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

NCT ID: NCT03504397

Last Updated: 2025-11-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 565 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-21
• Study Completion Date: 2026-03-31

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.

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.

Conditions

Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer; Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer; Metastatic Gastric Adenocarcinoma or Cancer; Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

zolbetuximab

Intervention Type: DRUG

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.

oxaliplatin

Intervention Type: DRUG

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.

folinic acid

Intervention Type: DRUG

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.

fluorouracil

Intervention Type: DRUG

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 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.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

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.

oxaliplatin

Intervention Type: DRUG

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.

folinic acid

Intervention Type: DRUG

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.

fluorouracil

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

IMAB362

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Astellas Pharma Global Development, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Global Medical Lead

Role: STUDY_DIRECTOR

Astellas Pharma Global Development, Inc.

Locations

Site CO57001

Cali, , Colombia

Site PE51005

Lima, , Peru

Site PE51006

Lima, , Peru

Site PE51001

Lima, , Peru

University of Arizona

Phoenix, Arizona, United States

The University of Arizona Medical Center

Tucson, Arizona, United States

CBCC Global Research, Inc. at Comprehensive Blood and Cancer

Bakersfield, California, United States

City of Hope Nat'l Medical Center

Duarte, California, United States

St. Jude Hospital Yorba Linda

Fullerton, California, United States

Pacific Shores Medical Group

Huntington Beach, California, United States

Loma Linda University

Loma Linda, California, United States

The Angeles Clinic and Research Institute

Los Angeles, California, United States

University of California Davis

Sacramento, California, United States

University of California - San Francisco

San Francisco, California, United States

University of Colorado

Aurora, Colorado, United States

Memorial Sloan Kettering Cancer Center

Middletown, Connecticut, United States

Memorial Cancer Institute - West

Hollywood, Florida, United States

University of Miami

Miami, Florida, United States

Orlando Health Inc

Orlando, Florida, United States

Memorial Hospital West

Pembroke Pines, Florida, United States

Cancer Treatment Centers of America, Atlanta

Newnan, Georgia, United States

Northwestern University Medical Center

Chicago, Illinois, United States

University of Chicago

Chicago, Illinois, United States

Norton Cancer Institute

Louisville, Kentucky, United States

University of Maryland Medical Center(UMMC)Transplant Center

Baltimore, Maryland, United States

Maryland Oncology Hematology

Brandywine, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Health Partners Institute

Saint Louis Park, Minnesota, United States

Regions Hospital

Saint Paul, Minnesota, United States

Memorial Sloan Kettering Cancer Center

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Cancer Center

Montvale, New Jersey, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

Memorial Sloan Kettering Cancer Center

Commack, New York, United States

Memorial Sloan Kettering Cancer Center

Harrison, New York, United States

Mount Sinai School of Medicine

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Stony Brook University Medical Center

Stony Brook, New York, United States

Memorial Sloan Kettering Cancer Center

Uniondale, New York, United States

The Ohio State University Medical Center

Columbus, Ohio, United States

Precision Cancer Research -Dayton Physicians Network

Middletown, Ohio, United States

University of Oklahoma Health Science Center

Oklahoma City, Oklahoma, United States

Earle A. Chiles Research Institute

Portland, Oregon, United States

Oregon Health & Science University

Portland, Oregon, United States

Lancaster General Hospital

Lancaster, Pennsylvania, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Cancer Treatment Centers of America, Philadelphia

Philadelphia, Pennsylvania, United States

Rhode Island Hospital-Lifespan Cancer Institute

Providence, Rhode Island, United States

Sanford Cancer Center

Sioux Falls, South Dakota, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Inova Dwight and Martha Schar Cancer Institute

