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Clinical Trials in the USA / NCT07169851
Recruiting Phase 2

A Study to Evaluate LY3537021 for the Treatment of Nausea and Vomiting Caused by Chemotherapy in Adults With Cancer

NCT07169851 · tracked via the Priya Life Science USA tracker
Sponsor
Eli Lilly and Company
Phase
Phase 2
Started
2025-11-28
Last updated
2026-09-04

Condition(s) studied

NauseaVomitingDrug-Related Side Effects and Adverse ReactionsNeoplasms

Investigational drug(s) / intervention(s)

LY3537021PlaceboStandard of Care Antiemetic TherapiesBackground Chemotherapy

LY3537021: Administered SC

Placebo: Administered SC

Standard of Care Antiemetic Therapies: 5-HT3 Receptor Antagonist, NK1 Receptor Antagonist, Dexamethasone administered orally, IV, or transdermally

Background Chemotherapy: Cisplatin or anthraxyline and cyclophosphamide (AC) administered IV

Study summary

The purpose of this study is to check how well LY35327021 works and how safe it is for controlling nausea and vomiting caused by chemotherapy. Participants who join this study will be in it until all parts are finished, which could take about 2 months.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Chemotherapy-naive participants, planned to receive AC or cisplatin-based chemotherapy greater than or equal to (≥)70 milligrams per square meter (mg/m²), on Day 1 of each cycle, with no multiple administrations during the CINV observation period, from Day 2 to Day 5 of each cycle. * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. Exclusion Criteria: * Have symptomatic or untreated central nervous system (CNS) metastases. * Have an established diagnosis of uncontrolled diabetes mellitus. * Have a history of, or current evidence of, a clinically significant cardiac condition or QT/QTcF-related conditions. * Have another etiology for nausea and vomiting, or receives medications with know or potential antiemetic activity * Signs, symptoms or history of thyroid tumors * Receives treatment with a gastric inhibitory polypetide (GIP) or glucagon-like peptide-1 (GLP-1) receptor agonist within 4 weeks prior to chemotherapy. * Have participated in a clinical study involving study intervention within 30 days of Cycle 1 Day 1 (C1D1). If the previous study intervention has a long half-life, within 3 months or 5 halflives, whichever is longer, of C1D1. * Are pregnant, breastfeeding, or intend to become pregnant during the study or within 30 days of the last dose of study intervention.

Primary outcome measure(s)

Trial sites (68)

FacilityCityRegionStatus
Marin Cancer Care Greenbrae California Recruiting
City of Hope Orange County Lennar Foundation Cancer Center Irvine California Recruiting
Cancer and Blood Specialty Clinic Los Alamitos California Recruiting
BASS Cancer Center Walnut Creek California Recruiting
UCHealth Harmony Fort Collins Colorado Recruiting
Clavis Medical Miami Lakes Florida Recruiting
BRCR Global - Tamarac Tamarac Florida Recruiting
Summit Cancer Care, PC Savannah Georgia Recruiting
Hope and Healing Cancer Services Hinsdale Illinois Recruiting
Indiana University Melvin and Bren Simon Cancer Center Indianapolis Indiana Recruiting
North Mississippi Hematology and Oncology Associates Tupelo Mississippi Recruiting
Laura and Isaac Perlmutter Cancer Center New York New York Recruiting
New York Cancer and Blood Specialists Shirley New York Not Yet Recruiting
Oncology Specialists of Charlotte Charlotte North Carolina Recruiting
Southern Oncology Specialists Huntersville North Carolina Recruiting
Asante Rogue Regional Medical Center Medford Oregon Recruiting
World Research Link Baytown Texas Recruiting
John Peter Smith Hospital Fort Worth Texas Recruiting
Kelsey-Seybold Clinic Houston Texas Not Yet Recruiting
Community Cancer Trials of Utah Ogden Utah Recruiting
Cancer Care Northwest Spokane Washington Recruiting
Ballarat Health Services Ballarat Central Australia Recruiting
Bendigo Health Care Group Bendigo Australia Recruiting
WA Country Health Service Trial Centre Perth Australia Recruiting
Goulburn Valley Health Shepparton Australia Recruiting
Latrobe Regional Health Traralgon Australia Recruiting
The First People's Hospital of Changde City Changde China Recruiting
Zhujiang Hospital Guangzhou China Recruiting
Zhejiang Provincial People's Hospital Hangzhou China Recruiting
Jiangmen Center Hospital Jiangmen China Recruiting
The First Affiliated Hospital of Henan University of Science &Technology Luoyang China Recruiting
Sainte Catherine Institut du Cancer Avignon Provence Avignon France Recruiting
Centre Hospitalier d'Annecy Epagny Metz-Tessy France Recruiting
Clinique Victor Hugo Le Mans Le Mans France Recruiting
Aou Ospedali Riuniti Umberto I Ancona Italy Recruiting
Azienda Ospedaliero Universitaria Modena Italy Not Yet Recruiting
Azienda Ospedaliera Universitaria Pisana Pisa Italy Not Yet Recruiting
AULSS8 Berica-Ospedale S.Bortolo Vicenza Italy Recruiting
Himeji Medical Center Himeji Japan Recruiting
The Cancer Institute Hospital of JFCR Kōtoku Japan Recruiting

+ 28 more sites — see the full list on the official registry below.

More Eli Lilly and Company trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07169851 on ClinicalTrials.gov ↗ ← All trials in the USA