non-small-cell lung cancer
Conditions
Interventions
Treatment group:gefitinib plus FZKA granule
Control group:gefitinib plus placebo granule
Sponsors
Guangdong Provincial Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. With histologically or cytologically confirmed stage IIIB or IV non-small-cell lung cancer with histologic features of adenocarcinoma, squamous-cell carcinoma or adeno-squamous carcinoma; 2. Aged from 18-80 years old; 3. Harbouring activating EGFR mutations (either exon 19 deletion or L858R in exon 21); 4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2; 5. No previous chemotherapy or biologic or immunologic therapy; 6. Measurable lesion according to the Response Evaluation Criteria in Solid Tumours (RECIST); 7. Adequate organ function; 8. Good compliance and voluntarily sign a written informed consent.
Exclusion criteria
Exclusion criteria: 1. Severe hypersensitivity to gefitinib or any component of FZKA; 2. Received previous drug therapy that had targeted EGFR; 3. Eexpected life expectancy less than 2 months; 4. Had a history of interstitial lung disease; 5. Any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic, or renal disease); 6. Diagnosed with central nervous system (CNS) metastasis that have not yet been treated with surgery and/or radiation; 7. Poorly controlled pleural effusion; 8. Pericardial effusion or ascites necessitating drainage; 9. Active double cancer; 10. Patients in pregnancy or breast-feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Objective response rate;Disease control rate;Safety; | — |
Countries
China
Contacts
Public ContactWanyin Wu
Outcome results
None listed