Evaluation of the Response to Tyrosine Kinase Inhibitors in Localized Non-small Cell Lung Cancer (NSCLC) Patients With EGFR Mutation in a Patient-derived Organoid Model

Study Overview
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Brief Summary
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Lung cancer is a major public health problem and remains the leading cause of cancer mortality worldwide. Moreover, in France, it is the 3rd most common cancer in terms of incidence. Its prognosis remains poor despite the emergence of new therapies, notably the Epithelial Growth Factor Receptor (EGFR) specific tyrosine kinase inhibitors which can be used in patients with adenocarcinoma presenting an activating mutation of EGFR. In addition, a number of questions remain regarding the use of these molecules, including the possibility of combining them with other therapies such as chemotherapy or radiotherapy. In addition, the duration of treatment with tyrosine kinase inhibitors is a matter of debate, mainly in localised forms (ADAURA trial). For this reason, we have proposed tests using TKIs on an in vitro platform based on organoid formation from tumour biopsies of NSCLC patients. This model will allow to test different molecules, in particular osimertinib which is a third generation tyrosine kinase inhibitor. In this way, it will be possible to evaluate in vitro responder patients within a timeframe compatible with the timeframe proposed by the INCA (4-6 weeks). For non-responders, it will also be possible to screen them in vitro and seek the ideal alternative therapy. This model therefore aims to develop personalised medicine in thoracic oncology and could be used as a decision aid during multidisciplinary consultation meetings.

Official Title
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Evaluation of the Response to Tyrosine Kinase Inhibitors in Localized Non-small Cell Lung Cancer (NSCLC) Patients With EGFR Mutation in a Patient-derived Organoid Model

Conditions
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Lung Cancer, Lung Adenocarcinoma, EGFR Activating Mutation, KRAS Mutation-Related Tumors, Non Small Cell Lung Cancer

Intervention / Treatment
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* Other: Collection of surgical waste


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18 years or older patient affiliated to a social security scheme having given their agreement to participate in the study with non small cell lung cancer of any stage undergoing surgical resection at the Nancy University Hospital Exclusion Criteria: Refusal to participate Hepatitis HIV Legal guardianship Guardianship Inability to give informed information to the patient Pregnant women-

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 |
| --- | --- |
| General cohorte<br>patient with non-small cell lung cancer undergoing surgical resection in the thoracic surgery department of the Nancy CHRU | Other: Collection of surgical waste<br>* collection of a fragment of healthy and tumorous lung tissue taken as part of the operating theatre procedure and normally destined to be destroyed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the in vitro efficacy of osimertinib in a patient-derived organoid model alone or in combination | Cell viability test | from day 0 to day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify non-responders to osimertinib in vitro | Cell viability test | from day 0 to day 30 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tyrosine kinase inhibitors, Lung adenocarcinoma, EGFR activating mutation, KRAS Mutation-related tumors