A Study to Compare Zolbetuximab (IMAB362) and Chemotherapy With Placebo and Chemotherapy in Adults With Gastric Cancer. (Spotlight)

May 1, 2026 updated by: Astellas Pharma Global Development, Inc.

A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus mFOLFOX6 Compared With Placebo Plus mFOLFOX6 as First-line Treatment of Subjects With Claudin (CLDN)18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

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. Most people with this type of cancer have a protein called Claudin 18.2 in their tumor. 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. There is an unmet medical need to treat people with advanced stomach cancer or GEJ cancer. This study will give more information about how well zolbetuximab works when given with chemotherapy in adults with advanced stomach cancer or GEJ cancer. In this study, adults with advanced stomach cancer or GEJ cancer will either be given zolbetuximab with chemotherapy or a placebo with chemotherapy. A placebo looks like zolbetuximab but doesn't have any medicine in it. Zolbetuximab with chemotherapy has already been approved to treat gastric cancer and GEJ cancer in some countries. This study is being done in countries where zolbetuximab has not yet been approved for use. If zolbetuximab becomes approved for use in those countries taking part in this study, the study doctor will switch study treatment in those countries to the licensed zolbetuximab. If this happens, people taking part in those countries will leave this study and receive licensed zolbetuximab.

The main aim of the study is to check if zolbetuximab and chemotherapy can prevent or delay the worsening of people's gastric cancer and GEJ cancer compared to placebo and chemotherapy.

Adults with advanced 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 of their cancer will also have the Claudin 18.2 protein. They may have been previously treated with certain standard therapies, but have not been treated with chemotherapy for their cancer. People cannot take part if they need to take medicines to suppress their immune system, 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 chemotherapy, or placebo with chemotherapy. People who take part will receive just 1 of the study treatments by chance. Study treatment will be double-blinded. That means that 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 cycles. The study treatment is given to people slowly through a tube into a vein. This is called an infusion. People will have 4 infusions in 6-week (42-day) cycles as follows:

  • Zolbetuximab or placebo - 2 infusions in a cycle.
  • Chemotherapy (called modified FOLFOX6 or mFOLFOX6) - 3 infusions in a cycle. The first infusion is combined with zolbetuximab or placebo on day 1 of each cycle. People may receive zolbetuximab or placebo until their cancer worsens, they cannot tolerate the study treatment, or they need to start another cancer treatment. People will receive mFOLFOX6 for up to 6 months (4 study treatment cycles). After the 6 months people may receive chemotherapy containing folinic acid and fluorouracil instead of mFOLFOX6. People may receive folinic acid and fluorouracil chemotherapy for more than 6 months, or until their cancer worsens, they cannot tolerate the study treatment, or they need to start another cancer treatment. People will visit the clinic on certain days during their study treatment. The study doctors will check if people had any medical problems from taking zolbetuximab or the other study treatments. Also, people in the study will have health checks. 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 after their study treatment has finished. People will visit the clinic after they stop their study treatment. People who start treatment with licensed zolbetuximab or mFOLFOX6 outside of this study will not need to visit the clinic. People will be asked about any medical problems and will have a health check. People will visit the clinic at 1 month after they stop their study treatment. People will continue to have scans every 9 or 12 weeks to check for any changes in their cancer. People 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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

After the marketing approval in Japan on 26 Mar 2024, this study continued as "post marketing clinical study" in Japan. In the rest of the countries which participated in this study, this study continued as clinical study.

Study Type

Interventional

Enrollment (Actual)

