Icotinib at Different Doses in Second-line Treatment for Non-small Cell Lung Cancer Patients With Wild Type EGFR
Conditions
Non-small Cell Lung Cancer
Conditions: official terms
Carcinoma, Non-Small-Cell Lung - Lung Neoplasms
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Icotinib of routine dose Type: Drug
Name: Icotinib of high dose Type: Drug
Overall Status
Recruiting
Summary
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
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.
Location
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin, China
Status: Recruiting
Contact: Changli Wang - wangchangli@medmail.com.cn
Start Date
October 2012
Completion Date
December 2015
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Source
Tianjin Medical University Cancer Institute and Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page