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Icotinib in Advanced Metastatic Patients With NSCLC Previously Treated With Chemotherapy

Sponsor
Betta Pharmaceuticals Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT02486354
Collaborator
(none)
128
Enrollment
10
Locations
1
Arm
25
Duration (Months)
12.8
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study was a single-arm, multi-center, prospective, phase 3 trial aimed to evaluate the efficacy and safety of icotinib in patients with locally advanced or metastatic NSCLC after failure of at least one platinum-based chemotherapy regimen.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
128 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Safety and Efficacy of Icotinib in Advanced Metastatic Patients With NSCLC Previously Treated With Chemotherapy: a Single-arm, Phase 3 Study
Study Start Date :
Mar 1, 2010
Actual Primary Completion Date :
Oct 1, 2011
Actual Study Completion Date :
Apr 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: icotinib

Patients were administered with oral icotinib (tablet form, 125 mg) three times daily within two days after enrollment until disease progression or unacceptable toxicity.

Drug: icotinib
Patients were administered with oral icotinib (tablet form, 125 mg) three times daily within two days after enrollment until disease progression or unacceptable toxicity.
Other Names:
  • Conmana

    		•

    Outcome Measures

    Primary Outcome Measures

    1. progression-free survival [6 months]

    Secondary Outcome Measures

    1. overall survival [12 months]

    2. objective response rate [2 months]

    3. number of patients suffered adverse events [15 months]

    Eligibility Criteria

    Criteria

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

    • Histologically or cytologically confirmed locally advanced/metastatic (stage IIIB/stage IV, using the American Joint Committee on Cancer [AJCC] 6th edition of tumor-node-metastasis [TNM] staging system) NSCLC patients

    • Progressed after at least one platinum-based chemotherapy regimen at entry

    • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2

    • At least one measurable lesion by Response Evaluation Criteria in Solid Tumors version 1.0

    • Adequate hematologic and biochemical values

    Exclusion Criteria:

    • Patients with symptomatic brain metastases

    • Malignant tumor within the previous five years

    • Severe infection; congestive heart failure

    • Previous treatment with drugs targeting EGFR

    • History of interstitial lung disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cancer Hospital, Chinese Academy of Medical Science Beijing Beijing China 100021
    2 Peking Union Medical College Hospital Beijing Beijing China 100032
    3 Bejing Cancer Hospital Beijing Beijing China 100036
    4 307 Hospital of PLA Beijing Beijing China 100071
    5 Beijing Chest Hospital Beijing Beijing China 101149
    6 Third Affiliated Hospital, Third Military Medical University Chongqing Chongqing China 400042
    7 Sun yat-sen Univerisity Cancer Center Guanzhou Guangdong China 510060
    8 Jiangsu Cancer Hospital Nanjing Jiangsu China 210009
    9 Shanghai Pulmonary Hospital Shanghai Shanghai China 200433
    10 The First Affiliated Hospital of College of Medicine, Zhejiang University Hangzhou Zhejiang China 310022

    Sponsors and Collaborators

    • Betta Pharmaceuticals Co., Ltd.

    Investigators

    • Study Chair: Yan Sun, 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:
    NCT02486354
    Other Study ID Numbers:
    • BD-IC-III01-V2
    First Posted:
    Jul 1, 2015
    Last Update Posted:
    Jul 1, 2015
    Last Verified:
    Jun 1, 2015
    Additional relevant MeSH terms:
    Carcinoma, Non-Small-Cell Lung

    Study Results

    No Results Posted as of Jul 1, 2015