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Opinion|Videos|April 13, 2026

LITESPARK-011 Trial Design and Endpoints

Author(s)Martin H. Voss, MD, Matthew T. Campbell, MD, MS

Episodes in this series

EP. 1 Framing LITESPARK-011 in a Changing RCC Landscape

EP. 1 Framing LITESPARK-011 in a Changing RCC Landscape

EP. 2 How Rapid Therapeutic Evolution Has Complicated RCC Sequencing

EP. 2 How Rapid Therapeutic Evolution Has Complicated RCC Sequencing

EP. 3 Selecting First-Line Therapy Based on Disease Biology and Risk

EP. 3 Selecting First-Line Therapy Based on Disease Biology and Risk

EP. 4 Treatment Intensity Tradeoffs and the Role of TKI Strategy

EP. 4 Treatment Intensity Tradeoffs and the Role of TKI Strategy

EP. 5 Targeting HIF-2 Alpha as a Novel Therapeutic Strategy

EP. 5 Targeting HIF-2 Alpha as a Novel Therapeutic Strategy

EP. 6 LITESPARK-011 Trial Design and Endpoints

EP. 6 LITESPARK-011 Trial Design and Endpoints

This segment reviews the design and statistical framework of the LITESPARK-011 trial. The study used dual primary endpoints of progression-free survival (PFS) and overall survival (OS), with a predefined allocation of type I error across endpoints to control statistical significance. Stratification factors included IMDC risk category, prior line of therapy, and geographic region, reflecting clinically relevant differences in patient populations. The discussion explains how the study incorporated interim analyses based on event-driven criteria, allowing for early evaluation of efficacy. Secondary endpoints included objective response rate, duration of response, safety, and patient-reported outcomes. The speakers highlight the importance of cabozantinib as an appropriate comparator, given its established role in the post-immunotherapy setting. This segment provides insight into how modern clinical trials are designed to capture multiple dimensions of treatment benefit while maintaining statistical rigor.

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