Icotinib in Advanced Metastatic Patients With NSCLC Previously Treated With Chemotherapy

Last updated: June 28, 2015
Sponsor: Betta Pharmaceuticals Co., Ltd.
Overall Status: Completed

Phase

3

Condition

Non-small Cell Lung Cancer

Treatment

N/A

Clinical Study ID

NCT02486354
BD-IC-III01-V2
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically or cytologically confirmed locally advanced/metastatic (stageIIIB/stage IV, using the American Joint Committee on Cancer [AJCC] 6th edition oftumor-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

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

Study Design

Total Participants: 128
Study Start date:
March 01, 2010
Estimated Completion Date:
April 30, 2012

Connect with a study center

  • 307 Hospital of PLA

    Beijing, Beijing 100071
    China

    Site Not Available

  • Beijing Chest Hospital

    Beijing, Beijing 101149
    China

    Site Not Available

  • Bejing Cancer Hospital

    Beijing, Beijing 100036
    China

    Site Not Available

  • Cancer Hospital, Chinese Academy of Medical Science

    Beijing, Beijing 100021
    China

    Site Not Available

  • Peking Union Medical College Hospital

    Beijing, Beijing 100032
    China

    Site Not Available

  • Third Affiliated Hospital, Third Military Medical University

    Chongqing, Chongqing 400042
    China

    Site Not Available

  • Sun yat-sen Univerisity Cancer Center

    Guanzhou, Guangdong 510060
    China

    Site Not Available

  • Jiangsu Cancer Hospital

    Nanjing, Jiangsu 210009
    China

    Site Not Available

  • Shanghai Pulmonary Hospital

    Shanghai, Shanghai 200433
    China

    Site Not Available

  • The First Affiliated Hospital of College of Medicine, Zhejiang University

    Hangzhou, Zhejiang 310022
    China

    Site Not Available

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