Accelerating Lung Cancer Diagnosis Through Liquid Biopsy

Study Overview
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Brief Summary
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This study will assess the utility of liquid biopsy to accelerate the time to treatment for patients with newly diagnosed advanced non-small cell lung cancer, compared to the conventional diagnostic pathway of molecular testing of tumour tissue after imaging and biopsy.

Official Title
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Accelerating Lung Cancer Diagnosis Through Liquid Biopsy

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Diagnostic Test: Liquid Biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Lung RAMP Multidisciplinary Cancer Conference or study team confirms radiologic (clinical) evidence of advanced, unresectable lung cancer; Measurable disease (presumed malignant) by RECIST 1.1; Age ≥18 years; Ability to provide written informed consent; Diagnostic biopsy and molecular profiling ordered or planned. Patients remain eligible even if biopsy or tumour testing later fails or is deemed not feasible. Exclusion Criteria: Pregnancy; Concurrent active malignancy except for localized non-melanomatous skin cancer or non-invasive cervical cancer. Any previous cancer (excluding NSCLC) must have been treated more than 2 years prior to study entry with no current evidence of active disease.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Advanced NSCLC<br>Patients with radiologic evidence of advanced (unresectable stage III or IV) non-small cell lung cancer | Diagnostic Test: Liquid Biopsy<br>* All patients will have a liquid biopsy with ctDNA molecular profiling<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to treatment | The time to treatment decision (TLB) in the study cohort by liquid (TL) and tissue biopsy (TB) is measured from the date of referral to the earliest date of receiving a liquid or tissue biopsy report indicating actionable genomic aberrations, or TLB = min (TL, TB). The time to treatment decision using tissue biopsy alone (TB) will be collected in a chart-review comparison cohort (patients referred in the previous 12 months that meet the eligibility criteria). The time to treatment decision by liquid biopsy (TLB) vs by tissue biopsy alone (TB) will be compared. | Up to 18 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to treatment - non-smoker subgroup | Measure the time to treatment, using the same parameters as the primary outcome measure, in a subgroup of patients with advanced non-squamous NSCLC with a smoking history of ≤15 pack years. | Up to 18 Months | 
| Turnaround time | Calculate the time (in days) from the date of request for testing to the report date for both liquid biopsy and tissue biopsy. | Up to 18 Months | 
| Concordance between liquid and tissue | Count the number of actionable targets identified by liquid biopsy and by tissue biopsy, by patient, that were in agreement. | Up to 18 Months | 
| Costs of upfront use of liquid biopsy vs standard tissue profiling | A cost-effectiveness model will be developed comparing the initial use of liquid biopsy versus the current standard of tissue biopsy and profiling. | Up to 24 Months |