Aprepitant for Chemotherapy Induced Nausea and Vomiting in Chinese Advanced Non-small Cell Lung Cancers
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|ClinicalTrials.gov Identifier: NCT02161991|
Recruitment Status : Completed
First Posted : June 12, 2014
Last Update Posted : March 26, 2020
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Non-small Cell Lung||Drug: Aprepitant Drug: placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||244 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Randomized Phase 3 Study of Aprepitant Versus Placebo in Chinese Advanced Non-small Cell Lung Cancer Who Received Highly Emetogenic Chemotherapy|
|Actual Study Start Date :||February 1, 2014|
|Actual Primary Completion Date :||February 1, 2017|
|Actual Study Completion Date :||January 31, 2018|
Experimental: aprepitant group
Patients assigned to aprepitant group should receive aprepitant for the control of CINV, aprepitant 125 mg for day1, 80mg for day2 and day3.
aprepitant should be give when patients receive platinum based chemotherapy, 125mg for day1, 80mg for day2 and day3.
Other Name: Emend
Placebo Comparator: placebo
Patients assigned to placebo group should receive placebo for the control of CINV compared with aprepitant group.
placebo should be give when patients receive platinum based chemotherapy, 125mg for day1, 80mg for day2 and day3.
- complete response rate of CINV [ Time Frame: 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
- adverse event [ Time Frame: during treatment, up to 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02161991
|Hunan Cancer hospital|
|Changsha, Hunan, China|
|Principal Investigator:||Nong Yang, MD||Hunan Cancer Hospital|