Gastric AdenocarcinomaDUPLICATENCT07427992
Real-WorlD ZolbetUximab in Patients With HER-2 Negative and CLaudin 18.2 PosItive MetastatiC AdEnocarcinoma
An observational study of Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, run by European Institute of Oncology at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
- How many people
- 70 participants
- Where
- 1 siteItaly
- Study dates
- 20 Jun 2025to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (≥ 18 years) with advanced HER-2 negative and Claudin 18.2 positive gastric or gastroesophageal junction adenocarcinoma.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
European Institute of Oncology
Milan, 20141
Nicola Fazio, MD,PhD, 0257489258, divisione.gastrointestinale@ieo.it
Nicola Fazio, MD,PhD
About this study
Official title: 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.
Read the 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.
- Keywords
- claudin, real world study, Gastric Adenocarcinoma, zolbetuximab, gastroesophageal junction adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
The primary endpoint of this one-arm observational study is progression-free survival
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start20 Jun 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gastric AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by European Institute of OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicola Fazio, MD, Study director, IEO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07427992
- Sponsor's protocol ID
- L2-356
- Other IDs
- UID 4835
- Acronym
- DUPLICATE
- Status last verified
- Jul 2025
- First submitted
- 17 Feb 2026
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shah MA, Shitara K, Ajani JA, Bang YJ, Enzinger P, Ilson D, Lordick F, Van Cutsem E, Gallego Plazas J, Huang J, Shen L, Oh SC, Sunpaweravong P, Soo Hoo HF, Turk HM, Oh M, Park JW, Moran D, Bhattacharya P, Arozullah A, Xu RH. Zolbetuximab plus CAPOX in CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma: the randomized, phase 3 GLOW trial. Nat Med. 2023 Aug;29(8):2133-2141. doi: 10.1038/s41591-023-02465-7. Epub 2023 Jul 31.
PubMed 37524953Shitara K, Lordick F, Bang YJ, Enzinger P, Ilson D, Shah MA, Van Cutsem E, Xu RH, Aprile G, Xu J, Chao J, Pazo-Cid R, Kang YK, Yang J, Moran D, Bhattacharya P, Arozullah A, Park JW, Oh M, Ajani JA. Zolbetuximab plus mFOLFOX6 in patients with CLDN18.2-positive, HER2-negative, untreated, locally advanced unresectable or metastatic gastric or gastro-oesophageal junction adenocarcinoma (SPOTLIGHT): a multicentre, randomised, double-blind, phase 3 trial. Lancet. 2023 May 20;401(10389):1655-1668. doi: 10.1016/S0140-6736(23)00620-7. Epub 2023 Apr 15.
PubMed 37068504
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-WorlD ZolbetUximab Combined With chemotheraPy in Patients With HER-2 Negative and CLaudin 18.2 PosItive MetastatiC GAsTric or Gastroesophageal Junction AdEnocarcinoma
- ClinicalTrials.gov ID
- NCT07427992
- Acronym / sponsor ID
- DUPLICATE / L2-356
- Keywords
- claudin, real world study, Gastric Adenocarcinoma, zolbetuximab, gastroesophageal junction adenocarcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- 20 Jun 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 23 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (≥ 18 years) with advanced HER-2 negative and Claudin 18.2 positive gastric or gastroesophageal junction adenocarcinoma.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Progression-free survival
Time frame: 2 years
The primary endpoint of this one-arm observational study is progression-free survival
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Background: PubMed 37524953Shah MA, Shitara K, Ajani JA, Bang YJ, Enzinger P, Ilson D, Lordick F, Van Cutsem E, Gallego Plazas J, Huang J, Shen L, Oh SC, Sunpaweravong P, Soo Hoo HF, Turk HM, Oh M, Park JW, Moran D, Bhattacharya P, Arozullah A, Xu RH. Zolbetuximab plus CAPOX in CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma: the randomized, phase 3 GLOW trial. Nat Med. 2023 Aug;29(8):2133-2141. doi: 10.1038/s41591-023-02465-7. Epub 2023 Jul 31.
- Results publication: PubMed 37068504Shitara K, Lordick F, Bang YJ, Enzinger P, Ilson D, Shah MA, Van Cutsem E, Xu RH, Aprile G, Xu J, Chao J, Pazo-Cid R, Kang YK, Yang J, Moran D, Bhattacharya P, Arozullah A, Park JW, Oh M, Ajani JA. Zolbetuximab plus mFOLFOX6 in patients with CLDN18.2-positive, HER2-negative, untreated, locally advanced unresectable or metastatic gastric or gastro-oesophageal junction adenocarcinoma (SPOTLIGHT): a multicentre, randomised, double-blind, phase 3 trial. Lancet. 2023 May 20;401(10389):1655-1668. doi: 10.1016/S0140-6736(23)00620-7. Epub 2023 Apr 15.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicola Fazio, MD study director
IEO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, run by European Institute of Oncology at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chiara Alessandra Cella, MD (00390257489258, divisione.gastrointestinale@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07427992, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.