Triple therapy aims to boost survival in Hard-to-Treat stomach cancers

NCT ID NCT06901531

Recruiting now Disease control Sponsor: Astellas Pharma Global Development, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial tests whether adding the targeted drug zolbetuximab to standard immunotherapy (pembrolizumab) and chemotherapy can help people with advanced stomach or gastroesophageal junction (GEJ) cancer live longer. The study enrolls 500 adults whose tumors have specific markers (CLDN18.2 and PD-L1) but lack HER2. Participants receive either the combination or a placebo with the same chemo and immunotherapy, and are followed to see how long they survive and how the cancer responds.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance

zolbetuximab (a targeted antibody) combined with pembrolizumab (immunotherapy) and chemotherapy (capecitabine, oxaliplatin, or 5-fluorouracil)

What this could lead to

If successful, this combination could offer a new first-line treatment option for people with advanced stomach or GEJ cancer, potentially extending survival.

What could go wrong

This is an early-phase 3 trial, so results are not yet known. The added drugs may increase side effects, and not all participants may benefit. The cancer may still progress.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Conditions

The condition(s) this trial relates to.

adenocarcinoma gastric adenocarcinoma gastroesophageal junction adenocarcinoma neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

LOCALLY ADVANCED UNRESECTABLE GASTRIC ADENOCARCINOMA OR CANCER LOCALLY ADVANCED UNRESECTABLE GASTROESOPHAGEAL JUNCTION (GEJ) ADENOCARCINOMA OR CANCER METASTATIC GASTRIC ADENOCARCINOMA OR CANCER METASTATIC GASTROESOPHAGEAL JUNCTION (GEJ) ADENOCARCINOMA

Contacts and locations

Show contact details

Study contacts

Contact

Phone: •••-•••-•••• Email: •••••@•••••

Locations

Affiliated Hospital of Hebei University
ACTIVE_NOT_RECRUITING

Baoding, 71000, China
Allegheny General Hospital (AGH)-Allegheny Singer Research Institute
RECRUITING

Pittsburgh, Pennsylvania, 15212, United States
Anhui Provincial Cancer Hospital
ACTIVE_NOT_RECRUITING

Hefei, Anhui, 230031, China
Barbara Ann Karmanos Cancer Center
RECRUITING

Detroit, Michigan, 48201, United States
CBCC Global Research - Comprehensive Blood & Cancer Center
RECRUITING

Bakersfield, California, 93309, United States
Capital Health - Hematology Oncology Specialists
RECRUITING

Pennington, New Jersey, 08534, United States
Chiba Cancer Center
ACTIVE_NOT_RECRUITING

Chiba, Chiba, Japan
Dana Farber/Harvard Cancer Center
RECRUITING

Boston, Massachusetts, 02215, United States
Duke University Medical Center - Duke Cancer Centre
RECRUITING

Durham, North Carolina, 27710, United States
Franciscan Health Oncology and Hematology Specialists
RECRUITING

Indianapolis, Indiana, 46237, United States
Fujian Provincial Hospital - Department of Medical Oncology
ACTIVE_NOT_RECRUITING

Fuzhou, Fujian, China
Gunma University Hospital
ACTIVE_NOT_RECRUITING

Maebashi, Gunma, Japan
Harbin Medical University Cancer Hospital - Oncology
ACTIVE_NOT_RECRUITING

Harbin, Heilongjiang, China
Hartford HealthCare - Hartford Hospital
RECRUITING

Hartford, Connecticut, 06102, United States
Henan Cancer Hospital - Oncology
ACTIVE_NOT_RECRUITING

Zhenngzhou, Henan, China
Henry Ford Cancer Institute-Henry Ford Hospital
RECRUITING

Detroit, Michigan, 48201, United States
Hokkaido University Hospital
ACTIVE_NOT_RECRUITING

Sapporo, Hokkaido, Japan
Holden Comprehensive Cancer Center
RECRUITING

Iowa City, Iowa, 52242, United States
Houston Methodist Cancer Center
RECRUITING

Houston, Texas, 77030, United States
Hubei Cancer Hospital - Oncology
ACTIVE_NOT_RECRUITING

Wuhan, Hubei, 430079, China
Hyogo Cancer Center
ACTIVE_NOT_RECRUITING

Akashi-shi, Hyōgo, Japan
Kagawa University Hospital
ACTIVE_NOT_RECRUITING

Kida-gun, Kagawa-ken, Japan
Kanagawa Cancer Ctr Hospital
ACTIVE_NOT_RECRUITING

Yokohama, Kanagawa, Japan
Kobe City Medical Center General Hospital
ACTIVE_NOT_RECRUITING

