NGS Genome Analysis in Personalisation of Lung Cancer Treatment

Study Overview
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Brief Summary
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The identification of driver mutations in the epidermal growth factor receptor (EGFR) as the primary oncogenic event in a subset of lung adenocarcinomas led to a model of targeted treatment and genetic profiling of the disease. EGFR tyrosine kinase inhibitors (TKIs) confer remission in some patients, but use of the EGFR-TKIs is limited to patients with adenocarcinomas who have known activating EGFR mutations. And resistance to TKI treatment has become an increasingly important cause of treatment failure. Therefore, identification of the molecular components involved could lead to the development of effective therapy. Today only a limited number of genetic alterations are studied. Next Generation Sequencing (NGS) has the potential of becoming an important tool in clinical and therapeutic decision-making in oncology owing to its enhanced sensitivity in DND mutation detection.

Official Title
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Genome Analysis by Next Generation Sequencing in Personalisation of Lung Cancer Treatment

Conditions
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Lung Cancer

Intervention / Treatment
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* Other: blood sample, biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients of bronchial adénocarcinoma with metastases can benefit from first-line therapy - targeted therapy by tyrosine kinase inhibitor(TKI) for EGFR mutation and chemotherapy for non EGFR mutation) Patients with epidermoid cancer of the lungs can benefit from chemotherapy man and women age ≥ 18 years Patients have signed a written informed consent form Patients are affiliated to s social health insurance Exclusion Criteria: Survival time ≤ 3 months Patients with cerebral metastases Patients could not benefit from treatment for others diseases Pregnancy or breast-feeding Incapacity to sign the consent form for psychiatric, behavioural disorders Private individuals of freedom or under tutelage

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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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: blood sample, biopsy<br> | Other: blood sample, biopsy<br>* Blood samples and tumor biopsies will taken from patients before treatment and when tumor progression on therapy for Next Generation Sequencing (NGS) mutation analysis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| search for EGFR, KRAS, BRAF, PIK3CA, HER2, ERBB2, AKT1... mutations and ALK, ROS rearrangements by NGS |  | search for EGFR, KRAS, BRAF, PIK3CA, HER2, ERBB2, AKT1,... mutations and ALK , ROS rearrangements by NGS methods before treatment and when tumor progression in patients with first line metastatic lung cancer therapy (chimiotherapy, targeted therapy) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparison of genome profiles (mutations and rearrangements) | To compare gene profiles (EGFR, KRAS, BRAF, PIK3CA, HER2, ERBB2, AKT1, APC, ... mutations and ALK , ROS rearrangements) in primary lung tumors before treatment and when tumor progression on therapy according to treatment groups (targeted therapy for EGFR mutation and chemotherapy for non EGFR mutation) using NGS methods | comparison of genome profiles (EGFR, KRAS, BRAF, PIK3CA, HER2, ERBB2, AKT1, ...mutations and ALK , ROS rearrangements) between targeted therapy for EGFR mutation and chemotherapy for non EGFR mutation | 
| tumor genetic profile (EGFR, KRAS, BRAF, PIK3CA, HER2, ERBB2, AKT1, APC, ... mutations and ALK , ROS rearrangements) and circulating DNA genetic profile (EGFR, KRAS, BRAF, PIK3CA, HER2, ERBB2, AKT1, APC, ... mutations and ALK , ROS rearrangements) |  | To compare tumor genetic profile (EGFR, KRAS, BRAF, PIK3CA, HER2, ERBB2, AKT1, APC, ... mutations and ALK , ROS rearrangements) with circulating DNA genetic profile (EGFR, KRAS, BRAF, PIK3CA, HER2, ERBB2, ...mutations and rearrangements using NGS methods | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lung cancer, mutations, patients, mutations