565

Phase

  • Phase 3

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Kogarah, Australia, 2217
        • Site AU61007
    • Queensland
      • Douglas, Queensland, Australia, 4814
        • Site AU61002
      • Tugun, Queensland, Australia, 4224
        • Site AU61011
    • South Australia
      • Adelaide, South Australia, Australia, 5011
        • Site AU61008
    • Victoria
      • East Bentleigh, Victoria, Australia, 3165
        • Site AU61006
  • Belgium
      • Bruges, Belgium, 8310
        • Site BE32005
      • Brussels, Belgium, 1000
        • Site BE32004
      • Charleroi, Belgium, 6000
        • Site BE32011
      • Haine-Saint-Paul, Belgium, 7100
        • Site BE32010
    • Antwerpen
      • Edegem, Antwerpen, Belgium, 2650
        • Site BE32007
    • Bruxelles-Capitale, Région de
      • Brussels, Bruxelles-Capitale, Région de, Belgium, 1200
        • Site BE32001
    • Hainaut
      • Mons, Hainaut, Belgium, 7000
        • Site BE32008
    • Liege
      • Brussels, Liege, Belgium, 1050
        • Site BE32002
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgium, 9000
        • Site BE32012
    • Vlaams Brabant
      • Leuven, Vlaams Brabant, Belgium, 3000
        • Site BE32006
  • Brazil
      • Belo Horizonte, Brazil, 30130-090
        • Site BR55017
      • Passo Fundo, Brazil, 99010-260
        • Site BR55016
      • Rio de Janeiro, Brazil, 22793-080
        • Site BR55015
      • Santa Catarina, Brazil, 88501-003
        • Site BR55018
      • São Paulo, Brazil, 01509-900
        • Site BR55009
      • São Paulo, Brazil, 08270-070
        • Site BR55004
    • Federal District
      • Brasília, Federal District, Brazil, 70200-730
        • Site BR55010
    • Rio Grande do Sul
      • Lajeado, Rio Grande do Sul, Brazil, 95900000
        • Site BR55006
    • Santa Catarina
      • Itajaí, Santa Catarina, Brazil, 88301-220
        • Site BR55002
    • São Paulo
      • Barretos, São Paulo, Brazil, 14784-400
        • Site BR55007
      • Santo André, São Paulo, Brazil, 09060-650
        • Site BR55003
      • São José do Rio Preto, São Paulo, Brazil, 15090-000
        • Site BR55005
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Site CA15005
    • New Brunswick
      • Saint John, New Brunswick, Canada, E2L 4L4
        • Site CA15009
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X5
        • Site CA15011
    • Quebec
      • Montreal, Quebec, Canada, H3T 1M5
        • Site CA15002
      • Montreal, Quebec, Canada, H4A 3J1
        • Site CA15008
  • Chile
      • Providencia, Chile, 7520378
        • Site CL56008
      • Santiago, Chile, 8330032
        • Site CL56005
      • Valdivia, Chile, 5090000
        • Site CL56007
    • Santiago Metropolitan
      • Providencia, Santiago Metropolitan, Chile, 7500921
        • Site CL56003
  • China
      • Beijing, China, 100030
        • Site CN86009
      • Beijing, China, 100071
        • Site CN86002
      • Hefei, China, 230022
        • Site CN86005
      • Xiamen, China
        • Site CN86001
      • Zhengzhou, China, 450000
        • Site CN86008
    • Heilongjiang
      • Haerbin, Heilongjiang, China, 150081
        • Site CN86003
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Site CN86006
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • Site CN86004
  • Colombia
      • Cali, Colombia
        • Site CO57001
      • Medellín, Colombia, 0574
        • Site CO57002
    • Antioquia
      • Medellín, Antioquia, Colombia, 574
        • Site CO57006
    • DC
      • Bogotá, DC, Colombia, 110231
        • Site CO57009
    • Departamento de Córdoba
      • Montería, Departamento de Córdoba, Colombia, 230002
        • Site CO57007
    • Valle del Cauca Department
      • Cali, Valle del Cauca Department, Colombia
        • Site CO57005
  • France
      • Créteil, France, 94000
        • Site FR33103
      • Nice, France, 06189
        • Site FR33007
      • Saint-Priest-en-Jarez, France, 42270
        • Site FR33104
    • Bourgogne-Franche-Comté
      • Dijon, Bourgogne-Franche-Comté, France, 21079
        • Site FR33009
    • Brittany Region
      • Brest, Brittany Region, France, 29609
        • Site FR33010
      • Rennes, Brittany Region, France, 35042
        • Site FR33001
    • Franche-Comte
      • Besançon, Franche-Comte, France, 25033
        • Site FR33008
    • Languedoc-Roussillon
      • Montpellier, Languedoc-Roussillon, France, 34298
        • Site FR33011
    • Paris
      • Paris, Paris, France, 75970
        • Site FR33002
    • Pays de la Loire Region
      • Saint-Herblain, Pays de la Loire Region, France, 44805
        • Site FR33101
    • Provence-Alpes-Côte d'Azur Region
      • Nice, Provence-Alpes-Côte d'Azur Region, France, 06200
        • Site FR33005
    • Rhone
      • Lyon, Rhone, France, 69008
        • Site FR33003
    • Vienne
      • Poitiers, Vienne, France, 86021
        • Site FR33006
  • Germany
      • Berlin, Germany, 13125
        • Site DE49012
      • Berlin, Germany, 13353
        • Site DE49011
      • Dresden, Germany, 1067
        • Site DE49018
      • Heilbronn, Germany, 74078
        • Site DE49019
    • Bavaria
      • Munich, Bavaria, Germany, 81377
        • Site DE49008
      • München, Bavaria, Germany, 81925
        • Site DE49007
    • Rhineland-Palatinate
      • Mainz, Rhineland-Palatinate, Germany, 55101
        • Site DE49002
    • Saxony
      • Dresden, Saxony, Germany, 01307
