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

NCT07169851 | Recruiting Phase 2 DMC FDA Drug

• 4 other identifiers: 274022025-522204-24-00J2R-MC-YAADU1111-1322-9151
• Study Type: interventional
• Target: 204
• Locations: 10 countries
• Sites: 66

Brief 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.

Conditions

Nausea; Vomiting; Drug-Related Side Effects and Adverse Reactions; Neoplasms

Keywords

Chemotherapy-Induced Nausea and Vomiting (CINV); Anthracycline and cyclophosphamide (AC); Glucose-dependent Insulinotropic Peptide (GIP); Incretins; Cisplatin

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants with a Complete Response (CR) in the Delayed Phase of CINV

  CR defined as no vomiting and no rescue medication

  24 to 120 hours after first chemotherapy infusion

Secondary Outcomes (4)

• Proportion of Participants with a CR to CINV

  Zero to 120 hours after the first chemotherapy infusion

• Proportion of Participants with a Response of 0 in the Nausea Item of the Vomiting and Nausea Diary and No Rescue Medication

  Zero to 120 hours after the first chemotherapy infusion

• Proportion of Participants with a Response of Less than or Equal to (≤)3 in the Nausea Item of the Vomiting and Nausea Diary and No Rescue Medication

  Zero to 120 hours after the first chemotherapy infusion

• Pharmacokinetics (PK) Trough Concentrations (Ctrough) of LY3537021

  From Day 1 of Cycle 1 until Day 1 of Cycle 2 (each cycle is expected to be 14, 21 or 28 days)

Study Arms (2)

LY3537021 + Antiemetic Therapies

EXPERIMENTAL

Prior to chemotherapy, participants receive LY3537021 administered subcutaneously (SC) with standard of care (SOC) antiemetic therapies orally, intravenously (IV), or transdermally, per local label

Drug: LY3537021; Drug: Standard of Care Antiemetic Therapies; Drug: Background Chemotherapy

Placebo + Antiemetic Therapies

PLACEBO COMPARATOR

Prior to chemotherapy, participants receive placebo administered SC with SOC antiemetic therapies orally, IV, or transdermally, per local label

Drug: Placebo; Drug: Standard of Care Antiemetic Therapies; Drug: Background Chemotherapy

Interventions

LY3537021 DRUG

Administered SC

LY3537021 + Antiemetic Therapies

Placebo DRUG

Administered SC

Placebo + Antiemetic Therapies

Background Chemotherapy DRUG

Cisplatin or anthraxyline and cyclophosphamide (AC) administered IV

LY3537021 + Antiemetic Therapies; Placebo + Antiemetic Therapies

Standard of Care Antiemetic Therapies DRUG

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

LY3537021 + Antiemetic Therapies; Placebo + Antiemetic Therapies

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (66)

