An Open, Single-Center,Single Arm Trial to Evaluate the Efficacy and Safety of Increased Dose of Icotinib in Advanced None Small Cell Lung Cancer Patients After Routine Gefitinib Therapy
Trial Snapshot
- Phase
- Phase 4
- Status
- Suspended
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Progression-free survival
Study Overview
Brief Summary
To evaluate the efficacy and safety of increased dose of icotinib in advanced NSCLC patients who progressed after gefitinib therapy.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Icotinib
Icotinib will be administered 250 mg one time by month, 3 times per day.
Intervention: Icotinib (Drug)
Outcomes
Primary Outcomes
Progression-free survival
Time Frame: 4.5 months
Progression-free survival is defined as a duration from the date that first dose is given to disease progression or death.
Secondary Outcomes
- Tumor response(6 weeks)
- Overall survival(12 months)
- Adverse Events(18 months)