Lung Adenocarcinoma
Conditions
Keywords
Icotinib, chemotherapy, EGFR
Brief summary
This is a prospective, open, single-center, phase Ⅱ study to assess the efficacy and safety of alternating Icotinib and chemotherapy for advanced non-small cell lung cancer with EGFR mutation.
Interventions
DRUGIcotinib
All cases that meet the criteria take Icotinib for 18 weeks, If there is no disease progression, then after 14 days of washout period, received 4 cycles of pemetrexed / carboplatin. After the chemotherapy, continue with Icotinib, 125mg Tid，PO. until disease progression.
All cases that meet the criteria take Icotinib for 18 weeks, If there is no disease progression, then after 14 days of washout period, received 4 cycles of pemetrexed / carboplatin (standard solution, 3 weeks for a cycle of chemotherapy : pemetrexed 500mg/m2 iv , 4 cycles. carboplatin AUC=5 iv ,4 cycles.). After the chemotherapy, continue with Icotinib, 125mg Tid，PO. until disease progression.
Sponsors
Henan Cancer Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Histological or cytological confirmation of non-small cell lung cancer (NSCLC) in phase ⅢB or phase Ⅳ. 2. Positive EGFR mutation(19 exon or 21 exon)。
Exclusion criteria
1. Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin, erbitux. 2. Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases. 3. Allergic to icotinib 4. metastases of spinal cord, meninges or meningeal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival | from the day confirmed NSCLC to the day of first detecting progression, up to 24 months |
Secondary
| Measure | Time frame |
|---|---|
| overall survival time | from the day confirmed NSCLC to the day of death, up to 36 months |
Countries
China
Outcome results
None listed