Lung Cancer Early Molecular Assessment Trial

Study Overview
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Brief Summary
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The investigators hypothesize that an early molecular profiling, that includes both tissue and blood-bases analysis, for all NSCLC patients, including stage I-III, will increase diagnostic efficiency. When molecular profiles are available at an earlier stage of disease, more patients will benefit from personalized therapy once needed. This will result in both a better quality of life and outcome.

Detailed Description
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In this prospective multicentre trial tumours of all patients presenting with NSCLC will be profiled upfront, irrespective of disease stage and pathology using both tissue and blood-based genetic testing. A minimal molecular profiling is depicted but other targets will be included in due time. The study is divided in two parts. In the first part participating centres will have a run-in period of half a year in which molecular profiling is performed as is currently standard of care. This period will be used to measure the impact of increased awareness on the diagnostic process. During the second part of the study a comprehensive upfront profiling according to local standards will take place for all NSCLC patients. Liquid (blood) biopsies will be included in order to increase the diagnostic yield for those patients where tissue biopsies are not adequate. Patients will be treated according to standard of care, or included in clinical studies where appropriate. Re-biopsies (both tissue and liquid) will be advocated at the time of establishing disease progression/disseminated disease, and personalized therapy will be initiated according to the existing data from the molecular profiling.

Official Title
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Lung Cancer Early Molecular Assessment Trial

Conditions
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Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
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* Genetic: Liquid (blood) biopsies and tumor biopsy (optional)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Suspicion of lung carcinoma or established NSCLC but awaiting start of definitive treatment Written informed consent to undergo diagnostic procedure and molecular analysis of the disease. Exclusion Criteria: Not motivated to receive any treatment at any point in time. Patients who consider undergoing treatment in the future are eligible.

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

| Intervention/Treatment |
| --- |
|Genetic: Liquid (blood) biopsies and tumor biopsy (optional)|Liquid (blood) biopsies: 40 ml (maximal 10 times per patient) Tumor biopsy (optional)|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of patients with EGFR mutation or ALK translocation using the combined tumour tissue and liquid biopsy analysis | Patients with EGFR mutation or ALK translocation using the combined tumour tissue and liquid biopsy analysis | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Include the test performance of both techniques in different stage of disease | Test performance of both techniques in different stage of disease | 3 years | 
| The percentage of patients with a predefined actionable genetic alteration | Patients with a predefined actionable genetic alteration | 3 years | 
| The costs | The costs | 3 years | 
| The influence of the liquid biopsies on the diagnostic yield of tissue molecular and pathological analysis. | Liquid biopsies on the diagnostic yield of tissue molecular | 3 years |