A Study to Compare Zolbetuximab (IMAB362) and Chemotherapy With Placebo and Chemotherapy in Adults With Gastric Cancer.
Spotlight
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
5 other identifiers
interventional
565
20 countries
220
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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2018
Longer than P75 for phase_3
220 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
April 12, 2018
CompletedFirst Posted
Study publicly available on registry
April 20, 2018
CompletedStudy Start
First participant enrolled
June 21, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 9, 2022
CompletedResults Posted
Study results publicly available
February 26, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2026
ExpectedMay 4, 2026
April 1, 2026
4.2 years
April 12, 2018
October 31, 2024
May 1, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival (PFS)
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 Outcomes (14)
Overall Survival (OS)
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)
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
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
From the date of randomization until 62 months and 18 days
Objective Response Rate (ORR)
From the date of randomization until 62 months and 18 days
- +9 more secondary outcomes
Study Arms (2)
mFOLFOX6 + Zolbetuximab
EXPERIMENTALParticipants 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.
Placebo plus mFOLFOX6
PLACEBO COMPARATORParticipants 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.
Interventions
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.
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
- +9 more criteria
You may not qualify if:
- 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.
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (220)
University of Arizona
Phoenix, Arizona, 85004, United States
The University of Arizona Medical Center
Tucson, Arizona, 85724, United States
CBCC Global Research, Inc. at Comprehensive Blood and Cancer
Bakersfield, California, 93309, United States
City of Hope Nat'l Medical Center
Duarte, California, 91010, United States
St. Jude Hospital Yorba Linda
Fullerton, California, 92835, United States
Pacific Shores Medical Group
Huntington Beach, California, 92648, United States
Loma Linda University
Loma Linda, California, 92354, United States
The Angeles Clinic and Research Institute
Los Angeles, California, 90025, United States
University of California Davis
Sacramento, California, 95817, United States
University of California - San Francisco
San Francisco, California, 94143, United States
University of Colorado
Aurora, Colorado, 80045, United States
Memorial Sloan Kettering Cancer Center
Middletown, Connecticut, 07748-3052, United States
Memorial Cancer Institute - West
Hollywood, Florida, 33021, United States
University of Miami
Miami, Florida, 33136, United States
Orlando Health Inc
Orlando, Florida, 32806, United States
Memorial Hospital West
Pembroke Pines, Florida, 33028, United States
Cancer Treatment Centers of America, Atlanta
Newnan, Georgia, 30265, United States
Northwestern University Medical Center
Chicago, Illinois, 60611, United States
University of Chicago
Chicago, Illinois, 60637, United States
Norton Cancer Institute
Louisville, Kentucky, 40217, United States
University of Maryland Medical Center(UMMC)Transplant Center
Baltimore, Maryland, 21201, United States
Maryland Oncology Hematology
Brandywine, Maryland, 20613, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114-2696, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Health Partners Institute
