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

Sponsor
Betta Pharmaceuticals Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT01719536
Collaborator
(none)
296
Enrollment
21
Locations
2
Arms
50.2
Duration (Months)
14.1
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
296 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Conmana Versus Pemetrexed-based First-line Induction and Maintenance Chemotherapy in Advanced Lung Adenocarcinoma With EGFR-mutation
Study Start Date :
Dec 1, 2012
Actual Primary Completion Date :
Sep 1, 2016
Actual Study Completion Date :
Feb 7, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Icotinib

Icotinib 125mg is administered orally three times per day.

Drug: Icotinib
Icotinib: 125 mg is administered orally three times per day.
Other Names:
  • BPI-2009
  • Conmana

    		•
    Active Comparator: Chemotherapy

    Patients in this arm will receive pemetrexed/cisplatin for 4 cycles, of who don't progress will receive maintenance treatment with pemetrexed.

    Drug: Chemotherapy
    First-line chemotherapy: pemetrexed/cisplatin for 4 cycles. Maintenance treatment: pemetrexed.
    Other Names:
  • ALIMTA

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Progression Free Survival [12 months]

      A duration from randomization date to disease progression(as defined by RECIST) or death. If a participant are known to have progressed, the time to progression is defined as the time from the date of randomization to the date of progression. Otherwise, a participant will be censored at the last date they are known not to be progressed.

    Secondary Outcome Measures

    1. Overall survival [20 months]

      Overall Survival is assessed via calculation of the time to death due to any cause. If a participant is known to have died, the time to death is defined as the time from the date of randomization to the date of death. Otherwise, a participant will be censored at the last date they are known to be alive.

    2. Objective response rate [12 weeks]

      Number of participants who achieve complete response or partial response. Either complete response (CR) or partial response (PR) will be evaluated by RECIST, confirmed at least 28 days following the date of the initial response.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 not previously irradiated, unless disease progression has been documented at that site.

    • Provision of written informed consent.

    Exclusion Criteria:

    • Experience of Anti-EGFR(the epidermal growth factor receptor) Monoclonal Antibody or small 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 makes it undesirable for the subject to participate in the study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The First Affiliated Hospital of Anhui Medical Univercity Hefei Anhui China 230022
    2 Chinese People's Liberation Army (PLA) General Hospital Beijing Beijing China 100853
    3 Beijing Hospital for Chest Tumors & Tuberculosis Diseases Beijing Beijing China 101149
    4 Xinqiao Hospital, The Third Military Medical University Chongqing Chongqing China 400037
    5 The First Affiliated Hospital Of Guangzhou Medical Collage Guangzhou Guangdong China 510120
    6 Nanfang Hospital, Southern Medical University Guangzhou Guangdong China 510515
    7 Hebei Provincal Tumor Hospital Shijiazhuang Hebei China 050011
    8 Harbin Medical Univercity Cancer Hospital Harbin Heilongjiang China 110001
    9 Henan Provincal Tumor Hospital Zhengzhou Henan China 450003
    10 Jiangsu Cancer Hospital Nanjing Jiangsu China 210009
    11 Jiangsu Provincal Tumor Hospital Nanjing Jiangsu China 210029
    12 The First Bethune Hospital of Jilin Univercity Changchun Jilin China 130021
    13 The First Hospital of China Medical University Shenyang Liaoning China 110001
    14 Shandong Cancer Hospital Jinan Shandong China 250117
    15 Shanghai Chest Hospital Affiliated to Shanghai Jiaotong Univercity Shanghai Shanghai China 200030
    16 Zhongshan Hospital Affiliated to Fudan Univercity Shanghai Shanghai China 200032
    17 Changhai Hospital, The Second Military Medical University Shanghai Shanghai China 200433
    18 Xijing Hospital Xian Shanxi China 710032
    19 Sichuan Provincal Tumor Hospital Chengdu Sichuan China 610041
    20 West China Hospital, Sichuan University Chengdu Sichuan China 610041
    21 Tianjin Medical University Cancer Institute and Hospital Tianjin Tianjin China 300060

    Sponsors and Collaborators

    • Betta Pharmaceuticals Co., Ltd.

    Investigators

    • Principal Investigator: Shi Yuankai, M.D., Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Betta Pharmaceuticals Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT01719536
    Other Study ID Numbers:
    • BD-IC-IV36
    First Posted:
    Nov 1, 2012
    Last Update Posted:
    Jul 5, 2019
    Last Verified:
    Jul 1, 2019
    Additional relevant MeSH terms:
    Adenocarcinoma
    Adenocarcinoma of Lung

    Study Results

    No Results Posted as of Jul 5, 2019