Safety and Efficacy Study of Icotinb in Non-small Cell Lung Cancer (NSCLC) Patients
- Registration Number
- NCT01040780
- Lead Sponsor
- Betta Pharmaceuticals Co., Ltd.
- Brief Summary
The purpose of this study is to determine whether Icotinib is at least non-inferior to Gefitinib in the treatment of advanced non-small cell lung cancer (NSCLC) patients after one or two chemotherapies.
- Detailed Description
Lung cancer is the rapidest increased type of cancer in China with over 5 times incidence rate increase during the past 30 years . It is the leading cause of death of cancer in man and 2nd in women. With the development of gefitinib and erlotinib, EGFR-TKI (epidermal growth factor receptor -tyrosine kinase inhibitor) is the most successful novel drugs developed for the treatment of these patients in recent years, especially for NSCLC patients in Asia including China. Icotinib is a novel EGFR-TKI developed by a group of Chinese scientists and clinician. It appears to be at least as good as gefitinib in terms of efficacy and better in terms of safety in phase I/II trials. In this study, a randomized, double-blind, gefitinib as control, multi-center phase III trial was designed to evaluate the safety and efficacy of icotinib in the treatment of advanced NSCLC patients after failure of 1 or 2 chemotherapy. PFS (progress free survival) is the primary end-point with OS (overall survival), ORR (objective response), TTP (time to progress), HRQOL and safety as the secondary end-point. A total of 400 patients will be recruited. EGFR and K-ras gene mutational analysis as well as a population PK study have also been proposed.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 399
- Confirmed NSCLC with Histology or cytology; advanced （IIIb/IV).
- Must have received 1 or 2 chemotherapy (at least 1 is platin based)before, and prior chemotherapy must be completed at least 4 weeks before study enrollment; =.
- Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin, erbitux.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Icotinib Icotinib 125 mg three times daily (375 mg per day) by mouth Gefitinib Gefitinib 250 mg every 24 hours by mouth
- Primary Outcome Measures
Name Time Method Progression Free Survival 2-7 months Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline.
- Secondary Outcome Measures
Name Time Method Overall Survival From first study treatment until time of death Median number of months from first study treatment until time of death
Best Tumor Response While receiving study treatment; assessed every 21 days until progression Change in size of tumor: Complete Response (CR) = no measurable tumor; Partial Response (PR) = 30% decrease in size of measurable tumor; Stable Disease (SD) = measurable tumor size has not changed; Progressive Disease (PD) = measurable tumor larger than at baseline
Time To Progression 2-7 months Median time until disease progression. Disease progression defined as radiological and/or symptomatic disease progression.
Safety and Tolerability Assessed over two years Adverse Events (AEs) and Serious AEs (SAEs) are presented regardless of causality for patients who received at least one dose of Icotinib or Gefitinib. Events were graded by the investigator using the NCI CTCAE Scale (version 3.0) which provides a grading scale for each AE term.
Grade 3 = Severe Grade 4 = Life-threatening or disabling
Trial Locations
- Locations (27)
307 Hospital of PLA
🇨🇳Beijing, Beijing, China
Peking University Third Hospital
🇨🇳Beijing, Beijing, China
the Second Xiangya Hospital，Central South University
🇨🇳Changsha, Hunan, China
Beijing Chest Hospital
🇨🇳Beijing, Beijing, China
Jiangsu Cancer Hospital
🇨🇳Nanjing, Jiangsu, China
Ruijin Hospital，Shanghai Jiao-Tong University
🇨🇳Shanghai, Shanghai, China
Xijing Hospital, Fourth Military Medical University
🇨🇳Xi-An, Shanxi, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China
Bejing Cancer Hospital
🇨🇳Beijing, Beijing, China
Beijing Chao-Yang Hospital
🇨🇳Beijing, Beijing, China
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China
Chinese PLA General Hospital
🇨🇳Beijing, Beijing, China
Guangdong General Hospital
🇨🇳Guangzhou, Guangdong, China
Third Affiliated Hospital, Third Military Medical University
🇨🇳Chongqing, Chongqing, China
Cancer Hospital, Chinese Academy of Medical Science
🇨🇳Beijing, Beijing, China
Nanfang Hospital， Southern Medical University
🇨🇳Guangzhou, Guangdong, China
Guanghzou General Hospital of PLA
🇨🇳Guangzhou, Guangdong, China
Sun yat-sen Univerisity Cancer Center
🇨🇳Guanzhou, Guangdong, China
Hunan Cancer Hospital
🇨🇳Changsha, Hunan, China
81 Hospital of PLA
🇨🇳Nanjing, Jiangsu, China
Nanjing General Hospital of Nanjing Command，PLA
🇨🇳Nanjing, Jiangsu, China
Jilin Cancer Hospital
🇨🇳Changchun, Jilin, China
Zhongshan Hospital，Fudan University
🇨🇳Shanghai, Shanghai, China
Shanghai Pulmonary Hospital
🇨🇳Shanghai, Shanghai, China
Changhai Hospital， Second Military Medical University
🇨🇳Shanghai, Shanghai, China
Tangdu Hospital, Fourth Military Medical University
🇨🇳Xi-an, Shanxi, China
The First Affiliated Hospital of College of Medicine, Zhejiang University
🇨🇳Hangzhou, Zhejiang, China