A Study of Zolbetuximab Together With Pembrolizumab and Chemotherapy in Adults With Gastric Cancer
LUCERNA
A Phase 3, Double-blind, Randomized Study of Zolbetuximab in Combination With Pembrolizumab and Chemotherapy (CAPOX or mFOLFOX6) in First-line Treatment of Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma in Participants Whose Tumors Are HER2-negative, Claudin (CLDN) 18.2-positive and Programmed Death-ligand 1 (PD-L1)-Positive
4 other identifiers
interventional
500
22 countries
249
Brief Summary
Zolbetuximab is being studied in people with cancer in and around the stomach or where the food pipe (esophagus) joins the stomach, called gastroesophageal junction (GEJ) cancer. Zolbetuximab with chemotherapy may be used to treat stomach and GEJ cancer when the cancer cells do not have a protein called HER2 (human epidermal growth factor receptor 2) on their surface (HER2-negative) but do have a protein called Claudin 18.2 (Claudin 18.2-positive). Zolbetuximab is thought to work by attaching to the Claudin 18.2 protein in their tumor, which switches on the body's immune system to attack the tumor. Certain stomach and GEJ cancers may be treated with immunotherapy, which helps the body's immune system fight cancer. This study will give more information about how well zolbetuximab works when given with an immunotherapy medicine called pembrolizumab and chemotherapy. In this study, adults with stomach cancer or GEJ cancer will either be given zolbetuximab with pembrolizumab and chemotherapy or a placebo with pembrolizumab and chemotherapy. A placebo looks like zolbetuximab but doesn't have any medicine in it. The main aim of the study is to check how long people with stomach cancer and GEJ cancer live after treatment with zolbetuximab with pembrolizumab and chemotherapy compared to placebo with pembrolizumab and chemotherapy. Adults with locally advanced unresectable or metastatic stomach cancer or GEJ cancer can take part. Locally advanced means the cancer has spread to nearby tissue. Unresectable means the cancer cannot be removed by surgery. Metastatic means the cancer has spread to other parts of the body. A tumor sample (biopsy) of their cancer will have the Claudin 18.2 protein, PD-L1 protein, and be HER2-negative. They may have been previously treated with certain standard therapies. People can also take part if they need to take medicines like steroids to suppress their immune system. They cannot take part if they have blockages or bleeding in their gut, have specific uncontrollable cancers such as symptomatic or untreated cancers in the nervous system, or have a specific heart condition, or infections. The study treatments are either zolbetuximab with pembrolizumab and chemotherapy, or placebo with pembrolizumab and chemotherapy. People who take part will receive just 1 of the study treatments by chance. The people in the study and the study doctors will not know who takes which of the study treatments. Study treatment will be given in 6-week (42-day) cycles. The study treatment is mainly given to people slowly through a tube into a vein. This is called an infusion. People will receive study treatment as follows: Zolbetuximab or placebo: 1 infusion every 2 or 3 weeks (2 or 3 infusions in a cycle) together with: Chemotherapy (1 of the following types of chemotherapy): 1. CAPOX (capecitabine and oxaliplatin): 1 infusion of oxaliplatin every 3 weeks (2 infusions in a cycle). People will also take 1 tablet of capecitabine twice a day for 2 weeks (14 days) at the start of each cycle (Day 1) and again in the middle of each cycle (Day 22). After 8 study treatments people will receive capecitabine only. 2. Modified FOLFOX6 or mFOLFOX6 (5-fluorouracil, folinic acid and oxaliplatin): 1 infusion every 2 weeks (3 infusions in a cycle). After 12 study treatments people will receive folinic acid and fluorouracil only, instead of mFOLFOX6. Pembrolizumab: 1 infusion every 3 or 6 weeks (1 or 2 infusions in a cycle). People can be in the study and will receive study treatment until their cancer worsens, they cannot tolerate the study treatment, or they need to start another cancer treatment. People may receive pembrolizumab for up to 2 years. People will visit the clinic on certain days to receive their study treatment and have health checks. The study doctors will check if people had any medical problems from taking zolbetuximab or the other study treatments. On some visits they will have scans to check for any changes in their cancer. People will have the option of giving a tumor sample if they stop treatment because their cancer has worsened. People will visit the clinic after they stop their study treatment. People will be asked about any medical problems and will have a health check. People will continue to have scans every 9 or 12 weeks to check for any changes in their cancer. They will have telephone health checks every 3 months. The number of visits and checks done at each visit will depend on the health of each person and whether they completed their study treatment or not.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2025
249 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2025
CompletedFirst Posted
Study publicly available on registry
March 30, 2025
CompletedStudy Start
First participant enrolled
May 22, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2027
July 31, 2026
July 1, 2026
1.9 years
March 27, 2025
July 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival (OS)
OS is defined as the time from the date of randomization until the date of death from any cause.
