Non-small Cell Lung Cancer
Conditions
Brief summary
We hypothesize that higher dose icotinib is related with better efficacy. The primary objective is to compare the progression-free survival of higher dose and routine dose of icotinib in treating pretreated advanced non-small cell lung cancer patients with stable disease after 8-week routine dose icotinib treatment.
Interventions
DRUGRoutine dose icotinib
Icotinib is administered 125 mg three times daily.
DRUGHigher dose icotinib
After 8-week induction of icotinib with a dose of 125 mg three times daily, icotinib is administered 375 mg three times per day.
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); * Pretreated with at least 1 platinum-based chemotherapy; * No previous targeted treatment such as gefitinib, erlotinib; * With a measurable disease(longest diameters \>=10mm with Spiral computed tomography (CT)and \>=20mm with conventional CT) according to RECIST Criteria; * WHO performance status(PS)\<= 2; * Adequate organ functions; * Signed and dated informed consent before the start of specific protocol procedures.
Exclusion criteria
* Allergic to icotinib; * Patients with metastatic brain tumors with symptoms; * Experience of Anti-EGFR(the epidermal growth factor receptor) Monoclonal Antibody or small molecular compounds therapy such as gefitinib, erlotinib or Cetuximab; * Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival | 5 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 18 months | — |
| Response rate assessed using the RECIST criteria | 2 months | — |
| The number of patients who suffered adverse events | 30 months | Adverse events are assessed by Common Terminology Criteria for Adverse Events v4.0 |
Countries
China
Outcome results
None listed