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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01040780
Recruitment Status : Completed
First Posted : December 30, 2009
Results First Posted : May 24, 2012
Last Update Posted : February 14, 2014
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: Icotinib Drug: Gefitinib Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 399 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : February 2009
Actual Primary Completion Date : March 2010
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Gefitinib

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 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 :
  1. Overall Survival [ Time Frame: From first study treatment until time of death ]
    Median number of months from first study treatment until time of death

  2. Best Tumor Response [ Time Frame: 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

  3. Time To Progression [ Time Frame: 2-7 months ]
    Median time until disease progression. Disease progression defined as radiological and/or symptomatic disease progression.

  4. Safety and Tolerability [ Time Frame: 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01040780

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China, Beijing
Beijing Chao-Yang Hospital
Beijing, Beijing, China, 100020
Cancer Hospital, Chinese Academy of Medical Science
Beijing, Beijing, China, 100021
Peking Union Medical College Hospital
Beijing, Beijing, China, 100032
Bejing Cancer Hospital
Beijing, Beijing, China, 100036
307 Hospital of PLA
Beijing, Beijing, China, 100071
Peking University Third Hospital
Beijing, Beijing, China, 100079
Chinese PLA General Hospital
Beijing, Beijing, China, 100853
Beijing Chest Hospital
Beijing, Beijing, China, 101149
China, Chongqing
Third Affiliated Hospital, Third Military Medical University
Chongqing, Chongqing, China, 400042
China, Guangdong
Guanghzou General Hospital of PLA
Guangzhou, Guangdong, China, 510000
Guangdong General Hospital
Guangzhou, Guangdong, China, 510080
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China, 510515
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
Ruijin Hospital,Shanghai Jiao-Tong University
Shanghai, Shanghai, China, 200023
Zhongshan Hospital,Fudan University
Shanghai, Shanghai, China, 200032
Changhai Hospital, Second Military Medical University
Shanghai, Shanghai, China, 200433
Shanghai Pulmonary Hospital
Shanghai, Shanghai, China, 200433
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.
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Principal Investigator: Yan Sun, M.D. Cancer Institute and 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.

Publications of Results:
Other Publications:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Betta Pharmaceuticals Co., Ltd. Identifier: NCT01040780     History of Changes
Other Study ID Numbers: BPI-2009
First Posted: December 30, 2009    Key Record Dates
Results First Posted: May 24, 2012
Last Update Posted: February 14, 2014
Last Verified: January 2014
Keywords provided by Betta Pharmaceuticals Co., Ltd.:
phase III
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action