Up to 72 months
Secondary Outcomes (11)
Progression Free Survival (PFS)
Up to 72 Months
Objective Response Rate (ORR)
Up to 57 Months
Duration of Response (DOR)
Up to 72 Months
Number of participants with adverse Events (AEs)
Up to 57 Months
Number of participants with electrocardiograms (ECG) abnormalities and/or AEs
Up to 57 Months
- +6 more secondary outcomes
Study Arms (2)
Arm A: zolbetuximab in combination with pembrolizumab and chemotherapy
EXPERIMENTALParticipants will receive zolbetuximab as an intravenous (via a vein) infusion at 800 mg/m2 loading dose at C1D1 followed by subsequent doses of 400 mg/m2 every 2 weeks; or 800 mg/m2 loading dose at C1D1 followed by subsequent doses of 600 mg/m2 every 3 weeks, followed by an intravenous infusion of pembrolizumab at a dose of 200 mg every 3 weeks or 400 mg every 6 weeks. Participants will then receive chemotherapy over 4 or more cycles of either up to 8 CAPOX treatments (oxaliplatin: 130 mg/m2 once every 3 weeks, capecitabine: 1000 mg/m2 twice daily on days 1 through 14 and days 22 through 35 of each cycle), or, up to 12 mFOLFOX6 treatments (oxaliplatin: 85 mg/m2, Folinic acid (leucovorin/local equivalent): 400 mg/m2, 5-FU bolus: 400 mg/m2, 5-FU infusion: 2400 mg/m2) once every 2 weeks (or components of mFOLFOX6 if some components are discontinued due to toxicity). The choice of chemotherapy for each participant is based on investigator's judgment. Each cycle is approximately 42 days.
Arm B: Placebo in combination with pembrolizumab and chemotherapy
ACTIVE COMPARATORParticipants will receive matching placebo as an intravenous (via a vein) infusion followed by an intravenous infusion of pembrolizumab at a dose of 200 mg every 3 weeks or 400 mg every 6 weeks. Participants will then receive chemotherapy over 4 or more cycles of either up to 8 CAPOX treatments (oxaliplatin: 130 mg/m2 once every 3 weeks, capecitabine: 1000 mg/m2 twice daily on days 1 through 14 and days 22 through 35 of each cycle), or, up to 12 mFOLFOX6 treatments (oxaliplatin: 85 mg/m2, Folinic acid (leucovorin/local equivalent): 400 mg/m2, 5-FU bolus: 400 mg/m2, 5-FU infusion: 2400 mg/m2) once every 2 weeks (or components of mFOLFOX6 if some components are discontinued due to toxicity). The choice of chemotherapy for each participant is based on investigator's judgment. Each cycle is approximately 42 days.
Interventions
Participants receiving mFOLFOX6 regimen of chemotherapy will receive an IV infusion of Folinic acid (leucovorin or local equivalent) once every 2 weeks.
Participants will receive an IV infusion of zolbetuximab on Cycle 1 Day 1 (C1D1) followed by subsequent IV infusion every 2 weeks or every 3 weeks.
Participants will receive an IV infusion of pembrolizumab every 3 weeks or every 6 weeks.
Participants receiving CAPOX regimen of chemotherapy will receive capecitabine Tablet twice daily orally on days 1 through 14 and days 22 through 35 of each cycle.
Participants receiving CAPOX or mFOLFOX6 regimen of chemotherapy will receive an IV infusion of oxaliplatin once every 2 or 3 weeks.
Participants receiving mFOLFOX6 regimen of chemotherapy will receive an IV infusion, or IV bolus of 5-FU once every 2 weeks.
Participants will receive an IV infusion of placebo (0.9% of sodium chloride) on C1D1 followed by subsequent IV infusion every 2 weeks or every 3 weeks.
Eligibility Criteria
You may qualify if:
- Participant has histologically confirmed gastric or Gastroesophageal Junction (GEJ) adenocarcinoma.
- Participant has radiographically confirmed, locally advanced, unresectable or metastatic disease within 28 days prior to randomization.
