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

NCT ID: NCT05136014

Last Updated: 2021-11-26

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-11-01
• Study Completion Date: 2022-11-01

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

General cohorte

patient with non-small cell lung cancer undergoing surgical resection in the thoracic surgery department of the Nancy CHRU

Collection of surgical waste

Intervention Type: 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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut de Cancérologie de Lorraine

OTHER

Sponsor Role: collaborator

Central Hospital, Nancy, France

OTHER

Sponsor Role: lead

Responsible Party

SEITLINGER Joseph

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Seitlinger

Vandœuvre-lès-Nancy, Lorraine, France

Countries

France

Other Identifiers

2021PI057

Identifier Type: -

Identifier Source: org_study_id