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

Gastrointestinal Neoplasms Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04592913
• Other study ID #: D910GC00001
• Secondary ID: 2019-001555-40
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: November 17, 2020
• Est. completion date: September 27, 2027

Study information

• Verified date: April 2024
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 958
• Est. completion date: September 27, 2027
• Est. primary completion date: October 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 200 Years

Eligibility

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.

Related Conditions & MeSH terms

• Digestive System Neoplasms
• Esophagogastric Junction
• Gastrointestinal Neoplasms

Intervention

Drug:
• Durvalumab
Human monoclonal antibody
• FLOT chemotherapy
A combination treatment made up of flurouroacil + leucovorin + oxaliplatin + docetaxel

Locations

Country	Name	City	State
Argentina	Research Site	Buenos Aires
Argentina	Research Site	Buenos Aires
Argentina	Research Site	Ciudad Autonoma Buenos Aires
Argentina	Research Site	Ciudad de Buenos Aires
Argentina	Research Site	Rosario
Argentina	Research Site	Rosario
Belgium	Research Site	Charleroi
Belgium	Research Site	Edegem
Belgium	Research Site	Leuven
Belgium	Research Site	Liège
Belgium	Research Site	Roeselare
Brazil	Research Site	Barretos
Brazil	Research Site	Natal
Brazil	Research Site	Porto Alegre
Brazil	Research Site	Porto Alegre
Brazil	Research Site	Rio de Janeiro
Brazil	Research Site	São José do Rio Preto
Brazil	Research Site	São Paulo
Canada	Research Site	Edmonton	Alberta
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Montreal
Canada	Research Site	North York	Ontario
Canada	Research Site	Oshawa	Ontario
Canada	Research Site	Toronto	Ontario
Chile	Research Site	La Serena
Chile	Research Site	Santiago
Chile	Research Site	Santiago
Chile	Research Site	Talca
Chile	Research Site	Temuco
Chile	Research Site	Temuco
Denmark	Research Site	Aalborg
Denmark	Research Site	København Ø
Denmark	Research Site	Odense C
France	Research Site	Avignon
France	Research Site	Besançon Cedex
France	Research Site	Brest Cedex
France	Research Site	Dijon
France	Research Site	Lyon
France	Research Site	Montpellier
France	Research Site	Nantes
France	Research Site	Nice
France	Research Site	Paris
France	Research Site	Paris cedex 10
France	Research Site	Paris cedex 15
France	Research Site	Rennes Cedex 9
Germany	Research Site	Berlin
Germany	Research Site	Dresden
Germany	Research Site	Frankfurt
Germany	Research Site	Hamburg
Germany	Research Site	Hamburg
Germany	Research Site	Heidelberg
Germany	Research Site	Heilbronn
Germany	Research Site	Jena
Germany	Research Site	Mainz Am Rhein
Germany	Research Site	München
Germany	Research Site	Schweinfurt
Germany	Research Site	Tübingen
Hungary	Research Site	Budapest
Hungary	Research Site	Gyor
Hungary	Research Site	Kecskemét
Hungary	Research Site	Szekszárd
Hungary	Research Site	Szolnok
Japan	Research Site	Chuo-ku
Japan	Research Site	Hidaka-shi
Japan	Research Site	Hirakata-shi
Japan	Research Site	Hiroshima-shi
Japan	Research Site	Kashiwa
Japan	Research Site	Kitaadachi-gun
Japan	Research Site	Kochi-shi
Japan	Research Site	Kurume-shi
Japan	Research Site	Nagoya-shi
Japan	Research Site	Niigata-shi
Japan	Research Site	Ogaki-shi
Japan	Research Site	Osaka-shi
Japan	Research Site	Osaka-shi
Japan	Research Site	Suita-shi
Japan	Research Site	Sunto-gun
Japan	Research Site	Tokyo
Japan	Research Site	Toyoake-shi
Japan	Research Site	Wakayama-shi
Japan	Research Site	Yokohama-shi
Korea, Republic of	Research Site	Hwasun-gun
Korea, Republic of	Research Site	Seongnam-si
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Netherlands	Research Site	Amsterdam
Netherlands	Research Site	Eindhoven
Netherlands	Research Site	Rotterdam
Peru	Research Site	Bellavista
Peru	Research Site	Lima
Peru	Research Site	Lima
Peru	Research Site	Lima
Peru	Research Site	San Isidro
Poland	Research Site	Bialystok
Poland	Research Site	Gdansk
Poland	Research Site	Kraków
Poland	Research Site	Lódz
Poland	Research Site	Poznan
Poland	Research Site	Poznan
Poland	Research Site	Warszawa
Poland	Research Site	Warszawa
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Novosibirsk
Russian Federation	Research Site	Obninsk
Russian Federation	Research Site	Saint-Petersburg
Spain	Research Site	Barcelona
Spain	Research Site	Barcelona
Spain	Research Site	Barcelona
Spain	Research Site	Madrid
Spain	Research Site	Madrid
Spain	Research Site	Málaga
Spain	Research Site	Ourense
Spain	Research Site	Santander
Spain	Research Site	Sevilla
Spain	Research Site	Valencia
Taiwan	Research Site	Kaohsiung
Taiwan	Research Site	Taichung
Taiwan	Research Site	Tainan City
Taiwan	Research Site	Taipei
Taiwan	Research Site	Taipei
Taiwan	Research Site	Taoyuan City
Turkey	Research Site	Adana
Turkey	Research Site	Ankara
Turkey	Research Site	Erzurum
Turkey	Research Site	Istanbul
Turkey	Research Site	Istanbul
Turkey	Research Site	Samsun
United Kingdom	Research Site	Cambridge
United Kingdom	Research Site	Dundee
United Kingdom	Research Site	Glasgow
United Kingdom	Research Site	Leicester
United Kingdom	Research Site	London
United Kingdom	Research Site	Manchester
United Kingdom	Research Site	Oxford
United Kingdom	Research Site	Surrey
United States	Research Site	Boston	Massachusetts
United States	Research Site	Dallas	Texas
United States	Research Site	Duarte	California
United States	Research Site	Fort Wayne	Indiana
United States	Research Site	Lancaster	Texas
United States	Research Site	Los Angeles	California
United States	Research Site	Los Angeles	California
United States	Research Site	Louisville	Kentucky
United States	Research Site	Nashville	Tennessee
United States	Research Site	New York	New York
United States	Research Site	Rochester	New York
United States	Research Site	Saint Petersburg	Florida
United States	Research Site	Seattle	Washington
United States	Research Site	Sylmar	California
United States	Research Site	Tallahassee	Florida
United States	Research Site	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Brazil,  Canada,  Chile,  Denmark,  France,  Germany,  Hungary,  Japan,  Korea, Republic of,  Netherlands,  Peru,  Poland,  Russian Federation,  Spain,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	To compare Arm A relative to Arm B on pathological complete response (pCR) rate	pCR rate is the proportion of patients who have no residual viable tumor in the resected specimens.	Up to 5 years