First-line Treatment With Icotinib in Elder NSCLC EGFR Mutated Patients
This trial is active, not recruiting.
|Condition||non-small cell lung cancer|
|Sponsor||Betta Pharmaceuticals Co.,Ltd.|
|Start date||July 2012|
|End date||December 2015|
|Trial size||35 participants|
|Trial identifier||NCT01646450, BD-IC-IV20|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Icotinib: 125mg, oral administration, three times per day.
Progression free survival
time frame: 12 months
time frame: 24 months
Objective response rate
time frame: 3-6 months
Number of Participants with Adverse Events as a Measure of Safety
time frame: 18 months
Male or female participants from 70 years up to 80 years old.
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.
|Official title||An Open Lable, Single Arm, Phase IV Study of Icotinib as First-line Treatment in Elder NSCLC Patients With EGFR Mutation|
|Principal investigator||Han Baohui, MD|
|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.|
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