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

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

204 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-28

Study Completion Date

2026-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Nausea Vomiting Drug-Related Side Effects and Adverse Reactions Neoplasms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

LY3537021

Intervention Type DRUG

Administered SC

Standard of Care Antiemetic Therapies

Intervention Type DRUG

5-HT3 Receptor Antagonist, NK1 Receptor Antagonist, Dexamethasone administered orally, IV, or transdermally

Background Chemotherapy

Intervention Type DRUG

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered SC

Standard of Care Antiemetic Therapies

Intervention Type DRUG

5-HT3 Receptor Antagonist, NK1 Receptor Antagonist, Dexamethasone administered orally, IV, or transdermally

Background Chemotherapy

Intervention Type DRUG

Cisplatin or anthraxyline and cyclophosphamide (AC) administered IV

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

LY3537021

Administered SC

Intervention Type DRUG

Placebo

Administered SC

Intervention Type DRUG

Standard of Care Antiemetic Therapies

5-HT3 Receptor Antagonist, NK1 Receptor Antagonist, Dexamethasone administered orally, IV, or transdermally

Intervention Type DRUG

Background Chemotherapy

Cisplatin or anthraxyline and cyclophosphamide (AC) administered IV

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

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

Explore where the study is taking place and check the recruitment status at each participating site.

