Assessing Durvalumab and FLOT Chemotherapy in Resectable... | NCT04592913

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

NCT04592913

Sponsor

AstraZeneca

Status

Active, not recruiting

Last Update Posted

Dec 24, 2025Actual

Enrollment

957Actual

Phase

Phase 3

Conditions

Gastrointestinal Neoplasms
Esophagogastric Junction

Interventions

Durvalumab
FLOT chemotherapy

Countries

United States
Argentina
Belgium
Brazil
Canada
Chile
Denmark
France
Germany
Hungary
Japan
Netherlands
Peru
Poland
Russia
South Korea
Spain
Taiwan
Turkey (Türkiye)
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
2019-001555-40	EudraCT Number

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 17, 2020Actual

Primary Completion Date

Dec 20, 2024Actual

Completion Date

Sep 27, 2027Estimated

First Submitted Date

Aug 26, 2020

First Submission Date that Met QC Criteria

Oct 13, 2020

First Posted Date

Oct 19, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Dec 16, 2025

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Apr 3, 2025Actual

Last Update Submitted Date

Dec 16, 2025

Last Update Posted Date

Dec 24, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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).

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

957Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm B	Placebo Comparator	placebo product and FLOT chemotherapy	Drug: FLOT chemotherapy
Arm A	Experimental	Durvalumab and FLOT chemotherapy	Drug: Durvalumab Drug: FLOT chemotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Durvalumab	Drug	Human monoclonal antibody	Arm A
FLOT chemotherapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
To compare Arm A relative to Arm B on overall survival (OS)	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

200 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Duarte	California	91010	United States
Research Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40454643	Derived	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.
35623069

See Also Links

Not provided

Available IPD Information

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Yes

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.

Types

Study Protocol
Statistical Analysis Plan (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

URL

https://astrazenecagroup-dt.pharmacm.com/DT/Home

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004066	Digestive System Diseases
D005767	Gastrointestinal Diseases