Saint Louis Park, Minnesota, 55426, United States
Regions Hospital
Saint Paul, Minnesota, 55101, United States
Memorial Sloan Kettering Cancer Center
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Cancer Center
Montvale, New Jersey, 07645, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Memorial Sloan Kettering Cancer Center
Commack, New York, 11725, United States
Memorial Sloan Kettering Cancer Center
Harrison, New York, 10604, United States
Mount Sinai School of Medicine
New York, New York, 10029-6574, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Stony Brook University Medical Center
Stony Brook, New York, 11794-9452, United States
Memorial Sloan Kettering Cancer Center
Uniondale, New York, 11553, United States
The Ohio State University Medical Center
Columbus, Ohio, 43210, United States
Precision Cancer Research -Dayton Physicians Network
Middletown, Ohio, 45042, United States
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, 73104, United States
Earle A. Chiles Research Institute
Portland, Oregon, 97213, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
Lancaster General Hospital
Lancaster, Pennsylvania, 17604, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Cancer Treatment Centers of America, Philadelphia
Philadelphia, Pennsylvania, 19124, United States
Rhode Island Hospital-Lifespan Cancer Institute
Providence, Rhode Island, 02903, United States
Sanford Cancer Center
Sioux Falls, South Dakota, 57104, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Inova Dwight and Martha Schar Cancer Institute
Fairfax, Virginia, 22031, United States
MultiCare Regional Cancer Center - Gig Harbor
Auburn, Washington, 98801, United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109, United States
Site AU61002
Douglas, Queensland, 4814, Australia
Site AU61011
Tugun, Queensland, 4224, Australia
Site AU61008
Adelaide, South Australia, 5011, Australia
Site AU61006
East Bentleigh, Victoria, 3165, Australia
Site AU61007
Kogarah, 2217, Australia
Site BE32007
Edegem, Antwerpen, 2650, Belgium
Site BE32001
Brussels, Bruxelles-Capitale, Région de, 1200, Belgium
Site BE32008
Mons, Hainaut, 7000, Belgium
Site BE32002
Brussels, Liege, 1050, Belgium
Site BE32012
Ghent, Oost-Vlaanderen, 9000, Belgium
Site BE32006
Leuven, Vlaams Brabant, 3000, Belgium
Site BE32005
Bruges, 8310, Belgium
Site BE32004
Brussels, 1000, Belgium
Site BE32011
Charleroi, 6000, Belgium
Site BE32010
Haine-Saint-Paul, 7100, Belgium
Site BR55010
Brasília, Federal District, 70200-730, Brazil
Site BR55006
Lajeado, Rio Grande do Sul, 95900000, Brazil
Site BR55002
Itajaí, Santa Catarina, 88301-220, Brazil
Site BR55007
Barretos, São Paulo, 14784-400, Brazil
Site BR55003
Santo André, São Paulo, 09060-650, Brazil
Site BR55005
São José do Rio Preto, São Paulo, 15090-000, Brazil
Site BR55017
Belo Horizonte, 30130-090, Brazil
Site BR55016
Passo Fundo, 99010-260, Brazil
Site BR55015
Rio de Janeiro, 22793-080, Brazil
Site BR55018
Santa Catarina, 88501-003, Brazil
Site BR55009
São Paulo, 01509-900, Brazil
Site BR55004
São Paulo, 08270-070, Brazil
Site CA15005
Edmonton, Alberta, T6G 1Z2, Canada
Site CA15009
Saint John, New Brunswick, E2L 4L4, Canada
Site CA15011
Toronto, Ontario, M5G 1X5, Canada
Site CA15002
Montreal, Quebec, H3T 1M5, Canada
Site CA15008
Montreal, Quebec, H4A 3J1, Canada
Site CL56003
Providencia, Santiago Metropolitan, 7500921, Chile
Site CL56008
Providencia, 7520378, Chile
Site CL56005
Santiago, 8330032, Chile
Site CL56007
Valdivia, 5090000, Chile
Site CN86003
Haerbin, Heilongjiang, 150081, China
Site CN86006