Kobe, Hyōgo, Japan
Kyushu University Hospital (Hematology, Oncology & Cardiovascular medicine)
ACTIVE_NOT_RECRUITING

Fukuoka, Fukuoka, Japan
Kyushu University Hospital(Gastrointestinal Surgery)
ACTIVE_NOT_RECRUITING

Fukuoka, Fukuoka, Japan
MedStar Georgetown University Hospital / Lombardi Comprehensive Cancer Center
RECRUITING

Washington D.C., District of Columbia, 20007, United States
Metro Minnesota Community Oncology Research Consortium (MMCORC)
RECRUITING

Saint Louis Park, Minnesota, 55426, United States
Montefiore Medical Center
RECRUITING

The Bronx, New York, 10461, United States
NYU Langone Medical Center
RECRUITING

New York, New York, 10016, United States
National Cancer Center Hospital
ACTIVE_NOT_RECRUITING

Chuo-ku, Tokyo, Japan
National Cancer Center Hospital East
ACTIVE_NOT_RECRUITING

Kashiwa, Chiba, Japan
National Hospital Organization Kyushu Cancer Center
ACTIVE_NOT_RECRUITING

Fukuoka, Fukuoka, Japan
National Hospital Organization Shikoku Cancer Center
ACTIVE_NOT_RECRUITING

Matsuyama, Ehime, Japan
Northwestern Memorial Hospital
RECRUITING

Chicago, Illinois, 60611, United States
Oncology Hematology West PC dba Nebraska Cancer Specialists
RECRUITING

Omaha, Nebraska, 68130, United States
Osaka General Medical Center
ACTIVE_NOT_RECRUITING

Osaka, Osaka, Japan
Osaka International Cancer Institute
ACTIVE_NOT_RECRUITING

Osaka, Osaka, Japan
Osaka University Hospital
ACTIVE_NOT_RECRUITING

Suita-shi, Osaka, Japan
Peking Union Medical College Hospital - Dongdan Campus
ACTIVE_NOT_RECRUITING

Beijing, China
Piedmont Physician Medical Oncology Atlanta
RECRUITING

Atlanta, Georgia, 30318, United States
Qinghai University Affiliated Hospital
ACTIVE_NOT_RECRUITING

Xining, Qinghai, China
Renji Hospital Shanghai Jiaotong Univ School of Medicine
ACTIVE_NOT_RECRUITING

Shanghai, Shanghai Municipality, 200127, China
Rhode Island Hospital
RECRUITING

Providence, Rhode Island, 02903, United States
Ruijin Hospital of Shanghai Jiaotong University School of Medicine
ACTIVE_NOT_RECRUITING

Shanghai, Shanghai Municipality, China
Saint Elizabeth Medical Center Edgewood
RECRUITING

Edgewood, Kentucky, 41017, United States
Saitama Cancer Center
ACTIVE_NOT_RECRUITING

Kitaadachi-gun Ina-machi, Saitama, Japan
Saitama Medical University International Medical Center
ACTIVE_NOT_RECRUITING

