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ICAPE: Icotinib as an Adjuvant Therapy for Patients With Stage IIA-IIIA Adenocarcinoma With EGFR Mutation

Sponsor
Betta Pharmaceuticals Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT02044328
Collaborator
(none)
79
Enrollment
1
Location
1
Arm
93
Actual Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Adjuvant therapy has been proved effective in treating earlier stage or less advanced non-small-cell lung cancer. This study is designed to evaluate the efficacy of icotinib as adjuvant therapy in treating stage IIA-IIIA adenocarcinoma patients with EGFR mutation. The primary endpoint is disease-free survival.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
79 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Icotinib as an Adjuvant Therapy for Patients With Stage IIA-IIIA Adenocarcinoma With EGFR Mutation: a Prospective, Exploratory Study
Actual Study Start Date :
Jan 1, 2014
Actual Primary Completion Date :
Jan 1, 2018
Actual Study Completion Date :
Oct 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Icotinib

Patients receive icotinib 125 mg three times daily as adjuvant chemotherapy with for 18 months after surgery.

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Disease-free survival [2 years]

    Secondary Outcome Measures

    1. 1-year Survival Rates [1 year]

    2. 3-year Survival Rates [3 years]

    3. Number of patients suffered adverse events [42 months]

      Adverse events are evaluated and coded by Common Terminology Criteria for Adverse Events version 4.0

    Other Outcome Measures

    1. Difference of disease-free survival by status of Bcl-2 interacting mediator of cell death [2 years]

      Compare the disease-free survival between patients with positive Bcl-2 interacting mediator of cell death mutation and patients without this mutation.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • The patients present with operable stage IIA-IIIA (N0-1) lung adenocarcinoma with 19 or 21 exon mutation

    • The patients have no history of anti-cancer therapies including chemotherapy, radiation therapy

    • The patients' Eastern Cooperative Oncology Group scores are ≤ 0-1

    • The patients signed the written informed consent

    Exclusion Criteria:

    • Patients with unresected tumor

    • Wild EGFR type

    • Allergic to the study drug

    • Patients have severe non-cancerous diseases

    • Patients are undergoing current administration of anti-cancer therapies, or are attending some other clinical trials

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Xuanwu Hospital, Capital Medical University Beijing Beijing China 100053

    Sponsors and Collaborators

    • Betta Pharmaceuticals Co., Ltd.

    Investigators

    • Principal Investigator: Zhang Yi, MD, Xuanwu Hospital, Beijing

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Betta Pharmaceuticals Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT02044328
    Other Study ID Numbers:
    • BD-IC-IV57
    First Posted:
    Jan 23, 2014
    Last Update Posted:
    Feb 8, 2022
    Last Verified:
    Jan 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Adenocarcinoma

    Study Results

    No Results Posted as of Feb 8, 2022