Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 3interventionalRules rewrite

Phase 3: testing Rilvegostomig for HER2-positive Gastric Cancer

This is a Phase Ⅲ, randomly assigned, open-label, Sponsor-blinded, 3-arm, global, multicenter study assessing the how well it works and safety of rilvegostomig in combination with fluoropyrimidine and T-DXd (Arm A) compared to trastuzumab, chemotherapy, and pembrolizumab (Arm B) in HER2-positive locally advanced or metastatic gastric or GEJ adenocarcinoma participants whose tumors express PD L1 CPS ≥ 1. Rilvegostomig in combination with trastuzumab and chemotherapy will be evaluated in a separate arm (Arm C) to assess the contribution of each component in the experimental arm.

Official registry: https://clinicaltrials.gov/study/NCT06764875 · AstraZeneca · enrollment listed as 840

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Rilvegostomig, Trastuzumab deruxtecan, or Trastuzumab. The registry lists allocation as randomized. This is a Phase Ⅲ, randomly assigned, open-label, Sponsor-blinded, 3-arm, global, multicenter study assessing the how well it works and safety of rilvegostomig in combination with fluoropyrimidine and T-DXd (Arm A) compared to trastuzumab, chemotherapy, and pembrolizumab (Arm B) in HER2-positive locally advanced or metastatic gastric or GEJ adenocarcinoma participants whose tumors express PD L1 CPS ≥ 1.

They plan to enroll about 840 people at 259 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Randomized, Phase Ⅲ Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan Versus Trastuzumab, Chemotherapy, and Pembrolizumab for the First Line Treatment of HER2-positive Gastric Cancer (ARTEMIDE-Gastric01)

Interventions: Rilvegostomig, Trastuzumab deruxtecan, Trastuzumab, Pembrolizumab, 5-fluorouracil, Capecitabine, Cisplatin, Oxaliplatin

Primary outcome (registry wording): Progression free survival (PFS)

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • HER2 positive for gastric cancer on a tumor biopsy
  • PD-L1 combined positive score (CPS) ≥ 1
  • Provision of tumor tissue sample from recent biopsy adequate for HER2 and PD-L1 testing
  • Previously untreated, unresectable, locally advanced or metastatic gastric or GEJ adenocarcinoma
  • WHO or Eastern Cooperative Oncology Group performance status of 0 or 1
  • Have measurable target disease assessed by the Investigator based on RECIST v1.1
  • Have adequate organ and bone marrow function

Public study contact (from the registry)

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

259 listed

+ 205 sites outside the US on the same record

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FAQ about this NCT record

Is NCT06764875 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06764875?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06764875?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary