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Clinical Trials List

Protocol NumberJ2R-MC-YAAD
NCT Number(ClinicalTrials.gov Identfier)NCT07169851
Active

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

    2026/08/13

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

Drug-Related Side Effects and Adverse Reactions

Objectives

本試驗之目的為確認LY35327021對於控制化療導致的噁心和嘔吐之療效和安全性。參與本試驗的參與者將持續進行試驗，直到完成所有部分為止，這可能需要大約2個月。

Test Drug

皮下注射劑

Active Ingredient

LY3537021

Dosage Form

220

Dosage

25 mg/1 mL

Endpoints

試驗延遲期間有完全反應的參與者比例，乃定義為首次化療輸注後24至120小時沒有嘔吐、未使用救援藥物者。

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

    220 participants

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