Rilvegostomig for HER2-positive Gastric Cancer Treatment

A Phase Ⅲ Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan as the First-line Treatment for HER2-positive Gastric Cancer

Recruiting Phase 3 Interventional Study
HER2-positive Gastric Cancer Gastroesophageal Junction Adenocarcinoma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
840 (estimated)
Sponsor
AstraZeneca · Industry
Who this trial is looking for

This trial is looking for individuals with advanced stomach cancer that tests positive for HER2. Participants will receive a combination of rilvegostomig, chemotherapy, and other treatments to see how well it works.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have been diagnosed with HER2-positive gastric cancer
  • I have a PD-L1 score of at least 1
  • I can provide a tumor sample from a recent biopsy
  • I have not received previous treatment for my cancer
  • I have measurable cancer as confirmed by a doctor
  • I have good overall health with performance status of 0 or 1
  • I have normal organ function
  • My heart function is normal with LVEF of at least 50%

You may not be able to join if

  • I cannot eat or have issues with my digestive tract
  • I have a serious heart or mental health condition
  • I have an ongoing infection that needs IV treatment
  • I have a history of certain severe skin reactions to drugs
  • I have had any major surgery recently
  • I have been treated with immune-suppressing medications recently
  • I have active liver infections like HBV or HCV
  • I have a history of lung problems or autoimmune diseases

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
This is a Phase Ⅲ, randomized, open-label, Sponsor-blinded, 3-arm, global, multicenter study assessing the efficacy 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. Rilvegost…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. HER2 positive for gastric cancer on a tumor biopsy. 2. PD-L1 combined positive score (CPS) ≥ 1. 3. Provision of tumor tissue sample from recent biopsy adequate for HER2 and PD-L1 testing. 4. Previously untreated, unresectable, locally advanced or metastatic gastric or GEJ ade…
Contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

CONTACT