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

Tianjin Medical University

Status and phase: Unknown; Phase 2

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: Icotinib of routine dose; Drug: Icotinib of high dose

Study type: Interventional

Funder types: Other

Identifiers

NCT01744925

BD-IC-IV26

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Icotinib of routine dose

Active Comparator group

Description:

Icotinib: 125mg, oral administration, three times per day.

Treatment:

Drug: Icotinib of routine dose

Icotinib of high dose

Experimental group

Description:

Icotinib: 375mg, oral administration, three times per day.

Treatment:

Drug: Icotinib of high dose