Docetaxel||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Single Arm, Phase II Clinical Study of Intermittent High Dose of Icotinib in Combination With Docetaxel as Second-line Treatment for Non-small Cell Lung Cancer Patients With Wild Type EGFR:|
|Study Start Date :||July 2014|
|Estimated Primary Completion Date :||July 2015|
|Estimated Study Completion Date :||July 2016|
Experimental: Intermittent High Dose of Icotinib
Intermittent High Dose of Icotinib in Combination With Docetaxel:
Icotinib 625mg tablet b ymouth three times per day for day1-2, Docetaxel 75mg/m2 injection intravenous drip for day 3, 3 weeks as 1 cycle
Other Name: Taxotere, Docecad
- Overall Response Rate(ORR) [ Time Frame: 10-12 months ]
- Progression Free Survival(PFS) [ Time Frame: 10-12 months ]
- Overall Survival(OS) [ Time Frame: 10-12momths ]
- Health Related Quality of Life(HRQoL) [ Time Frame: 10-12months ]
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): NCT02191059
|Contact: Zhehai Wang, MDfirstname.lastname@example.org|
|Shandong Cancer Hospital and Institute||Not yet recruiting|
|Jinan, Shandong, China, 250117|
|Contact: Zhehai Wang, MD 0086-531-67626331 email@example.com|
|Principal Investigator: Zhehai Wang, MD|
|Principal Investigator:||Zhehai Wang, MD||Shandong Cancer Hospital and Institute|