Gefitinib or Docetaxel as Second Line Therapy for Wild-type Epidermal Growth Factor Receptor (EGFR) NSCLC
|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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01755923
|Contact: Mengzhao Wang, MD||010-69155039 ext +firstname.lastname@example.org|
|Contact: Jing Zhao, MD||010-69158206 ext +email@example.com|
|Department of Respiratory Medicine, Peking Union Medical College Hospita||Recruiting|
|Beijing, Beijing, China, 100730|
|Contact: Mengzhao Wang, MD 010-69155039 ext +86 firstname.lastname@example.org|
|Contact: Jing Zhao, MD 010-69158206 ext +86 email@example.com|
|Sub-Investigator: Wei Zhong, MD|
|Sub-Investigator: Jinmei Luo, MD|
|Principal Investigator:||Mengzhao Wang, MD||Peking Union Medical College Hospital|