Efficiency of Icotinib in Plasma ctDNA EGFR Mutation-positive Patients Diagnosed With Lung Cancer

Study Overview
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Brief Summary
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this single arm，open-label，multi-center study is aimed to evaluate the efficiency of icotinib in plasma ctDNA EGFR mutation-positive patients diagnosed with lung cancer

Official Title
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Efficiency of Icotinib in Plasma ctDNA EGFR Mutation-positive Patients Diagnosed With Lung Cancer：a Single Arm，Multi-center，Open-label Study

Conditions
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Plasma EGFR Mutation-positive Lung Cancer

Intervention / Treatment
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* Drug: Icotinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of peripheral lung cancer, but the pathological diagnosis is not yet clear. Plasma EGFR mutations (EGFR 19del and/or 21L858R) positive (simultaneously detected by Super-ARMS, ddPCR and NGS，any positive). unavailable of radical surgery or radical radiotherapy. not previously received anticancer therapy like surgery, chemotherapy, radiation therapy, and biotherapy etc. Palliative radiotherapy for bone metastases is permitted, but there is no continuous toxicity associated with radiation therapy. Age 18-75 years old with performance status of 0 to 3. With a measurable disease(longest diameters >=10mm with Spiral computed tomography (CT)) according to RECIST Criteria.None of the lesions treated with radiotherapy could be used as target lesions. Adequate hematological, biochemical and organ functions. Exclusion Criteria: Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases. Evidence of interstitial lung diseases Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study Other situations researchers think not appropriate to enter the group

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: icotinib<br>Patients diagnosed with lung cancer with plasma EGFR mutation-positive are arranged to receive icotinib with a dose of 125 mg three times per day, till progressive disease or unaccepted toxicity | Drug: Icotinib<br>* Patients with plasma EGFR mutation-positive are arranged to receive icotinib with a dose of 125 mg three times per day, till progressive disease or unaccepted toxicity<br>* Other names: conmana;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR | Objective Response Rate | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | Progression-free survival | 12 months | 
| DCR | disease control rate | 12 months | 
| OS | overall survival | 20 months |