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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05136014
Other study ID # 2021PI057
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date November 1, 2021
Est. completion date November 1, 2022

Study information

Verified date November 2021
Source Central Hospital, Nancy, France
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 200
Est. completion date November 1, 2022
Est. primary completion date November 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

Other:
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

Locations

Country Name City State
France Seitlinger Vandoeuvre-lès-Nancy Lorraine

Sponsors (2)

Lead Sponsor Collaborator
Central Hospital, Nancy, France Institut de Cancérologie de Lorraine

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Identify non-responders to osimertinib in vitro Cell viability test from day 0 to day 30
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