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

NCT ID: NCT01646450

Last Updated: 2015-09-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2016-04-30

Brief Summary

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.

Detailed 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.

Conditions

Non-Small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Icotinib

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

Group Type: EXPERIMENTAL

Icotinib

Intervention Type: DRUG

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

Interventions

Icotinib

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

Intervention Type: DRUG

Other Intervention Names

BPI-2009; Commana

Eligibility Criteria

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.

• Minimum Eligible Age: 70 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Betta Pharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Han Baohui, MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Chest Hospital Affliated to Shanghai Jiaotong Univercity

Locations

Shanghai Chest Hospital Affliated to Shanghai Jiaotong Univercity

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

BD-IC-IV20

Identifier Type: -

Identifier Source: org_study_id