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

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

Status
Active
Cancer Type
Stomach/ Gastric Cancer
Unknown Primary
Trial Phase
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT06764875
Protocol IDs
D702AC00001 (primary)
NCI-2025-03123
2024-512583-57-00
Study Sponsor
AstraZeneca Pharmaceuticals LP

Summary

This is a Phase ?, 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.

Objectives

The purpose of this study is to assess 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.

This study will be conducted at up to 200-250 sites globally in approximately 25
countries.

Eligibility

  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 within 14 days before randomization.
  8. LVEF = 55% within 28 days before randomization.
  9. Adequate treatment washout period before randomization.

Treatment Sites in Georgia

Northwest Georgia Oncology Centers - Cobb Hospital (Hiram)


144 Bill Carruth Parkway
Suite 3100
Hiram, GA 30141
770-281-5131
www.ngoc.com

Northwest Georgia Oncology Centers - Douglasville


6002 Professional Parkway
Suite 140
Douglasville, GA 30134
770-281-5101
www.ngoc.com

Northwest Georgia Oncology Centers - Tanner Medical Center Villa Rica


157 Clinic Avenue
Suite 202
Carrollton, GA 30117
770-281-5101
www.ngoc.com

Northwest Georgia Oncology Centers (NGOC) - Cobb Hospital (Marietta)


340 Kennestone Hospital Blvd.
Suite 100
Marietta, GA 30060
770-281-5101


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