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Resistance to Oral Therapy in Lung Cancer

NCT ID: NCT04546282

Last Updated: 2020-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-01

Study Completion Date

2020-11-28

Brief Summary

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In the management of non-small cell lung cancer of the adenocarcinoma type, different therapeutic strategies can be proposed. These strategies are defined according to the results of a biological analysis of blood and/or tissue samples from the lung tumor. Mutations in the tumor DNA are sought. Thus, patients with sensitizing mutations can benefit from a treatment with a 3rd generation tyroine kinase inhibitor (TKI) whose efficacy has been widely demonstrated. Patients without tumor mutations will not benefit. However, resistance to TKIs appears after a certain time, often linked to the appearance of new mutations in the tumor. For this reason, blood biologic analyses are regularly performed to search for the emergence of resistance mutations and to propose a therapeutic alternative as soon as possible.

These analyses are performed routinely in the laboratory. In the course of these analyses, the investigators have identified conventional mutations but also new mutations not previously described in the literature.

Our objective is to list all the molecular abnormalities revealed during blood biological analyses, to determine their frequency and to study whether certain abnormalities can be linked to resistance to TKI.

Detailed Description

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Conditions

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Non Small Cell Lung Cancer

Keywords

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3rd Tyrosine kinase inhibitor Cell free DNA Mutations

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Osimertinib treated patients

Patients with metastatic adenocarcinoma of the lung for whom a 3rd generation TKI therapy is proposed and a search for resistance mutation by blood analysis as part of the usual management.

Description of the molecular alterations detected in blood samples of patients treated by osimertinib

Intervention Type OTHER

Description of the molecular alterations detected in blood samples of patients treated by osimertinib. This test is usualyy performed routinely to detect conventional mutations including EGFR T790M. We performed panel of genes screeining based on next generation sequencing. Thius, iIn some cases, new mutations can be detected by this assay.

Interventions

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Description of the molecular alterations detected in blood samples of patients treated by osimertinib

Description of the molecular alterations detected in blood samples of patients treated by osimertinib. This test is usualyy performed routinely to detect conventional mutations including EGFR T790M. We performed panel of genes screeining based on next generation sequencing. Thius, iIn some cases, new mutations can be detected by this assay.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* advanced non-small cell lung cancer stage IIIB/IV
* Documentation of activating EGFR mutations (exon 19 deletions or exon 21 L858R substitution mutations) at the time of initial diagnosis
* Patient may receive up to one line of third EGFR TKI
* Plasma sample testing performed to detect EGFR TKI resistance

Exclusion Criteria

* Patients have other concurrent cancers
* Patients who are not eligible receive TKI
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jerome Solassol

Role: STUDY_DIRECTOR

UH Montpellier

Locations

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University Hospital

Montpellier, Hérault, France

Site Status

Countries

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France

Other Identifiers

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RECHMPL20_0519

Identifier Type: -

Identifier Source: org_study_id