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
Overview
- Phase
- Phase 2
- Intervention
- Icotinib of routine dose
- Conditions
- Non-small Cell Lung Cancer
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Objective Response Rate
- Last Updated
- 9 years ago
Overview
Brief 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.
Investigators
Eligibility 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.
Arms & Interventions
Icotinib of routine dose
Icotinib: 125mg, oral administration, three times per day.
Intervention: Icotinib of routine dose
Icotinib of high dose
Icotinib: 375mg, oral administration, three times per day.
Intervention: Icotinib of high dose
Outcomes
Primary Outcomes
Objective Response Rate
Time Frame: 4 weeks
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 Outcomes
- Progression free survival(3 months)
- Overall survival(14 months)
- Number of Participants with Adverse Events(18 months)