Liquid biopsy at diagnosis for advanced NSCLC
Official title: Impatto Della Biopsia Liquida Sul Percorso Terapeutico Del Tumore al Polmone: Anticipare la Caratterizzazione Molecolare Dei Pazienti Con Adenocarcinoma Del Polmone in Stadio Avanzato Integrando la Biopsia Liquida Nella Fase Iniziale Del Percorso Diagnostico-terapeutico
Run by Regina Elena Cancer Institute · NCT07649629 · Data updated 2026-11-12
We’re testing whether a blood test (liquid biopsy) done early can speed up getting usable molecular information for adults with suspected advanced NSCLC.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 70 (estimated) |
| Sponsor | Regina Elena Cancer Institute Academic / other |
| Locations | 1 site (Roma, RM) |
| Status | Recruiting |
| Started | September 1, 2025 |
| Main results expected | March 1, 2027 |
| Study ends | March 1, 2027 |
| Registry record updated | June 16, 2026 |
| Trial ID | NCT07649629 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with suspected locally advanced or metastatic NSCLC, ECOG 0–1, and a planned or already performed tissue biopsy but without a confirmed NSCLC diagnosis at enrollment.
✕Probably not a fit
Patients without actionable targets or whose standard diagnostics already provide timely information may not benefit from the liquid biopsy approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter observational pilot study will enroll about 70 adults with radiological signs of locally advanced or metastatic NSCLC. Participants will have a blood draw for plasma-derived DNA and RNA analysis within a week of the first clinical assessment, while the standard diagnostic workup proceeds (including tissue biopsy when indicated). Researchers will compare blood-based results with tissue results to see how well they align and whether the blood test provides earlier molecular insights to guide therapy. The study is non-interventional and does not replace standard diagnostics.
Why it matters
Potential benefit: If successful, liquid biopsy could provide faster molecular information to guide treatment decisions for advanced NSCLC.
How similar studies have gone: Other studies have shown that liquid biopsy can reflect tumor genomics, supporting feasibility and concordance with tissue testing in NSCLC, though this remains an area of ongoing validation.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years. * Radiological suspicion of locally advanced lung cancer not amenable to locoregional treatment or metastatic lung cancer (stage III-IV). * Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1. * Tissue biopsy and/or cytological sampling planned but not yet performed, or already performed without an available histopathological diagnosis of non-small cell lung cancer (NSCLC). * Written informed consent for study participation and personal data processing obtained before any study-specific procedure. Exclusion Criteria: * Previous or current history of non-small cell lung cancer (NSCLC). * Histopathological diagnosis of NSCLC already available following tissue biopsy. * Eligibility for surgical removal of tumor tissue. * Ongoing or previous systemic oncological treatment for lung cancer.
Where it's running
-
IFO-IRE, Istituto Nazionale Tumori Regina Elena
Roma, Rm, Italy Recruiting
Study contacts
- Principal investigator: Federico Cappuzzo, MD — IFO-IRE, Istituto Nazionale Tumori Regina Elena
- Study coordinator: Maristella Giammaruco, MD
- Email: maristella.giammaruco@ifo.it
- Phone: +39 06 5266 5698
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.