        • Site DE49010
      • Leipzig, Saxony, Germany, 04103
        • Site DE49004
    • Saxony-Anhalt
      • Halle, Saxony-Anhalt, Germany, 06108
        • Site DE49021
      • Magdeburg, Saxony-Anhalt, Germany, 39104
        • Site DE49015
  • Israel
      • HaDarom, Israel, 7030000
        • Site IL97210
      • Haifa, Israel, 3109601
        • Site IL97201
      • Holon, Israel, 58100
        • Site IL97209
      • Jerusalem, Israel, 91031
        • Site IL97202
      • Tel Aviv, Israel, 64239
        • Site IL97203
    • Central District
      • Kfar Saba, Central District, Israel, 44281
        • Site IL97206
  • Italy
      • Ancona, Italy, 60126
        • Site IT39013
      • Bergamo, Italy, 24127
        • Site IT39004
      • Cremona, Italy, 26100
        • Site IT39009
      • Milan, Italy, 20132
        • Site IT39006
      • Milan, Italy, 20141
        • Site IT39008
      • Modena, Italy, 41124
        • Site IT39021
      • Padova, Italy, 35128
        • Site IT39016
      • Parma, Italy, 43126
        • Site IT39012
      • Perugia, Italy, 05100
        • Site IT39018
      • Piacenza, Italy, 29100
        • Site IT39003
      • Pisa, Italy, 56126
        • Site IT39019
      • Reggio Emilia, Italy, 42123
        • Site IT39022
      • Roma, Italy, 00128
        • Site IT39015
      • Terni, Italy, 5100
        • Site IT39026
      • Turin to, Italy, 5-10126
        • Site IT39024
    • Forli
      • Meldola, Forli, Italy, 47014
        • Site IT39011
    • Lombardy
      • Monza, Lombardy, Italy, 20052
        • Site IT39020
    • VI
      • Vicenza, VI, Italy, 36100
        • Site IT39023
  • Japan
      • Fukuoka, Japan
        • Site JP81005
      • Osaka, Japan
        • Site JP81004
      • Osaka, Japan
        • Site JP81011
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan
        • Site JP81009
    • Chiba
      • Kashiwa, Chiba, Japan
        • Site JP81003
    • Ehime
      • Matsuyama, Ehime, Japan
        • Site JP81002
    • Hokkaido
      • Sapporo, Hokkaido, Japan
        • Site JP81007
    • Hyōgo
      • Kobe, Hyōgo, Japan
        • Site JP81014
    • Osaka
      • Suita, Osaka, Japan
        • Site JP81001
    • Saitama
      • Hidaka, Saitama, Japan
        • Site JP81015
      • Kitaadachi-gun, Saitama, Japan
        • Site JP81010
    • Shizuoka
      • Sunto-gun, Shizuoka, Japan
        • Site JP81012
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan
        • Site JP81013
      • Chuo-ku, Tokyo, Japan
        • Site JP81006
      • Koto-ku, Tokyo, Japan
        • Site JP81008
  • Mexico
      • Aguascalientes, Mexico, 20230
        • Site MX52001
      • Distrito Federal, Mexico, 06720
        • Site MX52003
      • Jalisco, Mexico, 45030
        • Site MX52009
      • Oaxaca City, Mexico
        • Site MX52004
      • San Luis de Potosi, Mexico, 78250
        • Site MX52008
    • Mexico City
      • Mexico City, Mexico City, Mexico, 06760
        • Site MX52002
      • Mexico City, Mexico City, Mexico, 3100
        • Site MX52007
    • Veracruz
      • Veracruz, Ver, Veracruz, Mexico, 91900
        • Site MX52010
  • Peru
      • Arequipa, Peru, 4001
        • Site PE51003
      • Lima, Peru, 15036
        • Site PE51005
      • Lima, Peru, 15072
        • Site PE51006
      • Lima, Peru, L27
        • Site PE51001
    • Lima region
      • San Isidro, Lima region, Peru, L27
        • Site PE51004
  • Poland
      • Warsaw, Poland, 02-781
        • Site PL48009
    • Lubusz Voivodeship
      • Lublin, Lubusz Voivodeship, Poland, 20-090
        • Site PL48004
    • Masovian Voivodeship
      • Ostrołęka, Masovian Voivodeship, Poland, 07-410
        • Site PL48007
      • Wieliszew, Masovian Voivodeship, Poland, 05-135
        • Site PL48005
    • Podkarpackie Voivodeship
      • Brzozów, Podkarpackie Voivodeship, Poland, 36-20
        • Site PL48002
  • South Korea
      • Incheon, South Korea, 21556
        • Site KR82008
      • Seoul, South Korea, 03080
        • Site KR82003
      • Seoul, South Korea, 05505
        • Site KR82005
      • Seoul, South Korea, 152-703
        • Site KR82007
      • Seoul, South Korea, 6591
        • Site KR82006
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, South Korea, 13620
        • Site KR82002
    • Gyeonggido [Kyonggi-do]
      • Suwon, Gyeonggido [Kyonggi-do], South Korea, 16247
        • Site KR82009
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, South Korea, 06351
        • Site KR82004
  • Spain
      • Barcelona, Spain, 08003
        • Site ES34005
      • Barcelona, Spain, 08025
        • Site ES34016
      • Barcelona, Spain, 08035
        • Site ES34015
      • Burgos, Spain, 09006
        • Site ES34019
      • Madrid, Spain, 28007
        • Site ES34008
      • Madrid, Spain, 28033
        • Site ES34017
      • Madrid, Spain, 28034
        • Site ES34004
      • Murcia, Spain, 30120
        • Site ES34003
      • Seville, Spain, 41009
        • Site ES34018
      • Zaragoza, Spain, 50009
        • Site ES34006
    • Barcelona
      • Badalona, Barcelona, Spain, 08028
        • Site ES34013
    • Castille and León
      • Ávila, Castille and León, Spain, 05004
        • Site ES34010
    • Madrid
      • Alcorcón, Madrid, Spain, 28925
        • Site ES34011
  • Taiwan
      • Kaohsiung City, Taiwan, 80756
        • Site TW88608
      • Kaohsiung City, Taiwan, 833
        • Site TW88604
      • Taichung, Taiwan, 404
        • Site TW88603
