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

2025-522204-24-00 Protocol J2R-MC-YAAD Therapeutic exploratory (Phase II) Authorised, recruitment pending

Status Authorised, recruitment pending · 4 EU/EEA countries · 21 sites · Protocol J2R-MC-YAAD

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)
Status Authorised, recruitment pending
Participants planned 205
Countries 4
Sites 21

Drug-Related Side Effects and Adverse Reactions

To compare the efficacy of LY3537021 in combination with other antiemetic treatments to placebo in combination with other antiemetic treatments

Key facts

Sponsor
Eli Lilly & Co.
Participant type
Patients
Age range
18-64 years
Gender
Male and Female
Therapeutic area
Diseases [C] - Neoplasms [C04]
Decision date (initial)
2026-02-23
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No

External identifiers

EU CT number
2025-522204-24-00
WHO UTN
U1111-1322-9151
ClinicalTrials.gov
NCT07169851

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Dose response, Pharmacokinetic, Efficacy, Safety

To compare the efficacy of LY3537021 in combination with other antiemetic treatments to placebo in combination with other antiemetic treatments

Conditions and MedDRA coding

Drug-Related Side Effects and Adverse Reactions

Regulatory references

Scientific advice from competent authorities
European Medicines Agency
Plan to share IPD
Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

  1. Need treatment with an anti-cancer regimen that includes cisplatin or anthracycline and cyclophosphamide.
  2. Be well enough to walk and do light work.

Exclusion criteria 7

  1. Have had chemotherapy before.
  2. Need to receive chemotherapy from Day 2 to Day 5 of each cycle.
  3. Have cancer that has spread to the brain and/or spinal cord and is causing noticeable symptoms or has not yet been treated.
  4. Have uncontrolled diabetes or a serious heart problem or conditions related to the heart rhythm.
  5. Have another cause for nausea and vomiting, or receive medications known to prevent or treat nausea and vomiting.
  6. Have signs, symptoms, or history of thyroid tumors.
  7. Receive treatment with medications called incretins within 4 weeks before chemotherapy.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Proportion of Participants with a Complete Response (CR) in the Delayed Phase of CINV CR defined as no vomiting and no rescue medication

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 7

Dexamethasone Acetate

SCP10332310 · ATC

Active substance
Dexamethasone Acetate
Route of administration
ORAL USE
Max daily dose
12 mg milligram(s)
Max total dose
72 mg milligram(s)
Max treatment duration
8 Week(s)
Authorisation status
Authorised
ATC code
H02AB02 — DEXAMETHASONE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Ondansetron Hydrochloride

SCP107195639 · ATC

Active substance
Ondansetron Hydrochloride
Route of administration
ORAL USE
Max daily dose
24 mg milligram(s)
Max total dose
48 mg milligram(s)
Max treatment duration
8 Week(s)
Authorisation status
Authorised
ATC code
A04AA01 — ONDANSETRON
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Palonosetron

SCP12481635 · ATC

Active substance
Palonosetron
Route of administration
INTRAVENOUS USE
Max daily dose
0.5 mg milligram(s)
Max total dose
1 mg milligram(s)
Max treatment duration
8 Week(s)
Authorisation status
Authorised
ATC code
A04AA05 — PALONOSETRON
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Aprepitant

SCP187246 · ATC

Active substance
Aprepitant
Substance synonyms
ONO-7436, WEG-232, L-754,030, HT-001, MK-0869
Route of administration
ORAL USE
Max daily dose
285 mg milligram(s)
Max total dose
570 mg milligram(s)
Max treatment duration
8 Week(s)
Authorisation status
Authorised
ATC code
A04AD12 — APREPITANT
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Granisetron Hydrochloride

SCP128072 · ATC

Active substance
Granisetron Hydrochloride
Route of administration
ORAL USE
Max daily dose
2 mg milligram(s)
Max total dose
4 mg milligram(s)
Max treatment duration
8 Week(s)
Authorisation status
Authorised
ATC code
A04AA02 — GRANISETRON
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Palonosetron

SCP3720558 · ATC

Active substance
Palonosetron
Route of administration
ORAL USE
Max daily dose
300 mg milligram(s)
Max total dose
600 mg milligram(s)
Max treatment duration
8 Week(s)
Authorisation status
Authorised
ATC code
A04AA55 — PALONOSETRON, COMBINATIONS
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Lagipra

PRD12882679 · Product

Active substance
LY3537021
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS USE
Max daily dose
0 Other
Max total dose
0 Other
Max treatment duration
8 Week(s)
Authorisation status
Not Authorised
MA holder
ELI LILLY AND COMPANY LIMITED
Paediatric formulation
No
Orphan designation
No

Placebo 1

0.9% sodium chloride

N/A · Product

Other product name
N/A
Pharmaceutical form
N/A
ATC code
N/A — N/A
Marketing authorisation
N/A
MA holder
N/A
MA country
Iceland
Paediatric formulation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Eli Lilly & Co.

