Non-small Cell Lung Cancer
Conditions
Keywords
Efficacy, Safety, EGFR-TKI, phase IV, NSCLC, Dose escalation
Brief summary
To determine whether dose escalation can provide a better survival to patients who failed with icotinib at routine dose.
Detailed description
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.
Interventions
DRUGIcotinib
125 mg Tid (375 mg per day) 250 mg Tid (750 mg per day)
Sponsors
Betta Pharmaceuticals Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Confirmed NSCLC with Histology or cytology; advanced （IIIb/IV). 2. Must have received 1 or 2 chemotherapy (at least 1 is platin based)before, and prior chemotherapy must be completed at least 4 weeks before study enrollment. 3. Measurable, evaluable disease outside of a radiation port.
Exclusion criteria
1. Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin, erbitux. 2. Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free Survival | 6-12 months |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival | 6 months -1 year |
| Objective response rate | 3-6 months |
| Time to progression | 3-6 months |
| Health-Related Quality of Life (HR QOL) | 1 year |
| Number of Participants with adverse events and serious adverse events (SAEs) | 1 year |
Countries
China
Outcome results
None listed