Dose Escalation Of Icotinib In Previously Treated Patients With Routine Dose
To determine whether dose escalation can provide a better survival to patients who failed with icotinib at routine dose.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open , Single-Center, Single Arm Trial to Evaluate the Efficacy and Safety of Dose Escalation of Icotinib in Advanced NSCLC Patients After Routine Icotinib Therapy|
- Progression-free Survival [ Time Frame: 6-12 months ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: 6 months -1 year ] [ Designated as safety issue: No ]
- Objective response rate [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]
- Time to progression [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]
- Health-Related Quality of Life (HR QOL) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Number of Participants with adverse events and serious adverse events (SAEs) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2011|
|Study Completion Date:||February 2014|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
This is a single arm study.
125 mg Tid (375 mg per day) 250 mg Tid (750 mg per day)
Other Name: BPI-2009, Conmana
Lung cancer is a major cause of morbidity and mortality, which is the rapidest increased type of cancer in China with over 5 times incidence rate increase during the past 30 years. Tyrosine kinase inhibitors (TKIs) of the epidermal growth factor receptor (EGFR) have been widely used for the treatment of patients with non-small cell lung cancer(NSCLC). Icotinib is a novel EGFR-TKI developed by a group of Chinese scientists and clinician. Icotinib appears to be non-inferior to Gefitinib in terms of efficacy, better in terms of safety, and larger of therapeutic window in phase I-III trials. In this study, an open , single-center, single arm phase IV trial was designed to evaluate the safety and efficacy of dose escalation of icotinib in the treatment of advanced NSCLC patients after failure with routine dose. PFS (progress free survival) is the primary end-point with OS (overall survival), ORR (objective response), TTP (time to progress), HRQOL and safety as the secondary end-point.
|307 Hospital of People's Liberation Army（PLA）|
|Beijing, Beijing, China, 100071|
|Principal Investigator:||Li Xi qing, M.D.||307 Hospital of People's Liberation Army（PLA）|