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ICWIP: Icotinib Versus Placebo as Adjuvant Therapy in EGFR-mutant Lung Adenocarcinoma

Sponsor
Betta Pharmaceuticals Co., Ltd. (Industry)
Overall Status
Unknown status
CT.gov ID
NCT02125240
Collaborator
(none)
124
Enrollment
11
Locations
2
Arms
82
Duration (Months)
11.3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to compare 3years of disease-free survival (DFS) of Icotinib and placebo in the treatment of patients who EGFR mutation-positive II-IIIA lung adenocarcinoma.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

This study is designed to compare 3 years of disease-free survival (DFS) of Icotinib and placebo in the treatment of patients who EGFR mutation-positive II-IIIA lung adenocarcinoma.

Primary Outcome Measure:

Disease-free survival between Icotinib group and placebo group.

Secondary Outcome Measures:

Overall survival between Icotinib group and placebo group. Lung cancer symptoms and health-related quality of life (HRQoL) . Number of participants with adverse events.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
124 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Icotinib as an Adjuvant Therapy for Stage II-IIIA Adenocarcinoma With EGFR Mutation: A Placebo-controlled, Randomized, Double-blind, Phase III Study
Study Start Date :
Sep 1, 2014
Anticipated Primary Completion Date :
Dec 1, 2018
Anticipated Study Completion Date :
Jul 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Icotinib

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

Drug: Icotinib
125 mg three times daily (375 mg per day) by mouth
Other Names:
  • BPI-2009
  • Conmana

    		•
    Active Comparator: Placebo

    1 tablet three times daily by mouth

    Drug: Placebo
    1 tablet three times daily by mouth

    Outcome Measures

    Primary Outcome Measures

    1. Disease-free survival [36 months]

      DFS was defined as the time from the date of first dose of study medication to the date of death due to disease recurrence or disease progression.

    Secondary Outcome Measures

    1. Overall survival [60 months]

      OS was assessed via calculation of the time to death due to any cause from the date of randomization. A patient was censored at the last date they were known to be alive.

    2. Lung cancer symptoms and health-related quality of life (HRQoL) differences [60 months]

    3. Number of participants with adverse events [36 months]

    Eligibility Criteria

    Criteria

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

    • Pathologically confirmed lung adenocarcinoma after surgical resection

    • Stage II-IIIA disease according to 7th edition of TNM staging

    • Patients must harbor sensitive EGFR gene mutation (19/21)

    • Received four cycles of platinum-based adjuvant chemotherapy.There are many different kinds of chemotherapy regimens including vinorelbine, gemcitabine, docetaxel, paclitaxel, pemetrexed plus cisplatin or carboplatin.The first cycle of chemotherapy with cisplatin dose of 75 mg / m2 ± 10% or carboplatin AUC = 5 ± 10% to calculate the dose of chemotherapy

    Exclusion Criteria:

    • Previous systemic anti-tumor therapy, including chemotherapy or targeted therapy(Including but not limited to monoclonal antibodies, small molecule tyrosine kinase inhibitor, etc

    • Presence of metastatic disease

    • Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ

    • Any unresolved chronic toxicity from previous anticancer therapy

    • Received antitumor radiation therapy (except for the stage IIIA N2 patients who received adjuvant radiotherapy after surgery)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beijing Chaoyang Hospital Beijing Beijing China 100000
    2 Beijing Hospital Beijing Beijing China 100005
    3 Beijing Union Medical College Hospital Beijing Beijing China 100005
    4 Cancer Hospital, Chinese Academy of Medical Science Beijing Beijing China 100021
    5 China-japan friendship hospital in Beijing Beijing Beijing China 100029
    6 Peking University First Hospital Beijing Beijing China 100034
    7 Peking University People's Hospital Beijing Beijing China 100044
    8 304 Hospital of PLA Beijing Beijing China 100048
    9 Xuanwu Hospital, Capital Medical University Beijing Beijing China 100053
    10 People's Liberation Army General Hospital (301 Hospital) Beijing Beijing China 100853
    11 Capital Medical University, Beijing Chest Hospital Beijing Beijing China 101149

    Sponsors and Collaborators

    • Betta Pharmaceuticals Co., Ltd.

    Investigators

    • Principal Investigator: Yuan-Kai Shi, MD, Cancer Hospital, Chinese Academy of Medical Science

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Betta Pharmaceuticals Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT02125240
    Other Study ID Numbers:
    • BD-IC-IV-59
    First Posted:
    Apr 29, 2014
    Last Update Posted:
    Jul 16, 2018
    Last Verified:
    Jul 1, 2018
    Additional relevant MeSH terms:
    Adenocarcinoma

    Study Results

    No Results Posted as of Jul 16, 2018