Assessing Durvalumab and FLOT Chemotherapy in Resectable Gastric and Gastroesophageal Junction Cancer

December 16, 2025 updated by: AstraZeneca

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)

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study investigates treatment of durvalumab or placebo therapy combined with FLOT chemotherapy (flurouroacil + leucovorin + oxaliplatin + docetaxel) given before surgery (neoadjuvant) and durvalumab or placebo therapy combined with FLOT chemotherapy after surgery (adjuvant), will work and be safe for the treatment of resectable (removable by surgery) gastric or gastroesophageal cancer, and also to better understand the studied disease and associated health problems.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
957

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1431FWO
        • Research Site
      • Ciudad Autonoma Buenos Aires, Argentina, 1093
        • Research Site
      • Ciudad de Buenos Aires, Argentina, 1280
        • Research Site
      • Ciudad de Buenos Aires, Argentina, C1426ANZ
        • Research Site
      • Rosario, Argentina, 3101
        • Research Site
      • Rosario, Argentina, S2000DEJ
        • Research Site
  • Belgium
      • Charleroi, Belgium, 6060
        • Research Site
      • Edegem, Belgium, 2650
        • Research Site
      • Leuven, Belgium, 3000
        • Research Site
      • Liège, Belgium, 4000
        • Research Site
      • Roeselare, Belgium, 8800
        • Research Site
  • Brazil
      • Barretos, Brazil, 14784-400
        • Research Site
      • Natal, Brazil, 59075-740
        • Research Site
      • Porto Alegre, Brazil, 91350-200
        • Research Site
      • Porto Alegre, Brazil, 90035-903
        • Research Site
      • Rio de Janeiro, Brazil, 20231-050
        • Research Site
      • São José do Rio Preto, Brazil, 15090-000
        • Research Site
      • São Paulo, Brazil, 01246-000
        • Research Site
  • Canada
      • Montreal, Canada, H3T 1E2
        • Research Site
    • Alberta
      • Edmonton, Alberta, Canada, t6G1Z2
        • Research Site
    • Ontario
      • North York, Ontario, Canada, M2K 1E1
        • Research Site
      • Oshawa, Ontario, Canada, L1G 2B9,
        • Research Site
      • Toronto, Ontario, Canada, M5G 2M9
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada, H2X 0A9
        • Research Site
  • Chile
      • La Serena, Chile, 1720430
        • Research Site
      • Santiago, Chile, 7500921
        • Research Site
      • Santiago, Chile, 7500653
        • Research Site
      • Talca, Chile, 3461341
        • Research Site
      • Temuco, Chile, 4810218
        • Research Site
      • Temuco, Chile, 4800827
        • Research Site
  • Denmark
      • Aalborg, Denmark, 9000
        • Research Site
      • København Ø, Denmark, 2100
        • Research Site
      • Odense, Denmark, 5000
        • Research Site
  • France
      • Avignon, France, 84918
        • Research Site
      • Besançon, France, 25030
        • Research Site
      • Brest, France, 29609
        • Research Site
      • Dijon, France, 21000
        • Research Site
      • Lyon, France, 69373
        • Research Site
      • Montpellier, France, 34298
        • Research Site
      • Nantes, France, 44093
        • Research Site
      • Nice, France, 06100
        • Research Site
      • Paris, France, 75012
        • Research Site
      • Paris, France, 75475
        • Research Site
      • Paris, France, 75900
        • Research Site
      • Rennes, France, 35033
        • Research Site
  • Germany
      • Berlin, Germany, 13353
        • Research Site
      • Dresden, Germany, 01307
        • Research Site
      • Frankfurt, Germany, 60488
        • Research Site
      • Hamburg, Germany, 20246
        • Research Site
      • Hamburg, Germany, 20249
        • Research Site
      • Heidelberg, Germany, 69120
        • Research Site
      • Heilbronn, Germany, 74078
        • Research Site
      • Jena, Germany, 7743
        • Research Site
      • Mainz Am Rhein, Germany, 55131
        • Research Site
      • München, Germany, 81675