Nanjing, Jiangsu, 210008, China
Site CN86004
Hangzhou, Zhejiang, 310003, China
Site CN86009
Beijing, 100030, China
Site CN86002
Beijing, 100071, China
Site CN86005
Hefei, 230022, China
Site CN86001
Xiamen, China
Site CN86008
Zhengzhou, 450000, China
Site CO57006
Medellín, Antioquia, 574, Colombia
Site CO57009
Bogotá, DC, 110231, Colombia
Site CO57007
Montería, Departamento de Córdoba, 230002, Colombia
Site CO57005
Cali, Valle del Cauca Department, Colombia
Site CO57001
Cali, Colombia
Site CO57002
Medellín, 0574, Colombia
Site FR33009
Dijon, Bourgogne-Franche-Comté, 21079, France
Site FR33010
Brest, Brittany Region, 29609, France
Site FR33001
Rennes, Brittany Region, 35042, France
Site FR33008
Besançon, Franche-Comte, 25033, France
Site FR33011
Montpellier, Languedoc-Roussillon, 34298, France
Site FR33002
Paris, Paris, 75970, France
Site FR33101
Saint-Herblain, Pays de la Loire Region, 44805, France
Site FR33005
Nice, Provence-Alpes-Côte d'Azur Region, 06200, France
Site FR33003
Lyon, Rhone, 69008, France
Site FR33006
Poitiers, Vienne, 86021, France
Site FR33103
Créteil, 94000, France
Site FR33007
Nice, 06189, France
Site FR33104
Saint-Priest-en-Jarez, 42270, France
Site DE49008
Munich, Bavaria, 81377, Germany
Site DE49007
München, Bavaria, 81925, Germany
Site DE49002
Mainz, Rhineland-Palatinate, 55101, Germany
Site DE49010
Dresden, Saxony, 01307, Germany
Site DE49004
Leipzig, Saxony, 04103, Germany
Site DE49021
Halle, Saxony-Anhalt, 06108, Germany
Site DE49015
Magdeburg, Saxony-Anhalt, 39104, Germany
Site DE49012
Berlin, 13125, Germany
Site DE49011
Berlin, 13353, Germany
Site DE49018
Dresden, 1067, Germany
Site DE49019
Heilbronn, 74078, Germany
Site IL97206
Kfar Saba, Central District, 44281, Israel
Site IL97210
HaDarom, 7030000, Israel
Site IL97201
Haifa, 3109601, Israel
Site IL97209
Holon, 58100, Israel
Site IL97202
Jerusalem, 91031, Israel
Site IL97203
Tel Aviv, 64239, Israel
Site IT39011
Meldola, Forli, 47014, Italy
Site IT39020
Monza, Lombardy, 20052, Italy
Site IT39023
Vicenza, VI, 36100, Italy
Site IT39013
Ancona, 60126, Italy
Site IT39004
Bergamo, 24127, Italy
Site IT39009
Cremona, 26100, Italy
Site IT39006
Milan, 20132, Italy
Site IT39008
Milan, 20141, Italy
Site IT39021
Modena, 41124, Italy
Site IT39016
Padova, 35128, Italy
Site IT39012
Parma, 43126, Italy
Site IT39018
Perugia, 05100, Italy
Site IT39003
Piacenza, 29100, Italy
Site IT39019
Pisa, 56126, Italy
Site IT39022
Reggio Emilia, 42123, Italy
Site IT39015
Roma, 00128, Italy
Site IT39026
Terni, 5100, Italy
Site IT39024
Turin to, 5-10126, Italy
Site JP81009
Nagoya, Aichi-ken, Japan
Site JP81003
Kashiwa, Chiba, Japan
Site JP81002
Matsuyama, Ehime, Japan
Site JP81007
Sapporo, Hokkaido, Japan
Site JP81014
Kobe, Hyōgo, Japan
Site JP81001
Suita, Osaka, Japan
Site JP81015
Hidaka, Saitama, Japan
Site JP81010
Kitaadachi-gun, Saitama, Japan
Site JP81012
Sunto-gun, Shizuoka, Japan
Site JP81013
Bunkyo-ku, Tokyo, Japan
Site JP81006
Chuo-ku, Tokyo, Japan
Site JP81008
Koto-ku, Tokyo, Japan
Site JP81005
Fukuoka, Japan
Site JP81004
Osaka, Japan
Site JP81011
Osaka, Japan
Site MX52002
Mexico City, Mexico City, 06760, Mexico
Site MX52007
Mexico City, Mexico City, 3100, Mexico
Site MX52010
Veracruz, Ver, Veracruz, 91900, Mexico
Site MX52001
Aguascalientes, 20230, Mexico
Site MX52003
Distrito Federal, 06720, Mexico
Site MX52009
Jalisco, 45030, Mexico
Site MX52004
Oaxaca City, Mexico
Site MX52008
San Luis de Potosi, 78250, Mexico
Site PE51004
San Isidro, Lima region, L27, Peru
Site PE51003
Arequipa, 4001, Peru
Site PE51005
Lima, 15036, Peru
Site PE51006
Lima, 15072, Peru
Site PE51001
