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Icotinib at Different Doses in Second-line Treatment for Non-small Cell Lung Cancer Patients With Wild Type EGFR

This study is currently recruiting participants.
Verified August 2012 by Tianjin Medical University Cancer Institute and Hospital
Sponsor:
Information provided by (Responsible Party):
Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier:
NCT01744925
First received: December 5, 2012
Last updated: June 4, 2013
Last verified: August 2012
History of Changes
  Purpose

This study is designed to evaluate the safety and efficacy of icotinib at routine dose and higher dose as second-line treatment in non-small cell lung cancer patients with epidermal growth factor receptor of wild type.


Condition Intervention Phase
Non-small Cell Lung Cancer
 Drug: Icotinib of routine dose
Drug: Icotinib of high dose
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label,Randomized,Controlled Study to Evaluate the Safety and Efficacy for Icotinib at Different Doses in Second-line Treatment for Non-small Cell Lung Cancer Patients With Wild Type EGFR

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by Tianjin Medical University Cancer Institute and Hospital:

Primary Outcome Measures:
  • Objective Response Rate [ Time Frame: 4 weeks ] [ 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 Response Evaluation Criteria in Solid Tumors, confirmed at least 28 days following the date of the initial response.


Secondary Outcome Measures:
  • Progression free survival [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Progression free survival 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.

  • Overall survival [ Time Frame: 14 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.

  • Number of Participants with Adverse Events [ 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: 60
Study Start Date: October 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Icotinib of routine dose
Icotinib: 125mg, oral administration, three times per day.
 Drug: Icotinib of routine dose
Icotinib: 125mg, oral administration, three times per day.
Other Names:
  • Conmana
  • BPI-2009
Experimental: Icotinib of high dose
Icotinib: 375mg, oral administration, three times per day.
 Drug: Icotinib of high dose
Icotinib: 375mg, oral administration, three times per day.
Other Names:
  • BPI-2009
  • Conmana

  Eligibility

Ages Eligible for Study:   18 Years to 75 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 with Histologic or cytologic confirmation.
  • Wild type epidermal growth factor receptor status.
  • Progressed after first-line chemotherapy.
  • No previous systemic anticancer therapy.
  • Measurable lesion according to response evaluation criteria in solid tumors with at least one measurable lesion not previously irradiated.
  • 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).
  • Positive epidermal growth factor receptor mutation.
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01744925

Contacts
Contact: Changli Wang, MD 86-022-23340123 ext 3031 wangchangli@medmail.com.cn

Locations
China, Tianjin
Tianjin Medical University Cancer Institute and Hospital Recruiting
Tianjin, Tianjin, China, 300060
Contact: Changli Wang         wangchangli@medmail.com.cn    
Sponsors and Collaborators
Tianjin Medical University Cancer Institute and Hospital
Investigators
Principal Investigator: Changli Wang, M.D. Tianjin Medical University Cancer Institute and Hospital
  More Information

No publications provided

Responsible Party: Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier: NCT01744925     History of Changes
Other Study ID Numbers: BD-IC-IV26
Study First Received: December 5, 2012
Last Updated: June 4, 2013
Health Authority: China: Food and Drug Administration

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

ClinicalTrials.gov processed this record on June 18, 2013