        • Research Site
      • Schweinfurt, Germany, 97421
        • Research Site
      • Tübingen, Germany, 72016
        • Research Site
  • Hungary
      • Budapest, Hungary, 1122
        • Research Site
      • Győr, Hungary, 9024
        • Research Site
      • Kecskemét, Hungary, 6000
        • Research Site
      • Szekszárd, Hungary, 7100
        • Research Site
      • Szolnok, Hungary, 5004
        • Research Site
  • Japan
      • Chūōku, Japan, 104-0045
        • Research Site
      • Hidaka-shi, Japan, 350-1298
        • Research Site
      • Hirakata-shi, Japan, 573-1191
        • Research Site
      • Hiroshima, Japan, 730-8518
        • Research Site
      • Kashiwa, Japan, 277-8577
        • Research Site
      • Kitaadachi-gun, Japan, 362-0806
        • Research Site
      • Kochi, Japan, 781-8555
        • Research Site
      • Kurume-shi, Japan, 830-0011
        • Research Site
      • Nagoya, Japan, 464-8681
        • Research Site
      • Niigata, Japan, 951-8566
        • Research Site
      • Ogaki-shi, Japan, 503-8502
        • Research Site
      • Osaka, Japan, 541-8567
        • Research Site
      • Osaka, Japan, 534-0021
        • Research Site
      • Suita-shi, Japan, 565-0871
        • Research Site
      • Sunto-gun, Japan, 411-8777
        • Research Site
      • Tokyo, Japan, 135-8550
        • Research Site
      • Toyoake-shi, Japan, 470-1192
        • Research Site
      • Wakayama, Japan, 641-8510
        • Research Site
      • Yokohama, Japan, 241-8515
        • Research Site
  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • Research Site
      • Eindhoven, Netherlands, 5623EJ
        • Research Site
      • Rotterdam, Netherlands, 3015GD
        • Research Site
  • Peru
      • Bellavista, Peru, CALLAO 2
        • Research Site
      • Lima, Peru, LIMA 34
        • Research Site
      • Lima, Peru, LIMA 29
        • Research Site
      • Lima, Peru, Lima 32
        • Research Site
      • San Isidro, Peru, 27
        • Research Site
  • Poland
      • Bialystok, Poland, 15-027
        • Research Site
      • Gdansk, Poland, 80-952
        • Research Site
      • Krakow, Poland, 30-688
        • Research Site
      • Lodz, Poland, 93-513
        • Research Site
      • Poznan, Poland, 60-569
        • Research Site
      • Poznan, Poland, 61-866
        • Research Site
      • Warsaw, Poland, 02-034
        • Research Site
      • Warsaw, Poland, 04-141
        • Research Site
  • Russia
      • Kaluga, Russia, 248007
        • Research Site
      • Moscow, Russia, 115478
        • Research Site
      • Moscow, Russia, 111123
        • Research Site
      • Moscow, Russia, 125284
        • Research Site
      • Novosibirsk, Russia, 630108
        • Research Site
      • Obninsk, Russia, 249036
        • Research Site
      • Saint Petersburg, Russia, 197089
        • Research Site
  • South Korea
      • Hwasun-gun, South Korea, 58128
        • Research Site
      • Seongnam-si, South Korea, 13620
        • Research Site
      • Seoul, South Korea, 03080
        • Research Site
      • Seoul, South Korea, 03722
        • Research Site
      • Seoul, South Korea, 06351
        • Research Site
      • Seoul, South Korea, 06591
        • Research Site
  • Spain
      • Barcelona, Spain, 08035
        • Research Site
      • Barcelona, Spain, 08025
        • Research Site
      • Barcelona, Spain, 08908
        • Research Site
      • Madrid, Spain, 28034
        • Research Site
      • Madrid, Spain, 28007
        • Research Site
      • Málaga, Spain, 29009
        • Research Site
      • Ourense, Spain, 32005
        • Research Site
      • Santander, Spain, 39008
        • Research Site
      • Seville, Spain, 41013
        • Research Site
      • Valencia, Spain, 46010
        • Research Site
  • Taiwan
      • Kaohsiung City, Taiwan, 807
        • Research Site
      • Taichung, Taiwan, 40443
        • Research Site
      • Tainan, Taiwan, 70403
        • Research Site
      • Taipei, Taiwan, 112
        • Research Site
      • Taipei, Taiwan, 10048
        • Research Site
      • Taoyuan, Taiwan, 333
