Increased Dose of Icotinib in Advanced None Small Cell Lung Cancer Patients After Routine Gefitinib Therapy

Phase 4SuspendedNCT01720901

Betta Pharmaceuticals Co., Ltd.20 enrolled

Overview

To evaluate the efficacy and safety of increased dose of icotinib in advanced NSCLC patients who progressed after gefitinib therapy.

This single center, single arm open label study is designed to assess the safety and efficacy of using high dose of Icotinib (Conmana) as a way to treat patients with non-small cell lung cancer that progressed after routine gefitinib therapy by progression-free survival, as well as overall survival and disease control rate. The adverse events and adverse reaction are evaluated as well.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non-small Cell Lung Cancer

Interventions

IcotinibDRUG

Icotinib will be administered 250 mg one time by month, 3 times per day.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Histologically or cytologically confirmed local advanced or metastatic stage IIIB/IV NSCLC. * Have been treated with gefitinib and achieved completed response, partial remission, or stable disease within 3 months after first dose of gefitinib. * At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors. * Signed and dated informed consent before the start of specific protocol procedures. Exclusion Criteria: * Allergic to icotinib. * Gefitinib excepted, experience of Anti-tumor Monoclonal Antibody or small molecular compounds therapy such as erlotinib or Cetuximab. * Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.

Locations (1)

Xiangya Hospital, Central-South Univercity

Changsha, Hunan, China

Outcomes

Primary Outcomes

Progression-free survival

Progression-free survival is defined as a duration from the date that first dose is given to disease progression or death.

Time frame: 4.5 months

Secondary Outcomes

Overall survival

Overall survival is a duration from the date that first dose is given to the date of death.

Time frame: 12 months

Tumor response

Tumor response is designed by imaging according to Response Evaluation Criteria in Solid Tumors, including complete response, partial remission, stable disease as well as progressed disease.

Time frame: 6 weeks

Adverse Events

Adverse events will be coded in term of the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events.

Time frame: 18 months

Data from ClinicalTrials.gov

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