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

NCT05136014 | Unknown

• 1 other identifier: 2021PI057
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Cancer; Lung Adenocarcinoma; EGFR Activating Mutation; KRAS Mutation-Related Tumors; Non Small Cell Lung Cancer

Keywords

tyrosine kinase inhibitors; Lung adenocarcinoma; EGFR activating mutation; KRAS Mutation-related tumors

Outcome Measures

Primary Outcomes (1)

• Evaluation of the in vitro efficacy of osimertinib in a patient-derived organoid model alone or in combination

  Cell viability test

  from day 0 to day 30

Secondary Outcomes (1)

• Identify non-responders to osimertinib in vitro

  from day 0 to day 30

Study Arms (1)

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

Interventions

Collection of surgical waste OTHER

collection of a fragment of healthy and tumorous lung tissue taken as part of the operating theatre procedure and normally destined to be destroyed

General cohorte

Eligibility Criteria

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

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead
• Institut de Cancérologie de Lorraine: collaborator

Study Sites (1)

Seitlinger

Vandœuvre-lès-Nancy, Lorraine, 54500, France

Location

MeSH Terms

Conditions

Lung Neoplasms; Adenocarcinoma of Lung; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Carcinoma, Bronchogenic; Bronchial Neoplasms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 15, 2021
• First Posted: November 26, 2021
• Study Start: November 1, 2021
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2022
• Last Updated: November 26, 2021

Record last verified: 2021-11

Locations

FR (1)