Non-Small-Cell Lung Cancer
Conditions
Interventions
experimental group:Chemotherapy (on day 1 of each 3 week cycle) in combination with Gefitinib (250mg po once a day on days 2-15 of each 3 week cycle) for 4 cycles
then continue to receive gefitinib 250mg po once a day daily until progression
Sponsors
Qilu Hospital of Shandong University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Adult patients,>=18 years of age; 2. Advanced (stage IIIB/IV) non-small-cell lung cancer; 3. Although stage?-?A, have contraindications to surgery; 4. EGFR mutation-positive (EGFR exon-18, exon-19 or exon-21); 5. Measurable disease; 6. ECOG Performance Status 0 or 1 or 2.
Exclusion criteria
Exclusion criteria: 1. Wild-type EGFR; 2. Prior exposure to agents directed at the HER axis; 3. Prior chemotherapy or systemic anti-tumor therapy after advanced disease; 4. Unstable systemic disease; 5. Any other malignancy within last 5 years, except cured basal cell cancer of skin or cured cancer in situ of cervix; 6. Brain metastasis or spinal cord compression.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to progression;Objective response rate;Overall survival (OS); | — |
Countries
China
Contacts
Public ContactLi Yu
Qilu Hospital of Shandong University
Outcome results
None listed