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

Betta Pharmaceuticals

Status and phase

Unknown

Phase 4

Conditions

Non-Small Cell Lung Cancer

Treatments

Drug: Icotinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT01646450

BD-IC-IV20

Details and patient eligibility

About

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.

Full description

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.

Enrollment

35 estimated patients

Sex

All

Ages

70 to 80 years old

Volunteers

No Healthy Volunteers

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.