Hidaka-shi, Saitama, Japan
Shizuoka Cancer Center
ACTIVE_NOT_RECRUITING

Sunto-gun, Shizuoka, Japan
Sichuan Cancer Hospital
ACTIVE_NOT_RECRUITING

Chengdu, Sichuan, 610200, China
Site AU61001
RECRUITING

Fitzroy, Australia
Site AU61002
RECRUITING

Kogarah, New South Wales, Australia
Site AU61003
RECRUITING

Clayton, Victoria, Australia
Site AU61004
RECRUITING

Brisbane, Queensland, Australia
Site BE32001
RECRUITING

Brussels, Belgium
Site BE32002
RECRUITING

Bonheiden, Belgium
Site BE32003
RECRUITING

Ghent, Belgium
Site BE32004
RECRUITING

Liège, Belgium
Site BE32005
RECRUITING

Leuven, Belgium
Site BE32006
RECRUITING

Edegem, Belgium
Site BR55001
RECRUITING

São José do Rio Preto, Brazil
Site BR55002
RECRUITING

Blumenau, Brazil
Site BR55003
RECRUITING

Porto Alegre, Brazil
Site BR55004
RECRUITING

Lages, Brazil
Site BR55006
RECRUITING

São Caetano do Sul, Brazil
Site BR55007
RECRUITING

São Paulo, Brazil
Site BR55008
RECRUITING

Jaú, Brazil
Site BR55012
RECRUITING

Fortaleza, Brazil
Site BR55014
RECRUITING

Belo Horizonte, Brazil
Site CZ42002
RECRUITING

Prague, Czechia
Site CZ42003
RECRUITING

Prague, Czechia
Site CZ42004
RECRUITING

Prague, Czechia
Site CZ42005
RECRUITING

Olomouc, Czechia
Site CZ42006
RECRUITING

Brno, Czechia
Site DE49001
RECRUITING

Mainz, Germany
Site DE49002
RECRUITING

Saarbrücken, Germany
Site DE49004
RECRUITING

Leipzig, Germany
Site DE49006
RECRUITING

Nuremberg, Germany
Site DE49007
RECRUITING

Hanover, Germany
Site DE49010
RECRUITING

Essen, Germany
Site DE49011
RECRUITING

Schweinfurt, Germany
Site DE49013
RECRUITING

Berlin, Germany
Site DE49014
RECRUITING

Munich, Germany
Site DE49016
RECRUITING

Wolfsburg, Germany
Site DE49017
RECRUITING

Frankfurt am Main, Germany
Site ES34002
RECRUITING

Navarra, Pamplona, Spain
Site ES34003
RECRUITING

Madrid, Spain
Site ES34004
RECRUITING

Valencia, Spain
Site ES34005
RECRUITING

A Coruña, Spain
Site ES34006
RECRUITING

Barcelona, Spain
Site ES34007
RECRUITING

Valencia, Spain
Site ES34008
RECRUITING

Madrid, Spain
Site ES34009
RECRUITING

Barcelona, Spain
Site ES34010
RECRUITING

Barcelona, Spain
Site ES34011
RECRUITING

Barcelona, Spain
Site ES34012
RECRUITING

Seville, Spain
Site ES34013
RECRUITING

Pozuelo de Alarcón, Spain
Site ES34014
RECRUITING

Lleida, Spain
Site ES34015
RECRUITING

Zaragoza, Spain
Site ES34016
RECRUITING

Madrid, Spain
Site ES34017
RECRUITING

Madrid, Spain
Site ES34018
RECRUITING

Zaragoza, Spain
Site ES34019
RECRUITING

Madrid, Madrid, Spain
Site ES34021
RECRUITING

El Palmar, Spain
Site ES34022
RECRUITING

Elche, Alicante, Spain
Site ES34023
RECRUITING

San Cugat Del Valles Barcelona, Cataluyna, Spain
Site ES34024
RECRUITING

Barcelona, Spain
Site ES34025
RECRUITING

Seville, Spain
Site ES34026
RECRUITING

Barcelona, Spain
Site ES34027
RECRUITING

Madrid, Madrid, Spain
Site ES34028
RECRUITING

Barcelona, Spain
Site ES34029
RECRUITING

Santiago de Compostela, Spain
Site ES34030
RECRUITING

Murcia, Spain
Site ES34031
RECRUITING

Madrid, Spain
Site FR33002
RECRUITING

Lille, France
Site FR33003
RECRUITING

Paris, France
Site FR33004
RECRUITING

Poitiers, France
Site FR33005
RECRUITING

Dijon, France
Site FR33006
RECRUITING

Rouen, France
Site FR33007
RECRUITING

Lille, France
Site FR33008
RECRUITING

Brest, France
Site FR33009
RECRUITING

Carassonne, France
Site FR33010
RECRUITING

Paris, France
Site FR33011
RECRUITING

Strasbourg, France
Site FR33012
RECRUITING

Caen, France
Site FR33013
RECRUITING

Paris, France