Fairfax, Virginia, United States

MultiCare Regional Cancer Center - Gig Harbor

Auburn, Washington, United States

Seattle Cancer Care Alliance

Seattle, Washington, United States

Site AU61002

Douglas, Queensland, Australia

Site AU61011

Tugun, Queensland, Australia

Site AU61008

Adelaide, South Australia, Australia

Site AU61006

East Bentleigh, Victoria, Australia

Site AU61007

Kogarah, , Australia

Site BE32007

Edegem, Antwerpen, Belgium

Site BE32001

Brussels, Bruxelles-Capitale, Région de, Belgium

Site BE32008

Mons, Hainaut, Belgium

Site BE32002

Brussels, Liege, Belgium

Site BE32012

Ghent, Oost-Vlaanderen, Belgium

Site BE32006

Leuven, Vlaams Brabant, Belgium

Site BE32005

Bruges, , Belgium

Site BE32004

Brussels, , Belgium

Site BE32011

Charleroi, , Belgium

Site BE32010

Haine-Saint-Paul, , Belgium

Site BR55010

Brasília, Federal District, Brazil

Site BR55006

Lajeado, Rio Grande do Sul, Brazil

Site BR55002

Itajaí, Santa Catarina, Brazil

Site BR55007

Barretos, São Paulo, Brazil

Site BR55003

Santo André, São Paulo, Brazil

Site BR55005

São José do Rio Preto, São Paulo, Brazil

Site BR55017

Belo Horizonte, , Brazil

Site BR55016

Passo Fundo, , Brazil

Site BR55015

Rio de Janeiro, , Brazil

Site BR55018

Santa Catarina, , Brazil

Site BR55009

São Paulo, , Brazil

Site BR55004

São Paulo, , Brazil

Site CA15005

Edmonton, Alberta, Canada

Site CA15009

Saint John, New Brunswick, Canada

Site CA15011

Toronto, Ontario, Canada

Site CA15002

Montreal, Quebec, Canada

Site CA15008

Montreal, Quebec, Canada

Site CL56003

Providencia, Santiago Metropolitan, Chile

Site CL56008

Providencia, , Chile

Site CL56005

Santiago, , Chile

Site CL56007

Valdivia, , Chile

Site CN86003

Haerbin, Heilongjiang, China

Site CN86006

Nanjing, Jiangsu, China

Site CN86004

Hangzhou, Zhejiang, China

Site CN86009

Beijing, , China

Site CN86002

Beijing, , China

Site CN86005

Hefei, , China

Site CN86001

Xiamen, , China

Site CN86008

Zhengzhou, , China

Site CO57006

Medellín, Antioquia, Colombia

Site CO57009

Bogotá, DC, Colombia

Site CO57007

Montería, Departamento de Córdoba, Colombia

Site CO57005

Cali, Valle del Cauca Department, Colombia

Site CO57002

Medellín, , Colombia

Site FR33009

Dijon, Bourgogne-Franche-Comté, France

Site FR33010

Brest, Brittany Region, France

Site FR33001

Rennes, Brittany Region, France

Site FR33008

Besançon, Franche-Comte, France

Site FR33011

Montpellier, Languedoc-Roussillon, France

Site FR33002

Paris, Paris, France

Site FR33101

Saint-Herblain, Pays de la Loire Region, France

Site FR33005

Nice, Provence-Alpes-Côte d'Azur Region, France

Site FR33003

Lyon, Rhone, France

Site FR33006

Poitiers, Vienne, France

Site FR33103

Créteil, , France

Site FR33007

Nice, , France

Site FR33104

Saint-Priest-en-Jarez, , France

Site DE49008

Munich, Bavaria, Germany

Site DE49007

München, Bavaria, Germany

Site DE49002

Mainz, Rhineland-Palatinate, Germany

Site DE49010

Dresden, Saxony, Germany

Site DE49004

Leipzig, Saxony, Germany

Site DE49021

Halle, Saxony-Anhalt, Germany

Site DE49015

Magdeburg, Saxony-Anhalt, Germany

Site DE49012

Berlin, , Germany

Site DE49011

Berlin, , Germany

Site DE49018

Dresden, , Germany

Site DE49019

Heilbronn, , Germany

Site IL97206

Kfar Saba, Central District, Israel

Site IL97210

HaDarom, , Israel

Site IL97201

Haifa, , Israel

Site IL97209

Holon, , Israel

Site IL97202

Jerusalem, , Israel

Site IL97203

Tel Aviv, , Israel

Site IT39011

