STELLAR-304: a phase III study of zanzalintinib (XL092) plus nivolumab in advanced non-clear cell renal cell carcinoma
Year: 2025
Type: article
Abstract: Management of advanced non-clear cell renal cell carcinoma (nccRCC) is challenging due to disease rarity and heterogeneity. The combination of multi-targeted tyrosine kinase inhibitor (TKI) with immune checkpoint inhibitor (ICI) has emerged as an effective treatment strategy, but well-designed, phase III randomized clinical trials are needed to demonstrate superiority over current treatment options. Zanzalintinib is a novel, multi-targeted TKI that has demonstrated promising preclinical anti-tumor activity in combination with ICIs. STELLAR-304 is a phase III trial evaluating first-line zanzalintinib plus nivolumab versus sunitinib in advanced nccRCC. Primary endpoints are progression-free survival and objective response rate. Secondary endpoint is overall survival. To our knowledge, STELLAR-304 is the first phase III study assessing a TKI-ICI combination in nccRCC patients across multiple subtypes.Clinical Trial Registration: This trial is registered at ClinicalTrials.gov (identifier: NCT05678673)
Source: Future Oncology
Institutions: City Of Hope National Medical Center, City of Hope, St Bartholomew's Hospital, Barts Health NHS Trust, National Cancer Centre Singapore, Hospital Universitario Ramón y Cajal, Memorial Sloan Kettering Cancer Center, University Hospitals Seidman Cancer Center, Bristol-Myers Squibb (United States), Exelixis (United States), Vall d'Hebron Hospital Universitari
Language: English
Subfield: Pulmonary and Respiratory Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Funders: Exelixis, National Cancer Institute
Award: Cancer Center Support Grant
OpenAlex ID: W4407979652