Real-WorlD ZolbetUximab in Patients With HER-2 Negative and CLaudin 18.2 PosItive MetastatiC AdEnocarcinoma (DUPLICATE)

February 17, 2026 updated by: European Institute of Oncology

Real-WorlD ZolbetUximab Combined With chemotheraPy in Patients With HER-2 Negative and CLaudin 18.2 PosItive MetastatiC GAsTric or Gastroesophageal Junction AdEnocarcinoma

The primary objective is to validate, throughout a national real-world study, the efficacy and safety of Zolbetuximab combined with FOLFOX or XELOX regimens. Specific clinical issues will be studied by pre-planned subgroup analyses, addressing practical clinical needs which have not been specifically investigated in randomized clinical trials.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Advanced HER-2 negative gastric adenocarcinoma and gastroesophageal junction adenocarcinoma represents an oncological entity with a relatively poor prognosis and limited therapeutic options. Zolbetuximab, marketed as VYLOY, is a monoclonal antibody targeting the Claudin 18.2 protein, a tissue marker highly expressed in around 30 to 40% of GA or GEJA adenocarcinomas.

On September 20, 2024, the European Medicines Agency approved the use of VYLOY (zolbetuximab) in combination with fluoropyrimidine- and platinum-based chemotherapies as a first-line treatment for adult patients with locally advanced unresectable or metastatic HER2-negative and Claudin 18.2 positive gastric or gastroesophageal junction adenocarcinoma.

This approval is based on two positive phase III randomized clinical trials, SPOTLIGHT and GLOW, which demonstrated the efficacy of Zolbetuximab in this clinical context.

In October 2024, following this approval, an Early Access Program (EAP) was launched in Italy to provide early access to eligible patients for this treatment. (ClinicalTrials.gov ID NCT06048081) This national-scale prospective real-world observational study aims to validate the efficacy and safety data of zolbetuximab in combination with fluoropyrimidine- and platinum-based chemotherapies, analyzing specific clinical aspects through pre-planned subgroup analyses.

Study Type

Observational

Enrollment (Estimated)

70

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Milan, Italy, 20141
        • Recruiting
        • European Institute of Oncology
        • Sub-Investigator:
          • Lorenzo Gervaso, MD
        • Sub-Investigator:
          • Chiara Alessandra Cella, MD
        • Contact:
        • Principal Investigator:
          • Nicola Fazio, MD,PhD
        • Sub-Investigator:
          • Francesca Spada, MD
        • Sub-Investigator:
          • Lavinia Benini, MD
        • Sub-Investigator:
          • Davide Ciardiello, MD

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients (≥ 18 years) with advanced HER-2 negative and Claudin 18.2 positive gastric or gastroesophageal junction adenocarcinoma.

Description

Inclusion Criteria:

  • Patient with histologically confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma.
  • Patient with locally advanced, unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.
  • Patient whose tumor expresses claudin18.2 in ≥ 75% of tumor cells demonstrating moderate to strong membranous CLDN18 staining as determined by local or central immunohistochemistry testing.
  • Patient with a Human epidermal growth factor receptor 2 negative tumor by local testing on a gastric or gastroesophageal junction tumor specimen.
  • Patient with Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  • Patient who can have access to the Zolbetuximab EAP program or locally authorized and reimbursed (AIFA) procedure.
  • Patient who has about to start first-line Zolbetuximab + FOLFOX/XELOX or who has an ongoing Zolbetuximab FOLFOX/XELOX with available clinical data.

Exclusion Criteria:

  • Patient has previously received treatment in a clinical trial of zolbetuximab, or a clinical trial that included zolbetuximab as 1 of the treatment options, even if the patient was not given zolbetuximab.
  • Patient has known dihydropyrimidine dehydrogenase deficiency.
  • Patient has received prior systemic chemotherapy for locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. However, patient may have received either neoadjuvant or adjuvant chemotherapy, immunotherapy or other systemic anticancer therapies as long as it was completed at least 6 months prior to participation.

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

Cohorts and Interventions

Group / Cohort
patient with unresectable or metastatic gastric adenocarcinoma.
Adult patients (≥ 18 years) with advanced HER-2 negative and Claudin 18.2 positive gastric or gastroesophageal junction adenocarcinoma treated with Zolbetuximab in combination with fluoropyrimidine- and platinum-based chemotherapies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: 2 years
The primary endpoint of this one-arm observational study is progression-free survival
2 years

Collaborators and Investigators

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

Sponsor

European Institute of Oncology

Investigators

  • Study Director: Nicola Fazio, MD, IEO

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)

June 20, 2025

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

February 17, 2026

First Submitted That Met QC Criteria

February 17, 2026

First Posted (Actual)

February 23, 2026

Study Record Updates

Last Update Posted (Actual)

February 23, 2026

Last Update Submitted That Met QC Criteria

February 17, 2026

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • L2-356
  • UID 4835 (Other Identifier: Clinical Trial Office - Istituto Europeo di oncologia)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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