Clinical trial · Observational
PLAsma Genomic Testing in Patients With Advanced Non-Small Cell Lung Cancer: The PLAN Study
NCT05542485CI-TRIAL-00072322PLANunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a multi-centre, prospective, translational study investigating the use of plasma genotyping for initial genomic testing in newly diagnosed advanced/locally advanced non-squamous NSCLC. In this study, patients will have a plasma genotyping assay completed following confirmation of suspected diagnosis of non-squamous NSCLC at institutional Rapid Access Lung Cancer Clinics (RALCC), alongside standard tissue-based biopsy and genotyping.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ctDNA liquid biopsy - Roche Avenio Assay | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Time difference in days between the time of report of plsama genotyping result (next gen sequencing on ctDNA) versus the time to reporting of the tissue genotyping result (from a tissue biopsy sample)
- timeFrame
- 1 month
- description
- This will be calculated as such ; Time difference = (Number of days from the time of tissue biopsy to reporting of genomic result) - (Number of days from the time of liquid biopsy to result). The liquid biopsy and tissue biopsy will be completed on the same day.
Secondary outcomes (3)
- measure
- • Time difference between plasma genotyping and tissue genotyping initiation of treatment (time defined by primary endpoint) analysed as pairs with liquid and tissue biopsy
- timeFrame
- 1 month
- measure
- • Rate of genomic alterations identified by plasma genotyping assay.
- timeFrame
- 1 month
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Radiological suspicion of advanced or locally advanced non-small cell lung cancer 2. Age ≥18 years 3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 4. Ability of subject to understand and the willingness to sign a written informed consent document. Second arm additional criteria 5. Planned for systemic treatment with either single agent immunotherapy (IT) or combination chemotherapy/IT 6. No prior systemic therapy for advanced NSCLC Exclusion Criteria: 1. Squamous cell subtype NSCLC histology 2. Small cell carcinoma histology 3. Patients who have received systemic anti-cancer treatment
References
Publications (1)
- DERIVEDO'Reilly D, O'Grady A, Hayes C, Piggott L, Keane R, Fitzpatrick OM, Conroy M, Aretz NK, Synnott D, Dillon R, Dowling GP, Ryan DJ, O'Brien E, Morgan R, Breathnach O, Grogan L, Morris P, Greally M, Teo MY, Murphy A, Ryan G, Counihan I, Ryan C, Barrett H, O'Shea AM, Cuffe S, Korpanty G, Prior L, Barr MP, Finn S, O'Brien C, McCarron S, Cummins R, Toomey S, Dowling CM, Glavey S, Hennessy BT, Sorensen J, Bennett K, Nadarajan P, Doyle B, Naidoo J. Clinical benefit and cost of plasma-first next-generation sequencing in patients with newly diagnosed advanced non-small cell lung cancer in Ireland: The PLAN study. Eur J Cancer. 2025 Jul 25;225:115582. doi: 10.1016/j.ejca.2025.115582. Epub 2025 Jun 17. PMID 40578048