Safety and Efficacy Study of Icotinb in Non-small Cell Lung Cancer (NSCLC) Patients

Non-small Cell Lung Cancer Clinical Trial

— ICOGEN  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01040780
• Other study ID #: BPI-2009
• Status: Completed
• Phase: Phase 3
• First received: December 27, 2009
• Last updated: January 21, 2014
• Start date: February 2009
• Est. completion date: December 2011

Study information

• 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

Clinical Trial 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.

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 information / eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-small Cell Lung Cancer

Intervention

Drug:
• Icotinib
125 mg three times daily (375 mg per day) by mouth
• Gefitinib
250 mg every 24 hours by mouth

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Betta Pharmaceuticals Co.,Ltd.

Country where clinical trial is conducted

China, 

References & Publications (3)

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

Outcome

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