Comparing 5 approaches for gastric cancer
Official title: Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in Participants With Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma Expressing Claudin18.2
A Phase III, Multicentre, Randomised Controlled Study of Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in First-Line Claudin18.2-Positive, HER2-Negative, Advanced/Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (CLARITY-Gastric 02)
Interventions
Sonesitatug vedotin
Intravenous
Rilvegostomig
Intravenous
Nivolumab
Intravenous
Capecitabine
Oral
5-Fluorouracil
Intravenous
Oxaliplatin
Intravenous
Zolbetuximab
Intravenous
Leucovorin
Intravenous
Canadian Sites (13)
Research Site
Edmonton, Alberta, Canada
Research Site
Abbotsford British Columbia, British Columbia, Canada
Research Site
Vancouver, British Columbia, Canada
Research Site
Winnipeg, Manitoba, Canada
Research Site
Moncton, New Brunswick, Canada
Research Site
Barrie, Ontario, Canada
Research Site
Brampton, Ontario, Canada
Research Site
Ottawa, Ontario, Canada
Research Site
Sault Ste. Marie, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Québec, Quebec, Canada
Eligibility Criteria
See who this study is looking for25 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +CohortCohortA group of participants sharing a characteristic, followed together.Read more → 1: PD-L1 positive as determined by central IHC testing and the participant is deemed ICI eligible per investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → judgement.
- +Capable of giving signed informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
- +Participant must be 18 years or the legal age of consent in the jurisdiction in which the study is taking place, at the time of signing the informed consent.
- +Previously untreated histologically documented unresectable, locally advanced, or metastatic gastric, GEJ, or distal esophagus (distal third of the esophagus) adenocarcinoma
- +Positive CLDN18.2 expression, as determined prospectively by central IHC testing
- +Confirmed PD-L1 CPS status by central IHC testing and ICI eligibilityEligibility criteriaThe full list of requirements for taking part in a study.Read more → per investigator judgement is required to determine cohort eligibility as described below:
- +Cohort 2: PD-L1 negative as determined by central IHC testing OR the participant is ICI ineligible
- +Minimum life expectancy of ≥ 12 weeks.
- +At least one lesion (measurable and/or non-measurable) that can be accurately assessed by the investigator based on RECIST 1.1.
- +Adequate organ and bone marrow function as specified in the protocolProtocolThe detailed plan a study must follow.Read more →
- +Body weight ≥ 35 kg.
- +ECOG performance status of 0 or 1 with no deterioration to \> 1 over the previous 2 weeks prior to baselineBaselineYour starting measurements, taken before treatment begins.Read more → at screeningScreeningThe checks done before joining, to see whether a study fits.Read more → and prior to randomisationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →.
- +Sex and contraceptive requirements
Exclusion
- −Known HER2-positive status
- −Infectious disease including active hepatitis A infection; uncontrolled hepatitis B and/or chronic or active hepatitis B with HBV DNA ≥ 100 IU/mL; Known chronic, active, or uncontrolled hepatitis C; HIV infection that is not well controlled
- −Significant or unstable gastric bleeding and/or untreated gastric ulcers.
- −Active or history of autoimmune or inflammatory disorders requiring systemic treatment with steroids or other immunosuppressive treatment or assessed by investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → as not appropriate to participate due to undue risk are excluded.
- −CNS pathology
- −Clinically significant pleural effusions or ascites and/or pleural effusions or ascites that require drainage, peritoneal shunt, or indwelling catheter/drain.
- −Require parenteral nutrition support due to gastric or gastrointestinal obstruction.
- −Peripheral neuropathy, sensory or motor, ≥ CTCAE Grade 2 at screeningScreeningThe checks done before joining, to see whether a study fits.Read more →.
- −Persistent toxicities caused by previous anticancer therapy excluding alopecia, not yet improved to Grade ≤ 1 or baselineBaselineYour starting measurements, taken before treatment begins.Read more →.
- −Cardiac abnormalities as outlined in the protocolProtocolThe detailed plan a study must follow.Read more →
- −Uncontrolled diabetes or diabetic neuropathy within 3 months prior to randomisationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →.
- −Known partial or total DPD enzyme deficiency
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
What is being given or done in this study: Sonesitatug vedotin, Rilvegostomig, Nivolumab, Capecitabine, and 4 more.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
One group of people involved — usually the participants — is not told which treatment is which.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
There are 5 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 2,130 people.
The study is currently expected to finish around October 2031.
The main measurement is taken over: Up to approximately 5 years.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Progression Free Survival (PFS) (CohortCohortA group of participants sharing a characteristic, followed together.Read more → 1 and Cohort 2) — measured over Up to approximately 5 years.
Overall Survival (OS) (Cohort 1) — measured over Up to approximately 5 years.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07431281 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Sonesitatug vedotinDrug
Intravenous
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About RilvegostomigDrug
Intravenous
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About NivolumabDrug
Intravenous
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About CapecitabineDrug
Oral
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About 5-FluorouracilDrug
Intravenous
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About OxaliplatinDrug
Intravenous
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About ZolbetuximabDrug
Intravenous
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About LeucovorinDrug
Intravenous
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
One group of people involved — usually the participants — is not told which treatment is which.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Up to approximately 5 years.
The study as a whole is currently expected to finish around 2031-10-27.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 2,130 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 24 locations, including: Edmonton, Alberta, Canada; Abbotsford British Columbia, British Columbia, Canada; Vancouver, British Columbia, Canada; Winnipeg, Manitoba, Canada; Moncton, New Brunswick, Canada; Barrie, Ontario, Canada, and 18 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
The purpose of this study is to evaluate the efficacy and safety of sonesitatug vedotin in combination with capecitabine with or without rilvegostomig in first-line (1L) Claudin18.2 (CLDN18.2)-positive, human epidermal growth factor receptor 2 (HER2)-negative, gastric, gastroesophageal junction (GEJ), and esophageal adenocarcinoma.
Other Sites (16)
Research Site
Grand Rapids, Michigan, United States
Research Site
Burnsville, Minnesota, United States
Research Site
Duluth, Minnesota, United States
Research Site
Minneapolis, Minnesota, United States
Research Site
Rochester, Minnesota, United States
Research Site
New York, New York, United States
Research Site
New York, New York, United States
Research Site
New York, New York, United States
Research Site
New York, New York, United States
Research Site
The Bronx, New York, United States
Research Site
The Bronx, New York, United States
Research Site
White Plains, New York, United States
Research Site
Edmonds, Washington, United States
Research Site
Issaquah, Washington, United States
Research Site
Olympia, Washington, United States
Research Site
Seattle, Washington, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.