Efficacy of LY3537021 plus combination therapy versus placebo for chemotherapy-induced nausea and vomiting in adults with malignant disease

The primary objective of this study is to evaluate the efficacy of LY3537021 in comparison to a placebo when administered in combination with existing antiemetic therapies for the management of chemotherapy-induced nausea and vomiting in adults with malignant disease. This evaluation focuses on the therapeutic potential of the investigational product to mitigate emetic symptoms associated with oncological treatments. The study also involves assessments of safety, pharmacokinetics, and dose response.

This clinical trial involves a total of 128 patients. The study population consists of both male and female individuals within the specified age range. Participants are required to be undergoing an anti-cancer regimen that includes cisplatin or anthracycline and cyclophosphamide. Additionally, subjects must possess sufficient functional status to perform walking and light work. The population may present with medical conditions such as nausea, vomiting, neoplasms, or drug-related side effects and adverse reactions.

This Phase 2, double-blind, placebo-controlled study is designed to evaluate the efficacy of LY3537021 in combination with other antiemetic treatments compared to a placebo for the management of chemotherapy-induced nausea and vomiting in adults with neoplasms. The research methodology involves comparing the test product against 0.9% sodium chloride. The primary endpoint is the proportion of participants achieving a complete response in the delayed phase, defined as the absence of vomiting and the absence of rescue medication. Eligible participants must require an anti-cancer regimen containing cisplatin or an anthracycline and cyclophosphamide and must be capable of walking and performing light work. The study is scheduled to take place between February 2026 and June 2026.

The experimental medication LY3537021 is administered as a solution for injection via subcutaneous use.

Ondansetron hydrochloride is administered as an oral use pharmaceutical form at a dose of 24 mg.

Aprepitant is administered via oral use at a dose of 285 mg.

Palonosetron is administered via intravenous use at a dose of 0.5 mg, while palonosetron combinations are provided for oral use at a dose of 300 mg.

Granisetron hydrochloride is administered via oral use at a dose of 2 mg.

Dexamethasone acetate is administered via oral use at a dose of 12 mg.

A placebo consisting of 0.9% sodium chloride is utilized in the study protocol.

The primary efficacy endpoint for this study is the proportion of participants achieving a complete response (CR) during the delayed phase of chemotherapy-induced nausea and vomiting (CINV). A complete response is defined as the occurrence of no vomiting and the requirement of no rescue medication.