        • Research Site
  • Turkey (Türkiye)
      • Adana, Turkey (Türkiye), 01120
        • Research Site
      • Ankara, Turkey (Türkiye), 06340
        • Research Site
      • Erzurum, Turkey (Türkiye), 25240
        • Research Site
      • Istanbul, Turkey (Türkiye), 34098
        • Research Site
      • Istanbul, Turkey (Türkiye), 34457
        • Research Site
      • Samsun, Turkey (Türkiye), 55139
        • Research Site
  • United Kingdom
      • Cambridge, United Kingdom, CB2 0QQ
        • Research Site
      • Dundee, United Kingdom, DD1 9SY
        • Research Site
      • Glasgow, United Kingdom, G12 0YN
        • Research Site
      • Leicester, United Kingdom, LE2 7LZ
        • Research Site
      • London, United Kingdom, EC1A 7BE
        • Research Site
      • Manchester, United Kingdom, M20 4BX
        • Research Site
      • Oxford, United Kingdom, OX3 7LE
        • Research Site
      • Surrey, United Kingdom, SM2 5PT
        • Research Site
  • United States
    • California
      • Duarte, California, United States, 91010
        • Research Site
      • Los Angeles, California, United States, 90027
        • Research Site
      • Los Angeles, California, United States, 90095
        • Research Site
      • Sylmar, California, United States, 91342
        • Research Site
    • Florida
      • St. Petersburg, Florida, United States, 33705
        • Research Site
      • Tallahassee, Florida, United States, 32308
        • Research Site
      • West Palm Beach, Florida, United States, 33401
        • Research Site
    • Indiana
      • Fort Wayne, Indiana, United States, 46804
        • Research Site
    • Kentucky
      • Louisville, Kentucky, United States, 40217
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Research Site
    • New York
      • New York, New York, United States, 10065
        • Research Site
      • Rochester, New York, United States, 14642
        • Research Site
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Research Site
    • Texas
      • Dallas, Texas, United States, 75390
        • Research Site
      • Lancaster, Texas, United States, 75216
        • Research Site
    • Washington
      • Seattle, Washington, United States, 98109
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 200 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • 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.

Key Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Arm B
placebo product and FLOT chemotherapy
Drug: FLOT chemotherapy
A combination treatment made up of flurouroacil + leucovorin + oxaliplatin + docetaxel
Experimental: Arm A
Durvalumab and FLOT chemotherapy
Drug: FLOT chemotherapy
A combination treatment made up of flurouroacil + leucovorin + oxaliplatin + docetaxel
Drug: Durvalumab
Human monoclonal antibody

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Event-free survival (EFS)
Time Frame: Up to 5 years
EFS is the time from date of randomization until the date of disease progression or death.
Up to 5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To compare Arm A relative to Arm B on overall survival (OS)
Time Frame: Up to 5 years
Overall survival is length of time from randomization until the date of death due to any cause.
Up to 5 years
To compare Arm A relative to Arm B on pathological complete response (pCR) rate
Time Frame: Up to 5 years
pCR rate is the proportion of patients who have no residual viable tumor in the resected specimens.
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 17, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 20, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 27, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 26, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 13, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 19, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D910GC00001
  • 2019-001555-40 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing 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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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