      • Tainan, Taiwan, 704
        • Site TW88607
      • Taipei, Taiwan, 10002
        • Site TW88606
      • Taipei, Taiwan, 112
        • Site TW88601
    • Taoyuan
      • Kwei-Shan, Taoyuan, Taiwan, 333
        • Site TW88605
  • United Kingdom
      • Cambridge, United Kingdom, CB2 0QQ
        • Site GB44103
      • Coventry, United Kingdom, CV2 2DX
        • Site GB44009
      • Dundee, United Kingdom, DD2 4BF
        • Site GB44104
      • Leeds, United Kingdom, LS7 9TF
        • Site GB44008
      • London, United Kingdom, NW1 2PG
        • Site GB44002
      • London, United Kingdom, W1G 6AD
        • Site GB44004
      • Manchester, United Kingdom, M20 4BX
        • Site GB44001
    • Aberdeenshire
      • Aberdeen, Aberdeenshire, United Kingdom, AB25 2ZN
        • Site GB44003
    • London, City of
      • London, London, City of, United Kingdom, SW3 6JJ
        • Site GB44101
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • Site GB44102
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85004
        • University of Arizona
      • Tucson, Arizona, United States, 85724
        • The University of Arizona Medical Center
    • California
      • Bakersfield, California, United States, 93309
        • CBCC Global Research, Inc. at Comprehensive Blood and Cancer
      • Duarte, California, United States, 91010
        • City of Hope Nat'l Medical Center
      • Fullerton, California, United States, 92835
        • St. Jude Hospital Yorba Linda
      • Huntington Beach, California, United States, 92648
        • Pacific Shores Medical Group
      • Loma Linda, California, United States, 92354
        • Loma Linda University
      • Los Angeles, California, United States, 90025
        • The Angeles Clinic and Research Institute
      • Sacramento, California, United States, 95817
        • University of California Davis
      • San Francisco, California, United States, 94143
        • University of California - San Francisco
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado
    • Connecticut
      • Middletown, Connecticut, United States, 07748-3052
        • Memorial Sloan Kettering Cancer Center
    • Florida
      • Hollywood, Florida, United States, 33021
        • Memorial Cancer Institute - West
      • Miami, Florida, United States, 33136
        • University of Miami
      • Orlando, Florida, United States, 32806
        • Orlando Health Inc
      • Pembroke Pines, Florida, United States, 33028
        • Memorial Hospital West
    • Georgia
      • Newnan, Georgia, United States, 30265
        • Cancer Treatment Centers of America, Atlanta
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
      • Chicago, Illinois, United States, 60611
        • Northwestern University Medical Center
    • Kentucky
      • Louisville, Kentucky, United States, 40217
        • Norton Cancer Institute
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Medical Center(UMMC)Transplant Center
      • Brandywine, Maryland, United States, 20613
        • Maryland Oncology Hematology
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute
      • Boston, Massachusetts, United States, 02114-2696
        • Massachusetts General Hospital
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Karmanos Cancer Institute
    • Minnesota
      • Saint Louis Park, Minnesota, United States, 55426
        • Health Partners Institute
      • Saint Paul, Minnesota, United States, 55101
        • Regions Hospital
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Memorial Sloan Kettering Cancer Center
      • Montvale, New Jersey, United States, 07645
        • Memorial Sloan Kettering Cancer Center
    • New York
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute
      • Commack, New York, United States, 11725
        • Memorial Sloan Kettering Cancer Center
      • Harrison, New York, United States, 10604
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, United States, 10029-6574
        • Mount Sinai School of Medicine
      • Stony Brook, New York, United States, 11794-9452
        • Stony Brook University Medical Center
      • Uniondale, New York, United States, 11553
        • Memorial Sloan Kettering Cancer Center
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Medical Center
      • Middletown, Ohio, United States, 45042
        • Precision Cancer Research -Dayton Physicians Network
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Science Center
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University
      • Portland, Oregon, United States, 97213
        • Earle A. Chiles Research Institute
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17604
        • Lancaster General Hospital
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
      • Philadelphia, Pennsylvania, United States, 19124
        • Cancer Treatment Centers of America, Philadelphia
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital-Lifespan Cancer Institute
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
        • Sanford Cancer Center
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas MD Anderson Cancer Center
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Inova Dwight and Martha Schar Cancer Institute
    • Washington
      • Auburn, Washington, United States, 98801
        • MultiCare Regional Cancer Center - Gig Harbor
      • Seattle, Washington, United States, 98109
        • Seattle Cancer Care Alliance

