NGS Genome Analysis in Personalisation of Lung Cancer Treatment

Not Applicable

Completed

• Conditions: Lung Cancer
• Interventions: Other: blood sample, biopsy

• Registration Number: NCT02281214
• Lead Sponsor: Centre Georges Francois Leclerc

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-10-23
• Study Start: 2014-10-24
• Study First Submitted QC: 2014-10-30
• Study First Posted: 2014-11-02
• Primary Completion: 2014-11-17
• Study Completion: 2018-11-17
• Status Verified: 2018-12
• Last Update Submitted: 2019-01-02
• Last Update Posted: 2019-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 165

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
blood sample, biopsy	blood sample, biopsy	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
comparison of genome profiles (mutations and rearrangements)	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	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
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

Trial Locations

Locations (1)

Centre Georges François Leclerc; 🇫🇷 Dijon, France