First-line Treatment With Icotinib in Elder NSCLC EGFR Mutated Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Betta Pharmaceuticals Co.,Ltd.
Sponsor:
Information provided by (Responsible Party):
Betta Pharmaceuticals Co.,Ltd.
ClinicalTrials.gov Identifier:
NCT01646450
First received: July 17, 2012
Last updated: July 27, 2014
Last verified: July 2014
  Purpose

A single arm, open label, phase IV trial to evaluate safety and efficacy of icotinib as first-line treatment for the elder patients with advanced or metastatic (IIIb and IV) NSCLC and mutated EGFR.


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: Icotinib
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Lable, Single Arm, Phase IV Study of Icotinib as First-line Treatment in Elder NSCLC Patients With EGFR Mutation

Further study details as provided by Betta Pharmaceuticals Co.,Ltd.:

Primary Outcome Measures:
  • Progression free survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    PFS was defined as the time from the date of first dose of study medication to the date of first documentation of tumor progression or death due to any cause, whichever occurred first.


Secondary Outcome Measures:
  • Overall survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Overall Survival was assessed via calculation of the time to death due to any cause. If a participant was known to have died, the time to death was defined as the time from the date of randomization to the date of death. Otherwise, a participant was censored at the last date they were known to be alive.

  • Objective response rate [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]
    Number of participants with an objective response. An objective response (OR) was defined as a patient having a best overall response of either complete response (CR) or partial response (PR) according to RECIST, confirmed at least 28 days following the date of the initial response.

  • Number of Participants with Adverse Events as a Measure of Safety [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    Adverse events, Serious adverse events , incidence of and reason for study drug dose interruptions and discontinuations, laboratory assessments, vital signs.


Estimated Enrollment: 35
Study Start Date: July 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Icotinib
Icotinib: 125mg, oral administration, three times per day.
Drug: Icotinib
Icotinib: 125mg, oral administration, three times per day.
Other Names:
  • BPI-2009
  • Commana

Detailed Description:

A single arm, open label, prospective, phase IV trial to evaluate safety and efficacy of icotinib as first-line treatment for the elder patients with advanced or metastatic (IIIb and IV) NSCLC and mutated EGFR.

  • Primary endpoint to assess progression-free survival
  • Secondary endpoints to assess the overall survival, objective response rate, disease control rate and so on.
  Eligibility

Ages Eligible for Study:   70 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Recurrent or progressive Non-Small Cell Lung Cancer stage IV or IIIB patients.
  • Positive EGFR Mutation.
  • No previous systemic anticancer therapy.
  • Male and female patients aged over 70 years.
  • Measurable lesion according to RECIST with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site.
  • Provision of written informed consent.

Exclusion Criteria:

  • Evidence of clinically active Interstitial Lung Diseases (Patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded).
  • Known severe hypersensitivity to icotinib or any of the excipients of this product.
  • Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01646450

Contacts
Contact: Han Baohui, MD 0086-021-62808887

Locations
China, Shanghai
Shanghai Chest Hospital Affliated to Shanghai Jiaotong Univercity Recruiting
Shanghai, Shanghai, China, 200030
Contact: Han Baohui, MD    0086-021-62808887      
Sponsors and Collaborators
Betta Pharmaceuticals Co.,Ltd.
Investigators
Principal Investigator: Han Baohui, MD Shanghai Chest Hospital Affliated to Shanghai Jiaotong Univercity
  More Information

No publications provided

Responsible Party: Betta Pharmaceuticals Co.,Ltd.
ClinicalTrials.gov Identifier: NCT01646450     History of Changes
Other Study ID Numbers: BD-IC-IV20
Study First Received: July 17, 2012
Last Updated: July 27, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Betta Pharmaceuticals Co.,Ltd.:
NSCLC
EGFR Mutation
Elder patients

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Lung Neoplasms
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014