Clinical trial · Interventional
A Study to Evaluate LY3537021 for the Treatment of Nausea and Vomiting Caused by Chemotherapy in Adults With Cancer
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
NCT07169851CI-TRIAL-00125901recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Drug-Related Side Effects and Adverse Reactions | — | UNRESOLVED | — |
| Nausea | — | UNRESOLVED | — |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Vomiting | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Background Chemotherapy | Drug | — | UNRESOLVED |
| LY3537021 | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
| Standard of Care Antiemetic Therapies | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- LY3537021 + Antiemetic Therapies
- description
- Prior to chemotherapy, participants receive LY3537021 administered subcutaneously (SC) with standard of care (SOC) antiemetic therapies orally, intravenously (IV), or transdermally, per local label
- interventionNames
- Drug: LY3537021
- Drug: Standard of Care Antiemetic Therapies
- Drug: Background Chemotherapy
- type
- PLACEBO_COMPARATOR
- label
- Placebo + Antiemetic Therapies
- description
- Prior to chemotherapy, participants receive placebo administered SC with SOC antiemetic therapies orally, IV, or transdermally, per local label
- interventionNames
- Drug: Placebo
- Drug: Standard of Care Antiemetic Therapies
- Drug: Background Chemotherapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.