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)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Astrazeneca AB

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

1 Feb 2021 → ongoing

Decision date (initial)

2024-01-30

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

AstraZeneca AB

External identifiers

EU CT number

2023-507338-26-00

EudraCT number

2019-001555-40

ClinicalTrials.gov

NCT04592913

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To compare Arm A relative to Arm B on event-free survival (EFS)

Secondary objectives 11

1. To compare Arm A relative to Arm B on overall survival (OS)
2. To compare Arm A relative to Arm B on pathological complete response (pCR) rate
3. To compare Arm A relative to Arm B on the proportion of patients who undergo gastrectomy or gastrophagectomy
4. To compare Arm A relative to Arm B on the rate of complete resection (R0)
5. To compare Arm A relative to Arm B on metastasis-free survival (MFS) and disease-specific survival (DSS)
6. To compare Arm A relative to Arm B on disease-free survival in patients who undergo R0 resection surgery
7. To compare Arm A relative to Arm B on EFS24, EFS36, OS24, OS36, DFS24, and DFS36
8. To compare Arm A relative to Arm B on efficacy endpoints by PD-L1 expression
9. To compare Arm A relative to Arm B on disease-related symptoms, impacts, and HRQoL
10. To evaluate PK of Arm A and Arm B
11. To assess the immunogenicity of Arm A and Arm B

Conditions and MedDRA coding

Histologically documented gastric or gastroesophageal junction adenocarcinoma with resectable disease (Stage II or higher per AJCC 8th edition).

Study design 4 periods

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share 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 Vivli.org. All requests 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. AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment https://vivli.org/. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Patients with histologically documented gastric or gastroesophageal junction adenocarcinoma with resectable disease (Stage II or higher per AJCC 8th edition)
2. Patients must have undergo radical surgery
3. No prior anti-cancer therapy for the current malignancy
4. World Health Organization (WHO)/ECOG PS of 0 or 1 at enrollment
5. Adequate organ and marrow function
6. Availability of tumor sample prior to study entry
7. Must have a life expectancy of at least 24 weeks

Exclusion criteria 5

1. Patients with peritoneal dissemination or distant metastasis
2. Patients with adenosquamous cell carcinoma, squamous cell carcinoma, or GI stromal tumor
3. History of allogeneic organ transplantation
4. Contra-indication to any of the study drugs
5. Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. EFS (event free survival)

Secondary endpoints 2

1. OS (Overall Survival)
2. pCR rate

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 4

Placebo 1

Auxiliary 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Astrazeneca AB

Sponsor organisation

Astrazeneca AB

Address

Astraallen Gartuna, Karlebyhus Byggnad 674 Karlebyhus Byggnad 674

City

Sodertalje

Postcode

151 85

Country

Sweden

Scientific contact point

Organisation

Astrazeneca AB

Contact name

AstraZeneca Clinical Study Information Center

Public contact point

Organisation

Astrazeneca AB

Contact name

AstraZeneca Clinical Study Information Center

Locations

8 EU/EEA countries · 58 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 46 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

11 submissions — initial application plus substantial / non-substantial modifications