A Study to Evaluate LY3537021 for the Treatment of Nausea and Vomiting Caused by Chemotherapy in Adults With Cancer

Part of paid clinical trials in Greenbrae, California.

Sponsor
Eli Lilly and Company
Study ID
NCT07169851
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • LY3537021 — DRUG
    Administered SC
  • Placebo — DRUG
    Administered SC
  • Standard of Care Antiemetic Therapies — DRUG
    5-HT3 Receptor Antagonist, NK1 Receptor Antagonist, Dexamethasone administered orally, IV, or transdermally
  • Background Chemotherapy — DRUG
    Cisplatin or anthraxyline and cyclophosphamide (AC) administered IV

Study Details

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.

Key Dates

Start date
Nov 28, 2025
Status verified
Jun 2026
Primary completion
Dec 31, 2026
Completion
Feb 28, 2027

Study Design

Enrollment
204 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: LY3537021 + Antiemetic Therapies
    Prior to chemotherapy, participants receive LY3537021 administered subcutaneously (SC) with standard of care (SOC) antiemetic therapies orally, intravenously (IV), or transdermally, per local label
  • Placebo Comparator: Placebo + Antiemetic Therapies
    Prior to chemotherapy, participants receive placebo administered SC with SOC antiemetic therapies orally, IV, or transdermally, per local label

Primary Outcome Measure

Proportion of Participants with a Complete Response (CR) in the Delayed Phase of CINV [ Time Frame: 24 to 120 hours after first chemotherapy infusion ]

Central Contacts

  • Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
    1-317-615-4559
    [email protected]
  • Physicians interested in becoming principal investigators please contact
    [email protected]

Locations (19)

FacilityCityStateZIPSite coordinators
Marin Cancer CareGreenbraeCalifornia94904
Cyrus Mazidi (PRINCIPAL_INVESTIGATOR)
City of Hope Orange County Lennar Foundation Cancer CenterIrvineCalifornia92618
714-252-9415
Sudarsan Kollimuttathuillam (PRINCIPAL_INVESTIGATOR)
Cancer and Blood Specialty ClinicLos AlamitosCalifornia90720
Nihal Abdulla (PRINCIPAL_INVESTIGATOR)
BASS Cancer CenterWalnut CreekCalifornia94598
Jewel Johl (PRINCIPAL_INVESTIGATOR)
UCHealth HarmonyFort CollinsColorado80528
970-297-6150
Steven Schuster (PRINCIPAL_INVESTIGATOR)
Clavis MedicalMiami LakesFlorida33014
786-723-4001
Eloy Roman (PRINCIPAL_INVESTIGATOR)
BRCR Global - TamaracTamaracFlorida33321
561-477-0614
Chintan Gandhi (PRINCIPAL_INVESTIGATOR)
Summit Cancer Care, PCSavannahGeorgia31405
912-651-5771
Michael Chahin (PRINCIPAL_INVESTIGATOR)
Hope and Healing Cancer ServicesHinsdaleIllinois60521
630-560-0121
Srilata Gundala (PRINCIPAL_INVESTIGATOR)
Indiana University Health University HospitalIndianapolisIndiana46202
Tarah Ballinger (PRINCIPAL_INVESTIGATOR)
North Mississippi Hematology and Oncology AssociatesTupeloMississippi38801
Amit Jain (PRINCIPAL_INVESTIGATOR)
Laura and Isaac Perlmutter Cancer CenterNew YorkNew York10016
Olivia Seecof (PRINCIPAL_INVESTIGATOR)
Oncology Specialists of CharlotteCharlotteNorth Carolina28207
704-342-1900
Justin Favaro (PRINCIPAL_INVESTIGATOR)
Southern Oncology SpecialistsHuntersvilleNorth Carolina28078
William Mitchell (PRINCIPAL_INVESTIGATOR)
Asante Rogue Regional Medical CenterMedfordOregon97504
541-789-5003
Alison Savage (PRINCIPAL_INVESTIGATOR)
World Research LinkBaytownTexas77521
833-832-8328
Amir Rasheed (PRINCIPAL_INVESTIGATOR)
John Peter Smith HospitalFort WorthTexas76104
817-702-8049
Kalyani Narra (PRINCIPAL_INVESTIGATOR)
Community Cancer Trials of UtahOgdenUtah84405
801-689-3909
Carl Gray (PRINCIPAL_INVESTIGATOR)
Cancer Care NorthwestSpokaneWashington99202
Saritha Thumma (PRINCIPAL_INVESTIGATOR)

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Marin Cancer Care· Greenbrae, CACity of Hope Orange County Lennar Foundation Cancer Center· Irvine, CACancer and Blood Specialty Clinic· Los Alamitos, CABASS Cancer Center· Walnut Creek, CAUCHealth Harmony· Fort Collins, COClavis Medical· Miami Lakes, FL

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