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.

December 27, 2009
December 30, 2009
February 21, 2012
May 24, 2012
February 14, 2014
February 2009
March 2010   (Final data collection date for primary outcome measure)
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.
all cause progress or mortality [ Time Frame: 3-6 months ]
Complete list of historical versions of study NCT01040780 on Archive Site
  • Overall Survival [ Time Frame: From first study treatment until time of death ]
    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 ]
    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 ]
    Median time until disease progression. Disease progression defined as radiological and/or symptomatic disease progression.
  • 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

  • all cause mortality [ Time Frame: 6 months -1 year ]
  • response evaluation [ Time Frame: 3-6 months ]
  • all cause progress [ Time Frame: 3-6 months ]
  • Health-Related Quality of Life (HR QOL) [ Time Frame: 1 year ]
  • all cause adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: 1 year ]
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Safety and Efficacy Study of Icotinb in Non-small Cell Lung Cancer (NSCLC) Patients
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
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.
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.
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Non-small Cell Lung Cancer
  • Drug: Icotinib
    125 mg three times daily (375 mg per day) by mouth
    Other Names:
    • BPI-2009
    • Conmana
  • Drug: Gefitinib
    250 mg every 24 hours by mouth
    Other Names:
    • ZD1839
    • Iressa
  • Experimental: Icotinib
    125 mg three times daily (375 mg per day) by mouth
    Intervention: Drug: Icotinib
  • Active Comparator: Gefitinib
    250 mg every 24 hours by mouth
    Intervention: Drug: Gefitinib

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2011
March 2010   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Betta Pharmaceuticals Co.,Ltd.
Betta Pharmaceuticals Co.,Ltd.
Not Provided
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.
Betta Pharmaceuticals Co.,Ltd.
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP