NSCLC
Conditions
Keywords
Adverse Reaction to Drug, Self Efficacy
Brief summary
The purpose of this study is to evaluate the efficacy and safety of dose escalation of Icotinib in advanced non small cell lung cancer (NSCLC) patients after the therapy of Icotinib, Iressa and Tarceva.
Detailed description
* 1:to evaluate the efficacy correlation between the tyrosine kinase inhibitor (TKI) drugs and high-dose Icotonib group in advanced NSCLC patients with high -dose Icotinib going on after the routine TKI therapy * 2 to evaluate the efficacy correlation between different high-dose group in advanced NSCLC patients with high -dose Icotinib going on after the routine TKI therapy
Interventions
DRUGIcotinib
Patients can accept the treatment with Icotinib (250/375/500mg tid) until disease progression or unacceptable toxicities occurred. The overall study period takes about 24 months
Sponsors
Anhui Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. NSCLC patients were confirmed by histology or cytology 2. The time interval must be over 4 weeks from previous chemotherapy to registration to participate in this experiment if he or she received chemotherapy,and also have any toxicity to recover. 3. at least one measureable lesion accord to RECIST 1.1 criteria and the lesion accepted no radiotherapy. * 1 at least one measureable lesion .if only one measureable lesion, the biological nature must be confirmed by cytology or histology. * 2 a single diameter of lesion could be measured by at least one of the following methods: Chest or abdominal computed tomography(CT)or magnetic resonance imaging(MRI),conventional methods of diameter at least 20mm diameter spiral CT OR at least 10mm. 4. ECOG 0-2 score 5. at least 12 weeks of expected survival time 6. Women of childbearing age must have a pregnancy test 7 days before treatment and the result were negative ,men of childbearing age: surgical sterilization or treatment during and after the end of three months to take contraceptive measures 7. understand and sign a written informed consent voluntarily.
Exclusion criteria
If the subject meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| safety and efficacy | 2 years | 1. The efficacy of dose escalation of Icotinib in advanced NSCLC patients after failure of TKI (Icotinib 125mg po tid. Iressa 250mg po qd. Tarceva 150mg po qd) therapy will be evaluated according to the revised RECIST 1.1 (Response Evaluation Criteria In Solid Tumors). 2. The safety of high dosage of Icotinib will be evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. |
Countries
China
Contacts
Primary ContactHu Liu, MD
Outcome results
None listed