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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

399 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2011-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Non-small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Icotinib

125 mg three times daily (375 mg per day) by mouth

Group Type EXPERIMENTAL

Icotinib

Intervention Type DRUG

125 mg three times daily (375 mg per day) by mouth

Gefitinib

250 mg every 24 hours by mouth

Group Type ACTIVE_COMPARATOR

Gefitinib

Intervention Type DRUG

250 mg every 24 hours by mouth

Interventions

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Icotinib

125 mg three times daily (375 mg per day) by mouth

Intervention Type DRUG

Gefitinib

250 mg every 24 hours by mouth

Intervention Type DRUG

Other Intervention Names

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BPI-2009 Conmana ZD1839 Iressa

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yan Sun, M.D.

Role: PRINCIPAL_INVESTIGATOR

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Li Zhang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Fenlai Tan, M.D./Ph.D.

Role: STUDY_DIRECTOR

Zhejiang Betapharma Inc.

Locations

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