High Dose Versus Routine Dose Icotinib in Advanced Non-small Cell Lung Cancer Patients With Stable Disease
This trial is active, not recruiting.
|Condition||non-small cell lung cancer|
|Treatments||routine dose icotinib, higher dose icotinib|
|Sponsor||Betta Pharmaceuticals Co.,Ltd.|
|Start date||January 2014|
|End date||June 2016|
|Trial size||64 participants|
|Trial identifier||NCT02027090, BD-IC-IV17|
We hypothesize that higher dose icotinib is related with better efficacy. The primary objective is to compare the progression-free survival of higher dose and routine dose of icotinib in treating pretreated advanced non-small cell lung cancer patients with stable disease after 8-week routine dose icotinib treatment.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
time frame: 5 months
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
Male or female participants from 18 years up to 75 years old.
Inclusion Criteria: - Histologically or cytologically confirmed stage IIIB/IV lung cancer(exclude patients confirmed by sputum cytology); - Pretreated with at least 1 platinum-based chemotherapy; - No previous targeted treatment such as gefitinib, erlotinib; - With a measurable disease(longest diameters >=10mm with Spiral computed tomography (CT)and >=20mm with conventional CT) according to RECIST Criteria; - WHO performance status(PS)<= 2; - Adequate organ functions; - Signed and dated informed consent before the start of specific protocol procedures. Exclusion Criteria: - Allergic to icotinib; - Patients with metastatic brain tumors with symptoms; - Experience of Anti-EGFR(the epidermal growth factor receptor) Monoclonal Antibody or small molecular compounds therapy such as gefitinib, erlotinib or Cetuximab; - Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.
|Official title||High Dose Versus Routine Dose Icotinib in Pretreated Non-small Cell Lung Cancer Patients With Stable Disease: a Phase II Randomized Study|
|Principal investigator||Shun Lu, MD|
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