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

Phase 4

• Conditions: Non-Small Cell Lung Cancer
• Interventions: Drug: Icotinib

• Registration Number: NCT01646450
• Lead Sponsor: Betta Pharmaceuticals Co., Ltd.

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.

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-17
• Study First Submitted QC: 2012-07-19
• Study First Posted: 2012-07-20
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-05
• Last Update Posted: 2015-09-09
• Primary Completion: 2015-12
• Study Completion: 2016-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 35

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Progression free survival	12 months	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.

Secondary Outcome Measures

Name	Time	Method
Objective response rate	3-6 months	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.
Number of Participants with Adverse Events as a Measure of Safety	18 months	Adverse events, Serious adverse events , incidence of and reason for study drug dose interruptions and discontinuations, laboratory assessments, vital signs.
Overall survival	24 months	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.

Trial Locations

Locations (1)

Shanghai Chest Hospital Affliated to Shanghai Jiaotong Univercity; 🇨🇳 Shanghai, Shanghai, China