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

Lung Cancer Clinical Trial

— OS-TUMOVASC  

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05136014
• Other study ID #: 2021PI057
• Status: Enrolling by invitation
• 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
• 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-

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of Lung
• Carcinoma, Non-Small-Cell Lung
• EGFR Activating Mutation
• KRAS Mutation-Related Tumors
• Lung Adenocarcinoma
• Lung Cancer
• Lung Neoplasms
• Non Small Cell Lung Cancer

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