First-line Treatment With Icotinib in Elder NSCLC EGFR Mutated Patients

An Open Lable, Single Arm, Phase IV Study of Icotinib as First-line Treatment in Elder NSCLC Patients With EGFR Mutation

A single arm, open label, phase IV trial to evaluate safety and efficacy of icotinib as first-line treatment for the elder patients with advanced or metastatic (IIIb and IV) NSCLC and mutated EGFR.

A single arm, open label, prospective, phase IV trial to evaluate safety and efficacy of icotinib as first-line treatment for the elder patients with advanced or metastatic (IIIb and IV) NSCLC and mutated EGFR.

• Primary endpoint to assess progression-free survival
• Secondary endpoints to assess the overall survival, objective response rate, disease control rate and so on.

Inclusion Criteria:

• Recurrent or progressive Non-Small Cell Lung Cancer stage IV or IIIB patients.
• Positive EGFR Mutation.
• No previous systemic anticancer therapy.
• Male and female patients aged over 70 years.
• Measurable lesion according to RECIST with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site.
• 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).
• 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.