ARTEMIDE-Lung02
Research type
Research Study
Full title
A Phase III, Randomized, Double-blind, Multicenter, Global Study of Rilvegostomig or Pembrolizumab in Combination with Platinum-based Chemotherapy for the First-line Treatment of Patients with Metastatic Squamous Non-small Cell Lung Cancer Whose Tumors Express PD-L1 (ARTEMIDE-Lung02)
IRAS ID
1010437
Contact name
Yehan Wijesinghe
Contact email
Sponsor organisation
AstraZeneca AB
Clinicaltrials.gov Identifier
Research summary
This is an AstraZeneca sponsored phase III, double-blind randomized study investigating the effectiveness and safety of rilvegostomig plus chemotherapy to that of pembrolizumab plus chemotherapy in metastatic squamous non-small cell lung cancer expressing PD-L1. Rilvegostomig may help your immune system to find and attack cancer cells blocking signaling from two molecules called PD-1 and TIGIT on cells of your immune system. Cancer cells use PD-1 and TIGIT to avoid being attacked by the immune system. This trial hypothesizes that the Rilvegostomig plus chemotherapy will improve treatment efficacy over standard therapy. The participants will be randomized in a 1:1 ratio on the two arms. Pembrolizumab or rilvegostomig plus chemotherapy will be administered for 4 cycles followed by maintenance with pembrolizumab or rilvegostomig until the discontinuation criteria are met. The chemotherapy is carboplatin plus paclitaxel or nab-paclitaxel (nanoparticle albumin-bound paclitaxel) depending on the decision of your doctor. In order to assess their eligibility to the trial, potential participants will undergo tests including blood, radiological exam (CT scan or MRI where applicable), cardiac function tests and physical exam. Some of these tests will be repeated to ensure treatment is tolerated and can be continued and to assess tumour response. This study will be conducted in approximately 350 sites, across 25-30 countries to dose 880 participants. Overall, the study duration will be approximately 59 months (event-driven).
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
24/NW/0268
Date of REC Opinion
21 Oct 2024
REC opinion
Further Information Favourable Opinion