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PLAsma Genomic Testing in Patients With Advanced Non-Small Cell Lung Cancer: The PLAN Study (PLAN)

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ClinicalTrials.gov Identifier: NCT05542485
Recruitment Status : Not yet recruiting
First Posted : September 15, 2022
Last Update Posted : September 15, 2022
Information provided by (Responsible Party):
Royal College of Surgeons, Ireland

Brief Summary:

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.

Condition or disease Intervention/treatment
Non-small Cell Lung Cancer Diagnostic Test: ctDNA liquid biopsy - Roche Avenio Assay

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Study Type : Observational
Estimated Enrollment : 97 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: PLAsma Genomic Testing in Patients With Advanced Non-Small Cell Lung Cancer: The PLAN Study
Estimated Study Start Date : October 1, 2022
Estimated Primary Completion Date : October 1, 2022
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy Lung Cancer

Intervention Details:
  • Diagnostic Test: ctDNA liquid biopsy - Roche Avenio Assay
    The intervention will involve plasma ctDNA testing for patients with a radiological suspicion for newly diagnosed advanced NSCLC

Primary Outcome Measures :
  1. 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) [ Time Frame: 1 month ]
    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 Outcome Measures :
  1. • Time difference between plasma genotyping and tissue genotyping initiation of treatment (time defined by primary endpoint) analysed as pairs with liquid and tissue biopsy [ Time Frame: 1 month ]
  2. • Rate of genomic alterations identified by plasma genotyping assay. [ Time Frame: 1 month ]
  3. • Pattern of actionable genomic mutations alterations on plasma genotyping assay. [ Time Frame: 1 month ]

Biospecimen Retention:   Samples With DNA
We will be collecting cell free DNA from patients an one time point. These samples will be collected in EDTA tubes and stores for a maximum of 10 years from collection.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with a radiological suspicion of a new diagnosis of stage IV NSCLC will be considered for inclusion in this study

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
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Responsible Party: Royal College of Surgeons, Ireland
ClinicalTrials.gov Identifier: NCT05542485    
Other Study ID Numbers: 22193A01
First Posted: September 15, 2022    Key Record Dates
Last Update Posted: September 15, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms