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

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ClinicalTrials.gov Identifier: NCT04592913
Recruitment Status : Recruiting
First Posted : October 19, 2020
Last Update Posted : October 7, 2021
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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).

Condition or disease Intervention/treatment Phase
Gastrointestinal Neoplasms Esophagogastric Junction Drug: Durvalumab Drug: FLOT chemotherapy Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, Double-blind, Placebo-controlled study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : November 17, 2020
Estimated Primary Completion Date : February 14, 2025
Estimated Study Completion Date : February 14, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Durvalumab

Arm Intervention/treatment
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: Durvalumab
Human monoclonal antibody

Drug: FLOT chemotherapy
A combination treatment made up of flurouroacil + leucovorin + oxaliplatin + docetaxel




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 200 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04592913


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

Locations
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Sponsors and Collaborators
AstraZeneca
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT04592913    
Other Study ID Numbers: D910GC00001
2019-001555-40 ( EudraCT Number )
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: October 7, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

Supporting Materials: 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

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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
Additional relevant MeSH terms:
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Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Durvalumab
Antineoplastic Agents, Immunological
Antineoplastic Agents