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Female subject eligible to participate if she is not pregnant (negative serum pregnancy test at screening; female subjects with elevated serum beta human chorionic gonadotropin and a demonstrated non-pregnant status through additional testing are eligible) and at least one of the following conditions applies:

    • Not a woman of child-bearing potential (WOCBP) OR
    • WOCBP who agrees to follow the contraceptive guidance throughout the treatment period and for at least 9 months after the final administration of oxaliplatin and 6 months after the final administration of all other study drugs
  • Female subject must agree not to breastfeed starting at screening and throughout the study period, and for 6 months after the final study drug administration.
  • Female subject must not donate ova starting at screening and throughout the study period, and for 9 months after the final administration of oxaliplatin and 6 months after the final administration of all other study drugs.
  • A sexually active male subject with a female partner(s) who is of child-bearing potential must agree to use contraception during the treatment period and for at least 6 months after the final study drug administration.
  • Male subject must agree not to donate sperm starting at screening and throughout the study period, and for 6 months after the final study drug administration.
  • Male subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or time partner is breastfeeding throughout the study period and for 6 months after the final study drug administration.
  • Subject has histologically confirmed diagnosis of Gastric or GEJ adenocarcinoma.
  • Subject has radiologically confirmed locally advanced unresectable or metastatic disease within 28 days prior to randomization.
  • Subject has radiologically evaluable disease (measurable and/or non-measurable disease according to RECIST 1.1), per local assessment, ≤ 28 days prior to randomization. For subjects 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.
  • Subject's tumor expresses CLDN18.2 in ≥ 75% of tumor cells demonstrating moderate to strong membranous staining as determined by central immunohistochemistry (IHC) testing.
  • Subject has a HER2-Negative tumor as determined by local or central testing on a gastric or GEJ tumor specimen. (Unique to China: Subject has a known HER2-negative gastric or GEJ tumor.)
  • Subject has ECOG performance status 0 to 1.
  • Subject has predicted life expectancy ≥ 12 weeks.

