non small lung cancer
Conditions
Interventions
Experimental group:Gefitinib and zoledronate. zoledronate 4 mg intravenous (IV) monthly +Gefitinib 250mg orally (PO) daily.Placebo Comparator: Arm B Gefitinib and placebo. Placebo was given to patient
Placebo Comparator:Gefitinib and placebo. Placebo was given to patients in the same way as that of zoledronate
Sponsors
Enshi Tujia and Miao Autonomous Prefecture Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients must have Histologically or cytologically confirmed non small cell carcinoma of the lung harboring EGFR activating mutations and are previously untreated; 2. Patient must have measurable disease at stage IIIB (contralateral hilar lymph node metastases)/ IV (includes M1a, M1b stages or recurrent disease). However, patients with bone metastasis are not eligible; 3. Aged from 18 to 70 years old; both male and female; 4. Patients must have a Life Expectancy of greater than 12 weeks; 5. Functions of major organs (haemogram,heart,liver, kidney) are basically normal, White blood count >=3.5* 10^9/L with neutrophils >=1.5*10^9/L, platelet count>=100*10^9/L, and hemoglobin >=90g/L. Total bilirubin <=1.5 times upper limit of normal (ULN) range; alkaline phosphatase(ALP)<=2.5 times ULN, Transaminases AST (SGOT) and ALT (SGPT) <=2.5 times ULN, serum creatinine <=1.2 times ULN; 6. With ECOG performance status 0-2; 7. Patients must have the ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
Exclusion criteria: 1. Any evidence of severe or uncontrolled systemic diseases (e.g., unstable respiratory, cardiac, hepatic, or renal disease or other serious internal diseases or uncontrolled infection); 2. Known severe hypersensitivity to zoledronate or Gefitinib or any of the excipients of this product; 3. Any evidence of clinically active interstitial lung disease; 4. Current active dental problems including infection of the teeth or jawbone; dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw or of slow healing after dental procedures; 5. Recent (within 6 weeks) or planned dental or jaw surgery 6 weeks; 6. Women that are pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) of the patients.; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival (OS);Response to therapy; | — |
Countries
China
Contacts
Public ContactChuying Huang
Outcome results
None listed