Resistance to Oral Therapy in Lung Cancer

Non Small Cell Lung Cancer Clinical Trial

— RESTKI  

Official title:

Mechanisms of Resistance to 3rd Generation Thyrosine Kinase Inhibitors in Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04546282
• Other study ID #: RECHMPL20_0519
• Status: Completed
• Start date: July 1, 2017
• Est. completion date: November 28, 2020

Study information

• Verified date: December 2020
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 28, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Other:
• 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.

Locations

Country	Name	City	State
France	University Hospital	Montpellier	Hérault

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Frequency of detected molecular alterations	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.