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

Non-Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01646450
• Other study ID #: BD-IC-IV20
• Status: Active, not recruiting
• Phase: Phase 4
• First received: July 17, 2012
• Last updated: September 5, 2015
• Start date: July 2012
• Est. completion date: April 2016

Study information

• Verified date: September 2015
• Source: Betta Pharmaceuticals Co.,Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 35
• Est. completion date: April 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years to 80 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-Small Cell Lung Cancer

Intervention

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

Locations

Country	Name	City	State
China	Shanghai Chest Hospital Affliated to Shanghai Jiaotong Univercity	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Betta Pharmaceuticals Co.,Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival	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.	12 months	No
Secondary	Overall survival	Overall Survival was assessed via calculation of the time to death due to any cause. If a participant was known to have died, the time to death was defined as the time from the date of randomization to the date of death. Otherwise, a participant was censored at the last date they were known to be alive.	24 months	No
Secondary	Objective response rate	Number of participants with an objective response. An objective response (OR) was defined as a patient having a best overall response of either complete response (CR) or partial response (PR) according to RECIST, confirmed at least 28 days following the date of the initial response.	3-6 months	No
Secondary	Number of Participants with Adverse Events as a Measure of Safety	Adverse events, Serious adverse events , incidence of and reason for study drug dose interruptions and discontinuations, laboratory assessments, vital signs.	18 months	Yes