Icotinib Versus First-line Chemotherapy Plus Maintenance Treatment in EGFR Positive Lung Adenocarcinoma Patients

Last updated: July 2, 2019
Sponsor: Betta Pharmaceuticals Co., Ltd.
Overall Status: Completed

Phase

3

Condition

Non-small Cell Lung Cancer

Adenocarcinoma

Lung Cancer

Treatment

N/A

Clinical Study ID

NCT01719536
BD-IC-IV36
  • Ages 18-75
  • All Genders

Study Summary

The purpose of this study is to compare icotinib with induction and maintenance chemotherapy in the first-line treatment of advanced non-small cell lung cancer (NSCLC) patients with EGFR mutation.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Recurrent or progressive Non-Small Cell Lung Cancer stage IV or IIIB patients.

  • Positive EGFR Mutation.

  • No previous systemic anticancer therapy.

  • Measurable lesion according to RECIST with at least one measurable lesion notpreviously irradiated, unless disease progression has been documented at that site.

  • Provision of written informed consent.

Exclusion

Exclusion Criteria:

  • Experience of Anti-EGFR(the epidermal growth factor receptor) Monoclonal Antibody orsmall molecular compounds therapy such as gefitinib, erlotinib or Cetuximab.

  • Evidence of clinically active Interstitial Lung Diseases (Patients with chronic,stable, radiographic changes who are asymptomatic need not be excluded).

  • Known severe hypersensitivity to icotinib or any of the excipients of this product.

  • Evidence of any other significant clinical disorder or laboratory finding that makesit undesirable for the subject to participate in the study.

Study Design

Total Participants: 296
Study Start date:
December 01, 2012
Estimated Completion Date:
February 07, 2017

Study Description

This study is designed to evaluate the efficacy and safety of icotinib and pemetrexed-based first-line induction and maintenance chemotherapy in advanced lung adenocarcinoma with EGFR-mutation,primary endpoint is progress-free survival,second endpoints include overall survival, time to progression, and so on.

Connect with a study center

  • The First Affiliated Hospital of Anhui Medical Univercity

    Hefei, Anhui 230022
    China

    Site Not Available

  • Beijing Hospital for Chest Tumors & Tuberculosis Diseases

    Beijing, Beijing 101149
    China

    Site Not Available

  • Chinese People's Liberation Army (PLA) General Hospital

    Beijing, Beijing 100853
    China

    Site Not Available

  • Xinqiao Hospital, The Third Military Medical University

    Chongqing, Chongqing 400037
    China

    Site Not Available

  • Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong 510515
    China

    Site Not Available

  • The First Affiliated Hospital Of Guangzhou Medical Collage

    Guangzhou, Guangdong 510120
    China

    Site Not Available

  • Hebei Provincal Tumor Hospital

    Shijiazhuang, Hebei 050011
    China

    Site Not Available

  • Harbin Medical Univercity Cancer Hospital

    Harbin, Heilongjiang 110001
    China

    Site Not Available

  • Henan Provincal Tumor Hospital

    Zhengzhou, Henan 450003
    China

    Site Not Available

  • Jiangsu Cancer Hospital

    Nanjing, Jiangsu 210009
    China

    Site Not Available

  • Jiangsu Provincal Tumor Hospital

    Nanjing, Jiangsu 210029
    China

    Site Not Available

  • The First Bethune Hospital of Jilin Univercity

    Changchun, Jilin 130021
    China

    Site Not Available

  • The First Hospital of China Medical University

    Shenyang, Liaoning 110001
    China

    Site Not Available

  • Shandong Cancer Hospital

    Jinan, Shandong 250117
    China

    Site Not Available

  • Changhai Hospital, The Second Military Medical University

    Shanghai, Shanghai 200433
    China

    Site Not Available

  • Shanghai Chest Hospital Affiliated to Shanghai Jiaotong Univercity

    Shanghai, Shanghai 200030
    China

    Site Not Available

  • Zhongshan Hospital Affiliated to Fudan Univercity

    Shanghai, Shanghai 200032
    China

    Site Not Available

  • Xijing Hospital

    Xian, Shanxi 710032
    China

    Site Not Available

  • Sichuan Provincal Tumor Hospital

    Chengdu, Sichuan 610041
    China

    Site Not Available

  • West China Hospital, Sichuan University

    Chengdu, Sichuan 610041
    China

    Site Not Available

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin 300060
    China

    Site Not Available

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