ARTEMIDE-Gastric01
Research type
Research Study
Full title
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)
IRAS ID
1010116
Contact name
Niloufar Davoudi
Contact email
Sponsor organisation
AstraZeneca AB
Research summary
Researchers are looking for a better way to treat HER2-positive, PD-L1 positive stomach cancer.
HER2 is a protein that causes certain cancer cells to grow and spread faster. PD-L1 proteins can help the cancer cells hide from the immune system and stay alive for longer. The standard treatment for HER2-positive stomach cancer that cannot be treated by surgery is combination of HER2-targeted therapy, immunotherapy that inactivates the effect of PD-L1, and two chemotherapy drugs.
The trial drug trastuzumab deruxtecan (T-DXd) is a targeted therapy that is designed to find and kill tumor cells that have the HER2 protein. Researchers think that T-DXd can also be used instead of one of the drugs in doublet chemotherapy. The trial drug rilvegostomig is an immunotherapy drug designed to block PD-L1 proteins and help the immune system kill cancer cells.
The researchers think that T-DXd combined with rilvegostomig and one standard chemotherapy drug can help treat HER2-positive PD-L1 positive stomach cancer. They want to know how well this treatment combination works and how safe it is compared to the standard treatment.
This trial currently has 2 groups, some participants will receive T-DXd combined with rilvegostomig and one chemotherapy drug (Group 1) and some will receive standard treatment combination of HER2-targeted therapy (trastuzumab), immunotherapy (pembrolizumab), and two chemotherapy drugs (Group 2).
The drugs are given through a needle directly into a vein over a period of time (IV infusion) except for one of the chemotherapy drugs (capecitabine), which is taken as tablets by mouth.
AstraZeneca is the sponsor of this trial, and patients will be recruited from geographic region Asia/Americas/ European Union/Rest of world. This trial will include about 560 participants. All participants in this trial will be 18 years of age or older with stomach cancer that has HER2 and PD-L1 proteins.REC name
South Central - Oxford B Research Ethics Committee
REC reference
24/SC/0292
Date of REC Opinion
17 Oct 2024
REC opinion
Further Information Favourable Opinion