Non-small Cell Lung Cancer Clinical Trial
— ICOGENOfficial title:
A Randomized,Double-blind,Multicenter Phase III Trial to Evaluate the Safety and Efficacy of Icotinib and Gefitinib in Advanced NSCLC Patients Previously Treated With Chemotherapy
Verified date | January 2014 |
Source | Betta Pharmaceuticals Co.,Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 399 |
Est. completion date | December 2011 |
Est. primary completion date | March 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: 1. Confirmed NSCLC with Histology or cytology; advanced (IIIb/IV). 2. 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; =. Exclusion Criteria: 1. Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin, erbitux. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | 307 Hospital of PLA | Beijing | Beijing |
China | Beijing Chao-Yang Hospital | Beijing | Beijing |
China | Beijing Chest Hospital | Beijing | Beijing |
China | Bejing Cancer Hospital | Beijing | Beijing |
China | Cancer Hospital, Chinese Academy of Medical Science | Beijing | Beijing |
China | Chinese PLA General Hospital | Beijing | Beijing |
China | Peking Union Medical College Hospital | Beijing | Beijing |
China | Peking University Third Hospital | Beijing | Beijing |
China | Jilin Cancer Hospital | Changchun | Jilin |
China | Hunan Cancer Hospital | Changsha | Hunan |
China | the Second Xiangya Hospital,Central South University | Changsha | Hunan |
China | Third Affiliated Hospital, Third Military Medical University | Chongqing | Chongqing |
China | Guangdong General Hospital | Guangzhou | Guangdong |
China | Guanghzou General Hospital of PLA | Guangzhou | Guangdong |
China | Nanfang Hospital, Southern Medical University | Guangzhou | Guangdong |
China | Sun yat-sen Univerisity Cancer Center | Guanzhou | Guangdong |
China | The First Affiliated Hospital of College of Medicine, Zhejiang University | Hangzhou | Zhejiang |
China | Zhejiang Cancer Hospital | Hangzhou | Zhejiang |
China | 81 Hospital of PLA | Nanjing | Jiangsu |
China | Jiangsu Cancer Hospital | Nanjing | Jiangsu |
China | Nanjing General Hospital of Nanjing Command,PLA | Nanjing | Jiangsu |
China | Changhai Hospital, Second Military Medical University | Shanghai | Shanghai |
China | Ruijin Hospital,Shanghai Jiao-Tong University | Shanghai | Shanghai |
China | Shanghai Pulmonary Hospital | Shanghai | Shanghai |
China | Zhongshan Hospital,Fudan University | Shanghai | Shanghai |
China | Tangdu Hospital, Fourth Military Medical University | Xi-an | Shanxi |
China | Xijing Hospital, Fourth Military Medical University | Xi-An | Shanxi |
Lead Sponsor | Collaborator |
---|---|
Betta Pharmaceuticals Co.,Ltd. |
China,
Camidge DR. Icotinib: kick-starting the Chinese anticancer drug industry. Lancet Oncol. 2013 Sep;14(10):913-4. doi: 10.1016/S1470-2045(13)70385-1. Epub 2013 Aug 13. — View Citation
Shi Y, Zhang L, Liu X, Zhou C, Zhang L, Zhang S, Wang D, Li Q, Qin S, Hu C, Zhang Y, Chen J, Cheng Y, Feng J, Zhang H, Song Y, Wu YL, Xu N, Zhou J, Luo R, Bai C, Jin Y, Liu W, Wei Z, Tan F, Wang Y, Ding L, Dai H, Jiao S, Wang J, Liang L, Zhang W, Sun Y. I — View Citation
Zhao Q, Shentu J, Xu N, Zhou J, Yang G, Yao Y, Tan F, Liu D, Wang Y, Zhou J. Phase I study of icotinib hydrochloride (BPI-2009H), an oral EGFR tyrosine kinase inhibitor, in patients with advanced NSCLC and other solid tumors. Lung Cancer. 2011 Aug;73(2):195-202. doi: 10.1016/j.lungcan.2010.11.007. Epub 2010 Dec 8. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression Free Survival | 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. | 2-7 months | No |
Secondary | Overall Survival | Median number of months from first study treatment until time of death | From first study treatment until time of death | No |
Secondary | Best Tumor Response | 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 | While receiving study treatment; assessed every 21 days until progression | No |
Secondary | Time To Progression | Median time until disease progression. Disease progression defined as radiological and/or symptomatic disease progression. | 2-7 months | No |
Secondary | Safety and Tolerability | 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 |
Assessed over two years | Yes |
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