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NCT07169851PHASE2Recruiting

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

Eli Lilly and Company

Start Date

11/28/2025

Completion Date

2/1/2027

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 Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

LY3537021

DRUG

Placebo

DRUG

Standard of Care Antiemetic Therapies

DRUG

Background Chemotherapy

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Conditions

NauseaVomitingDrug-Related Side Effects and Adverse ReactionsNeoplasms

Locations

Marin Cancer Care

Greenbrae, California 94904

United States

City of Hope Orange County Lennar Foundation Cancer Center

Irvine, California 92618

United States

Cancer and Blood Specialty Clinic

Los Alamitos, California 90720

United States

BASS Cancer Center

Walnut Creek, California 94598

United States

UCHealth Harmony

Fort Collins, Colorado 80528

United States

Clavis Medical

Miami Lakes, Florida 33014

United States

BRCR Global - Tamarac

Tamarac, Florida 33321

United States

Summit Cancer Care, PC

Savannah, Georgia 31405

United States

Hope and Healing Cancer Services

Hinsdale, Illinois 60521

United States

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana 46202

United States

North Mississippi Hematology and Oncology Associates

Tupelo, Mississippi 38801

United States

Laura and Isaac Perlmutter Cancer Center

New York, New York 10016

United States

New York Cancer and Blood Specialists

Shirley, New York 11967

United States

Oncology Specialists of Charlotte

Charlotte, North Carolina 28207

United States

Southern Oncology Specialists

Huntersville, North Carolina 28078

United States

Asante Rogue Regional Medical Center

Medford, Oregon 97504

United States

World Research Link

Baytown, Texas 77521

United States

John Peter Smith Hospital

Fort Worth, Texas 76104

United States

Community Cancer Trials of Utah

Ogden, Utah 84405

United States

Cancer Care Northwest

Spokane, Washington 99202

United States

Ballarat Health Services

Ballarat Central, 3350

Australia

Bendigo Health Care Group

Bendigo, 3550

Australia

WA Country Health Service Trial Centre

Perth, 6102

Australia

Goulburn Valley Health

Shepparton, 3630

Australia

Latrobe Regional Health

Traralgon, 3844

Australia

The First People's Hospital of Changde City

Changde, 415003

China

Zhujiang Hospital

Guangzhou, 510280

China

Zhejiang Provincial People's Hospital

Hangzhou, 310014

China

Jiangmen Center Hospital

Jiangmen,

China

The First Affiliated Hospital of Henan University of Science &Technology

Luoyang, 471003

China

Sainte Catherine Institut du Cancer Avignon Provence

Avignon, 84918

France

Centre Hospitalier d'Annecy

Epagny Metz-Tessy, 74370

France

Clinique Victor Hugo Le Mans

Le Mans, 72000

France

Aou Ospedali Riuniti Umberto I

Ancona, 60126

Italy

Azienda Ospedaliero Universitaria

Modena, 41125

Italy

Azienda Ospedaliera Universitaria Pisana

Pisa, 56126

Italy

AULSS8 Berica-Ospedale S.Bortolo

Vicenza, 36100

Italy

Himeji Medical Center

Himeji, 670-8520

Japan

The Cancer Institute Hospital of JFCR

Kōtoku, 135-8550

Japan

Kyoto University Hospital

Kyoto, 606-8507

Japan

Shizuoka Cancer Center

Nagaizumi-cho,Sunto-gun, 411-8777

Japan

SC Memorial Healthcare International SRL

Bucharest, 013812

Romania

Spitalul Clinic Colentina

Bucharest, 020125

Romania

Spitalul Clinic Colțea

Bucharest, 030171

Romania

Centrul de Oncologie "Sfântul Nectarie"

Craiova, 200542

Romania

Ovidius Clinical Hospital OCH

Ovidiu, 905900

Romania

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041

Spain

FutureMeds - Madrid

Madrid, 28003

Spain

Hospital General Universitario Gregorio Marañon

Madrid, 28009

Spain

Hospital Universitario Fundación Jiménez Díaz

Madrid, 28040

Spain

Hospital de Mataró

Mataró, 08304

Spain

Hospital Universitario Virgen de la Victoria

Málaga, 29010

Spain

Hospital Universitari Sant Joan de Reus

Reus, 43204

Spain

E-Da Cancer Hospital

Kaohsiung City, 82445

Taiwan

National Cheng Kung University Hospital

Tainan, 704

Taiwan

Chi Mei Hospital - Liouying Branch

Tainan, 73657

Taiwan

Taipei Veterans General Hospital

Taipei, 11217

Taiwan

Chang Gung Medical Foundation-Linkou Branch

Taoyuan, 333

Taiwan

Adana Medical Park Seyhan Hastanesi

Adana, 01140

Turkey (Türkiye)

Ankara Bilkent Şehir Hastanesi

Ankara, 06800

Turkey (Türkiye)

Antalya Egitim ve Arastırma Hastanesi

Antalya, 07100

Turkey (Türkiye)

Ege Universitesi Hastanesi

Bornova, 35100

Turkey (Türkiye)

Dicle Üniversitesi

Diyarbakır, 21200

Turkey (Türkiye)

Trakya University

Edirne, 22030

Turkey (Türkiye)

Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi

Gaziantep, 27310

Turkey (Türkiye)

T.C. Sağlik Bakanliği- Marmara Üniversitesi İstanbul Pendik Eğitim Ve Araştirma Hastanesi

Pendik, 34899

Turkey (Türkiye)

Sakarya Training and Research Hospital

Sakarya, 54100

Turkey (Türkiye)