Marin Cancer Care

Greenbrae, California, United States

Site Status RECRUITING

City of Hope Orange County Lennar Foundation Cancer Center

Irvine, California, United States

Site Status NOT_YET_RECRUITING

Cancer and Blood Specialty Clinic

Los Alamitos, California, United States

Site Status NOT_YET_RECRUITING

BASS Cancer Center

Walnut Creek, California, United States

Site Status RECRUITING

UCHealth Harmony

Fort Collins, Colorado, United States

Site Status NOT_YET_RECRUITING

Clavis Medical

Miami Lakes, Florida, United States

Site Status RECRUITING

BRCR Global - Tamarac

Tamarac, Florida, United States

Site Status RECRUITING

Summit Cancer Care, PC

Savannah, Georgia, United States

Site Status RECRUITING

Hope and Healing Cancer Services

Hinsdale, Illinois, United States

Site Status RECRUITING

North Mississippi Hematology and Oncology Associates

Tupelo, Mississippi, United States

Site Status RECRUITING

Laura and Isaac Perlmutter Cancer Center

New York, New York, United States

Site Status RECRUITING

Oncology Specialists of Charlotte

Charlotte, North Carolina, United States

Site Status RECRUITING

Southern Oncology Specialists

Huntersville, North Carolina, United States

Site Status RECRUITING

Asante Rogue Regional Medical Center

Medford, Oregon, United States

Site Status NOT_YET_RECRUITING

World Research Link

Baytown, Texas, United States

Site Status RECRUITING

John Peter Smith Hospital

Fort Worth, Texas, United States

Site Status RECRUITING

Community Cancer Trials of Utah

Ogden, Utah, United States

Site Status RECRUITING

Cancer Care Northwest

Spokane, Washington, United States

Site Status NOT_YET_RECRUITING

Ballarat Health Services

Ballarat Central, , Australia

Site Status NOT_YET_RECRUITING

Bendigo Health Care Group

Bendigo, , Australia

Site Status NOT_YET_RECRUITING

WA Country Health Service Trial Centre

Perth, , Australia

Site Status NOT_YET_RECRUITING

Goulburn Valley Health

Shepparton, , Australia

Site Status NOT_YET_RECRUITING

Latrobe Regional Health

Traralgon, , Australia

Site Status NOT_YET_RECRUITING

The First People's Hospital of Changde City

Changde, , China

Site Status RECRUITING

Zhujiang Hospital

Guangzhou, , China

Site Status RECRUITING

Zhejiang Provincial People's Hospital

Hangzhou, , China

Site Status RECRUITING

Jiangmen Center Hospital

Jiangmen, , China

Site Status RECRUITING

The First Affiliated Hospital of Henan University of Science &Technology

Luoyang, , China

Site Status RECRUITING

Sainte Catherine Institut du Cancer Avignon Provence

Avignon, , France

Site Status NOT_YET_RECRUITING

Centre Hospitalier d'Annecy

Epagny Metz-Tessy, , France

Site Status NOT_YET_RECRUITING

Clinique Victor Hugo Le Mans

Le Mans, , France

Site Status NOT_YET_RECRUITING

Centre Leon Berard

Lyon Cedex08, , France

Site Status NOT_YET_RECRUITING

Aou Ospedali Riuniti Umberto I

Ancona, , Italy

Site Status NOT_YET_RECRUITING

Azienda Ospedaliero Universitaria

Modena, , Italy

Site Status NOT_YET_RECRUITING

Azienda Ospedaliera Universitaria Pisana

Pisa, , Italy

Site Status NOT_YET_RECRUITING

AULSS8 Berica-Ospedale S.Bortolo

Vicenza, , Italy

Site Status NOT_YET_RECRUITING

Himeji Medical Center

Himeji, , Japan

Site Status RECRUITING

The Cancer Institute Hospital of JFCR

Kōtoku, , Japan

Site Status RECRUITING

Kyoto University Hospital

Kyoto, , Japan

Site Status RECRUITING

Shizuoka Cancer Center

Nagaizumi-cho,Sunto-gun, , Japan

Site Status RECRUITING

SC Memorial Healthcare International SRL

Bucharest, , Romania

Site Status NOT_YET_RECRUITING

Spitalul Clinic Colentina

Bucharest, , Romania

Site Status NOT_YET_RECRUITING

Spitalul Clinic Colțea

Bucharest, , Romania

Site Status NOT_YET_RECRUITING

Centrul de Oncologie "Sfântul Nectarie"

Craiova, , Romania

Site Status NOT_YET_RECRUITING

Ovidius Clinical Hospital OCH

Ovidiu, , Romania

Site Status NOT_YET_RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Site Status NOT_YET_RECRUITING

FutureMeds - Madrid

Madrid, , Spain

Site Status NOT_YET_RECRUITING

Hospital General Universitario Gregorio Marañon

Madrid, , Spain

Site Status NOT_YET_RECRUITING

Hospital Universitario Fundación Jiménez Díaz

Madrid, , Spain

Site Status NOT_YET_RECRUITING

Hospital Universitario 12 de Octubre

Madrid, , Spain

Site Status NOT_YET_RECRUITING

Hospital de Mataró

Mataró, , Spain

Site Status NOT_YET_RECRUITING

Hospital Universitario Virgen de la Victoria

Málaga, , Spain

Site Status NOT_YET_RECRUITING

Hospital Universitari Sant Joan de Reus

Reus, , Spain

Site Status NOT_YET_RECRUITING

E-Da Cancer Hospital

Kaohsiung City, , Taiwan

Site Status NOT_YET_RECRUITING

National Cheng Kung University Hospital

Tainan, , Taiwan

Site Status RECRUITING

Chi Mei Hospital - Liouying Branch

Tainan, , Taiwan

Site Status NOT_YET_RECRUITING

Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status NOT_YET_RECRUITING

Chang Gung Medical Foundation-Linkou Branch

Taoyuan District, , Taiwan

Site Status RECRUITING

Adana Medical Park Seyhan Hastanesi

Adana, , Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

Ankara Bilkent Şehir Hastanesi

Ankara, , Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

Antalya Egitim ve Arastırma Hastanesi

Antalya, , Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

Ege Universitesi Hastanesi

Bornova, , Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

Dicle Üniversitesi

Diyarbakır, , Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

Trakya University

Edirne, , Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi

Gaziantep, , Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

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

Pendik, , Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

Sakarya Training and Research Hospital

Sakarya, , Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States Australia China France Italy Japan Romania Spain Taiwan Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

Role: CONTACT

1-317-615-4559

Physicians interested in becoming principal investigators please contact

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Role: primary

714-252-9415

Role: primary

970-297-6150

Role: primary

786-723-4001

Role: primary

561-477-0614

Role: primary

912-651-5771

Role: primary

630-560-0121

Role: primary

704-342-1900

Role: primary

541-789-5003

Role: primary

833-832-8328

Role: primary

817-702-8049

Role: primary

801-689-3909

Role: primary

61358323777

Role: primary

13380091897

Role: primary

18933183766

Role: primary

490276857

Role: primary

334 26 55 67 52

Role: primary

+33243297908

Role: primary

33478782657

Role: primary

0715965715

Role: primary

+390594224767

Role: primary

0444 753906

Role: primary

81120023812

Role: primary

81120023812

Role: primary

81120023812

Role: primary

81120023812

Role: primary

40721298677

Role: primary

40727774974

Role: primary

0724877013

Role: primary

+34 93 556 56 38

Role: primary

606827688

Role: primary

951032267

Role: primary

886-7-6150022

Role: primary

0912777918

Role: primary

905056166338

Role: primary

905555306271

Role: primary

905336488217

Role: primary

05322202675

Role: primary

90 5337677131

Role: primary

90 5334364678

Role: primary

05065118207

Role: primary

905323233799

Role: primary

+90 5054785576

Related Links

Access external resources that provide additional context or updates about the study.

https://trials.lilly.com/en-US/trial/654075

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

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

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

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.