Actively Recruiting
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
Led by Eli Lilly and Company · Updated on 2026-06-04
204
Participants Needed
67
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating LY3537021 to see how well it controls nausea and vomiting caused by chemotherapy in adults with cancer. This phase 2, double-blind, placebo-controlled study aims to assess both the effectiveness and safety of LY3537021 when added to standard antiemetic treatments. Participants are adults who have not previously received chemotherapy and are planned to receive specific chemotherapy drugs. Before chemotherapy, participants receive either LY3537021 or a placebo, both given as a subcutaneous injection. Alongside this, they receive standard of care antiemetic therapies, which may be given orally, intravenously, or through the skin. The chemotherapy drugs used include cisplatin or anthracycline and cyclophosphamide, administered intravenously. The study includes a randomized assignment to one of the two treatment groups and is expected to last about two months for each participant. Participants will be monitored for nausea and vomiting responses up to 120 hours after chemotherapy infusion. Researchers will collect data on complete response rates, nausea levels, and medication use. Pharmacokinetics of LY3537021 will also be assessed during the treatment cycles. Safety will be monitored throughout the study, and participants will be involved until all study parts are completed, with various assessments done at regular intervals.
CONDITIONS
Brief Title
A Study to Evaluate LY3537021 for the Treatment of Nausea and Vomiting Caused by Chemotherapy in Adults With Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Chemotherapy-naive participants planned to receive AC or cisplatin-based chemotherapy at doses equal to or greater than 70 mg/m² on Day 1 of each cycle
- No multiple chemotherapy administrations during the nausea and vomiting observation period from Day 2 to Day 5 of each cycle
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
You will not qualify if you...
- Presence of symptomatic or untreated central nervous system (CNS) metastases
- Diagnosis of uncontrolled diabetes mellitus
- History or current evidence of significant cardiac conditions or QT/QTcF-related conditions
- Other causes of nausea and vomiting or use of medications with known or potential antiemetic activity
- Signs, symptoms, or history of thyroid tumors
- Treatment with gastric inhibitory polypeptide (GIP) or glucagon-like peptide-1 (GLP-1) receptor agonists within 4 weeks before chemotherapy
- Participation in another clinical study involving study intervention within 30 days before Cycle 1 Day 1, or longer if the prior drug has a long half-life
- Pregnancy, breastfeeding, or intention to become pregnant during the study or within 30 days after last dose of study intervention
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Each cycle is expected to be 14, 21, or 28 days
Participants receive LY3537021 or placebo administered subcutaneously prior to chemotherapy along with standard of care antiemetic therapies to manage nausea and vomiting caused by chemotherapy.
Visits on Day 1 of each chemotherapy cycle
Trial Site Locations
Total: 67 locations
1
Marin Cancer Care
Greenbrae, California, United States, 94904
Actively Recruiting
2
City of Hope Orange County Lennar Foundation Cancer Center
Irvine, California, United States, 92618
Not Yet Recruiting
3
Cancer and Blood Specialty Clinic
Los Alamitos, California, United States, 90720
Actively Recruiting
4
BASS Cancer Center
Walnut Creek, California, United States, 94598
Actively Recruiting
5
UCHealth Harmony
Fort Collins, Colorado, United States, 80528
Actively Recruiting
6
Clavis Medical
Miami Lakes, Florida, United States, 33014
Actively Recruiting
7
BRCR Global - Tamarac
Tamarac, Florida, United States, 33321
Actively Recruiting
8
Summit Cancer Care, PC
Savannah, Georgia, United States, 31405
Actively Recruiting
9
Hope and Healing Cancer Services
Hinsdale, Illinois, United States, 60521
Actively Recruiting
10
Indiana University Health University Hospital
Indianapolis, Indiana, United States, 46202
Not Yet Recruiting
11
North Mississippi Hematology and Oncology Associates
Tupelo, Mississippi, United States, 38801
Actively Recruiting
12
Laura and Isaac Perlmutter Cancer Center
New York, New York, United States, 10016
Actively Recruiting
13
Oncology Specialists of Charlotte
Charlotte, North Carolina, United States, 28207
Actively Recruiting
14
Southern Oncology Specialists
Huntersville, North Carolina, United States, 28078
Actively Recruiting
15
Asante Rogue Regional Medical Center
Medford, Oregon, United States, 97504
Actively Recruiting
16
World Research Link
Baytown, Texas, United States, 77521
Actively Recruiting
17
John Peter Smith Hospital
Fort Worth, Texas, United States, 76104
Actively Recruiting
18
Community Cancer Trials of Utah
Ogden, Utah, United States, 84405
Actively Recruiting
19
Cancer Care Northwest
Spokane, Washington, United States, 99202
Actively Recruiting
20
Ballarat Health Services
Ballarat Central, Australia, 3350
Actively Recruiting
21
Bendigo Health Care Group
Bendigo, Australia, 3550
Actively Recruiting
22
WA Country Health Service Trial Centre
Perth, Australia, 6102
Actively Recruiting
23
Goulburn Valley Health
Shepparton, Australia, 3630
Actively Recruiting
24
Latrobe Regional Health
Traralgon, Australia, 3844
Actively Recruiting
25
The First People's Hospital of Changde City
Changde, China, 415003
Actively Recruiting
26
Zhujiang Hospital
Guangzhou, China, 510280
Actively Recruiting
27
Zhejiang Provincial People's Hospital
Hangzhou, China, 310014
Actively Recruiting
28
Jiangmen Center Hospital
Jiangmen, China
Actively Recruiting
29
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang, China, 471003
Actively Recruiting
30
Sainte Catherine Institut du Cancer Avignon Provence
Avignon, France, 84918
Not Yet Recruiting
31
Centre Hospitalier d'Annecy
Epagny Metz-Tessy, France, 74370
Not Yet Recruiting
32
Clinique Victor Hugo Le Mans
Le Mans, France, 72000
Not Yet Recruiting
33
Centre Leon Berard
Lyon Cedex08, France, 69373
Suspended
34
Aou Ospedali Riuniti Umberto I
Ancona, Italy, 60126
Not Yet Recruiting
35
Azienda Ospedaliero Universitaria
Modena, Italy, 41125
Not Yet Recruiting
36
Azienda Ospedaliera Universitaria Pisana
Pisa, Italy, 56126
Not Yet Recruiting
37
AULSS8 Berica-Ospedale S.Bortolo
Vicenza, Italy, 36100
Not Yet Recruiting
38
Himeji Medical Center
Himeji, Japan, 670-8520
Actively Recruiting
39
The Cancer Institute Hospital of JFCR
Kōtoku, Japan, 135-8550
Actively Recruiting
40
Kyoto University Hospital
Kyoto, Japan, 606-8507
Actively Recruiting
41
Shizuoka Cancer Center
Nagaizumi-cho,Sunto-gun, Japan, 411-8777
Actively Recruiting
42
SC Memorial Healthcare International SRL
Bucharest, Romania, 013812
Not Yet Recruiting
43
Spitalul Clinic Colentina
Bucharest, Romania, 020125
Not Yet Recruiting
44
Spitalul Clinic Colțea
Bucharest, Romania, 030171
Not Yet Recruiting
45
Centrul de Oncologie "Sfântul Nectarie"
Craiova, Romania, 200542
Not Yet Recruiting
46
Ovidius Clinical Hospital OCH
Ovidiu, Romania, 905900
Not Yet Recruiting
47
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08041
Not Yet Recruiting
48
FutureMeds - Madrid
Madrid, Spain, 28003
Not Yet Recruiting
49
Hospital General Universitario Gregorio Marañon
Madrid, Spain, 28009
Not Yet Recruiting
50
Hospital Universitario Fundación Jiménez Díaz
Madrid, Spain, 28040
Not Yet Recruiting
51
Hospital de Mataró
Mataró, Spain, 08304
Not Yet Recruiting
52
Hospital Universitario Virgen de la Victoria
Málaga, Spain, 29010
Not Yet Recruiting
53
Hospital Universitari Sant Joan de Reus
Reus, Spain, 43204
Not Yet Recruiting
54
E-Da Cancer Hospital
Kaohsiung City, Taiwan, 82445
Actively Recruiting
55
National Cheng Kung University Hospital
Tainan, Taiwan, 704
Actively Recruiting
56
Chi Mei Hospital - Liouying Branch
Tainan, Taiwan, 73657
Actively Recruiting
57
Taipei Veterans General Hospital
Taipei, Taiwan, 11217
Actively Recruiting
58
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, Taiwan, 333
Actively Recruiting
59
Adana Medical Park Seyhan Hastanesi
Adana, Turkey (Türkiye), 01140
Not Yet Recruiting
60
Ankara Bilkent Şehir Hastanesi
Ankara, Turkey (Türkiye), 06800
Not Yet Recruiting
61
Antalya Egitim ve Arastırma Hastanesi
Antalya, Turkey (Türkiye), 07100
Not Yet Recruiting
62
Ege Universitesi Hastanesi
Bornova, Turkey (Türkiye), 35100
Not Yet Recruiting
63
Dicle Üniversitesi
Diyarbakır, Turkey (Türkiye), 21200
Not Yet Recruiting
64
Trakya University
Edirne, Turkey (Türkiye), 22030
Not Yet Recruiting
65
Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi
Gaziantep, Turkey (Türkiye), 27310
Not Yet Recruiting
66
T.C. Sağlik Bakanliği- Marmara Üniversitesi İstanbul Pendik Eğitim Ve Araştirma Hastanesi
Pendik, Turkey (Türkiye), 34899
Not Yet Recruiting
67
Sakarya Training and Research Hospital
Sakarya, Turkey (Türkiye), 54100
Not Yet Recruiting
Research Team
T
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
P
Physicians interested in becoming principal investigators please contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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