ARTEMIDE-Lung04
Research type
Research Study
Full title
A Phase III, Randomized, Double-blind, Multicenter, Global Study of Rilvegostomig or Pembrolizumab Monotherapy for the First-line Treatment of Patients with PD-L1-high Metastatic Non small Cell Lung Cancer.
IRAS ID
1012168
Contact name
Venkat Chintapalli
Contact email
Sponsor organisation
AstraZeneca
Eudract number
2024-517780-24
Clinicaltrials.gov Identifier
Research summary
This is a Phase 3, randomized, double-blind trial study to find a better treatment for high PD-L1 metastatic non-small cell lung cancer (NSCLC).
In NSCLC, the body cannot control the growth of certain cells in the lungs, leading to tumour formation. High PD-L1 indicates that the tumours have elevated levels of the PD-L1 protein.
Currently, pembrolizumab is the first-line treatment for this condition. However, pembrolizumab is not effective for everyone with NSCLC.
The new drug being tested, rilvegostomig, is designed to enhance the immune system's ability to kill cancer cells by blocking two proteins on immune cells: PD-L1 and TIGIT.
Researchers believe rilvegostomig might be more effective than pembrolizumab as a first-line treatment for adults with high PD-L1 metastatic NSCLC. The trial aims to determine how well rilvegostomig works and how safe it is compared to pembrolizumab.
This Phase 3 trial involves randomly assigning participants to receive either rilvegostomig or pembrolizumab. The assignment is done by a computer program, and neither the participants nor the researchers will know which treatment each participant receives.
The trial will continue until the cancer progresses, participants experience significant medical issues, or they choose to leave the trial for other reasons.
The trial will include up to 830 participants who are at least 18 years old and have high PD-L1 metastatic NSCLC.
Participants must have PD-L1 proteins on more than half of their tumour cells, which is considered high PD-L1. They must not have certain genetic mutations that could reduce the effectiveness of the trial treatments.
Both rilvegostomig and pembrolizumab are administered through an intravenous (IV) infusion, where the drug is delivered directly into a vein over a period of time.
REC name
Wales REC 2
REC reference
25/WA/0182
Date of REC Opinion
28 Jul 2025
REC opinion
Further Information Favourable Opinion