Assessing Durvalumab and FLOT Chemotherapy in Resectable Gastric and Gastroesophageal Junction Cancer
A Randomized, Double-blind, Placebo-controlled, Phase III Study of Neoadjuvant-Adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Patients With Resectable Gastric and Gastroesophageal Junction Cancer (GC/GEJC)
2 other identifiers
interventional
957
20 countries
156
Brief Summary
This is a Global Study of Neoadjuvant-Adjuvant Durvalumab or Placebo and FLOT Chemotherapy Followed by Adjuvant Durvalumab or Placebo in Patients with Resectable Gastric and Gastroesophageal Cancer (GC/GEJC) (MATTERHORN).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2020
Longer than P75 for phase_3
156 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
August 26, 2020
CompletedFirst Posted
Study publicly available on registry
October 19, 2020
CompletedStudy Start
First participant enrolled
November 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 27, 2027
ExpectedDecember 24, 2025
December 1, 2025
4.1 years
August 26, 2020
December 16, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Event-free survival (EFS)
EFS is the time from date of randomization until the date of disease progression or death.
Up to 5 years
Secondary Outcomes (2)
To compare Arm A relative to Arm B on overall survival (OS)
Up to 5 years
To compare Arm A relative to Arm B on pathological complete response (pCR) rate
Up to 5 years
Study Arms (2)
Arm B
PLACEBO COMPARATORplacebo product and FLOT chemotherapy
Arm A
EXPERIMENTALDurvalumab and FLOT chemotherapy
Interventions
A combination treatment made up of flurouroacil + leucovorin + oxaliplatin + docetaxel
Eligibility Criteria
You may qualify if:
- Patients with histologically documented gastric or gastroesophageal junction adenocarcinoma with resectable disease (Stage II or higher per AJCC 8th edition).
- 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.
You may not qualify if:
- Patients with peritoneal dissemination or distant metastasis.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (156)
Research Site
Duarte, California, 91010, United States
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Los Angeles, California, 90027, United States
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Los Angeles, California, 90095, United States
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Sylmar, California, 91342, United States
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St. Petersburg, Florida, 33705, United States
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Tallahassee, Florida, 32308, United States
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West Palm Beach, Florida, 33401, United States
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Fort Wayne, Indiana, 46804, United States
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Louisville, Kentucky, 40217, United States
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Boston, Massachusetts, 02215, United States
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New York, New York, 10065, United States
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Rochester, New York, 14642, United States
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Nashville, Tennessee, 37203, United States
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Dallas, Texas, 75390, United States
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Lancaster, Texas, 75216, United States
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Seattle, Washington, 98109, United States
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Buenos Aires, C1431FWO, Argentina
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Ciudad Autonoma Buenos Aires, 1093, Argentina
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Ciudad de Buenos Aires, 1280, Argentina
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Ciudad de Buenos Aires, C1426ANZ, Argentina
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Rosario, 3101, Argentina
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Rosario, S2000DEJ, Argentina
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Charleroi, 6060, Belgium
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Edegem, 2650, Belgium
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Leuven, 3000, Belgium
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Liège, 4000, Belgium
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Roeselare, 8800, Belgium
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Barretos, 14784-400, Brazil
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Natal, 59075-740, Brazil
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Porto Alegre, 90035-903, Brazil
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Porto Alegre, 91350-200, Brazil
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Rio de Janeiro, 20231-050, Brazil
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São José do Rio Preto, 15090-000, Brazil
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São Paulo, 01246-000, Brazil
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Edmonton, Alberta, t6G1Z2, Canada
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North York, Ontario, M2K 1E1, Canada
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Oshawa, Ontario, L1G 2B9,, Canada
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Toronto, Ontario, M5G 2M9, Canada
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Montreal, Quebec, H2X 0A9, Canada
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Montreal, H3T 1E2, Canada
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La Serena, 1720430, Chile
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Santiago, 7500653, Chile
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Santiago, 7500921, Chile
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Talca, 3461341, Chile
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Temuco, 4800827, Chile
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Temuco, 4810218, Chile
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Aalborg, 9000, Denmark
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København Ø, 2100, Denmark
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Odense, 5000, Denmark
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Avignon, 84918, France
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Besançon, 25030, France
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Brest, 29609, France
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Dijon, 21000, France
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Lyon, 69373, France
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Montpellier, 34298, France
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Nantes, 44093, France
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Nice, 06100, France
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Paris, 75012, France
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Paris, 75475, France
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Paris, 75900, France
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Rennes, 35033, France
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Berlin, 13353, Germany
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Dresden, 01307, Germany
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Frankfurt, 60488, Germany
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Hamburg, 20246, Germany
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Hamburg, 20249, Germany
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Heidelberg, 69120, Germany
