RecruitingHER2-positive Gastric CancerGastroesophageal Junction Adenocarcinoma

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

Eligible age

18+ yrs

Accepts

All genders

Locations

29 states

Healthy volunteers

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About this study

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. 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.

Sponsor: AstraZeneca

You may qualify if…

✓ 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.

You may not qualify if…

✕ 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.