- Participant has radiologically evaluable disease (measurable and/or nonmeasurable) according to Response Evaluation Criteria in Solid Tumors (RECIST) V1.1, ≤ 28 days prior to randomization. For participants with only 1 evaluable lesion and prior radiotherapy ≤ 3 months before randomization, the lesion must either be outside the field of prior radiotherapy or have documented progression following radiation therapy.
- Participant has Eastern Cooperative Oncology Group Performance Status (ECOG) performance status 0 to 1.
- Participant has predicted life expectancy ≥ 12 weeks.
- Participant must be a candidate to receive mFOLFOX6 or CAPOX and pembrolizumab.
- Female participant is not pregnant and at least 1 of the following conditions apply:
- Not a woman of child bearing potential (WOCBP)
- WOCBP who has a negative urine or serum pregnancy test at screening (Specific to Japan: with a medical interview), and agrees to follow the contraceptive guidance from the time of informed consent through at least 9 months after the final oxaliplatin administration and 6 months after the final administration of all other study interventions.
- Female participant must not be breastfeeding or lactating starting at screening and throughout the investigational period and for 5 half-lives (at least 9 months after the final oxaliplatin administration and 6 months after the final administration of all other study interventions).
- Female participant must not donate ova starting at first administration of study intervention and throughout the investigational period, and for 9 months after the final administration of oxaliplatin and for 6 months after final administration of all other study interventions.
- Male participant must agree to use contraception with female partner(s) of childbearing potential (including breastfeeding partner) throughout the treatment period, and for 6 months after final investigational study intervention administration.
- Male participant must agree to remain abstinent or use a condom with pregnant partner(s) for the duration of the pregnancy throughout the investigational period and for 6 months after the final investigational study intervention administration.
- Male participant must not donate sperm during the treatment period and for 6 months after the final investigational study intervention administration
- Participant has a Human Epidermal Growth Factor Receptor 2 (HER2) -negative tumor.
- +5 more criteria
You may not qualify if:
- Participant has prior severe allergic reaction or intolerance to zolbetuximab or other monoclonal antibodies, pembrolizumab, mFOLFOX6 or CAPOX.
- Participant has a complete gastric outlet syndrome or a partial gastric outlet syndrome with persistent recurrent vomiting.
- Participant has significant gastric bleeding and/or untreated gastric ulcers that would preclude the participant from participation.
- Participant has unresolved pneumonitis or history of non-infectious pneumonitis such as immune-related pneumonitis, radiation induced pneumonitis.
- Participant has history of central nervous system metastases and/or carcinomatous meningitis from gastric/GEJ cancer.
- Participant has a known history of a positive test for Human Immunodeficiency Virus (HIV) infection or known active Hepatitis B Surface Antigen (positive HBsAg) or hepatitis C infection. NOTE: Screening for these infections should be conducted per local requirements.
- For participants who are negative for HBsAg, but hepatitis B core antibody (HBcAb) positive, a hepatitis B DNA test will be performed and if positive the participant will be excluded.
- Participants with positive Hepatitis C virus (HCV) serology, but negative HCV RNA test results are eligible.
- Participants treated for HCV with undetectable viral load results are eligible.
- Participant has active infection requiring systemic therapy that has not completely resolved within 7 days prior to randomization.
- Participant has active autoimmune disease that has required systemic treatment within the past 3 months prior to randomization. Participants with stable autoimmune disease who are receiving physiologic replacement doses of hydrocortisone or its equivalent are allowed.
- Participant has a clinically significant disease or comorbidity that may adversely affect the safe delivery of treatment within this study or make the participant unsuitable for study participation.
- Participant has another malignancy for which treatment is required.
- Participant has known complete Dihydropyrimidine Dehydrogenase (DPD) deficiency (screening for DPD deficiency should be conducted per local requirements).
- Participant has known peripheral neuropathy \> grade 1 (absence of deep tendon reflexes as the sole neurological abnormality does not render the participant ineligible).
