Evaluating Circulating Tumor DNA Clearance as an Early Intermediate End Point Predicting Clinical Benefit in Metastatic Nonsquamous NSCLC After First-Line Chemoimmunotherapy.

ABSTRACT:

Introduction

In the first-line (1L) NSCLC setting, overall survival (OS) as a trial end point is increasingly challenging due to longer survival and confounding from novel later-line therapies. This study aims to evaluate whether circulating tumor DNA (ctDNA) clearance (alone or with radiographic response) is a reliable early surrogate end point for progression-free survival (PFS) and OS in 1L NSCLC studies.

Methods

Data from a phase III trial (IMpower150) of patients with untreated metastatic nonsquamous NSCLC were used. ctDNA clearance, unconfirmed radiographic response, and confirmed radiographic response at approximately 6 months after treatment were evaluated as surrogates for PFS and OS. The meta-analytic approaches were used. The data were randomly split into four coh

SUBMITTER: Yuan M 

PROVIDER: S-EPMC12629878 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature