Icotinib as First-line and Maintenance Treatment in EGFR Mutated Patients With Lung Adenocarcinoma

Study Overview
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Brief Summary
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This study is designed to compare the efficacy and safety of first-line icotinib treatment and first-line chemotherapy followed by maintenance treatment with icotinib.

Detailed Description
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This study is designed to compare the efficacy and safety of first-line icotinib treatment and first-line chemotherapy followed by maintenance with icotinib. Primary endpoint: Progression-free survival between first-line icotinib treatment and first-line chemotherapy followed by maintenance with icotinib Secondary endpoint: Overall survival between icotinib and chemotherapy Time to Progression between icotinib and chemotherapy Objective response rate and disease control rate between icotinib and chemotherapy

Official Title
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Randomized, Open Label, Positive Controlled, Multicenter Trial to Evaluate Icotinib as First-line and Maintenance Treatment in EGFR Mutated Patients With Lung Adenocarcinoma

Conditions
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EGFR Positive Non-small Cell Lung Cancer, Adenocarcinoma

Intervention / Treatment
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* Drug: Experimental
* Drug: Chemotherapy
* Drug: Chemotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathologic confirmation of lung adenocarcinoma with measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded on CT); Patients must have previously untreated locally advanced or metastatic NSCLC; Patients must have lung cancer with a documented EGFR activating mutation (exon 19 deletion, L858R). Exclusion Criteria: Prior chemotherapy Prior treatment with gefitinib, erlotinib, or other drugs that target EGFR Patients must not be receiving any other investigational agents Any evidence of interstitial lung disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Icotinib<br>Icotinib: 125mg, oral administration, three times per day. | Drug: Experimental<br>* Icotinib: 125mg, oral administration, three times per day.<br>* Other names: Commana;|
| Active Comparator: Chemotherapy Regimen 1<br>Chemotherapy Regimen 1：Pemetrexe 500 mg/m^2 on Day 1, Cisplatin 75 mg/m^2 on Day 1, 21 days/1 cycle, 2/4 cycles totally, until progression, withdrawal of consent, or unacceptable toxicity. | Drug: Chemotherapy<br>* Chemotherapy Regimen 1：Pemetrexe 500 mg/m^2 on Day 1, Cisplatin 75 mg/m^2 on Day 1, 21 days/1 cycle, 2/4 cycles totally, until progression, withdrawal of consent, or unacceptable toxicity.<br>* Other names: ALIMTA;Drug: Chemotherapy<br>* Chemotherapy Regimen 2：Docetaxel 75 mg/m^2 on Day 1, Cisplatin 75 mg/m^2 on Day 1, 21 days/1 cycle, 2/4 cycles totally, until progression, withdrawal of consent, or unacceptable toxicity.<br>* Other names: Taxotere;|
| Active Comparator: Chemotherapy Regimen 2<br>Chemotherapy Regimen 2：Docetaxel 75 mg/m^2 on Day 1, Cisplatin 75 mg/m^2 on Day 1, 21 days/1 cycle, 2/4 cycles totally, until progression, withdrawal of consent, or unacceptable toxicity. | Drug: Chemotherapy<br>* Chemotherapy Regimen 1：Pemetrexe 500 mg/m^2 on Day 1, Cisplatin 75 mg/m^2 on Day 1, 21 days/1 cycle, 2/4 cycles totally, until progression, withdrawal of consent, or unacceptable toxicity.<br>* Other names: ALIMTA;Drug: Chemotherapy<br>* Chemotherapy Regimen 2：Docetaxel 75 mg/m^2 on Day 1, Cisplatin 75 mg/m^2 on Day 1, 21 days/1 cycle, 2/4 cycles totally, until progression, withdrawal of consent, or unacceptable toxicity.<br>* Other names: Taxotere;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | OS was assessed via calculation of the time to death due to any cause from the date of randomization. A patient was censored at the last date they were known to be alive. | 24 months | 
| Time to Tumor Progression | TTP was defined as the time from the date of first dose of study medication to first documentation of objective tumor progression. If tumor progression data included more than 1 date, the first date was used. TTP (in weeks) was calculated as (first event date minus first dose date +1)/7. Kaplan-Meier method was used. | 8 months | 
| Objective response rate | Number of Subjects With Overall Confirmed Objective Disease Response According to the Response Evaluation Criteria in Solid Tumors(RECIST)1.1. | 3 months | 
| Number of participants with adverse events | Adverse events assessed by CTCAE4.0. | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Icotinib, EGFR positive mutation, First-line treatment, Maintenance treatment