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

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: NCT01719536
Recruitment Status : Completed
First Posted : November 1, 2012
Last Update Posted : July 5, 2019
Information provided by (Responsible Party):
Betta Pharmaceuticals Co., Ltd.

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
NSCLC Drug: Icotinib Drug: Chemotherapy 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.

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Study Type : Interventional  (Clinical Trial)
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 : December 2012
Actual Primary Completion Date : September 2016
Actual Study Completion Date : February 7, 2017

Resource links provided by the National Library of Medicine

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 Name: ALIMTA

Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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

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.

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 identifier (NCT number): NCT01719536

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Sponsors and Collaborators
Betta Pharmaceuticals Co., Ltd.
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Principal Investigator: Shi Yuankai, M.D. Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Publications of Results:
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Responsible Party: Betta Pharmaceuticals Co., Ltd. Identifier: NCT01719536    
Other Study ID Numbers: BD-IC-IV36
First Posted: November 1, 2012    Key Record Dates
Last Update Posted: July 5, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Adenocarcinoma of Lung
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site