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

Phase 4
70 Years
80 Years
Open (Enrolling)
Non-Small Cell Lung Cancer

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Trial Information

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, 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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression free survival

Outcome Description:

PFS was defined as the time from the date of first dose of study medication to the date of first documentation of tumor progression or death due to any cause, whichever occurred first.

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

Han Baohui, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Shanghai Chest Hospital Affliated to Shanghai Jiaotong Univercity


China: Food and Drug Administration

Study ID:




Start Date:

July 2012

Completion Date:

December 2013

Related Keywords:

  • Non-Small Cell Lung Cancer
  • EGFR Mutation
  • Elder patients
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms