Clinical trial • Phase II • Oncology
LY3537021 for Nausea|Vomiting|Drug-related adverse reactions|Neoplasms
Phase II trial of LY3537021 for Nausea|Vomiting|Drug-related adverse reactions|Neoplasms.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Nausea|Vomiting|Drug-related adverse reactions|Neoplasms
- Trial Stage
- Phase II
- Drug Modality
- Peptide/protein/enzyme|Small molecule
Key dates
- Initial CTIS Submission Date
- 20-10-2025
- First CTIS Authorization Date
- 23-02-2026
Trial design
Randomised, placebo (0.9% sodium chloride) in combination with standard antiemetic treatments (ondansetron, aprepitant/fosaprepitant, palonosetron, granisetron, dexamethasone); specific doses/schedule not specified in the provided data.-controlled Phase II trial in France, Italy, Romania and others.
- Randomised
- Yes
- Comparator
- Placebo (0.9% sodium chloride) in combination with standard antiemetic treatments (ondansetron, aprepitant/fosaprepitant, palonosetron, granisetron, dexamethasone); specific doses/schedule not specified in the provided data.
- Target Sample Size
- 128
Eligibility
Recruits 128 No vulnerable population selected; trial enrols adults only. Informed consent is obtained via Subject Information Sheet and Informed Consent Form documents (L1/L2 documents referenced). Assent not applicable..
- Vulnerable Population
- No vulnerable population selected; trial enrols adults only. Informed consent is obtained via Subject Information Sheet and Informed Consent Form documents (L1/L2 documents referenced). Assent not applicable.
Inclusion criteria
- {"criterion_text":"- Need treatment with an anti-cancer regimen that includes cisplatin or anthracycline and cyclophosphamide.\n- Be well enough to walk and do light work."}
Exclusion criteria
- {"criterion_text":"- Have had chemotherapy before.\n- Need to receive chemotherapy from Day 2 to Day 5 of each cycle.\n- Have cancer that has spread to the brain and/or spinal cord and is causing noticeable symptoms or has not yet been treated.\n- Have uncontrolled diabetes or a serious heart problem or conditions related to the heart rhythm.\n- Have another cause for nausea and vomiting, or receive medications known to prevent or treat nausea and vomiting.\n- Have signs, symptoms, or history of thyroid tumors.\n- Receive treatment with medications called incretins within 4 weeks before chemotherapy."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Proportion of Participants with a Complete Response (CR) in the Delayed Phase of CINV CR defined as no vomiting and no rescue medication","definition_or_measurement_approach":"CR defined as no vomiting and no rescue medication (as stated in endpoint text)"}
Recruitment
- Planned Sample Size
- 128
- Recruitment Window Months
- 4
- Consent Approach
- Informed consent is obtained from adult participants using Subject Information Sheets and Informed Consent Forms (L1/L2 documents referenced). ICFs and study synopses are available in multiple languages (English plus translations referenced in Spanish, French, Italian, Romanian). Consent is provided by the participant; no assent process is applicable (adults only).
Methods
- Site-based recruitment via participating hospitals/oncology clinics (site-facing recruitment materials and a list of participating sites are referenced in K1/K2 documents).
- Patient screening, recruitment and retention services provided by third-party vendors (organisations listed with duties including 'Patient Screening, Recruitment, and/or Retention' such as Greenphire LLC, Care Access Research LLC, and others).
- Patient-facing recruitment materials and clinician referral letters (K2 recruitment brochures and a doctor referral letter are listed among documents).
Geography
- Total Number Of Sites
- 22
- Total Number Of Participants
- 77
France
- Earliest CTIS Part Ii Submission Date
- 08-02-2026
- Latest Decision Or Authorization Date
- 23-02-2026
- Processing Time Days
- 15
- Number Of Sites
- 4
- Number Of Participants
- 15
Sites
- Site Name
- Centre Hospitalier Annecy Genevois
- Department Name
- Oncologie
- Principal Investigator Name
- Melodie Carbonnaux
- Principal Investigator Email
- mcarbonnaux@ch-annecygenevois.fr
- Contact Person Name
- Melodie Carbonnaux
- Contact Person Email
- mcarbonnaux@ch-annecygenevois.fr
- Site Name
- Clinique Victor Hugo Le Mans
- Principal Investigator Name
- Yoann Pointreau
- Principal Investigator Email
- essaispointreau@ilcgroupe.fr
- Contact Person Name
- Yoann Pointreau
- Contact Person Email
- essaispointreau@ilcgroupe.fr
- Site Name
- Sainte Catherine Institut Du Cancer Avignon-Provence
- Department Name
- Medical Oncology
- Principal Investigator Name
- Alma Stancu
- Principal Investigator Email
- a.stancu@isc84.org
- Contact Person Name
- Alma Stancu
- Contact Person Email
- a.stancu@isc84.org
- Site Name
- Centre Leon Berard
- Principal Investigator Name
- Benedicte Mastroianni
- Principal Investigator Email
- benedicte.mastroianni@lyon.unicancer.fr
- Contact Person Name
- Benedicte Mastroianni
- Contact Person Email
- benedicte.mastroianni@lyon.unicancer.fr
Italy
- Earliest CTIS Part Ii Submission Date
- 15-12-2025
- Latest Decision Or Authorization Date
- 25-02-2026
- Processing Time Days
- 72
- Number Of Sites
- 4
- Number Of Participants
- 15
Sites
- Site Name
- Azienda Unita Locale Socio Sanitaria N 8 Berica
- Department Name
- Oncologia clinica
- Principal Investigator Name
- Beatrice Benetti
- Principal Investigator Email
- beatrice.benetti@aulss8.veneto.it
- Contact Person Name
- Beatrice Benetti
- Contact Person Email
- beatrice.benetti@aulss8.veneto.it
- Site Name
- Azienda Ospedaliero Universitaria Delle Marche
- Department Name
- Clinica Oncologica
- Principal Investigator Name
- Rossana Berardi
- Principal Investigator Email
- rossana.berardi@ospedaliriuniti.marche.it
- Contact Person Name
- Rossana Berardi
- Contact Person Email
- rossana.berardi@ospedaliriuniti.marche.it
- Site Name
- Azienda Ospedaliero Universitaria Pisana
- Department Name
- U.O. Oncologia 2 Universitaria
- Principal Investigator Name
- Luca Galli
- Principal Investigator Email
- lugal71@yahoo.it
- Contact Person Name
- Luca Galli
- Contact Person Email
- lugal71@yahoo.it
- Site Name
- Azienda Ospedaliero Universitaria Di Modena
- Department Name
- DH Oncologia
- Principal Investigator Name
- Roberto Sabbatini
- Principal Investigator Email
- sabbatini@unimore.it
- Contact Person Name
- Roberto Sabbatini
- Contact Person Email
- sabbatini@unimore.it
Romania
- Earliest CTIS Part Ii Submission Date
- 03-11-2025
- Latest Decision Or Authorization Date
- 02-03-2026
- Processing Time Days
- 119
- Number Of Sites
- 5
- Number Of Participants
- 19
Sites
- Site Name
- Spitalul Clinic Colentina Bucuresti
- Department Name
- Oncologie Medicala
- Principal Investigator Name
- Andrei Popescu
- Principal Investigator Email
- andreipopescu1983@gmail.com
- Contact Person Name
- Andrei Popescu
- Contact Person Email
- andreipopescu1983@gmail.com
- Site Name
- Ovidius Clinical Hospital S.R.L.
- Department Name
- Oncologie
- Principal Investigator Name
- Laura Mazilu
- Principal Investigator Email
- lauragrigorov@gmail.com
- Contact Person Name
- Laura Mazilu
- Contact Person Email
- lauragrigorov@gmail.com
- Site Name
- Memorial Healthcare International S.R.L.
- Department Name
- Oncologie
- Principal Investigator Name
- Ingrid Iordan
- Principal Investigator Email
- mireliordan@yahoo.com
- Contact Person Name
- Ingrid Iordan
- Contact Person Email
- mireliordan@yahoo.com
- Site Name
- Spitalul Clinic Coltea
- Department Name
- Oncologie
- Principal Investigator Name
- Raluca Patru
- Principal Investigator Email
- raluca.patru@gmail.com
- Contact Person Name
- Raluca Patru
- Contact Person Email
- raluca.patru@gmail.com
- Site Name
- Centrul De Oncologie SF Nectarie S.R.L.
- Department Name
- Oncologie
- Principal Investigator Name
- Michael Schenker
- Principal Investigator Email
- mike_schenker@yahoo.com
- Contact Person Name
- Michael Schenker
- Contact Person Email
- mike_schenker@yahoo.com
Spain
- Earliest CTIS Part Ii Submission Date
- 03-02-2026
- Latest Decision Or Authorization Date
- 27-02-2026
- Processing Time Days
- 24
- Number Of Sites
- 9
- Number Of Participants
- 28
Sites
- Site Name
- Hospital de la Santa Creu i Sant Pau
- Department Name
- Oncology
- Principal Investigator Name
- Margarita Majem Tarruella
- Principal Investigator Email
- mmajem@santpau.cat
- Contact Person Name
- Margarita Majem Tarruella
- Contact Person Email
- mmajem@santpau.cat
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Oncology
- Principal Investigator Name
- Juan Montes González
- Principal Investigator Email
- dr.montes.onc@gmail.com
- Contact Person Name
- Juan Montes González
- Contact Person Email
- dr.montes.onc@gmail.com
- Site Name
- Futuremeds Spain S.L.
- Department Name
- Oncology
- Principal Investigator Name
- Esther Holgado
- Principal Investigator Email
- esther.holgado@genesiscare.es
- Contact Person Name
- Esther Holgado
- Contact Person Email
- esther.holgado@genesiscare.es
- Site Name
- Hospital Universitario Virgen De La Victoria
- Department Name
- Oncology
- Principal Investigator Name
- José Carlos Benítez Montañez
- Principal Investigator Email
- Josecarlos.benitez@ibima.eu
- Contact Person Name
- José Carlos Benítez Montañez
- Contact Person Email
- Josecarlos.benitez@ibima.eu
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Oncology
- Principal Investigator Name
- Silvia Garcia Adrian
- Principal Investigator Email
- silvia_g_adrian@hotmail.com
- Contact Person Name
- Silvia Garcia Adrian
- Contact Person Email
- silvia_g_adrian@hotmail.com
- Site Name
- Salut Sant Joan De Reus
- Department Name
- Oncology
- Principal Investigator Name
- Kepa Amillano Parraga
- Principal Investigator Email
- kepa.amillano@salutsantjoan.cat
- Contact Person Name
- Kepa Amillano Parraga
- Contact Person Email
- kepa.amillano@salutsantjoan.cat
- Site Name
- Consorci Sanitari Del Maresme
- Department Name
- Oncology
- Principal Investigator Name
- Laura Punti Brun
- Principal Investigator Email
- lpunti@csdm.cat
- Contact Person Name
- Laura Punti Brun
- Contact Person Email
- lpunti@csdm.cat
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Oncology
- Principal Investigator Name
- Imanol Martinez Salas
- Principal Investigator Email
- imanol.martinez@quironsalud.es
- Contact Person Name
- Imanol Martinez Salas
- Contact Person Email
- imanol.martinez@quironsalud.es
- Site Name
- Hospital Universitario 12 De Octubre (additional entry)
- Department Name
- Oncology
Sponsor
Primary sponsor
- Full Name
- Eli Lilly & Co.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Q2 Solutions LLC
- Responsibilities
- sponsorDuties code 4
- Name
- Labcorp Drug Development Inc
- Responsibilities
- sponsorDuties code 4
- Name
- IQVIA Limited
- Responsibilities
- Laboratory & Diagnostics Central ECG
- Name
- Pharmaceutical Product Development LLC
- Responsibilities
- sponsorDuties code 4
Third parties
- {"country":"United States","full_name":"Tier 1 Impact Pbc Inc.","duties_or_roles":"Study Training","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Q2 Solutions LLC","duties_or_roles":"sponsorDuties code 4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"sponsorDuties code 6","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient Screening, Recruitment, and/or Retention","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp Drug Development Inc","duties_or_roles":"sponsorDuties code 4","organisation_type":"Health care"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Laboratory & Diagnostics Central ECG","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Care Access Research LLC","duties_or_roles":"Patient Screening, Recruitment and/or retention","organisation_type":"Health care"}
- {"country":"Belgium","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"sponsorDuties code 4","organisation_type":"Health care"}
- {"country":"United States","full_name":"The Hibbert Co.","duties_or_roles":"Patient Screening Recruitment, and/or Retention","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Medable Inc.","duties_or_roles":"sponsorDuties code 7","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Florence","duties_or_roles":"Computer System","organisation_type":"Health care"}
Investigational products
- Investigational Product Name
- Lagipra
- Active Substance
- LY3537021
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- SUBCUTANEOUS USE
- Route
- subcutaneous
- Investigational Product Name
- ONDANSETRON
- Active Substance
- ONDANSETRON HYDROCHLORIDE
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- oral
- Maximum Dose
- 24 mg (max daily)
- Investigational Product Name
- APREPITANT
- Active Substance
- APREPITANT
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- oral
- Maximum Dose
- 285 mg (max daily)
- Investigational Product Name
- PALONOSETRON (IV)
- Active Substance
- PALONOSETRON
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS USE
- Route
- intravenous
- Maximum Dose
- 0.5 mg (max daily)
- Investigational Product Name
- PALONOSETRON, COMBINATIONS
- Active Substance
- PALONOSETRON
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- oral
- Maximum Dose
- 300 mg (max daily)
- Investigational Product Name
- GRANISETRON
- Active Substance
- GRANISETRON HYDROCHLORIDE
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- oral
- Maximum Dose
- 2 mg (max daily)
- Investigational Product Name
- DEXAMETHASONE
- Active Substance
- DEXAMETHASONE ACETATE
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- oral
- Maximum Dose
- 12 mg (max daily)
- Investigational Product Name
- 0.9% sodium chloride
- Modality
- Other
- Combination Treatment
- Yes
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