NCT06764875 · AstraZeneca
A Phase Ⅲ Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan as the First-line Treatment for HER2-positive Gastric Cancer
What this study is about
This is a Phase Ⅲ, randomly assigned, where both patients and doctors know the treatment given, Sponsor-blinded, 3-treatment group$1, global, conducted at multiple hospitals study assessing the effectiveness and safety of rilvegostomig in combination with fluoropyrimidine and T-DXd (treatment group$1 A) compared to trastuzumab, chemotherapy, and pembrolizumab (treatment group$1 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 treatment group$1 (treatment group$1 C) to
View original scientific description
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.
Interventions
DRUG
Rilvegostomig
Q3W, intravenous infusion
DRUG
Trastuzumab deruxtecan
Q3W, intravenous infusion
DRUG
Trastuzumab
Q3W, intravenous infusion
DRUG
Pembrolizumab
Q3W, intravenous infusion
DRUG
5-fluorouracil
Q3W, intravenous infusion
DRUG
Capecitabine
BID, oral administration
DRUG
Cisplatin
Q3W, intravenous infusion
DRUG
Oxaliplatin
Q3W, intravenous infusion
Primary outcome measures
Progression free survival (PFS)
Time frame: Up to approximately 6 years
PFS is defined as time from randomization until progression per RECIST v1.1, or death due to any cause.
Overall Survival (OS)
Time frame: Up to approximately 6 years
OS is defined as time from randomization until the date of death due to any cause.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 within 14 days before randomization.
- LVEF ≥ 55% within 28 days before randomization.
- Adequate treatment washout period before randomization.
Exclusion criteria
- Lack of physiological integrity of the upper gastrointestinal tract.
- Known dihydropyrimidine dehydrogenase enzyme deficiency.
- Contraindication to pembrolizumab or trastuzumab, contraindications to fluoropyrimidine (5-FU and capecitabine) or platinum (cisplatin and oxaliplatin) treatment as per local label.
Where
- Anchorage, Alaska
- Phoenix, Arizona
- Duarte, California
- Glendale, California
- La Jolla, California
- Los Alamitos, California
- Los Angeles, California
- Santa Monica, California
- Solvang, California
- Upland, California
- Walnut Creek, California
- Aurora, Colorado
And 39 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 16, 2026 · Source of record for eligibility and locations