Lima, L27, Peru
Site PL48004
Lublin, Lubusz Voivodeship, 20-090, Poland
Site PL48007
Ostrołęka, Masovian Voivodeship, 07-410, Poland
Site PL48005
Wieliszew, Masovian Voivodeship, 05-135, Poland
Site PL48002
Brzozów, Podkarpackie Voivodeship, 36-20, Poland
Site PL48009
Warsaw, 02-781, Poland
Site KR82002
Seongnam-si, Gyeonggi-do, 13620, South Korea
Site KR82009
Suwon, Gyeonggido [Kyonggi-do], 16247, South Korea
Site KR82004
Seoul, Seoul Teugbyeolsi, 06351, South Korea
Site KR82008
Incheon, 21556, South Korea
Site KR82003
Seoul, 03080, South Korea
Site KR82005
Seoul, 05505, South Korea
Site KR82007
Seoul, 152-703, South Korea
Site KR82006
Seoul, 6591, South Korea
Site ES34013
Badalona, Barcelona, 08028, Spain
Site ES34010
Ávila, Castille and León, 05004, Spain
Site ES34011
Alcorcón, Madrid, 28925, Spain
Site ES34005
Barcelona, 08003, Spain
Site ES34016
Barcelona, 08025, Spain
Site ES34015
Barcelona, 08035, Spain
Site ES34019
Burgos, 09006, Spain
Site ES34008
Madrid, 28007, Spain
Site ES34017
Madrid, 28033, Spain
Site ES34004
Madrid, 28034, Spain
Site ES34003
Murcia, 30120, Spain
Site ES34018
Seville, 41009, Spain
Site ES34006
Zaragoza, 50009, Spain
Site TW88605
Kwei-Shan, Taoyuan, 333, Taiwan
Site TW88608
Kaohsiung City, 80756, Taiwan
Site TW88604
Kaohsiung City, 833, Taiwan
Site TW88603
Taichung, 404, Taiwan
Site TW88607
Tainan, 704, Taiwan
Site TW88606
Taipei, 10002, Taiwan
Site TW88601
Taipei, 112, Taiwan
Site GB44003
Aberdeen, Aberdeenshire, AB25 2ZN, United Kingdom
Site GB44101
London, London, City of, SW3 6JJ, United Kingdom
Site GB44102
Sutton, Surrey, SM2 5PT, United Kingdom
Site GB44103
Cambridge, CB2 0QQ, United Kingdom
Site GB44009
Coventry, CV2 2DX, United Kingdom
Site GB44104
Dundee, DD2 4BF, United Kingdom
Site GB44008
Leeds, LS7 9TF, United Kingdom
Site GB44002
London, NW1 2PG, United Kingdom
Site GB44004
London, W1G 6AD, United Kingdom
Site GB44001
Manchester, M20 4BX, United Kingdom
Related Publications (2)
Shitara K, Shah MA, Lordick F, Bang YJ, Ilson D, Van Cutsem E, Enzinger P, Kim SS, Klempner SJ, Moran D, Park JW, Bhattacharya P, Ajani JA, Xu RH. Zolbetuximab plus chemotherapy for locally advanced unresectable or metastatic stomach or gastroesophageal junction cancers: a plain language summary. Future Oncol. 2024;20(26):1861-1877. doi: 10.1080/14796694.2024.2342107. Epub 2024 May 24.
PMID: 38861294DERIVEDShitara K, Lordick F, Bang YJ, Enzinger P, Ilson D, Shah MA, Van Cutsem E, Xu RH, Aprile G, Xu J, Chao J, Pazo-Cid R, Kang YK, Yang J, Moran D, Bhattacharya P, Arozullah A, Park JW, Oh M, Ajani JA. Zolbetuximab plus mFOLFOX6 in patients with CLDN18.2-positive, HER2-negative, untreated, locally advanced unresectable or metastatic gastric or gastro-oesophageal junction adenocarcinoma (SPOTLIGHT): a multicentre, randomised, double-blind, phase 3 trial. Lancet. 2023 May 20;401(10389):1655-1668. doi: 10.1016/S0140-6736(23)00620-7. Epub 2023 Apr 15.
PMID: 37068504DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Transparency
- Organization
- Astellas Pharma Global Development, Inc
Study Officials
- STUDY DIRECTOR
Global Medical Lead
Astellas Pharma Global Development, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
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
April 12, 2018
First Posted
April 20, 2018
Study Start
June 21, 2018
Primary Completion
September 9, 2022
Study Completion (Estimated)
September 30, 2026
Last Updated
May 4, 2026
Results First Posted
February 26, 2025
Record last verified: 2026-04
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 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/.