Marin Cancer Care

Greenbrae, California, 94904, United States

RECRUITING

City of Hope Orange County Lennar Foundation Cancer Center

Irvine, California, 92618, United States

NOT YET RECRUITING

Cancer and Blood Specialty Clinic

Los Alamitos, California, 90720, United States

RECRUITING

BASS Cancer Center

Walnut Creek, California, 94598, United States

RECRUITING

UCHealth Harmony

Fort Collins, Colorado, 80528, United States

RECRUITING

Clavis Medical

Miami Lakes, Florida, 33014, United States

RECRUITING

BRCR Global - Tamarac

Tamarac, Florida, 33321, United States

RECRUITING

Summit Cancer Care, PC

Savannah, Georgia, 31405, United States

RECRUITING

Hope and Healing Cancer Services

Hinsdale, Illinois, 60521, United States

RECRUITING

North Mississippi Hematology and Oncology Associates

Tupelo, Mississippi, 38801, United States

RECRUITING

Laura and Isaac Perlmutter Cancer Center

New York, New York, 10016, United States

RECRUITING

Oncology Specialists of Charlotte

Charlotte, North Carolina, 28207, United States

RECRUITING

Southern Oncology Specialists

Huntersville, North Carolina, 28078, United States

RECRUITING

Asante Rogue Regional Medical Center

Medford, Oregon, 97504, United States

RECRUITING

World Research Link

Baytown, Texas, 77521, United States

RECRUITING

John Peter Smith Hospital

Fort Worth, Texas, 76104, United States

RECRUITING

Community Cancer Trials of Utah

Ogden, Utah, 84405, United States

RECRUITING

Cancer Care Northwest

Spokane, Washington, 99202, United States

RECRUITING

Ballarat Health Services

Ballarat Central, 3350, Australia

RECRUITING

Bendigo Health Care Group

Bendigo, 3550, Australia

RECRUITING

WA Country Health Service Trial Centre

Perth, 6102, Australia

RECRUITING

Goulburn Valley Health

Shepparton, 3630, Australia

RECRUITING

Latrobe Regional Health

Traralgon, 3844, Australia

RECRUITING

The First People's Hospital of Changde City

Changde, 415003, China

RECRUITING

Zhujiang Hospital

Guangzhou, 510280, China

RECRUITING

Zhejiang Provincial People's Hospital

Hangzhou, 310014, China

RECRUITING

Jiangmen Center Hospital

Jiangmen, China

RECRUITING

The First Affiliated Hospital of Henan University of Science &Technology

Luoyang, 471003, China

RECRUITING

Sainte Catherine Institut du Cancer Avignon Provence

Avignon, 84918, France

NOT YET RECRUITING

Centre Hospitalier d'Annecy

Epagny Metz-Tessy, 74370, France

NOT YET RECRUITING

Clinique Victor Hugo Le Mans

Le Mans, 72000, France

NOT YET RECRUITING

Centre Leon Berard

Lyon Cedex08, 69373, France

SUSPENDED

Aou Ospedali Riuniti Umberto I

Ancona, 60126, Italy

NOT YET RECRUITING

Azienda Ospedaliero Universitaria

Modena, 41125, Italy

NOT YET RECRUITING

Azienda Ospedaliera Universitaria Pisana

Pisa, 56126, Italy

NOT YET RECRUITING

AULSS8 Berica-Ospedale S.Bortolo

Vicenza, 36100, Italy

NOT YET RECRUITING

Himeji Medical Center

Himeji, 670-8520, Japan

RECRUITING

The Cancer Institute Hospital of JFCR

Kōtoku, 135-8550, Japan

RECRUITING

Kyoto University Hospital

Kyoto, 606-8507, Japan

RECRUITING

Shizuoka Cancer Center

Nagaizumi-cho,Sunto-gun, 411-8777, Japan

RECRUITING

SC Memorial Healthcare International SRL

Bucharest, 013812, Romania

NOT YET RECRUITING

Spitalul Clinic Colentina

Bucharest, 020125, Romania

NOT YET RECRUITING

Spitalul Clinic Colțea

Bucharest, 030171, Romania

NOT YET RECRUITING

Centrul de Oncologie "Sfântul Nectarie"

Craiova, 200542, Romania

NOT YET RECRUITING

Ovidius Clinical Hospital OCH

Ovidiu, 905900, Romania

NOT YET RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

NOT YET RECRUITING

FutureMeds - Madrid

Madrid, 28003, Spain

NOT YET RECRUITING

Hospital General Universitario Gregorio Marañon

Madrid, 28009, Spain

NOT YET RECRUITING

Hospital Universitario Fundación Jiménez Díaz

Madrid, 28040, Spain

NOT YET RECRUITING

Hospital de Mataró

Mataró, 08304, Spain

NOT YET RECRUITING

Hospital Universitario Virgen de la Victoria

Málaga, 29010, Spain

NOT YET RECRUITING

Hospital Universitari Sant Joan de Reus

Reus, 43204, Spain

NOT YET RECRUITING

E-Da Cancer Hospital

Kaohsiung City, 82445, Taiwan

RECRUITING

National Cheng Kung University Hospital

Tainan, 704, Taiwan

RECRUITING

Chi Mei Hospital - Liouying Branch

Tainan, 73657, Taiwan

RECRUITING

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

RECRUITING

Chang Gung Medical Foundation-Linkou Branch

Taoyuan District, 333, Taiwan

RECRUITING

Adana Medical Park Seyhan Hastanesi

Adana, 01140, Turkey (Türkiye)

NOT YET RECRUITING

Ankara Bilkent Şehir Hastanesi

Ankara, 06800, Turkey (Türkiye)

NOT YET RECRUITING

Antalya Egitim ve Arastırma Hastanesi

Antalya, 07100, Turkey (Türkiye)

NOT YET RECRUITING

Ege Universitesi Hastanesi

Bornova, 35100, Turkey (Türkiye)

NOT YET RECRUITING

Dicle Üniversitesi

Diyarbakır, 21200, Turkey (Türkiye)

NOT YET RECRUITING

Trakya University

Edirne, 22030, Turkey (Türkiye)

NOT YET RECRUITING

Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi

Gaziantep, 27310, Turkey (Türkiye)

NOT YET RECRUITING

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

Pendik, 34899, Turkey (Türkiye)

NOT YET RECRUITING

Sakarya Training and Research Hospital

Sakarya, 54100, Turkey (Türkiye)

NOT YET RECRUITING

Related Links

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

MeSH Terms

Conditions

Nausea; Vomiting; Drug-Related Side Effects and Adverse Reactions; Neoplasms

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Chemically-Induced Disorders

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Central Study Contacts

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

CONTACT

1-317-615-4559; LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: September 12, 2025
• Study Start: November 28, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
• Access Criteria: A research proposal should be approved by an independent review panel and researchers should sign a data sharing agreement.

Locations

US (18); AU (5); CN (5); RO (5); FR (4); TU (9); TW (5); ES (7); JP (4); IT (4)