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Heilbronn, 74078, Germany
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Jena, 7743, Germany
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Mainz Am Rhein, 55131, Germany
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München, 81675, Germany
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Schweinfurt, 97421, Germany
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Tübingen, 72016, Germany
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Budapest, 1122, Hungary
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Győr, 9024, Hungary
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Kecskemét, 6000, Hungary
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Szekszárd, 7100, Hungary
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Szolnok, 5004, Hungary
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Chūōku, 104-0045, Japan
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Hidaka-shi, 350-1298, Japan
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Hirakata-shi, 573-1191, Japan
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Hiroshima, 730-8518, Japan
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Kashiwa, 277-8577, Japan
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Kitaadachi-gun, 362-0806, Japan
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Kochi, 781-8555, Japan
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Kurume-shi, 830-0011, Japan
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Nagoya, 464-8681, Japan
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Niigata, 951-8566, Japan
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Ogaki-shi, 503-8502, Japan
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Osaka, 534-0021, Japan
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Osaka, 541-8567, Japan
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Suita-shi, 565-0871, Japan
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Sunto-gun, 411-8777, Japan
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Tokyo, 135-8550, Japan
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Toyoake-shi, 470-1192, Japan
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Wakayama, 641-8510, Japan
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Yokohama, 241-8515, Japan
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Amsterdam, 1066 CX, Netherlands
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Eindhoven, 5623EJ, Netherlands
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Rotterdam, 3015GD, Netherlands
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Bellavista, CALLAO 2, Peru
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Lima, LIMA 29, Peru
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Lima, Lima 32, Peru
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Lima, LIMA 34, Peru
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San Isidro, 27, Peru
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Bialystok, 15-027, Poland
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Gdansk, 80-952, Poland
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Krakow, 30-688, Poland
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Lodz, 93-513, Poland
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Poznan, 60-569, Poland
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Poznan, 61-866, Poland
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Warsaw, 02-034, Poland
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Warsaw, 04-141, Poland
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Kaluga, 248007, Russia
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Moscow, 111123, Russia
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Moscow, 115478, Russia
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Moscow, 125284, Russia
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Novosibirsk, 630108, Russia
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Obninsk, 249036, Russia
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Saint Petersburg, 197089, Russia
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Hwasun-gun, 58128, South Korea
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Seongnam-si, 13620, South Korea
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Seoul, 03080, South Korea
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Seoul, 03722, South Korea
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Seoul, 06351, South Korea
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Seoul, 06591, South Korea
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Barcelona, 08025, Spain
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Barcelona, 08035, Spain
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Barcelona, 08908, Spain
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Madrid, 28007, Spain
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Madrid, 28034, Spain
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Málaga, 29009, Spain
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Ourense, 32005, Spain
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Santander, 39008, Spain
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Seville, 41013, Spain
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Valencia, 46010, Spain
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Kaohsiung City, 807, Taiwan
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Taichung, 40443, Taiwan
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Tainan, 70403, Taiwan
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Taipei, 10048, Taiwan
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Taipei, 112, Taiwan
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Taoyuan, 333, Taiwan
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Adana, 01120, Turkey (Türkiye)
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Ankara, 06340, Turkey (Türkiye)
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Erzurum, 25240, Turkey (Türkiye)
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Istanbul, 34098, Turkey (Türkiye)
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Istanbul, 34457, Turkey (Türkiye)
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Samsun, 55139, Turkey (Türkiye)
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Cambridge, CB2 0QQ, United Kingdom
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Dundee, DD1 9SY, United Kingdom
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Glasgow, G12 0YN, United Kingdom
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Leicester, LE2 7LZ, United Kingdom
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London, EC1A 7BE, United Kingdom
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Manchester, M20 4BX, United Kingdom
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Oxford, OX3 7LE, United Kingdom
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Surrey, SM2 5PT, United Kingdom
Related Publications (4)
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.
PMID: 40454643DERIVEDChang 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.
PMID: 35623069DERIVEDJanjigian 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.
PMID: 35535555DERIVEDCowzer 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.
PMID: 35179774DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2020
First Posted
October 19, 2020
Study Start
November 17, 2020
Primary Completion
December 20, 2024
Study Completion (Estimated)
September 27, 2027
Last Updated
December 24, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.