NSCLC
Conditions
Brief summary
This randomized, open-label study is aimed to evaluate the efficacy of high-dose icotinib in treating advanced non-small cell lung cancer patients with positive EGFR 21 exon mutation.
Interventions
DRUGicotinib
Sponsors
Betta Pharmaceuticals Co., Ltd.
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
* Histologically or cytologically confirmed stage IIIB/IV lung cancer(exclude patients confirmed by sputum cytology) * Positive EGFR 21 exon mutation or 19 exon deletion * Age 18-75 years old with performance status of 0 to 2 * With a measurable disease(longest diameters \>=10mm with Spiral computed tomography (CT)and \>=20mm with conventional CT) according to RECIST Criteria * Adequate hematological, biochemical and organ functions.
Exclusion criteria
* Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases. * Evidence of interstitial lung diseases * 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 |
|---|---|
| Progression-free survival | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival | 20 months |
| Objective response rates | 12 weeks |
Countries
China
Contacts
Primary ContactZhang Shucai, MD
Outcome results
None listed