Correlation Between Early Trends of a Prognostic Biomarker and Overall Survival in Non-Small-Cell Lung Cancer Clinical Trials.

ABSTRACT:

Purpose

Overall survival (OS) is the primary end point in phase III oncology trials. Given low success rates, surrogate end points, such as progression-free survival or objective response rate, are used in early go/no-go decision making. Here, we investigate whether early trends of OS prognostic biomarkers, such as the ROPRO and DeepROPRO, can also be used for this purpose.

Methods

Using real-world data, we emulated a series of 12 advanced non-small-cell lung cancer (aNSCLC) clinical trials, originally conducted by six different sponsors and evaluated four different mechanisms, in a total of 19,920 individuals. We evaluated early trends (until 6 months) of the OS biomarker alongside early OS within the joint model (JM) framework. Study-level estimates of early OS and ROPRO t

SUBMITTER: Loureiro H 

PROVIDER: S-EPMC10730042 | biostudies-literature | 2023 Sep

REPOSITORIES: biostudies-literature