Trial reportJournal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer2025
LIBELULE: A Randomized Phase III Study to Evaluate the Clinical Relevance of Early Liquid Biopsy in Patients With Suspicious Metastatic Lung Cancer.
Trial report in Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03721120 (A Randomized Phase III Clinical Trial to Evaluate the Feasibility and Clinical Relevance of Liquid Biopsy in Patients With Suspicious Metastatic Lung Cancer), which is not on this map. Cited by 19 papers.
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The trial behind it
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A Randomized Phase III Clinical Trial to Evaluate the Feasibility and Clinical Relevance of Liquid Biopsy in Patients With Suspicious Metastatic Lung Cancer
Who cites it
19 citing papers in PubMed.
- Decoding Brain Metastasis With Liquid Biopsy: Biomarkers and Technologies in EGFR-Mutant NSCLC.Cancer medicine · 2026Review
- Early liquid biopsy in advanced non-small cell lung cancer: insights from the LIBELULE trial.Translational lung cancer research · 2026Article
- Review
- Emerging Predictive Biomarkers of Immunotherapy Sensitivity in Patients with Non-Small Cell Lung Cancer.ImmunoTargets and therapy · 2026Review
- Circulating tumor DNA in lung cancer immunotherapy: prognostic marker today, predictive tool tomorrow?Frontiers in immunology · 2026Review
- Circulating tumor DNA as part of the routine work-up for patients with suspected advanced lung cancer.The journal of liquid biopsy · 2025Article
- Liquid biopsies across the cancer care continuum.Nature medicine · 2025Review
- Extending the clinical indications of liquid biopsy: plasma next-generation sequencing in suspected lung cancer.Translational lung cancer research · 2025Article
- Paving the way for ctDNA-guided trials in lung cancer: insights from the LIBELULE study.Translational lung cancer research · 2025Article
- Clinical Utility of ctDNA Analysis in Lung Cancer-A Review.Advances in respiratory medicine · 2025Review
- Clinical Utility of Combined Tissue and Plasma Next-Generation Sequencing in Patients With Advanced, Treatment-Naïve NSCLC.JTO clinical and research reports · 2025Article
- Clinical Utility of Liquid Biopsy for the Early Diagnosis of EGFR-Mutant Advanced Lung Cancer Patients in a Real-Life Setting (CLEAR Study).Current oncology (Toronto, Ont.) · 2025Article
- The Role of ctDNA in the Management of Non-Small-Cell Lung Cancer in the AI and NGS Era.International journal of molecular sciences · 2024Review
- Utilizing Plasma-Based Next-Generation Sequencing to Expedite the Diagnostic Process in Suspected Lung Cancer: A Case Report.International journal of molecular sciences · 2024Article
- Oncogenic alterations in advanced NSCLC: a molecular super-highway.Biomarker research · 2024Review
- Liquid Biopsy of Lung Cancer Before Pathological Diagnosis Is Associated With Shorter Time to Treatment.JCO precision oncology · 2024Article
- "Plasma-first" approach for molecular genotyping in non-small cell lung cancer: A narrative review.The journal of liquid biopsy · 2023Review
- Moving liquid biopsies to the Front-line of lung cancer treatment decisions.The journal of liquid biopsy · 2023Article
- Circulating tumor DNA in clinical trials for solid tumors: Challenges and current applications.The journal of liquid biopsy · 2023Review
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Authors and funding
24 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesGenomic profiling is a major component for first-line treatment decisions in patients with NSCLC and the timeliness of biomarker testing is essential to improve time to treatment initiation (TTI) or avoid inappropriate treatment.
methodsThe phase III LIquid Biopsy for the Early detection of LUng cancer Lesion trial (NCT03721120) included patients with radiological suspicion of advanced lung cancer. They were randomized (1:1), the control arm receiving diagnostic procedures according to each center's practice, and the liquid biopsy arm with additional testing performed at the first visit using the InVisionFirst-Lung assay. Treatment initiation and type were defined according to the European Society for Medical Oncology guidelines. Primary endpoint was the time from randomization to initiation of appropriate treatment on the basis of informative genomic and pathological results in the intention-to-treat population.
resultsA total of 319 patients were enrolled (liquid biopsy [LB]: 161; control: 158). The median age was 68 years, 28.8% were non-smokers, 18.1% had a performance status of 2 or higher, and 56.7% had adenocarcinoma. In the LB arm, 81% of patients had circulating tumor DNA findings. The mean TTI was not significantly reduced (LB: 29.0 d; control 34 d (p = 0.26)). Sensitivity analyses found a shorter TTI in patients from the LB arm who received systemic treatment (LB: 29.1 d; control: 38.9 d, p = 0.01), in patients with advanced non-squamous NSCLC (LB: 29.5 d; control: 40.3 d, p = 0.01), and in patients with first-line targetable alterations (LB: 21d; control 37.4 d) (p = 0.004). Time to contributory genomic results was significantly reduced (LB: 17.9 d; control: 25.6 d, p < 0.001).
conclusionEarly liquid biopsy testing did not significantly shorten the TTI in unselected patients referred for suspected advanced lung cancer. Nevertheless, it could reduce the TTI in patients eligible for systemic treatment, particularly for those with actionable alterations.
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