137 Total trials 45 Recruiting 84 Ended
Commercial
Sponsor organisation
Eli Lilly & Co.
Address
1 Lilly Corporate Center
City
Indianapolis
Postcode
46285-0001
Country
United States

Scientific contact point

Organisation
Eli Lilly & Co.
Contact name
Lilly Clinical Trials information desk

Public contact point

Organisation
Eli Lilly & Co.
Contact name
Lilly Clinical Trials information desk

Third parties 12

OrganisationCity, countryDuties
IQVIA Limited
ORG-100008655
 Reading, United Kingdom On site monitoring
IQVIA Limited
ORG-100008655
 Reading, United Kingdom Other
Care Access Research LLC
ORL-000015894
 Boston, MA, United States Other
Pharmaceutical Product Development LLC
ORL-000015890
 Zaventem, Belgium Laboratory analysis
Tier 1 Impact Pbc Inc.
ORG-100050163
 Covington, United States Other
Q2 Solutions LLC
ORG-100017000
 Valencia, United States Laboratory analysis
Medable Inc.
ORG-100043083
 Palo Alto, United States E-data capture
The Hibbert Co.
ORG-100047639
 Trenton, United States Other
Florence
ORL-000012320
 Atlanta, United States Other
Labcorp Drug Development Inc
ORL-000015887
 Wisconsin, United States Laboratory analysis
Greenphire LLC
ORG-100041621
 King Of Prussia, United States Other
RWS Life Sciences Inc.
ORG-100042348
 East Hartford, United States Data management

Locations

4 EU/EEA countries · 21 investigational sites

By country

CountryMS statusPlanned subjectsSites
France Authorised, recruitment pending 15 4
Italy Authorised, recruitment pending 15 4
Romania Authorised, recruitment pending 19 5
Spain Authorised, recruitment pending 28 8
Rest of world
Taiwan, China, United States, Turkey, Japan, Australia
 — 128 —

Investigational sites

France

4 sites · Authorised, recruitment pending
Centre Hospitalier Annecy Genevois
Oncologie, 1 Avenue De L Hopital, Bp 90074, Epagny Metz Tessy
Sainte Catherine Institut Du Cancer Avignon-Provence
Medical Oncology, 250 Chemin De Baigne Pieds, 84918, Avignon Cedex 9
Centre Leon Berard
N/A, 28, Rue Laennec, Rhône-Alpes
Clinique Victor Hugo Le Mans
N/A, 64-66 rue de Degré, Le Mans,, Sarthe

Italy

4 sites · Authorised, recruitment pending
Azienda Ospedaliero Universitaria Pisana
U.O. Oncologia Medica 2 Universitaria, Via Roma 67, 56126, Pisa
Azienda Unita Locale Socio Sanitaria N 8 Berica
Oncologia clinica, Viale Ferdinando Rodolfi 37, 36100, Vicenza
Azienda Ospedaliero Universitaria Delle Marche
Clinica Oncologica, Via Conca 71, 60126, Ancona
Azienda Ospedaliero Universitaria Di Modena
DH Oncologia, Largo Del Pozzo 71, 41124, Modena

Romania

5 sites · Authorised, recruitment pending
Centrul De Oncologie SF Nectarie S.R.L.
Oncologie, Strada Caracal Nr 109, 200542, Craiova
Spitalul Clinic Colentina Bucuresti
Oncologie Medicala, Soseaua Stefan Cel Mare 19-21, 020125, Bucharest
Spitalul Clinic Coltea
Oncologie, Bulevardul Bratianu C. Ion 1-3, 030171, Bucharest
Memorial Healthcare International S.R.L.
Oncologie, Soseaua Ionescu-Sisesti Gheorghe Nr 8a, 013823, Bucharest
Ovidius Clinical Hospital S.R.L.
Oncologie, Dn 2a Km 202 880, 905900, Ovidiu

Spain

8 sites · Authorised, recruitment pending
Hospital General Universitario Gregorio Maranon
Oncology, Calle Del Doctor Esquerdo 46, 28007, Madrid
Hospital Universitario Fundacion Jimenez Diaz
Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital de la Santa Creu i Sant Pau
Oncology, Carrera del Mas Casanovas 90, Bloque A, Barcelona
Salut Sant Joan De Reus
Oncology, Avinguda Del Doctor Josep Laporte 2, 43204, Reus
Consorci Sanitari Del Maresme
Oncology, Carretera De Cirera 230, 08304, Mataro
Futuremeds Spain S.L.
Oncology, Calle De La Granja 8, 28003, Madrid
Hospital Universitario 12 De Octubre
Oncology, Avenida De Cordoba Sn, 28041, Madrid
Hospital Universitario Virgen De La Victoria
Oncology, Campus De Teatinos Sn, Puerto De La Torre, Malaga

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 38 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_Protocol 2025-522204-24-00_Redacted c
Protocol (for publication) D4_Patient Facing Documents_Copyright Template 1
Recruitment arrangements (for publication) K1_List of participating sites 1
Recruitment arrangements (for publication) K1_Recruitment and consenting procedure 1
Recruitment arrangements (for publication) K1_Recruitment and informed consent procedure 1.0
Recruitment arrangements (for publication) K1_Recruitment arrangements 1.0
Recruitment arrangements (for publication) K1_Recruitment Arrangements Statement 1
Recruitment arrangements (for publication) K1_Recruitment Arrangements Statement 1
Recruitment arrangements (for publication) K1_Recruitment Arrangements Statement 1
Recruitment arrangements (for publication) K2_Recruitment material_Brochure 2.0
Recruitment arrangements (for publication) K2_Recruitment material_Brochure 1.0
Recruitment arrangements (for publication) K2_Recruitment material_Brochure_Tracked changes 1
Recruitment arrangements (for publication) K2_Recruitment material_Patient facing_Brochure 1
Recruitment arrangements (for publication) K2_Recruitment material_Site facing_Dr referral letter 1
Recruitment arrangements (for publication) K2_Recruitment material_Site facing_Inclusion-Exclusion Criteria Card 1
Recruitment arrangements (for publication) K3_Document additionnel_Redacted 1.0
Subject information and informed consent form (for publication) L1_ SIS and ICF_Addendum Genetic_Redacted 1
Subject information and informed consent form (for publication) L1_ SIS and ICF_Main_Redacted 2.1
Subject information and informed consent form (for publication) L1_Main ICF_Redacted 1
Subject information and informed consent form (for publication) L1_SIS and ICF_Addendum Genetic Research_Redacted 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF_Main_Redacted 1
Subject information and informed consent form (for publication) L1_SIS and ICF_Pregnant partner 1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Redacted 1.2
Subject information and informed consent form (for publication) L2_Other subject information material_Patient Card 1.0
Subject information and informed consent form (for publication) L2_Patient cards 1
Subject information and informed consent form (for publication) L2_Study Participant Contact Card 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Aprepitant n/a
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Dexamethasone n/a
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Fosaprepitant n/a
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Granisetron n/a
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Netupitant-palonosetron_Fosnetupitant-Palonosetron n/a
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Ondansetron n/a
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Palonosetron n/a
Synopsis of the protocol (for publication) D1_Protocol Synopsis_2025-522204-24-00_ENG_Redacted b
Synopsis of the protocol (for publication) D1_Protocol synopsis_2025-522204-24-00_FR_Redacted b
Synopsis of the protocol (for publication) D1_Protocol Synopsis_IT_ 2025-522204-24-00_Redacted b
Synopsis of the protocol (for publication) D1_Protocol_synopsis _RO_2025-522201-24-00_Redacted b
Synopsis of the protocol (for publication) D1_Protocol_Synopsis_ES_2025-522204-24-00_Redacted b

Application history

2 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2025-10-20 Italy Acceptable with conditions
2026-02-23
 2026-02-23
2 SUBSTANTIAL MODIFICATION SM-1 2026-03-26 Italy Acceptable with conditions
2026-05-28
 2026-05-29