Icotinib in Advanced Metastatic Patients With NSCLC Previously Treated With Chemotherapy

June 28, 2015 updated by: Betta Pharmaceuticals Co., Ltd.

Safety and Efficacy of Icotinib in Advanced Metastatic Patients With NSCLC Previously Treated With Chemotherapy: a Single-arm, Phase 3 Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

128

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100032
        • Peking Union Medical College Hospital
      • Beijing, Beijing, China, 100071
        • 307 Hospital of PLA
      • Beijing, Beijing, China, 101149
        • Beijing Chest Hospital
      • Beijing, Beijing, China, 100021
        • Cancer Hospital, Chinese Academy of Medical Science
      • Beijing, Beijing, China, 100036
        • Bejing Cancer Hospital
    • Chongqing
      • Chongqing, Chongqing, China, 400042
        • Third Affiliated Hospital, Third Military Medical University
    • Guangdong
      • Guanzhou, Guangdong, China, 510060
        • Sun Yat-Sen Univerisity Cancer Center
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Jiangsu Cancer Hospital
    • Shanghai
      • Shanghai, Shanghai, China, 200433
        • Shanghai Pulmonary Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • The First Affiliated Hospital of College of Medicine, Zhejiang University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
progression-free survival
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: 12 months
12 months
objective response rate
Time Frame: 2 months
2 months
number of patients suffered adverse events
Time Frame: 15 months
15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Betta Pharmaceuticals Co., Ltd.

Investigators

  • Study Chair: Yan Sun, MD, Cancer Hospital, Chinese Academy of Medical Science

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

June 28, 2015

First Submitted That Met QC Criteria

June 28, 2015

First Posted (Estimate)

July 1, 2015

Study Record Updates

Last Update Posted (Estimate)

July 1, 2015

Last Update Submitted That Met QC Criteria

June 28, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BD-IC-III01-V2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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