Evaluation of the Response to Tyrosine Kinase Inhibitors in Localized Non-small Cell Lung Cancer (NSCLC) Patients With EGFR Mutation in a Patient-derived Organoid Model (OS-TUMOVASC)

November 24, 2021 updated by: SEITLINGER Joseph, Central Hospital, Nancy, France

Lung cancer is a major public health problem and remains the leading cause of cancer mortality worldwide. Moreover, in France, it is the 3rd most common cancer in terms of incidence. Its prognosis remains poor despite the emergence of new therapies, notably the Epithelial Growth Factor Receptor (EGFR) specific tyrosine kinase inhibitors which can be used in patients with adenocarcinoma presenting an activating mutation of EGFR.

In addition, a number of questions remain regarding the use of these molecules, including the possibility of combining them with other therapies such as chemotherapy or radiotherapy. In addition, the duration of treatment with tyrosine kinase inhibitors is a matter of debate, mainly in localised forms (ADAURA trial). For this reason, we have proposed tests using TKIs on an in vitro platform based on organoid formation from tumour biopsies of NSCLC patients. This model will allow to test different molecules, in particular osimertinib which is a third generation tyrosine kinase inhibitor. In this way, it will be possible to evaluate in vitro responder patients within a timeframe compatible with the timeframe proposed by the INCA (4-6 weeks).

For non-responders, it will also be possible to screen them in vitro and seek the ideal alternative therapy. This model therefore aims to develop personalised medicine in thoracic oncology and could be used as a decision aid during multidisciplinary consultation meetings.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Lorraine
      • Vandoeuvre-lès-Nancy, Lorraine, France, 54500
        • Seitlinger

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients with non small cell lung cancer of any stage undergoing surgical resection at the Nancy University Hospital

Description

Inclusion Criteria:

  • age 18 years or older
  • patient affiliated to a social security scheme
  • having given their agreement to participate in the study
  • with non small cell lung cancer of any stage undergoing surgical resection at the Nancy University Hospital

Exclusion Criteria:

  • Refusal to participate
  • Hepatitis
  • HIV
  • Legal guardianship
  • Guardianship
  • Inability to give informed information to the patient
  • Pregnant women-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
General cohorte
patient with non-small cell lung cancer undergoing surgical resection in the thoracic surgery department of the Nancy CHRU
Other: Collection of surgical waste
collection of a fragment of healthy and tumorous lung tissue taken as part of the operating theatre procedure and normally destined to be destroyed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the in vitro efficacy of osimertinib in a patient-derived organoid model alone or in combination
Time Frame: from day 0 to day 30
Cell viability test
from day 0 to day 30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identify non-responders to osimertinib in vitro
Time Frame: from day 0 to day 30
Cell viability test
from day 0 to day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Collaborators

Institut de Cancérologie de Lorraine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2021

Primary Completion (Actual)

November 1, 2021

Study Completion (Anticipated)

November 1, 2022

Study Registration Dates

First Submitted

November 15, 2021

First Submitted That Met QC Criteria

November 24, 2021

First Posted (Actual)

November 26, 2021

Study Record Updates

Last Update Posted (Actual)

November 26, 2021

Last Update Submitted That Met QC Criteria

November 24, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021PI057

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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