  • Subject must meet all of the following criteria based on the centrally or locally analyzed laboratory tests collected within 14 days prior to randomization. In the case of multiple sample collections within this period, the most recent sample collection with available results should be used to determine eligibility.

    • Hemoglobin (Hgb) ≥ 9 g/dL. Subjects requiring transfusions are eligible if they have a post-transfusion Hgb ≥ 9 g/dL.
    • Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L
    • Platelets ≥ 100 x 10^9/L
    • Albumin ≥ 2.5 g/dL
    • Total bilirubin ≤ 1.5 x upper limit of normal (ULN) without liver metastases (or < 3.0 x ULN if liver metastases are present)
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN without liver metastases (or ≤ 5 x ULN if liver metastases are present)
    • Estimated creatinine clearance ≥ 30 mL/min
    • Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) ≤ 1.5 x ULN (except for subjects receiving anticoagulation therapy)

Exclusion Criteria:

  • Subject has received prior systemic chemotherapy for locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma. However, subject may have received either neo-adjuvant or adjuvant chemotherapy, immunotherapy or other systemic anticancer therapies, as long as it was completed at least 6 months prior to randomization. Subject may have received treatment with herbal medications that have known antitumor activity > 28 days prior to randomization.
  • Subject has received radiotherapy for locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma ≤ 14 days prior to randomization and has not recovered from any related toxicity.
  • Subject has received systemic immunosuppressive therapy, including systemic corticosteroids within 14 days prior to randomization. Subjects using a physiologic replacement dose of hydrocortisone or its equivalent (defined as up to 30 mg per day of hydrocortisone or up to 10 mg per day of prednisone), receiving a single dose of systemic corticosteroids or receiving systemic corticosteroids as premedication for radiologic imaging contrast use are allowed.
  • Subject has received other investigational agents or devices within 28 days prior to randomization.
  • Subject has prior severe allergic reaction or intolerance to known ingredients of zolbetuximab or other monoclonal antibodies, including humanized or chimeric antibodies.
  • Subject has known immediate or delayed hypersensitivity, intolerance or contraindication to any component of study treatment.
  • Subject has prior severe allergic reaction or intolerance to any component of mFOLFOX6.
  • Subject has known dihydropyrimidine dehydrogenase deficiency.
  • Subject has a complete gastric outlet syndrome or a partial gastric outlet syndrome with persistent/recurrent vomiting.
  • Subject has significant gastric bleeding and/or untreated gastric ulcers that would exclude the subject from participation.

  • Subject has a known history of a positive test for human immunodeficiency virus (HIV) infection or known active hepatitis B (positive hepatitis B surface antigen (HBs Ag)) or C infection. NOTE: Screening for these infections should be conducted per local requirements.

    • For subjects who are negative for HBs Ag, but hepatitis B core antibody (HBc Ab) positive, an HB deoxyribonucleic acid (DNA) test will be performed and if positive, the subject will be excluded.
    • Subjects with positive hepatitis C virus (HCV) serology, but negative HCV ribonucleic acid (RNA) test are eligible.
    • Subjects treated for HCV with undetectable viral load results are eligible.
  • Subject has an active autoimmune disease that has required systemic treatment within the past 3 months prior to randomization.
  • Subject has active infection requiring systemic therapy that has not completely resolved within 7 days prior to randomization.

  • Subject has significant cardiovascular disease, including any of the following:

    • Congestive heart failure (defined as New York Heart Association Class III or IV), myocardial infarction, unstable angina, coronary angioplasty, stenting, coronary artery bypass graft, cerebrovascular accident (CVA) or hypertensive crisis within 6 months prior to randomization.
    • History of clinically significant ventricular arrhythmias (i.e., sustained ventricular tachycardia, ventricular fibrillation or Torsades de Pointes)
    • QTc interval > 450 msec for male subjects; QTc interval > 470 msec for female subjects
    • History or family history of congenital long QT syndrome
    • Cardiac arrhythmias requiring anti-arrhythmic medications (Subject with rate controlled atrial fibrillation for > 1 month prior to randomization are eligible).
  • Subject has a history of central nervous system metastases and/or carcinomatous meningitis from gastric/GEJ cancer.
  • Subject has known peripheral sensory neuropathy > Grade 1 unless the absence of deep tendon reflexes is the sole neurological abnormality.

  • Subject has had a major surgical procedure ≤ 28 days prior to randomization.

