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OpenTrials
Completed

NCT Number: NCT04546282

Resistance to Oral Therapy in Lung Cancer

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital

Montpellier, Hérault, 34000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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

    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.

Secondary outcomes

  1. Frequency of detected molecular alterations

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

    Frequency of detected molecular alterations

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Acronym: RESTKI

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Sep 14, 2020
Registry last updated
Dec 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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