Overview

Icotinib at Different Doses in Second-line Treatment for Non-small Cell Lung Cancer Patients With Wild Type EGFR

Status:
Unknown status
Trial end date:
2017-12-01
Target enrollment:
0
Participant gender:
All
Summary
This study is designed to evaluate the safety and efficacy of icotinib at routine dose and higher dose as second-line treatment in non-small cell lung cancer patients with epidermal growth factor receptor of wild type.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Criteria
Inclusion Criteria:

- Recurrent or progressive Non-Small Cell Lung Cancer stage IV or IIIB patients with
Histologic or cytologic confirmation.

- Wild type epidermal growth factor receptor status.

- Progressed after first-line chemotherapy.

- No previous systemic anticancer therapy.

- Measurable lesion according to response evaluation criteria in solid tumors with at
least one measurable lesion not previously irradiated.

- Provision of written informed consent.

Exclusion Criteria:

- Evidence of clinically active Interstitial Lung Diseases (Patients with chronic,
stable, radiographic changes who are asymptomatic need not be excluded).

- Positive epidermal growth factor receptor mutation.

- Known severe hypersensitivity to icotinib or any of the excipients of this product.

- Evidence of any other significant clinical disorder or laboratory finding that makes
it undesirable for the subject to participate in the study.