HARMONi-3
Research type
Research Study
Full title
A Randomized, Controlled, Multiregional Phase 3 Study of Ivonescimab Combined with Chemotherapy Versus Pembrolizumab Combined with Chemotherapy for the First-line Treatment of Metastatic Squamous Non-small Cell Lung Cancer (HARMONi-3)
IRAS ID
1008174
Contact name
Kathryn Fransen
Contact email
Sponsor organisation
Summit Therapeutics Inc
Clinicaltrials.gov Identifier
Research summary
This is a randomized Phase 3 study to investigate first-line treatment of metastatic squamous non-small cell lung cancer with Ivonescimab combined with chemotherapy verses Pembrolizumab combined with chemotherapy. Ivonescimab is a new investigational drug. The main purpose of this study is to compare the safety and effectiveness of the new treatment against the current standard treatment (Pembrolizumab combined with chemotherapy). Because doctors do not yet know which treatment is better, study participants are picked at random (called randomised) to get either the standard treatment or the new treatment. The chemotherapy drugs which will be used as part of the combination are carboplatin and paclitaxel or nab-paclitaxel. Ivonescimab (the study drug) is an engineered antibody that blocks two cancer-related targets in the body that help cancer cells live, grow, and spread. It is possible that the study drug may slow the growth and spread of cancer cells. About 400 participants will take part in this research across North America, Europe, and Asia.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
24/NW/0219
Date of REC Opinion
23 Aug 2024
REC opinion
Further Information Favourable Opinion