Assessing Durvalumab and FLOT Chemotherapy in Resectable Gastric and Gastroesophageal Junction Cancer
NCT ID: NCT04592913
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
957 participants
INTERVENTIONAL
2020-11-17
2027-09-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Arm B
placebo product and FLOT chemotherapy
FLOT chemotherapy
A combination treatment made up of flurouroacil + leucovorin + oxaliplatin + docetaxel
Arm A
Durvalumab and FLOT chemotherapy
Durvalumab
Human monoclonal antibody
FLOT chemotherapy
A combination treatment made up of flurouroacil + leucovorin + oxaliplatin + docetaxel
Interventions
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Durvalumab
Human monoclonal antibody
FLOT chemotherapy
A combination treatment made up of flurouroacil + leucovorin + oxaliplatin + docetaxel
Eligibility Criteria
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Inclusion Criteria
* Patients must undergo radical surgery.
* No prior anti-cancer therapy for the current malignancy.
* World Health Organization (WHO)/ECOG performance status of 0 or 1 at enrollment.
* Adequate organ and marrow function.
* Availability of tumor sample prior to study entry.
* Must have a life expectancy of at least 24 weeks.
Exclusion Criteria
* Patients with adenosquamous cell carcinoma, squamous cell carcinoma, or GI stromal tumor.
* Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab.
* Contra-indication to any of the study drugs.
* History of allogeneic organ transplantation.
18 Years
200 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Duarte, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Sylmar, California, United States
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St. Petersburg, Florida, United States
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Tallahassee, Florida, United States
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West Palm Beach, Florida, United States
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Fort Wayne, Indiana, United States
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Louisville, Kentucky, United States
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Boston, Massachusetts, United States
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New York, New York, United States
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Rochester, New York, United States
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Nashville, Tennessee, United States
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Dallas, Texas, United States
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Lancaster, Texas, United States
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Seattle, Washington, United States
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Buenos Aires, , Argentina
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Ciudad Autonoma Buenos Aires, , Argentina
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Ciudad de Buenos Aires, , Argentina
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Ciudad de Buenos Aires, , Argentina
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Rosario, , Argentina
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Rosario, , Argentina
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Charleroi, , Belgium
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Edegem, , Belgium
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Leuven, , Belgium
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Liège, , Belgium
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Roeselare, , Belgium
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Barretos, , Brazil
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Natal, , Brazil
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Porto Alegre, , Brazil
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Porto Alegre, , Brazil
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Rio de Janeiro, , Brazil
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São José do Rio Preto, , Brazil
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São Paulo, , Brazil
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Edmonton, Alberta, Canada
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North York, Ontario, Canada
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Oshawa, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Montreal, , Canada
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La Serena, , Chile
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Santiago, , Chile
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Santiago, , Chile
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Talca, , Chile
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Temuco, , Chile
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Temuco, , Chile
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Aalborg, , Denmark
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København Ø, , Denmark
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Odense, , Denmark
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Avignon, , France
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Besançon, , France
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Brest, , France
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Dijon, , France
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Lyon, , France
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Montpellier, , France
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Nantes, , France
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Nice, , France
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Paris, , France
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Paris, , France
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Paris, , France
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Rennes, , France
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Berlin, , Germany
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Dresden, , Germany
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Frankfurt, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Heidelberg, , Germany
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Heilbronn, , Germany
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Jena, , Germany
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Mainz Am Rhein, , Germany
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München, , Germany
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Schweinfurt, , Germany
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Tübingen, , Germany
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Budapest, , Hungary
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Győr, , Hungary
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Kecskemét, , Hungary
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Szekszárd, , Hungary
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Szolnok, , Hungary
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Chūōku, , Japan
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Hidaka-shi, , Japan
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Hirakata-shi, , Japan
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Hiroshima, , Japan
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Kashiwa, , Japan
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Kitaadachi-gun, , Japan
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Kochi, , Japan
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Kurume-shi, , Japan
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Nagoya, , Japan
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Niigata, , Japan
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Ogaki-shi, , Japan
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Osaka, , Japan
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Osaka, , Japan
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Suita-shi, , Japan
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Sunto-gun, , Japan
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Tokyo, , Japan
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Toyoake-shi, , Japan
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Wakayama, , Japan
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Yokohama, , Japan
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Amsterdam, , Netherlands
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Eindhoven, , Netherlands
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Rotterdam, , Netherlands
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Bellavista, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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San Isidro, , Peru
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Bialystok, , Poland
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Gdansk, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Poznan, , Poland
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Poznan, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Kaluga, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Novosibirsk, , Russia
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Obninsk, , Russia
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Saint Petersburg, , Russia
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Hwasun-gun, , South Korea
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Seongnam-si, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Barcelona, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Málaga, , Spain
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Ourense, , Spain
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Santander, , Spain
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Seville, , Spain
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Valencia, , Spain
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Kaohsiung City, , Taiwan
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Taichung, , Taiwan
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Tainan, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taoyuan, , Taiwan
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Adana, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Erzurum, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Samsun, , Turkey (Türkiye)
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Cambridge, , United Kingdom
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Dundee, , United Kingdom
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Glasgow, , United Kingdom
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Leicester, , United Kingdom
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London, , United Kingdom
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Manchester, , United Kingdom
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Oxford, , United Kingdom
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Surrey, , United Kingdom
Countries
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References
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Janjigian YY, Al-Batran SE, Wainberg ZA, Muro K, Molena D, Van Cutsem E, Hyung WJ, Wyrwicz L, Oh DY, Omori T, Moehler M, Garrido M, Oliveira SCS, Liberman M, Oliden VC, Smyth EC, Stein A, Bilici M, Alvarenga ML, Kozlov V, Rivera F, Kawazoe A, Serrano O, Heilbron E, Negro A, Kurland JF, Tabernero J; MATTERHORN Investigators. Perioperative Durvalumab in Gastric and Gastroesophageal Junction Cancer. N Engl J Med. 2025 Jul 17;393(3):217-230. doi: 10.1056/NEJMoa2503701. Epub 2025 Jun 1.
Chang X, Ge X, Zhang Y, Xue X. The current management and biomarkers of immunotherapy in advanced gastric cancer. Medicine (Baltimore). 2022 May 27;101(21):e29304. doi: 10.1097/MD.0000000000029304.
Janjigian YY, Van Cutsem E, Muro K, Wainberg Z, Al-Batran SE, Hyung WJ, Molena D, Marcovitz M, Ruscica D, Robbins SH, Negro A, Tabernero J. MATTERHORN: phase III study of durvalumab plus FLOT chemotherapy in resectable gastric/gastroesophageal junction cancer. Future Oncol. 2022 Jun;18(20):2465-2473. doi: 10.2217/fon-2022-0093. Epub 2022 May 10.
Cowzer D, Janjigian YY. Top advances in esophageal/gastroesophageal junction cancers in 2021. Cancer. 2022 May 15;128(10):1894-1899. doi: 10.1002/cncr.34140. Epub 2022 Feb 18. No abstract available.
Other Identifiers
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2019-001555-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D910GC00001
Identifier Type: -
Identifier Source: org_study_id