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)
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)
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.
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.
Inclusion Criteria:
Exclusion Criteria:
information.center@astrazeneca.com1-877-240-9479
Ciudad Autónoma Buenos Aires, C1430EFA, Argentina
Ciudad de Buenos Aires, 1280, Argentina
Akashi-shi, 673-8558, Japan
Hidaka-shi, 350-1298, Japan
Hirakata-shi, 573-1191, Japan
Kasama-shi, 309-1793, Japan
Kita-gun, 761-0793, Japan
Kitaadachi-gun, 362-0806, Japan
Osakasayama-shi, 589-8511, Japan
Ota-shi, 373-8550, Japan
Shiwa-gun, 028-3695, Japan
Suita-shi, 565-0871, Japan
Sunto-gun, 411-8777, Japan
Toyoake-shi, 470-1192, Japan
Jeonnam, 519-763, South Korea
Banphaeo, 74120, Thailand
Muang, 22000, Thailand
Hồ Chí Minh, 700000, Vietnam