Site FR33014
RECRUITING

Lyon, France
Site FR33015
RECRUITING

Plérin, France
Site FR33016
RECRUITING

Bordeaux, France
Site FR33017
RECRUITING

Lyon, France
Site FR33018
RECRUITING

Nice, France
Site FR33019
RECRUITING

Saint Herbian Cedex, France
Site FR33020
RECRUITING

Montpellier, France
Site GB44002
RECRUITING

Coventry, United Kingdom
Site GB44003
RECRUITING

Cardiff, United Kingdom
Site GB44004
RECRUITING

Glasgow, United Kingdom
Site GB44005
RECRUITING

London, United Kingdom
Site GB44008
RECRUITING

Sheffield, United Kingdom
Site GB44010
RECRUITING

Cottingham, East Riding Of Yorkshire, United Kingdom
Site IT39001
RECRUITING

Rome, Italy
Site IT39002
RECRUITING

Verona, Italy
Site IT39003
RECRUITING

Torrette Di Ancona, Italy
Site IT39004
RECRUITING

Reggio Emilia, Italy
Site IT39006
RECRUITING

Cremona, Italy
Site IT39007
RECRUITING

Meldola, Italy
Site IT39009
RECRUITING

Brescia, Italy
Site IT39011
RECRUITING

Florence, Italy
Site IT39012
RECRUITING

Milan, Italy
Site IT39014
RECRUITING

Candiolo, Italy
Site IT39015
RECRUITING

Pisa, Italy
Site IT39016
RECRUITING

Roma, Italy
Site IT39017
RECRUITING

Bologna, Italy
Site IT39018
RECRUITING

Milan, Italy
Site IT39019
RECRUITING

Bergamo, Italy
Site IT39020
RECRUITING

Milan, Italy
Site IT39021
RECRUITING

Naples, Italy
Site IT39022
RECRUITING

Udine, Italy
Site KR82001
ACTIVE_NOT_RECRUITING

Seoul, South Korea
Site KR82002
ACTIVE_NOT_RECRUITING

Seoul, South Korea
Site KR82003
ACTIVE_NOT_RECRUITING

Seocho-gu, Seoul, South Korea
Site KR82004
ACTIVE_NOT_RECRUITING

Daegu, South Korea
Site KR82005
ACTIVE_NOT_RECRUITING

Incheon, South Korea
Site KR82006
ACTIVE_NOT_RECRUITING

Seoul, South Korea
Site KR82007
ACTIVE_NOT_RECRUITING

Seongnam-si, Gyeonggi-do, South Korea
Site KR82008
ACTIVE_NOT_RECRUITING

Seoul, South Korea
Site KR82009
ACTIVE_NOT_RECRUITING

Cheongju-si, North Chungcheong, South Korea
Site KR82010
ACTIVE_NOT_RECRUITING

Seoul, South Korea
Site KR82011
ACTIVE_NOT_RECRUITING

Goyang-si, Gyeonggi-do, South Korea
Site KR82012
ACTIVE_NOT_RECRUITING

Seoul, South Korea
Site KR82013
ACTIVE_NOT_RECRUITING

Suwon, Gyeonggi-do, South Korea
Site KR82014
ACTIVE_NOT_RECRUITING

Hwasungun, Joellanamdo, South Korea
Site KR82015
ACTIVE_NOT_RECRUITING

Suwon, Gyeonggi-do, South Korea
Site LT37001
RECRUITING

Kaunas, Lithuania
Site LT37002
RECRUITING

Vilnius, Lithuania
Site MX52001
RECRUITING

Oaxaca City, Mexico
Site MX52003
RECRUITING

Mexico City, Mexico
Site NL31001
RECRUITING

Nijmegen, Netherlands
Site NL31002
RECRUITING

Leeuwarden, Netherlands
Site PL48001
RECRUITING

Brzozów, Woj Podkarpackie, Poland
Site PL48002
RECRUITING

Przemyśl, Poland
Site PL48004
RECRUITING

Warsaw, Masovian Voivodeship, Poland
Site PL48005
RECRUITING

Lubin, Lubusz Voivodeship, Poland
Site PL48006
RECRUITING

Gliwice, Poland
Site PL48007
RECRUITING

Warsaw, Poland
Site PL48008
RECRUITING

Olsztyn, Poland
Site PL48009
RECRUITING

Swidnica, Poland
Site PT35102
RECRUITING

Lisbon, Portugal
Site PT35103
RECRUITING

Braga, Portugal
Site PT35104
RECRUITING

Guimarães, Portugal
Site PT35105
RECRUITING

Porto, Portugal
Site PT35106
RECRUITING

Almada, Portugal
Site PT35107
RECRUITING

Lisbon, Portugal
Site PT35108
RECRUITING

Porto, Portugal
Site PT35109
RECRUITING

Porto, Portugal
Site RO40001
RECRUITING

Cluj-Napoca, Romania
Site RO40002
RECRUITING

Floreşti, Romania
Site RO40003
RECRUITING

Craiova, Romania
Site RO40004
RECRUITING

Timișoara, Romania
Site RO40005
RECRUITING

