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Clinical Trials List

Protocol NumberJ2R-MC-YAAD
NCT Number(ClinicalTrials.gov Identfier)NCT07169851
Not yet recruiting

2025-11-01 - 2027-08-22

Phase II

Recruiting5

A Phase 2, Double-blind, Placebo-Controlled Study to Evaluate LY3537021 for the Treatment of Chemotherapy-Induced Nausea and Vomiting in Adult Participants With Malignant Disease

  • Trial Applicant

    ELI LILLY AND COMPANY(TAIWAN), INC.

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/04/10

Investigators and Locations

Principal Investigator 黃文聰 Division of Hematology & Oncology
Chi Mei Hospital, Liouying

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chia-Hsun Hsieh Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 饒坤銘 Division of Hematology & Oncology
E-DA Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Muh-Hwa Yang Division of Hematology & Oncology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chun-Hui Lee
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

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

Objectives

The purpose of this trial is to confirm the efficacy and safety of LY35327021 in controlling chemotherapy-induced nausea and vomiting. Participants will continue the trial until all parts are completed, which may take approximately two months.

Test Drug

subcutaneous injection

Active Ingredient

LY3537021

Dosage Form

220

Dosage

mg/ mL

Endpoints

Outcome Measure: The proportion of participants who achieved a complete response (CR) during the delayed period of CINV.
Measurement Description: CR is defined as no vomiting and no use of rescue medication.
Time Range: 24 to 120 hours after the first chemotherapy infusion.

Inclution Criteria

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

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.

The Estimated Number of Participants

  • Taiwan

    42 participants

  • Global

    204 participants

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