Overview

Evaluation of the High Dose of Icotinib in Advanced Lung Cancer Patients After Failure of Target Therapy

Status:
Unknown status
Trial end date:
2019-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Anhui Medical University
Criteria
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 exclusion criteria ,he is no eligible to
participate in this study,

1. Before enrollment in this trial have used Erbitux, Herceptin and carried out
anti-cancer therapy.

2. use of phenytoin, carbamazepine, rifampicin, phenobarbital or St. John's Wort when
take this trial

3. severe allergies to Icotinib