Volume 24, Issue 4 e70024
MAIN PAPER

A General Approach for Sample Size Calculation With Nonproportional Hazards and Cure Rates

Huan Cheng

Corresponding Author

Huan Cheng

BeOne Medicines USA, California, USA

Correspondence:

Huan Cheng ([email protected])

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Xiaoyun Li

Xiaoyun Li

BeOne Medicines USA, California, USA

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Jianghua He

Jianghua He

Department of Biostatistics and Data Science, University of Kansas Medical Center, Kansas City, Kansas, USA

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First published: 06 July 2025

Funding: The authors received no specific funding for this work.

ABSTRACT

With the ongoing advancements in cancer drug development, a subset of patients can live quite long, or are even considered cured in certain cancer types. Additionally, nonproportional hazards, such as delayed treatment effects and crossing hazards, are commonly observed in cancer clinical trials with immunotherapy. To address these challenges, various cure models have been proposed to integrate the cure rate into trial designs and accommodate delayed treatment effects. In this article, we introduce a unified approach for calculating sample sizes, taking into account different cure rate models and nonproportional hazards. Our approach supports both the traditional weighted logrank test and the Maxcombo test, which demonstrates robust performance under nonproportional hazards. Furthermore, we assess the accuracy of our sample size estimation through Monte Carlo simulations across various scenarios and compare our method with existing approaches. Several illustrative examples are provided to demonstrate the proposed method.

Conflicts of Interest

The authors declare no conflicts of interest.

Data Availability Statement

Data sharing is not applicable. The code used for sample size calculation in Examples is provided in Appendix A. All functions required are available in the CRAN nphPower package [18].

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