Real-WorlD ZolbetUximab in Patients With HER-2 Negative and CLaudin 18.2 PosItive MetastatiC AdEnocarcinoma
Real-WorlD ZolbetUximab Combined With chemotheraPy in Patients With HER-2 Negative and CLaudin 18.2 PosItive MetastatiC GAsTric or Gastroesophageal Junction AdEnocarcinoma
European Institute of Oncology
70 participants
Jun 20, 2025
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria7
- 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 Criteria3
- 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.
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Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07427992