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Non-proportional hazards (NPH) have been observed recently in manyimmuno-oncology clinical trials. Weighted log-rank tests (WLRT) with suitablychosen weights can be used to improve the power of detecting the difference ofthe two survival curves in the presence of NPH. However, it is not easy tochoose a proper WLRT in practice when both robustness and efficiency areconsidered. A versatile maxcombo test was proposed to achieve the balance ofrobustness and efficiency and has received increasing attentions in bothmethodology development and application. However, survival trials often warrantinterim analyses due to its high cost and long duration. The integration andapplication of maxcombo tests in interim analyses often require extensivesimulation studies. In this paper, we propose a simulation-free approach forgroup sequential design with maxcombo test in survival trials. The simulationresults support that the proposed approaches successfully control both the typeI error rate and offer great accuracy and flexibility in estimating samplesizes, at the expense of light computation burden. Notably, our methods displaya strong robustness towards various model misspecifications, and have beenimplemented in an R package for free access online.

A Simulation-free Group Sequential Design with Max-combo Tests in the Presence of Non-proportional Hazards