Non-small-cell Lung Cancer
Conditions
Brief summary
The purpose of this study is to evaluate the overall response rate and disease free survival for IIIAN2 non-small-cell lung cancer patients with EGFR 19 or 21 exon mutation.
Detailed description
Neoadjuvant therapy has been used for years to treat patients with non-small-cell lung cancer whose primary tumors are too large to allow for surgery. Reduction in size of the primary tumor with neoadjuvant therapy has made it possible for those patients. Moreover, the goals have expanded to include: determination of the sensitivity of the tumor so that subsequent therapy can be modified accordingly; to prolong disease free survival; to prolong survival.
Interventions
DRUGIcotinib
Patients receive 8-week icotinib induction treatment before surgery and 1-year icotinib adjuvant therapy after surgery.Icotinib is administered orally with a dose 125 mg 3 times daily.
DRUGChemotherapy
After surgery patients receive 4-cycle adjuvant chemotherapy with vinorelbine /cisplatin regimen, until untolerable toxicity or disease progression.
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 70 Years
Healthy volunteers
No
Inclusion criteria
* 1.The patients signed the written informed consent. 2.The patients present with operable IIIAN2 non-small-cell lung cancers with 19 or 21 exon mutation. 3.The patients have no history of anti-cancer therapies including chemotherapy, radiation therapy, and surgical therapy. 4.The patients' Eastern Cooperative Oncology Group scores are ≤ 0-1. 5.The age of patient is ≥ 18 years old with a life expectancy longer than 3 months.
Exclusion criteria
* 1\. Patients with unresected tumor. 2. Wild EGFR type. 3. Allergic to the study drug. 4. Patients have severe non-cancerous diseases. 5. Patients are undergoing current administration of anti-cancer therapies, or are attending some other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate | 8 weeks |
| Disease free survival | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| The pathological complete response rate after neoadjuvant therapy with icotinib | 8 weeks |
| The lymph node staging reduction rate of patients after neoadjuvant therapy with icotinib | 8 weeks |
| The resection rate of patients after neoadjuvant therapy with icotinib | 2 months |
Countries
China
Outcome results
None listed