- +21 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (249)
UAB Medicine - UAB Hospital
Birmingham, Alabama, 35294, United States
CBCC Global Research - Comprehensive Blood & Cancer Center
Bakersfield, California, 93309, United States
TOI Clinical Research
Cerritos, California, 90703, United States
University of California, San Diego Moores Cancer Center
La Jolla, California, 92037-0845, United States
The Angeles Clinic and Research Institute, West Los Angeles Office
Los Angeles, California, 90025, United States
Hartford HealthCare - Hartford Hospital
Hartford, Connecticut, 06102, United States
Yale University School of Medicine
New Haven, Connecticut, 06510, United States
MedStar Georgetown University Hospital / Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, 20007, United States
Piedmont Physician Medical Oncology Atlanta
Atlanta, Georgia, 30318, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
Franciscan Health Oncology and Hematology Specialists
Indianapolis, Indiana, 46237, United States
Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242, United States
University of Kansas Cancer Center
Westwood, Kansas, 66205, United States
Saint Elizabeth Medical Center Edgewood
Edgewood, Kentucky, 41017, United States
University of Maryland Medical System - University of Maryland Medical Center
Baltimore, Maryland, 21021, United States
Dana Farber/Harvard Cancer Center
Boston, Massachusetts, 02215, United States
University of Massachusetts - UMass Chan Medical School
Worcester, Massachusetts, 01655, United States
University of Michigan Health System
Ann Arbor, Michigan, 48109, United States
Barbara Ann Karmanos Cancer Center
Detroit, Michigan, 48201, United States
Henry Ford Cancer Institute-Henry Ford Hospital
Detroit, Michigan, 48201, United States
Metro Minnesota Community Oncology Research Consortium (MMCORC)
Saint Louis Park, Minnesota, 55426, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68105, United States
Oncology Hematology West PC dba Nebraska Cancer Specialists
Omaha, Nebraska, 68130, United States
Capital Health - Hematology Oncology Specialists
Pennington, New Jersey, 08534, United States
NYU Langone Medical Center
New York, New York, 10016, United States
Montefiore Medical Center
The Bronx, New York, 10461, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Duke University Medical Center - Duke Cancer Centre
Durham, North Carolina, 27710, United States
Allegheny General Hospital (AGH)-Allegheny Singer Research Institute
Pittsburgh, Pennsylvania, 15212, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
The University of Tennessee Medical Center
Knoxville, Tennessee, 37920, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Texas Oncology-Baylor Charles A Sammons Cancer Center
Dallas, Texas, 75246, United States
The Center For Cancer And Blood Disorders (Texas Cancer Care)
Fort Worth, Texas, 76104, United States
Houston Methodist Cancer Center
Houston, Texas, 77030, United States
Utah Cancer Specialists Cancer Center - Medical Oncology
Salt Lake City, Utah, 84106, United States
Inova Schar Cancer Institute Clinical Trials
Fairfax, Virginia, 22031, United States
Site AU61002
Kogarah, New South Wales, Australia
Site AU61004
Brisbane, Queensland, Australia
Site AU61003
Clayton, Victoria, Australia
Site AU61001
Fitzroy, Australia
Site BE32002
Bonheiden, Belgium
Site BE32001
Brussels, Belgium
Site BE32006
Edegem, Belgium
Site BE32003
Ghent, Belgium
Site BE32005
Leuven, Belgium
Site BE32004
Liège, Belgium
Site BR55014
Belo Horizonte, Brazil
Site BR55002
Blumenau, Brazil
Site BR55012
Fortaleza, Brazil
Site BR55008
Jaú, Brazil
Site BR55004
Lages, Brazil
Site BR55003
Porto Alegre, Brazil
Site BR55006
São Caetano do Sul, Brazil
Site BR55001
São José do Rio Preto, Brazil
Site BR55007
São Paulo, Brazil
Site CL56004
Las Condes, Chile
Site CL56001
