High Dose Versus Routine Dose Icotinib in Advanced Non-small Cell Lung Cancer Patients With Stable Disease
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|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
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): NCT02027090
|Shanghai Chest Hospital Affiliated to Shanghai Jiaotong University|
|Shanghai, Shanghai, China, 200030|
|Principal Investigator:||Shun Lu, MD||Shanghai Chest Hospital|