Gefitinib or Docetaxel as Second Line Therapy for Wild-type Epidermal Growth Factor Receptor (EGFR) NSCLC
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|ClinicalTrials.gov Identifier: NCT01755923|
Recruitment Status : Unknown
Verified December 2012 by Peking Union Medical College Hospital.
Recruitment status was: Recruiting
First Posted : December 24, 2012
Last Update Posted : December 24, 2012
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer||Drug: Gefitinib Drug: Docetaxel||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase Ⅱ Randomized Controlled Trial to Compare Gefitinib With Docetaxel as Second-line Therapy for Advanced or Metastatic Non-squamous NSCLC Patients With Wild-type EGFR|
|Study Start Date :||December 2012|
|Estimated Primary Completion Date :||December 2013|
|Estimated Study Completion Date :||December 2014|
Gefitinib (Iressa) 250mg once per day until progression disease or intolerant side effects
Gefitinib 250mg once per day until the progression disease or intolerant side effects
Other Name: Iressa
Active Comparator: Docetaxel
Docetaxel 75mg/m2,d1,every 3 weeks, at least 2-6 cycles depending on the progression disease or the patient's physical condition
Docetaxel 75mg/m2 iv, d1,every 3 weeks, at least 2-6 cycles depending on the progression disease or the patient's physical condition
Other Name: Taxotere
- Progression free survival [ Time Frame: up to 52 weeks (about one year) ]From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 52 weeks.
- Overall survival [ Time Frame: Up to 100 weeks ]From the date of randomization until the date of death from any cause, assessed up to 100 weeks.
- Objective response rate [ Time Frame: up to 9 weeks ]The objective response rate includes the complete remission and partial remission rate.
- the score of functional assessment of cancer treatment-lung (FACT-L) [ Time Frame: up to 100 weeks ]FACT-L is assessed at different time points.(Date of randomization, 1 week after chemotherapy/EGFR-TKI, every cycle of chemotherapy/EGFR-TKI, every month of EGFR-TKI treatment/observation, up to 100 weeks)
- Number of participants with adverse events [ Time Frame: Up to 6 months ]The adverse events are assessed by National Cancer Institute-Common Toxcity Criteria (Version 3.0)(NCI-CTC).
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): NCT01755923
|Contact: Mengzhao Wang, MD||010-69155039 ext +email@example.com|
|Contact: Jing Zhao, MD||010-69158206 ext +firstname.lastname@example.org|
|Department of Respiratory Medicine, Peking Union Medical College Hospita||Recruiting|
|Beijing, Beijing, China, 100730|
|Contact: Mengzhao Wang, MD 010-69155039 ext +86 email@example.com|
|Contact: Jing Zhao, MD 010-69158206 ext +86 firstname.lastname@example.org|
|Sub-Investigator: Wei Zhong, MD|
|Sub-Investigator: Jinmei Luo, MD|
|Principal Investigator:||Mengzhao Wang, MD||Peking Union Medical College Hospital|