Meldola, Forli, Italy

Site IT39020

Monza, Lombardy, Italy

Site IT39023

Vicenza, VI, Italy

Site IT39013

Ancona, , Italy

Site IT39004

Bergamo, , Italy

Site IT39009

Cremona, , Italy

Site IT39006

Milan, , Italy

Site IT39008

Milan, , Italy

Site IT39021

Modena, , Italy

Site IT39016

Padua, , Italy

Site IT39012

Parma, , Italy

Site IT39018

Perugia, , Italy

Site IT39003

Piacenza, , Italy

Site IT39019

Pisa, , Italy

Site IT39022

Reggio Emilia, , Italy

Site IT39015

Roma, , Italy

Site IT39026

Terni, , Italy

Site IT39024

Turin to, , 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, Mexico

Site MX52007

Mexico City, Mexico City, Mexico

Site MX52010

Veracruz, Ver, Veracruz, Mexico

Site MX52001

Aguascalientes, , Mexico

Site MX52003

Distrito Federal, , Mexico

Site MX52009

Jalisco, , Mexico

Site MX52004

Oaxaca City, , Mexico

Site MX52008

San Luis de Potosi, , Mexico

Site PE51004

San Isidro, Lima region, Peru

Site PE51003

Arequipa, , Peru

Site PL48004

Lublin, Lubusz Voivodeship, Poland

Site PL48007

Ostrołęka, Masovian Voivodeship, Poland

Site PL48005

Wieliszew, Masovian Voivodeship, Poland

Site PL48002

Brzozów, Podkarpackie Voivodeship, Poland

Site PL48009

Warsaw, , Poland

Site KR82002

Seongnam-si, Gyeonggi-do, South Korea

Site KR82009

Suwon, Gyeonggido [Kyonggi-do], South Korea

Site KR82004

Seoul, Seoul Teugbyeolsi, South Korea

Site KR82008

Incheon, , South Korea

Site KR82003

Seoul, , South Korea

Site KR82005

Seoul, , South Korea

Site KR82007

Seoul, , South Korea

Site KR82006

Seoul, , South Korea

Site ES34013

Badalona, Barcelona, Spain

Site ES34010

Ávila, Castille and León, Spain

Site ES34011

Alcorcón, Madrid, Spain

Site ES34005

Barcelona, , Spain

Site ES34016

Barcelona, , Spain

Site ES34015

Barcelona, , Spain

Site ES34019

Burgos, , Spain

Site ES34008

Madrid, , Spain

Site ES34017

Madrid, , Spain

Site ES34004

Madrid, , Spain

Site ES34003

Murcia, , Spain

Site ES34018

Seville, , Spain

Site ES34006

Zaragoza, , Spain

Site TW88605

Kwei-Shan, Taoyuan, Taiwan

Site TW88608

Kaohsiung City, , Taiwan

Site TW88604

Kaohsiung City, , Taiwan

Site TW88603

Taichung, , Taiwan

Site TW88607

Tainan City, , Taiwan

Site TW88606

Taipei, , Taiwan

Site TW88601

Taipei, , Taiwan

Site GB44003

Aberdeen, Aberdeenshire, United Kingdom

Site GB44101

London, London, City of, United Kingdom

Site GB44102

Sutton, Surrey, United Kingdom

Site GB44103

Cambridge, , United Kingdom

Site GB44009

Coventry, , United Kingdom

Site GB44104

Dundee, , United Kingdom

Site GB44008

Leeds, , United Kingdom

Site GB44002

London, , United Kingdom

Site GB44004

London, , United Kingdom

Site GB44001

Manchester, , United Kingdom

Countries

United States; Australia; Belgium; Brazil; Canada; Chile; China; Colombia; France; Germany; Israel; Italy; Japan; Mexico; Peru; Poland; South Korea; Spain; Taiwan; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 38861294 (View on PubMed)

Shitara 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.

Reference Type: DERIVED

PMID: 37068504 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2017-002567-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CTR20190258

Identifier Type: REGISTRY

Identifier Source: secondary_id

jRCT2080224032

Identifier Type: OTHER

Identifier Source: secondary_id

2024-511365-11-00

Identifier Type: OTHER

Identifier Source: secondary_id

8951-CL-0301

Identifier Type: -

Identifier Source: org_study_id