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

• Conditions: KRAS Mutation-Related Tumors; Lung Cancer; Non Small Cell Lung Cancer; Lung Adenocarcinoma; EGFR Activating Mutation
• Interventions: Other: Collection of surgical waste

• Registration Number: NCT05136014
• Lead Sponsor: Central Hospital, Nancy, France

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-11
• Study Start: 2021-11-01
• Primary Completion: 2021-11-01
• Study First Submitted: 2021-11-15
• Study First Submitted QC: 2021-11-24
• Last Update Submitted: 2021-11-24
• Study First Posted: 2021-11-26
• Last Update Posted: 2021-11-26
• Study Completion: 2022-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
General cohorte	Collection of surgical waste	patient with non-small cell lung cancer undergoing surgical resection in the thoracic surgery department of the Nancy CHRU

Primary Outcome Measures

Name	Time	Method
Evaluation of the in vitro efficacy of osimertinib in a patient-derived organoid model alone or in combination	from day 0 to day 30	Cell viability test

Secondary Outcome Measures

Name	Time	Method
Identify non-responders to osimertinib in vitro	from day 0 to day 30	Cell viability test

Trial Locations

Locations (1)

Seitlinger; 🇫🇷 Vandoeuvre-lès-Nancy, Lorraine, France