Resistance to Oral Therapy in Lung Cancer

NCT04546282 | Completed

• 1 other identifier: RECHMPL20_0519
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non Small Cell Lung Cancer

Keywords

3rd Tyrosine kinase inhibitor; Cell free DNA; Mutations

Outcome Measures

Primary Outcomes (1)

• Description of the molecular alterations detected in patients treated with 3rd TKI and assessment link with progression free survival and overall survival features.

  This retrospective study will collate the molecular alterations detected during routine analysis. The elements extracted from the file will be age, sex, type of tumor and clinical-histological characteristics, dates of diagnosis and start of treatment. In addition, information on the dates of appearance of resistances (radiographic or clinical) will also be provided. No additional analysis will be performed since the study will consist of the analysis of data generated by the analyses performed in the context of patient management and biological monitoring. This research does not aim to modify your care. There will be no additional consultation or examination, nor will there be any changes in the treatment prescribed by your doctor.

  The analysis of the TKI effectiveness and the appearance of mutations will be performed over a period of 24 months.

Secondary Outcomes (1)

• Frequency of detected molecular alterations

  The analysis of the TKI effectiveness and the appearance of mutations will be performed over a period of 24 months.

Study Arms (1)

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.

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

Interventions

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

Osimertinib treated patients

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with metastatic adenocarcinoma

You may qualify if:

• 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

You may not qualify if:

• Patients have other concurrent cancers
• Patients who are not eligible receive TKI

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

University Hospital

Montpellier, Hérault, 34000, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

cell free DNA extracted from blood

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jerome Solassol

  UH Montpellier

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2020
• First Posted: September 14, 2020
• Study Start: July 1, 2017
• Primary Completion: July 1, 2020
• Study Completion: November 28, 2020
• Last Updated: December 29, 2020

Record last verified: 2020-12

Locations

FR (1)