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)

Central Hospital, Nancy, France

Status: Unknown

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

Treatments: Other: Collection of surgical waste

Study type: Observational

Funder types: Other

Identifiers

NCT05136014

2021PI057

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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-

Trial design

200 participants in 1 patient group

General cohorte

Description:

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

Treatment:

Other: Collection of surgical waste