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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Betta Pharmaceuticals Co.,Ltd.
ClinicalTrials.gov Identifier:
NCT01040780
First received: December 27, 2009
Last updated: January 21, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Non-small Cell Lung Cancer
Drug: Icotinib
Drug: Gefitinib
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Betta Pharmaceuticals Co.,Ltd.:

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: 2-7 months ] [ Designated as safety issue: No ]
    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:
  • Overall Survival [ Time Frame: From first study treatment until time of death ] [ Designated as safety issue: No ]
    Median number of months from first study treatment until time of death

  • Best Tumor Response [ Time Frame: While receiving study treatment; assessed every 21 days until progression ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2-7 months ] [ Designated as safety issue: No ]
    Median time until disease progression. Disease progression defined as radiological and/or symptomatic disease progression.

  • Safety and Tolerability [ Time Frame: Assessed over two years ] [ Designated as safety issue: Yes ]

    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



Enrollment: 399
Study Start Date: February 2009
Study Completion Date: December 2011
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Icotinib
125 mg three times daily (375 mg per day) by mouth
Drug: Icotinib
125 mg three times daily (375 mg per day) by mouth
Other Names:
  • BPI-2009
  • Conmana
Active Comparator: Gefitinib
250 mg every 24 hours by mouth
Drug: Gefitinib
250 mg every 24 hours by mouth
Other Names:
  • ZD1839
  • Iressa

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01040780

Locations
China, Beijing
Cancer Hospital, Chinese Academy of Medical Science
Beijing, Beijing, China, 100021
307 Hospital of PLA
Beijing, Beijing, China, 100071
Peking Union Medical College Hospital
Beijing, Beijing, China, 100032
Beijing Chest Hospital
Beijing, Beijing, China, 101149
Beijing Chao-Yang Hospital
Beijing, Beijing, China, 100020
Bejing Cancer Hospital
Beijing, Beijing, China, 100036
Peking University Third Hospital
Beijing, Beijing, China, 100079
Chinese PLA General Hospital
Beijing, Beijing, China, 100853
China, Chongqing
Third Affiliated Hospital, Third Military Medical University
Chongqing, Chongqing, China, 400042
China, Guangdong
Guangdong General Hospital
Guangzhou, Guangdong, China, 510080
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China, 510515
Guanghzou General Hospital of PLA
Guangzhou, Guangdong, China, 510000
Sun yat-sen Univerisity Cancer Center
Guanzhou, Guangdong, China, 510060
China, Hunan
the Second Xiangya Hospital,Central South University
Changsha, Hunan, China, 410011
Hunan Cancer Hospital
Changsha, Hunan, China, 410013
China, Jiangsu
81 Hospital of PLA
Nanjing, Jiangsu, China, 210002
Nanjing General Hospital of Nanjing Command,PLA
Nanjing, Jiangsu, China, 210002
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China, 210009
China, Jilin
Jilin Cancer Hospital
Changchun, Jilin, China, 130012
China, Shanghai
Shanghai Pulmonary Hospital
Shanghai, Shanghai, China, 200433
Changhai Hospital, Second Military Medical University
Shanghai, Shanghai, China, 200433
Zhongshan Hospital,Fudan University
Shanghai, Shanghai, China, 200032
Ruijin Hospital,Shanghai Jiao-Tong University
Shanghai, Shanghai, China, 200023
China, Shanxi
Tangdu Hospital, Fourth Military Medical University
Xi-an, Shanxi, China, 710000
Xijing Hospital, Fourth Military Medical University
Xi-An, Shanxi, China, 710032
China, Zhejiang
The First Affiliated Hospital of College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310022
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Sponsors and Collaborators
Betta Pharmaceuticals Co.,Ltd.
Investigators
Principal Investigator: Yan Sun, M.D. Cancer Hospital, Chinese Academy of Medical Sciences
Principal Investigator: Li Zhang, M.D. Sun Yat-sen University
Study Director: Fenlai Tan, M.D./Ph.D. Zhejiang Betapharma Inc.
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Betta Pharmaceuticals Co.,Ltd.
ClinicalTrials.gov Identifier: NCT01040780     History of Changes
Other Study ID Numbers: BPI-2009
Study First Received: December 27, 2009
Results First Received: February 21, 2012
Last Updated: January 21, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Betta Pharmaceuticals Co.,Ltd.:
Efficacy
Safety
EGFR-TKI
phase III
NSCLC

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Gefitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014