A Study to Evaluate LY3537021 for the Treatment of Nausea and Vomiting Caused by Chemotherapy in Adults With Cancer
NCT ID: NCT07169851
Last Updated: 2026-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
204 participants
INTERVENTIONAL
2025-11-28
2026-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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LY3537021 + Antiemetic Therapies
Prior to chemotherapy, participants receive LY3537021 administered subcutaneously (SC) with standard of care (SOC) antiemetic therapies orally, intravenously (IV), or transdermally, per local label
LY3537021
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
Placebo + Antiemetic Therapies
Prior to chemotherapy, participants receive placebo administered SC with SOC antiemetic therapies orally, IV, or transdermally, per local label
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Marin Cancer Care
Greenbrae, California, United States
City of Hope Orange County Lennar Foundation Cancer Center
Irvine, California, United States
Cancer and Blood Specialty Clinic
Los Alamitos, California, United States
BASS Cancer Center
Walnut Creek, California, United States
UCHealth Harmony
Fort Collins, Colorado, United States
Clavis Medical
Miami Lakes, Florida, United States
BRCR Global - Tamarac
Tamarac, Florida, United States
Summit Cancer Care, PC
Savannah, Georgia, United States
Hope and Healing Cancer Services
Hinsdale, Illinois, United States
North Mississippi Hematology and Oncology Associates
Tupelo, Mississippi, United States
Laura and Isaac Perlmutter Cancer Center
New York, New York, United States
Oncology Specialists of Charlotte
Charlotte, North Carolina, United States
Southern Oncology Specialists
Huntersville, North Carolina, United States
Asante Rogue Regional Medical Center
Medford, Oregon, United States
World Research Link
Baytown, Texas, United States
John Peter Smith Hospital
Fort Worth, Texas, United States
Community Cancer Trials of Utah
Ogden, Utah, United States
Cancer Care Northwest
Spokane, Washington, United States
Ballarat Health Services
Ballarat Central, , Australia
Bendigo Health Care Group
Bendigo, , Australia
WA Country Health Service Trial Centre
Perth, , Australia
Goulburn Valley Health
Shepparton, , Australia
Latrobe Regional Health
Traralgon, , Australia
The First People's Hospital of Changde City
Changde, , China
Zhujiang Hospital
Guangzhou, , China
Zhejiang Provincial People's Hospital
Hangzhou, , China
Jiangmen Center Hospital
Jiangmen, , China
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang, , China
Sainte Catherine Institut du Cancer Avignon Provence
Avignon, , France
Centre Hospitalier d'Annecy
Epagny Metz-Tessy, , France
Clinique Victor Hugo Le Mans
Le Mans, , France
Centre Leon Berard
Lyon Cedex08, , France
Aou Ospedali Riuniti Umberto I
Ancona, , Italy
Azienda Ospedaliero Universitaria
Modena, , Italy
Azienda Ospedaliera Universitaria Pisana
Pisa, , Italy
AULSS8 Berica-Ospedale S.Bortolo
Vicenza, , Italy
Himeji Medical Center
Himeji, , Japan
The Cancer Institute Hospital of JFCR
Kōtoku, , Japan
Kyoto University Hospital
Kyoto, , Japan
Shizuoka Cancer Center
Nagaizumi-cho,Sunto-gun, , Japan
SC Memorial Healthcare International SRL
Bucharest, , Romania
Spitalul Clinic Colentina
Bucharest, , Romania
Spitalul Clinic Colțea
Bucharest, , Romania
Centrul de Oncologie "Sfântul Nectarie"
Craiova, , Romania
Ovidius Clinical Hospital OCH
Ovidiu, , Romania
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
FutureMeds - Madrid
Madrid, , Spain
Hospital General Universitario Gregorio Marañon
Madrid, , Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital de Mataró
Mataró, , Spain
Hospital Universitario Virgen de la Victoria
Málaga, , Spain
Hospital Universitari Sant Joan de Reus
Reus, , Spain
E-Da Cancer Hospital
Kaohsiung City, , Taiwan
National Cheng Kung University Hospital
Tainan, , Taiwan
Chi Mei Hospital - Liouying Branch
Tainan, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Chang Gung Medical Foundation-Linkou Branch
Taoyuan District, , Taiwan
Adana Medical Park Seyhan Hastanesi
Adana, , Turkey (Türkiye)
Ankara Bilkent Şehir Hastanesi
Ankara, , Turkey (Türkiye)
Antalya Egitim ve Arastırma Hastanesi
Antalya, , Turkey (Türkiye)
Ege Universitesi Hastanesi
Bornova, , Turkey (Türkiye)
Dicle Üniversitesi
Diyarbakır, , Turkey (Türkiye)
Trakya University
Edirne, , Turkey (Türkiye)
Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi
Gaziantep, , Turkey (Türkiye)
T.C. Sağlik Bakanliği- Marmara Üniversitesi İstanbul Pendik Eğitim Ve Araştirma Hastanesi
Pendik, , Turkey (Türkiye)
Sakarya Training and Research Hospital
Sakarya, , Turkey (Türkiye)
Countries
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Central Contacts
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Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Role: CONTACT
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Role: CONTACT
Facility Contacts
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Related Links
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A Study to Evaluate LY3537021 for the Treatment of Nausea and Vomiting Caused by Chemotherapy in Adults With Cancer
Other Identifiers
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2025-522204-24-00
Identifier Type: CTIS
Identifier Source: secondary_id
J2R-MC-YAAD
Identifier Type: OTHER
Identifier Source: secondary_id
U1111-1322-9151
Identifier Type: OTHER
Identifier Source: secondary_id
27402
Identifier Type: -
Identifier Source: org_study_id
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