High Dose Versus Routine Dose Icotinib in Advanced Non-small Cell Lung Cancer Patients With Stable Disease
|ClinicalTrials.gov Identifier: NCT02027090|
Recruitment Status : Unknown
Verified May 2015 by Betta Pharmaceuticals Co.,Ltd..
Recruitment status was: Active, not recruiting
First Posted : January 3, 2014
Last Update Posted : May 22, 2015
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer||Drug: Routine dose icotinib Drug: Higher dose icotinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||64 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||High Dose Versus Routine Dose Icotinib in Pretreated Non-small Cell Lung Cancer Patients With Stable Disease: a Phase II Randomized Study|
|Study Start Date :||January 2014|
|Estimated Primary Completion Date :||June 2016|
|Estimated Study Completion Date :||December 2016|
Experimental: Higher dose icotinib
Patients with stable disease after 8-week routine dose icotinib treatment, are randomly assigned to higher dose icotinib group to receive icotinib with a dose of 375 mg three times per day, till progressive disease or unaccepted toxicity.
Drug: Higher dose icotinib
After 8-week induction of icotinib with a dose of 125 mg three times daily, icotinib is administered 375 mg three times per day.
Other Name: Commana
Active Comparator: Routine dose icotinib
Patients with stable disease after 8-week routine dose icotinib treatment, are administered with icotinib with a dose of 125 mg three times per day, till progressive disease or unaccepted toxicity.
Drug: Routine dose icotinib
Icotinib is administered 125 mg three times daily.
Other Name: Commana
- Progression-free survival [ Time Frame: 5 months ]
- Overall survival [ Time Frame: 18 months ]
- Response rate assessed using the RECIST criteria [ Time Frame: 2 months ]
- The number of patients who suffered adverse events [ Time Frame: 30 months ]Adverse events are assessed by Common Terminology Criteria for Adverse Events v4.0
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02027090
|Shanghai Chest Hospital Affiliated to Shanghai Jiaotong University|
|Shanghai, Shanghai, China, 200030|
|Principal Investigator:||Shun Lu, MD||Shanghai Chest Hospital|