Santiago, Chile
Anhui Provincial Cancer Hospital
Hefei, Anhui, 230031, China
Fujian Provincial Hospital - Department of Medical Oncology
Fuzhou, Fujian, China
Sun Yat-sen University - Cancer Center
Guangzhou, Guangdong, 510060, China
Sun Yat-sen University - Cancer Center
Guangzhou, Guangdong, 510555, China
Harbin Medical University Cancer Hospital - Oncology
Harbin, Heilongjiang, China
Henan Cancer Hospital - Oncology
Zhenngzhou, Henan, China
Hubei Cancer Hospital - Oncology
Wuhan, Hubei, 430079, China
Qinghai University Affiliated Hospital
Xining, Qinghai, China
Renji Hospital Shanghai Jiaotong Univ School of Medicine
Shanghai, Shanghai Municipality, 200127, China
Ruijin Hospital of Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Sichuan Cancer Hospital
Chengdu, Sichuan, 610200, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China
Affiliated Hospital of Hebei University
Baoding, 71000, China
Peking Union Medical College Hospital - Dongdan Campus
Beijing, China
Site CZ42006
Brno, Czechia
Site CZ42005
Olomouc, Czechia
Site CZ42002
Prague, Czechia
Site CZ42003
Prague, Czechia
Site CZ42004
Prague, Czechia
Site FR33016
Bordeaux, France
Site FR33008
Brest, France
Site FR33012
Caen, France
Site FR33009
Carassonne, France
Site FR33005
Dijon, France
Site FR33002
Lille, France
Site FR33007
Lille, France
Site FR33014
Lyon, France
Site FR33017
Lyon, France
Site FR33020
Montpellier, France
Site FR33018
Nice, France
Site FR33003
Paris, France
Site FR33010
Paris, France
Site FR33013
Paris, France
Site FR33015
Plérin, France
Site FR33004
Poitiers, France
Site FR33006
Rouen, France
Site FR33019
Saint Herbian Cedex, France
Site FR33011
Strasbourg, France
Site DE49013
Berlin, Germany
Site DE49010
Essen, Germany
Site DE49017
Frankfurt am Main, Germany
Site DE49007
Hanover, Germany
Site DE49004
Leipzig, Germany
Site DE49001
Mainz, Germany
Site DE49014
Munich, Germany
Site DE49006
Nuremberg, Germany
Site DE49002
Saarbrücken, Germany
Site DE49011
Schweinfurt, Germany
Site DE49016
Wolfsburg, Germany
Site IT39019
Bergamo, Italy
Site IT39017
Bologna, Italy
Site IT39009
Brescia, Italy
Site IT39014
Candiolo, Italy
Site IT39006
Cremona, Italy
Site IT39011
Florence, Italy
Site IT39007
Meldola, Italy
Site IT39012
Milan, Italy
Site IT39018
Milan, Italy
Site IT39020
Milan, Italy
Site IT39021
Naples, Italy
Site IT39015
Pisa, Italy
Site IT39004
Reggio Emilia, Italy
Site IT39016
Roma, Italy
Site IT39001
Rome, Italy
Site IT39003
Torrette Di Ancona, Italy
Site IT39022
Udine, Italy
Site IT39002
Verona, Italy
Chiba Cancer Center
Chiba, Chiba, Japan
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, Japan
Kyushu University Hospital (Hematology, Oncology & Cardiovascular medicine)
Fukuoka, Fukuoka, Japan
Kyushu University Hospital(Gastrointestinal Surgery)
Fukuoka, Fukuoka, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, Fukuoka, Japan
Gunma University Hospital
Maebashi, Gunma, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Hyogo Cancer Center
Akashi-shi, Hyōgo, Japan
Kobe City Medical Center General Hospital
Kobe, Hyōgo, Japan
Kagawa University Hospital
Kida-gun, Kagawa-ken, Japan
St. Marianna University Hospital
Kawasaki-shi, Kanagawa, Japan
Kanagawa Cancer Ctr Hospital
Yokohama, Kanagawa, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
Osaka General Medical Center
Osaka, Osaka, Japan
Osaka International Cancer Institute
Osaka, Osaka, Japan
Osaka University Hospital
Suita-shi, Osaka, Japan
Saitama Medical University International Medical Center
Hidaka-shi, Saitama, Japan
Saitama Cancer Center
Kitaadachi-gun Ina-machi, Saitama, Japan
Shizuoka Cancer Center
Sunto-gun, Shizuoka, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan
The Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, Japan
Site LT37001
Kaunas, Lithuania
Site LT37002
Vilnius, Lithuania
Site MX52003
Mexico City, Mexico
Site MX52001
Oaxaca City, Mexico
Site NL31002
Leeuwarden, Netherlands
Site NL31001
Nijmegen, Netherlands
Site PL48005
Lubin, Lubusz Voivodeship, Poland
Site PL48004
Warsaw, Masovian Voivodeship, Poland
Site PL48001
Brzozów, Woj Podkarpackie, Poland
Site PL48006
Gliwice, Poland
Site PL48008
Olsztyn, Poland
Site PL48002
Przemyśl, Poland
Site PL48009
Swidnica, Poland
Site PL48007
Warsaw, Poland
Site PT35106
Almada, Portugal
Site PT35103
Braga, Portugal
Site PT35104
Guimarães, Portugal
Site PT35102
Lisbon, Portugal
Site PT35107
Lisbon, Portugal
Site PT35105
Porto, Portugal
Site PT35108
Porto, Portugal
Site PT35109
Porto, Portugal
Site RO40008
Bucharest, Romania
Site RO40001
Cluj-Napoca, Romania
Site RO40005
Cluj-Napoca, Romania
Site RO40006
Cluj-Napoca, Romania
Site RO40003
Craiova, Romania
Site RO40002
Floreşti, Romania
Site RO40007
Iași, Romania
Site RO40004
Timișoara, Romania
Site KR82011
Goyang-si, Gyeonggi-do, South Korea
Site KR82007
Seongnam-si, Gyeonggi-do, South Korea
Site KR82013
Suwon, Gyeonggi-do, South Korea
Site KR82015
Suwon, Gyeonggi-do, South Korea
Site KR82014
Hwasungun, Joellanamdo, South Korea
Site KR82009
Cheongju-si, North Chungcheong, South Korea
Site KR82003
Seocho-gu, Seoul, South Korea
Site KR82004
Daegu, South Korea
Site KR82005
Incheon, South Korea
Site KR82001
Seoul, South Korea
Site KR82002
Seoul, South Korea
Site KR82006
Seoul, South Korea
Site KR82008
Seoul, South Korea
Site KR82010
Seoul, South Korea
Site KR82012
Seoul, South Korea
Site ES34022
Elche, Alicante, Spain
Site ES34023
San Cugat Del Valles Barcelona, Cataluyna, Spain
Site ES34019
Madrid, Madrid, Spain
Site ES34027
Madrid, Madrid, Spain
Site ES34002
Navarra, Pamplona, Spain
Site ES34005
A Coruña, Spain
Site ES34006
Barcelona, Spain
Site ES34009
Barcelona, Spain
Site ES34010
Barcelona, Spain
Site ES34011
Barcelona, Spain
Site ES34024
Barcelona, Spain
Site ES34026
Barcelona, Spain
Site ES34028
Barcelona, Spain
Site ES34021
El Palmar, Spain
Site ES34014
Lleida, Spain
Site ES34003
Madrid, Spain
Site ES34008
Madrid, Spain
Site ES34016
Madrid, Spain
Site ES34017
Madrid, Spain
Site ES34031
Madrid, Spain
Site ES34030
Murcia, Spain
Site ES34013
Pozuelo de Alarcón, Spain
Site ES34029
Santiago de Compostela, Spain
Site ES34012
Seville, Spain
Site ES34025
Seville, Spain
Site ES34004
Valencia, Spain
Site ES34007
Valencia, Spain
Site ES34015
Zaragoza, Spain
Site ES34018
Zaragoza, Spain
Site TW88603
Dawan, Taiwan, Taiwan
Site TW88604
Kaohsiung City, Taiwan
Site TW88601
Taichung, Taiwan
Site TW88606
Tainan, Taiwan
Site TW88605
Taipei, Taiwan
Site TR90011
Adana, Turkey (Türkiye)
Site TR90001
Ankara, Turkey (Türkiye)
Site TR90004
Ankara, Turkey (Türkiye)
Site TR90006
Ankara, Turkey (Türkiye)
Site TR90014
Bursa, Turkey (Türkiye)
Site TR90005
Istanbul, Turkey (Türkiye)
Site TR90013
Konya, Turkey (Türkiye)
Site TR90009
Samsun, Turkey (Türkiye)
Site TR90015
Van, Turkey (Türkiye)
Site GB44010
Cottingham, East Riding Of Yorkshire, United Kingdom
Site UK44001
Bristol, United Kingdom
Site GB44003
Cardiff, United Kingdom
Site GB44002
Coventry, United Kingdom
Site UK44006
Dundee, United Kingdom
Site GB44004
Glasgow, United Kingdom
Site GB44005
London, United Kingdom
Site UK44011
London, United Kingdom
Site UK44014
London, United Kingdom
Site UK44015
London, United Kingdom
Site UK44016
London, United Kingdom
Site UK44009
Manchester, United Kingdom
Site GB44008
Sheffield, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Astellas Pharma Global Development, Inc.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
March 27, 2025
First Posted
March 30, 2025
Study Start
May 22, 2025
Primary Completion (Estimated)
March 31, 2027
Study Completion (Estimated)
March 31, 2027
Last Updated
July 31, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
- Access Criteria
- Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.