LY3537021 for preventing chemo-related nausea and vomiting in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2 interventional trial in adults who are chemotherapy-naive and scheduled to receive anthracycline+cyclophosphamide (AC) or cisplatin ≥70 mg/m² on Day 1 of each cycle. Participants will receive background chemotherapy and standard antiemetic therapies, plus either LY3537021 or placebo, and will be followed through the acute and delayed CINV observation period (days 1–5) with safety monitoring for about two months. The study will compare rates and severity of nausea and vomiting and collect safety and tolerability data. Key exclusions include symptomatic or untreated CNS metastases, uncontrolled diabetes, certain cardiac/QT conditions, recent use of GIP/GLP-1 receptor agonists, and history of thyroid tumors.

Why it matters

Who can join: the full rules

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.

Where it's running

• Marin Cancer Care
  Greenbrae, California, United States Recruiting
• City of Hope Orange County Lennar Foundation Cancer Center
  Irvine, California, United States Recruiting
• Cancer and Blood Specialty Clinic
  Los Alamitos, California, United States Recruiting
• BASS Cancer Center
  Walnut Creek, California, United States Recruiting
• UCHealth Harmony
  Fort Collins, Colorado, United States Recruiting
• BRCR Global - Tamarac
  Tamarac, Florida, United States Recruiting

+17 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
• Email: LillyTrials@Lilly.com
• Phone: 1-317-615-4559

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.