← Back to Search

Fosparepitant administered in 1st cycle for Non-Small Cell Lung Cancer

Phase 2
Waitlist Available
Led By Ajeet Gajra, MD FACP
Research Sponsored by Ajeet Gajra
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up collection of data at the completion of 2 cycles, day 42.
Awards & highlights

Study Summary

This study evaluates the addition of fosaprepitant to currently available antiemtic treatments of carboplatin chemotherapy-induced nausea and vomiting in advanced non-small cell lung cancer patients. Half of the patients will receive fosaprepitant in their first chemotherapy cycle, and a placebo on their second chemotherapy cycle. The other half of the patients will begin their first chemotherapy cycle.

Eligible Conditions
  • Non-Small Cell Lung Cancer
  • Vomiting
  • Nausea

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~collection of data at the completion of 2 cycles, day 42.
This trial's timeline: 3 weeks for screening, Varies for treatment, and collection of data at the completion of 2 cycles, day 42. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Assess the impact of addition of fosaprepitant upon the complete response (C.R.) rate (no emetic episodes or use of rescue medications) in patients with advanced NSCLC receiving carboplatin-based combination chemotherapy.
Secondary outcome measures
Asses nausea based on visual analog scale (VAS)
No emesis (defined as no emetic episodes regardless of use of rescue therapy)
Patient's preferred cycle

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Fosparepitant administered in 1st cycleActive Control2 Interventions
Fosaprepitant (Emend) for Injection 150 mg is administered, one time, intravenously on day 1 only, as an infusion with a duration of 30 minutes. It will be initiated approximately 30 minutes prior to the subjects first chemotherapy cycle. An intravenous saline placebo will be administered on day 1 of the second chemotherapy cycle, in the same manor as EMEND for Injection.
Group II: Fosaprepitant administered in 2nd cyclePlacebo Group2 Interventions
Subject will receive a saline Placebo intravenously on day 1 of their first chemotherapy cycle. For the subject's second chemotherapy cycle, EMEND for Injection 150 mg is administered, one time, intravenously on day 1, as an infusion with a duration of 30 minutes. It will be initiated approximately 30 minutes prior to the subjects second chemotherapy cycle.

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,421 Total Patients Enrolled
Ajeet GajraLead Sponsor
Ajeet Gajra, MD FACPPrincipal InvestigatorState University of New York - Upstate Medical University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Study Assessing Fosaprepitant in Advanced NSCLC Patients Treated With Carboplatin Based Chemotherapy
Ajeet Gajra 2015. "Study Assessing Fosaprepitant in Advanced NSCLC Patients Treated With Carboplatin Based Chemotherapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02407600.
All > Osa
~15 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top