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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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05136014
Acronym
OS-TUMOVASC
Enrollment
200
Registered
2021-11-26
Start date
2021-11-01
Completion date
2022-11-01
Last updated
2021-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

EGFR Activating Mutation, KRAS Mutation-Related Tumors, Lung Adenocarcinoma, Lung Cancer, Non Small Cell Lung Cancer

Keywords

tyrosine kinase inhibitors, Lung adenocarcinoma, EGFR activating mutation, KRAS Mutation-related tumors

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.

Interventions

OTHERCollection 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

Sponsors

Institut de Cancérologie de Lorraine
CollaboratorOTHER
Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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-

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of the in vitro efficacy of osimertinib in a patient-derived organoid model alone or in combinationfrom day 0 to day 30Cell viability test

Secondary

MeasureTime frameDescription
Identify non-responders to osimertinib in vitrofrom day 0 to day 30Cell viability test

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026