    • Subject is without complete recovery from a major surgical procedure ≤ 14 days prior to randomization.
  • Subject has psychiatric illness or social situations that would preclude study compliance.
  • Subject has another malignancy for which treatment is required.
  • Subject has any concurrent disease, infection or comorbid condition that interferes with the ability of the subject to participate in the study, which places the subject at undue risk or complicates the interpretation of data.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: mFOLFOX6 + Zolbetuximab
Participants received intravenous (IV) infusion (minimum 2-hour) of zolbetuximab at a loading dose of 800 milligrams per square meter (mg/m^2) on cycle1 day1(C1D1) followed by 600 mg/m^2 every 3 weeks starting from C1D22 until study treatment discontinuation criteria were met. Participants also received upto 12 treatments of mFOLFOX6 (or components if some were discontinued due to toxicity) over 4/more cycles. mFOLFOX6 was administered on Days 1, 15 & 29 of each cycle (5-FU:400mg/m^2 IV bolus over 5-15 minutes followed by 2400mg/m^2 over 46-48 hours continuous IV infusion every 2 weeks for 4 cycles. Folinic acid: 400mg/m^2 IV infusion over 2 hours; oxaliplatin: 85mg/m^2 IV infusion over 2 hours) A maximum of 12 doses of oxaliplatin was permitted. After mFOLFOX6 treatments, participants continued to receive 5-FU & Folinic acid on Days 1, 15 & 29 of each cycle at the investigator discretion or until study treatment discontinuation criteria were met. Each cycle was approximately 42 days.
Drug: zolbetuximab
Participants received an IV infusion (as a minimum of 2-hour infusion) of zolbetuximab at a loading dose of 800 mg/m^2 on C1D1 followed by subsequent doses of 600 mg/m^2 every 3 weeks starting from C1D22 until participant meets study treatment discontinuation criteria. Each cycle was approximately 42 days.
Other Names:
  • IMAB362
Drug: oxaliplatin
Participants received up to 12 treatments of oxaliplatin administered 85 mg/m^2 IV infusion over 2 hours) on Days 1, 15 and 29 of each cycle.. A maximum of 12 doses of oxaliplatin was permitted. Each cycle was approximately 42 days.
Drug: folinic acid
Participants received up to 12 treatments of folinic acid administered 400 mg/m^2 IV infusion over 2 hours 4 or more cycles on Days 1, 15 and 29 of each cycle. participants could continue to receive folinic acid on Days 1, 15 and 29 of each cycle at the investigator's discretion or until the participant met the study treatment discontinuation criteria. Each cycle was approximately 42 days.
Drug: fluorouracil
Participants received up to 12 treatments of 5-fluorouracil over 4 or more cycles administered by IV bolus 400 mg/m^2 over 5 to 15 minutes followed by 2400mg/m^2 over 46-48 hours continuous IV infusion every 2 weeks for 4 cycles. Participants could continue to receive 5-fluorouracil on Days 1, 15 and 29 of each cycle at the investigator's discretion or until the participant met the study treatment discontinuation criteria. Each cycle was approximately 42 days.
Placebo Comparator: Placebo plus mFOLFOX6
Participants received an IV infusion (minimum 2-hour infusion) of placebo matched to zolbetuximab on C1D1, followed by subsequent doses every 3 weeks starting from C1D22 until study treatment discontinuation criteria were met. Participants also received up to 12 treatments of mFOLFOX6 (or components if some were discontinued due to toxicity) over 4 or more cycles. mFOLFOX6 was administered on Days 1, 15, and 29 of each cycle (5-fluorouracil: 400 mg/m^2 IV bolus over 5-15 minutes followed by 2400mg/m^2 over 46-48 hours continuous IV infusion every 2 weeks for 4 cycles. Folinic acid: 400 mg/m^2 IV infusion over 2 hours; oxaliplatin: 85 mg/m^2 IV infusion over 2 hours). A maximum of 12 doses of oxaliplatin was permitted. After mFOLFOX6 treatments, participants could continue to receive 5-FU and folinic acid on Days 1, 15, and 29 of each cycle at the investigator's discretion or until study treatment discontinuation criteria were met. Each cycle was approximately 42 days.
Drug: oxaliplatin
Participants received up to 12 treatments of oxaliplatin administered 85 mg/m^2 IV infusion over 2 hours) on Days 1, 15 and 29 of each cycle.. A maximum of 12 doses of oxaliplatin was permitted. Each cycle was approximately 42 days.
Drug: folinic acid
Participants received up to 12 treatments of folinic acid administered 400 mg/m^2 IV infusion over 2 hours 4 or more cycles on Days 1, 15 and 29 of each cycle. participants could continue to receive folinic acid on Days 1, 15 and 29 of each cycle at the investigator's discretion or until the participant met the study treatment discontinuation criteria. Each cycle was approximately 42 days.
Drug: fluorouracil
Participants received up to 12 treatments of 5-fluorouracil over 4 or more cycles administered by IV bolus 400 mg/m^2 over 5 to 15 minutes followed by 2400mg/m^2 over 46-48 hours continuous IV infusion every 2 weeks for 4 cycles. Participants could continue to receive 5-fluorouracil on Days 1, 15 and 29 of each cycle at the investigator's discretion or until the participant met the study treatment discontinuation criteria. Each cycle was approximately 42 days.
Drug: placebo
Participants received an IV infusion (as a minimum of 2-hour infusion) of placebo matched to zolbetuximab on C1D1 followed by subsequent doses every 3 weeks starting from C1D22 until participant met study treatment discontinuation criteria. Each cycle was approximately 42 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS)
Time Frame: From date of randomization until the date of first documented radiological progression or date of death from any cause, whichever occurred first (up to 62 months and 18 days)
PFS was defined as the time from the date of randomization until the date of radiological progressive disease (PD) (per Response Evaluation Criteria in Solid Tumors [RECIST] 1.1 by independent review committee [IRC]) or death from any cause, whichever was earliest. PD was defined as development of new, or progression of existing metastases to the primary cancer under the study. Kaplan -Meier (KM) estimates was used.
From date of randomization until the date of first documented radiological progression or date of death from any cause, whichever occurred first (up to 62 months and 18 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics (PK) of Zolbetuximab in Serum: Trough Concentration (Ctrough)
Time Frame: Predose on C1D22, C3D1, C5D1, C7D1, C9D1
Ctrough was defined as the predose concentration at the end of dosing interval.
Predose on C1D22, C3D1, C5D1, C7D1, C9D1
Number of Participants With Anti-drug Antibodies (ADA)
Time Frame: Predose on C1D1, C1D22, C3D1, C5D1, C7D1, C9D1, 30-day follow up, 90-day follow up
Immunogenicity will be measured by the number of participants that are ADA positive.
Predose on C1D1, C1D22, C3D1, C5D1, C7D1, C9D1, 30-day follow up, 90-day follow up
Overall Survival (OS)
Time Frame: From the date of randomization until 62 months and 18 days
OS was defined as the time from the date of randomization until the date of death from any cause. Kaplan-Meier estimates was used.
From the date of randomization until 62 months and 18 days
Time to Confirmed Deterioration (TTCD) Using Physical Functioning (PF) as Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30)
Time Frame: From the date of randomization until 62 months and 18 days
TTCD: time from randomization to first clinically meaning full deterioration (CMD) that was confirmed at next scheduled visit. EORTC-QLQ-C30 was a 30-item cancer-specific instrument consisting of 5 functional scales (physical,role,emotional,social & cognitive), 9 symptom scales (fatigue, nausea/vomiting,general pain,dyspnea,insomnia,appetite loss,constipation,diarrhea,financial difficulties) & global health status scale. Most items were scored 1(not at all) to 4(very much) except for items contributing to global health status/QoL, which were scored 1(very poor) to 7(excellent). All raw domain scores were linearly transformed to 0-100scale with higher scores on symptoms indicate worse health state. CMD was defined if a participant's change from baseline exceeded a pre-specified threshold of -13. This was derived from an Exit Survey conducted using Patient Global Impression of Severity/Change(PGIS/PGIC) questionnaires as an anchor for estimating meaningful change. KM estimates was used.
From the date of randomization until 62 months and 18 days
Time to Confirmed Deterioration (TTCD) Using Oesophago-gastric Questionnaire (OG25) on Abdominal Pain and Discomfort as Measured by EORTC QLQ-OG25
Time Frame: From the date of randomization until 62 months and 18 days
