Aprepitant for Chemotherapy Induced Nausea and Vomiting in Chinese Advanced Non-small Cell Lung Cancers

Study Overview
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Brief Summary
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Aprepitant is an oral neurokinin-1(NK-1) antagonist which is widely used for the prevention of chemotherapy-induced nausea and vomiting(CINV), it is metabolized by CYP34A, however, up to now it was still unknown the CINV control rate of aprepitant in Chinese non-small cell lung cancer(NSCLC) patients, we hypothesis that CYP3A4 and NK-1 polymorphism would influence aprepitant plasma concentration, which may lead to the individual difference of CINV control rate.

Detailed Description
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Patients pathologic diagnosed of advanced non-small cell lung cancer, according to NCCN non-small cell lung cancer guide line(2014 V2),the patient should receive standard platinum based chemotherapy, are randomized divided into two groups, aprepitant group and placebo group. In aprepitant group, patients would receive aprepitant 125 mg at day1, then 80 mg at day2 and day3. In placebo group, patients would receive placebo from day1 to day3. In both group, dexamethasone and 5-HT inhibitor palonosetron were give at the same dose. During the treatment, any grade of nausea and vomiting should be recorded in order to evaluate the complete response rate of CINV, other side-effects should be recorded. In aprepitant group, plasma should be taken for the analyze of plasma concentration, gene polymorphism of CYP3A4 and NK-1 should be analyzed for all the patients who received aprepitant if possible.

Official Title
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Randomized Phase 3 Study of Aprepitant Versus Placebo in Chinese Advanced Non-small Cell Lung Cancer Who Received Highly Emetogenic Chemotherapy

Conditions
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Carcinoma, Non-small Cell Lung

Intervention / Treatment
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* Drug: Aprepitant
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients pathologic diagnosed of advanced non-small cell lung cancer according to NCCN non-small cell lung cancer guide line(2014 V2), patients are suitable for platinum based chemotherapy. Exclusion Criteria: patients could not receive platinum based chemotherapy judged by clinical doctors pregnancy or breast-feeding women any serious disease which could not be controled urine protein≥++, or 24h urine protein>1g less than 18 years old or more than 75 years old

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: aprepitant group<br>Patients assigned to aprepitant group should receive aprepitant for the control of CINV, aprepitant 125 mg for day1, 80mg for day2 and day3. | Drug: Aprepitant<br>* aprepitant should be give when patients receive platinum based chemotherapy, 125mg for day1, 80mg for day2 and day3.<br>* Other names: Emend;|
| Placebo Comparator: placebo<br>Patients assigned to placebo group should receive placebo for the control of CINV compared with aprepitant group. | Drug: placebo<br>* placebo should be give when patients receive platinum based chemotherapy, 125mg for day1, 80mg for day2 and day3.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete response rate of CINV | complete response rate of CINV should be recorded when platinum based chemotherapy begun, during inhospital treatment, up to 6 months | during treatment, up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse event |  | during treatment, up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aprepitant, non-small cell lung cancer