Clinical trial NCT05136014: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
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
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
Collaborators: name: Institut de Cancérologie de Lorraine
First posted: 2021-11-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with non small cell lung cancer of any stage undergoing surgical resection at the Nancy University Hospital

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.


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-

Primary outcomes:
measure: Evaluation of the in vitro efficacy of osimertinib in a patient-derived organoid model alone or in combination
timeFrame: from day 0 to day 30
Secondary outcomes:
measure: Identify non-responders to osimertinib in vitro
timeFrame: from day 0 to day 30
Other outcomes:
Locations:
city: Vandoeuvre-lès-Nancy
country: France
facility: Seitlinger
state: Lorraine
Study officials:
References: