Multicenter randomized phase 3 trial to evaluate the clinical relevance of early liquid biopsy in patients with suspected metastatic NSCLC

The multicenter phase 3 LIBELULE trial in France included patient with radiological suspicion of metastatic non-small cell lung cancer (mNSCLC) who were randomized 1:1 to diagnostic procedures according to each center’s practice (control group) or additional liquid biopsy testing at the first visit (LB group). The primary end point was time to treatment initiation (TTI). The mean TTI was not significantly reduced in the LB group versus the control group (29.0 versus 34.0 days; p=0.26), but was significantly reduced among patients receiving systemic treatment (29.1 versus 38.8 days; p=0.01), as well as among patients with non-squamous disease (29.5 versus 40.3 days; p=0.01), and among patients with first-line targetable alterations (21 versus 37.4 days; p=0.004). The authors conclude that early liquid biopsy testing did not significantly shorten TTI among unselected patients, but did shorten TTI in subgroups.