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

Phase 3

Completed

• Conditions: Carcinoma, Non-small Cell Lung
• Interventions: Drug: placebo; Drug: Aprepitant

• Registration Number: NCT02161991
• Lead Sponsor: Hunan Province Tumor Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-02-01
• Study First Submitted: 2014-06-02
• Study First Submitted QC: 2014-06-10
• Study First Posted: 2014-06-12
• Primary Completion: 2017-02-01
• Study Completion: 2018-01-31
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-25
• Last Update Posted: 2020-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 244

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	Patients assigned to placebo group should receive placebo for the control of CINV compared with aprepitant group.
aprepitant group	Aprepitant	Patients assigned to aprepitant group should receive aprepitant for the control of CINV, aprepitant 125 mg for day1, 80mg for day2 and day3.

Primary Outcome Measures

Name	Time	Method
complete response rate of CINV	during treatment, up to 6 months	complete response rate of CINV should be recorded when platinum based chemotherapy begun, during inhospital treatment, up to 6 months

Secondary Outcome Measures

Name	Time	Method
adverse event	during treatment, up to 6 months

Trial Locations

Locations (1)

Hunan Cancer hospital; 🇨🇳 Changsha, Hunan, China