Cluj-Napoca, Romania
Site RO40006
RECRUITING

Cluj-Napoca, Romania
Site RO40007
RECRUITING

Iași, Romania
Site RO40008
RECRUITING

Bucharest, Romania
Site TR90001
RECRUITING

Ankara, Turkey (Türkiye)
Site TR90004
RECRUITING

Ankara, Turkey (Türkiye)
Site TR90005
RECRUITING

Istanbul, Turkey (Türkiye)
Site TR90006
RECRUITING

Ankara, Turkey (Türkiye)
Site TR90009
RECRUITING

Samsun, Turkey (Türkiye)
Site TR90011
RECRUITING

Adana, Turkey (Türkiye)
Site TR90013
RECRUITING

Konya, Turkey (Türkiye)
Site TR90014
RECRUITING

Bursa, Turkey (Türkiye)
Site TR90015
RECRUITING

Van, Turkey (Türkiye)
Site TW88601
ACTIVE_NOT_RECRUITING

Taichung, Taiwan
Site TW88603
ACTIVE_NOT_RECRUITING

Dawan, Taiwan, Taiwan
Site TW88604
ACTIVE_NOT_RECRUITING

Kaohsiung City, Taiwan
Site TW88605
ACTIVE_NOT_RECRUITING

Taipei, Taiwan
Site TW88606
ACTIVE_NOT_RECRUITING

Tainan, Taiwan
Site UK44001
RECRUITING

Bristol, United Kingdom
Site UK44006
RECRUITING

Dundee, United Kingdom
Site UK44009
RECRUITING

Manchester, United Kingdom
Site UK44011
RECRUITING

London, United Kingdom
Site UK44014
RECRUITING

London, United Kingdom
Site UK44015
RECRUITING

London, United Kingdom
Site UK44016
RECRUITING

London, United Kingdom
St. Marianna University Hospital
ACTIVE_NOT_RECRUITING

Kawasaki-shi, Kanagawa, Japan
Sun Yat-sen University - Cancer Center
ACTIVE_NOT_RECRUITING

Guangzhou, Guangdong, 510060, China
Sun Yat-sen University - Cancer Center
ACTIVE_NOT_RECRUITING

Guangzhou, Guangdong, 510555, China
TOI Clinical Research
RECRUITING

Cerritos, California, 90703, United States
Texas Oncology-Baylor Charles A Sammons Cancer Center
RECRUITING

Dallas, Texas, 75246, United States
The Angeles Clinic and Research Institute, West Los Angeles Office
RECRUITING

Los Angeles, California, 90025, United States
The Cancer Institute Hospital of JFCR
ACTIVE_NOT_RECRUITING

Koto-ku, Tokyo, Japan
The Center For Cancer And Blood Disorders (Texas Cancer Care)
RECRUITING

Fort Worth, Texas, 76104, United States
The First Affiliated Hospital of Zhejiang University
ACTIVE_NOT_RECRUITING

Hangzhou, Zhejiang, China
The University of Tennessee Medical Center
RECRUITING

Knoxville, Tennessee, 37920, United States
Tianjin Medical University General Hospital
ACTIVE_NOT_RECRUITING

Tianjin, Tianjin Municipality, China
Tohoku University Hospital
ACTIVE_NOT_RECRUITING

Sendai, Miyagi, Japan
UAB Medicine - UAB Hospital
RECRUITING

Birmingham, Alabama, 35294, United States
University of California, San Diego Moores Cancer Center
RECRUITING

La Jolla, California, 92037-0845, United States
University of Kansas Cancer Center
RECRUITING

Westwood, Kansas, 66205, United States
University of Maryland Medical System - University of Maryland Medical Center
RECRUITING

Baltimore, Maryland, 21021, United States
University of Massachusetts - UMass Chan Medical School
RECRUITING

Worcester, Massachusetts, 01655, United States
University of Michigan Health System
RECRUITING

Ann Arbor, Michigan, 48109, United States
University of Nebraska Medical Center
RECRUITING

Omaha, Nebraska, 68105, United States
University of North Carolina at Chapel Hill
RECRUITING

Chapel Hill, North Carolina, 27599, United States
Utah Cancer Specialists Cancer Center - Medical Oncology
RECRUITING

Salt Lake City, Utah, 84106, United States
Vanderbilt University Medical Center
RECRUITING

Nashville, Tennessee, 37232, United States
Yale University School of Medicine
RECRUITING

New Haven, Connecticut, 06510, United States