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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.
 
ClinicalTrials.gov Identifier: NCT01040780
Recruitment Status : Completed
First Posted : December 30, 2009
Results First Posted : May 24, 2012
Last Update Posted : February 14, 2014
Sponsor:
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

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
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.


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 ClinicalTrials.gov identifier (NCT number): NCT01040780


Locations
Show Show 27 study locations
Sponsors and Collaborators
Betta Pharmaceuticals Co., Ltd.
Investigators
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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 ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Betta Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier: NCT01040780    
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.:
Efficacy
Safety
EGFR-TKI
phase III
NSCLC
Additional relevant MeSH terms:
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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
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action