Non-small Cell Lung Cancer
Conditions
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.
Interventions
Icotinib: 125mg, oral administration, three times per day.
Icotinib: 375mg, oral administration, three times per day.
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate | 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
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival | 3 months | 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 | 14 months | 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 | 18 months | Adverse events, Serious adverse events , incidence of and reason for study drug dose interruptions and discontinuations, laboratory assessments, vital signs. |
Countries
China
Contacts
Primary ContactChangli Wang, MD
Outcome results
None listed