Home › Trials › NCT06764875

New treatment for HER2-positive gastric cancer using rilvegostomig and chemotherapy

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)

Phase 3 Interventional AstraZeneca · NCT06764875

This study is testing a new treatment combining rilvegostomig with chemotherapy for people with HER2-positive gastric cancer to see if it works better than current standard treatments.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment840 (estimated)
Ages18 Years and up
SexAll
SponsorAstraZeneca Industry-sponsored
Drugs / interventionspembrolizumab, trastuzumab, CART, chemotherapy
Locations289 sites (Anchorage, Alaska and 288 other locations)
Trial IDNCT06764875 on ClinicalTrials.gov

What this trial studies

This Phase Ⅲ clinical trial evaluates the efficacy and safety of rilvegostomig combined with fluoropyrimidine and trastuzumab deruxtecan as a first-line treatment for patients with HER2-positive locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma. Participants will be randomly assigned to one of three treatment arms: the experimental combination, a standard treatment with trastuzumab and pembrolizumab, or a combination of trastuzumab and chemotherapy. The study aims to determine the effectiveness of the new treatment compared to existing therapies, with a focus on patients whose tumors express PD-L1. The trial will take place at multiple sites across approximately 25 countries.

Who should consider this trial

Good fit: Ideal candidates include adults with HER2-positive gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment and whose tumors express PD-L1 CPS ≥ 1.

Not a fit: Patients with contraindications to the study drugs or those with resectable disease may not benefit from this trial.

Why it matters

Potential benefit: If successful, this treatment could provide a more effective first-line option for patients with HER2-positive gastric cancer.

How similar studies have performed: Other studies have shown promising results with similar combinations of targeted therapies and chemotherapy in treating HER2-positive cancers.

Eligibility criteria

Show full inclusion / exclusion 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 adenocarcinoma.
5. WHO or Eastern Cooperative Oncology Group performance status of 0 or 1.
6. Have measurable target disease assessed by the Investigator based on RECIST v1.1.
7. Have adequate organ and bone marrow function.
8. LVEF ≥ 50% within 28 days before randomization.
9. Adequate treatment washout period before randomization.

Exclusion Criteria:

1. Lack of physiological integrity of the upper gastrointestinal tract.
2. Known dihydropyrimidine dehydrogenase enzyme deficiency.
3. Contraindication to pembrolizumab or trastuzumab, contraindications to fluoropyrimidine (5-FU and capecitabine) or platinum (cisplatin and oxaliplatin) treatment as per local label.
4. History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 3 years before the first dose of study intervention and of low potential risk for recurrence.
5. Persistent toxicities caused by previous anti-cancer therapy.
6. Spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring corticosteroid or anticonvulsant may be included in the study if they have recovered from the acute toxic effect of radiotherapy.
7. Uncontrolled infection including tuberculosis and active hepatitis A infection.
8. Uncontrolled infection requiring intravenous (IV) antibiotics, anti-virals, or antifungals.
9. Recent receipt of live, attenuated vaccine.
10. Chronic/active HBV or HCV infection unless controlled.
11. Clinically significant cardiac or psychological conditions.
12. Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment.
13. History of (non-infectious) ILD/pneumonitis, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
14. Lung-specific intercurrent clinically significant illnesses.
15. Any active non-infectious skin disease requiring systemic treatment.
16. A pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or cell-free and concentrated ascites reinfusion therapy (CART).
17. History of any of the following: drug-induced severe cutaneous adverse reaction.
18. Any concurrent antic-ancer treatment with the exception of receptor activator of nuclear factor kappa-B ligand inhibitors.
19. Have had major surgical procedure recently (excluding placement of vascular access) or recent significant traumatic injury or an anticipated need for major surgery during the study.
20. Current or prior use of immunosuppressive medication within 14 days before study intervention.

Where this trial is running

Anchorage, Alaska and 288 other locations

+239 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions HER2-positive Gastric CancerGastroesophageal Junction Adenocarcinoma
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.