TTCD: time from randomization to first CMD that was confirmed at next scheduled visit. EORTC QLQ-OG25 evaluated gastric and GEJ cancer specific symptoms. A 25 item instrument with 6 scales: dysphagia (3 items), eating restrictions (4 ), reflux (2), odynophagia (2), pain and discomfort (2), anxiety (2), as well as 10 single items: eating in front of others, dry mouth, trouble with taste, body image, trouble swallowing saliva, choked when swallowing, trouble with coughing, trouble talking, weight and hair loss. Items were scored:1: not at all; 2: a little, 3: quite a bit, 4: very much, and were transformed linearly into scores (0 to 100) with higher scores indicating worse symptoms. CMD was defined if a participant's change from baseline exceeded a pre-specified threshold of 16.67. This was derived from an Exit Survey conducted to use PGIS/PGIC questionnaires as an anchor for estimating the meaningful change. KM estimates was used.
From the date of randomization until 62 months and 18 days
Time to Confirmed Deterioration (TTCD) Using Global Health Status as Measured by EORTC QLQ-C30
Time Frame: From the date of randomization until 62 months and 18 days
TTCD: time from randomization to first CMD that was confirmed at the next scheduled visit. The EORTC-QLQ-C30 was a 30-item cancer-specific instrument consisting of 5 functional scales (physical, role, emotional, social and cognitive), 9 symptom scales/items (fatigue, nausea/vomiting, general pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) and a global health status scale. Most items were scored 1 ("not at all") to 4 ("very much") except for the items contributing to the global health status/QoL, which were scored 1 ("very poor") to 7 ("excellent"). All raw domain scores were linearly transformed to a 0-100 scale with higher scores on symptoms indicate a worse health state. CMD was defined if a participant's change from baseline exceeded a pre-specified threshold of -10. This was derived from an Exit Survey conducted to use PGIS/PGIC questionnaires as an anchor for estimating the meaningful change. KM estimates was used.
From the date of randomization until 62 months and 18 days
Objective Response Rate (ORR)
Time Frame: From the date of randomization until 62 months and 18 days
ORR was defined as the percentage of participants who had best overall response (BOR) of complete response (CR) or partial response (PR) as was assessed by IRC per RECIST 1.1. CR was defined as complete resolution of all attributable clinical symptoms and physical findings. PR was defined as partial resolution of at Least some of the clinical symptoms and physical findings.
From the date of randomization until 62 months and 18 days
Duration Of Response (DOR)
Time Frame: From date of first response (CR/PR) until 62 months and 18 day
DOR was defined as the time from the date of the first response (CR/PR) until the date of PD as assessed by IRC per RECIST 1.1 or date of death from any cause, whichever is earliest.CR was defined as complete resolution of all attributable clinical symptoms and physical findings. PR was defined as partial resolution of at Least some of the clinical symptoms and physical findings.PD was defined as development of new, or progression of existing metastases to the primary cancer under the sudy.
From date of first response (CR/PR) until 62 months and 18 day
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time Frame: From first dose until 62 months and 18 days
An Adverse event (AE) is any untoward medical occurrence in a participant administered a study drug, and which does not have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of a medicinal product, whether or notconsidered related to the medicinal product. TEAE defined as an AE observed after starting administration of the study drug through 30 days after the last dose.
From first dose until 62 months and 18 days
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Time Frame: Baseline, cycle (C) 1 day (D) 22, D1 and D22 of C2 through C39
ECOG grades 0-5, where 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; 2 = Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair and 5 = Dead.
Baseline, cycle (C) 1 day (D) 22, D1 and D22 of C2 through C39
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Time Frame: Baseline, C1D22, D1 and D22 of C2 through C25, C26D1, C27D1,C28D1 30 day follow up, 90 day follow up
The EORTC-QLQ-C30 is a 30-item cancer-specific instrument consisting of 5 functional scales (physical, role, emotional, social and cognitive), 9 symptom scales/items (fatigue, nausea/vomiting, general pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) and a global health status scale. Most items are scored 1 ("not at all") to 4 ("very much") except for the items contributing to the global health status/QoL, which are scored 1 ("very poor") to 7 ("excellent"). All raw domain scores are linearly transformed to a 0-100 scale with higher scores on symptoms indicate a worse health state.
Baseline, C1D22, D1 and D22 of C2 through C25, C26D1, C27D1,C28D1 30 day follow up, 90 day follow up
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Time Frame: Baseline, C1D22, D1 and D22 of C2 through C25, C26D1, C27D1,C28D1 30 day follow up, 90 day follow up
The EORTC-QLQ-OG25 consists of a 25-item instrument that evaluates gastric and GEJ cancer-specific symptoms such as stomach discomfort, difficulties eating and swallowing and indigestion. This module consists of 6 scales: dysphagia (3 items), eating restrictions (4 items), reflux (2 items), odynophagia (2 items), pain and discomfort (2 items) and anxiety (2 items), as well as 10 single items: eating in front of others, dry mouth, trouble with taste, body image, trouble swallowing saliva, choked when swallowing, trouble with coughing, trouble talking, weight loss and hair loss. All questions have four response alternatives (1:not at all; 2:a little, 3:quite a bit, 4:very much). Questionnaire responses were transformed lineraly into scores ranging from 0 to 100 For symptom scales/items, higher scores indicate worse symptoms.
Baseline, C1D22, D1 and D22 of C2 through C25, C26D1, C27D1,C28D1 30 day follow up, 90 day follow up
Change From Baseline in HRQoL Measured by Global Pain (GP)
Time Frame: Baseline, C1D22, D1 and D22 of C2 through C25, C26D1, C27D1,C28D1 30 day follow up, 90 day follow up
The GP instrument is a single assessment of overall pain. Participants were assessed in global pain according to the following response categories: 1= no pain (anymore), 2 = less pain, 3 = no change and 4 = more pain.
Baseline, C1D22, D1 and D22 of C2 through C25, C26D1, C27D1,C28D1 30 day follow up, 90 day follow up
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Time Frame: Baseline, C1D22, D1 and D22 of C2 through C25, C26D1, C27D1,C28D1 30 day follow up, 90 day follow up
EQ-5D-5L is a standardized instrument for use as a measure of health outcomes consisting of 6 items that cover 5 main domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and a general visual analog scale for health status.It was developed by the EuroQol Group for use as a generic, preference-based measure of health outcomes. Each dimension comprises 5 levels (no problems, slight problems, moderate problems, severe problems, extreme problems). A unique EQ-5D-5L health state is defined by combining 1 level from each of the 5 dimensions. This questionnaire also records the respondent's self-rated health status on a vertical graduated (0 = the worst health a participant can imagine to 100 = the best health a participant can imagine) visual analogue scale. Responses to the 5 items will also be converted to a weighted health state index (utility score) based on values derived from general population samples.
Baseline, C1D22, D1 and D22 of C2 through C25, C26D1, C27D1,C28D1 30 day follow up, 90 day follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Global Development, Inc.

Investigators

  • Study Director: Global Medical Lead, Astellas Pharma Global Development, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 21, 2018

Primary Completion (Actual)

September 9, 2022

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

April 12, 2018

First Submitted That Met QC Criteria

April 12, 2018

First Posted (Actual)

April 20, 2018

Study Record Updates

Last Update Posted (Actual)

May 4, 2026

Last Update Submitted That Met QC Criteria

May 1, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8951-CL-0301
  • 2017-002567-17 (EudraCT Number)
  • CTR20190258 (Registry Identifier: ChinaDrugTrials.org.cn)
  • jRCT2080224032 (Other Identifier: jRCT)
  • 2024-511365-11-00 (Other Identifier: EU(CTIS))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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 products 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/.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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