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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 (OS-TUMOVASC)

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ClinicalTrials.gov Identifier: NCT05136014
Recruitment Status : Enrolling by invitation
First Posted : November 26, 2021
Last Update Posted : November 26, 2021
Sponsor:
Collaborator:
Institut de Cancérologie de Lorraine
Information provided by (Responsible Party):
SEITLINGER Joseph, Central Hospital, Nancy, France

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.


Condition or disease Intervention/treatment
Lung Cancer Lung Adenocarcinoma EGFR Activating Mutation KRAS Mutation-Related Tumors Non Small Cell Lung Cancer Other: Collection of surgical waste

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
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
Actual Study Start Date : November 1, 2021
Actual Primary Completion Date : November 1, 2021
Estimated Study Completion Date : November 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Tyrosine

Group/Cohort Intervention/treatment
General cohorte
patient with non-small cell lung cancer undergoing surgical resection in the thoracic surgery department of the Nancy CHRU
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




Primary Outcome Measures :
  1. Evaluation of the in vitro efficacy of osimertinib in a patient-derived organoid model alone or in combination [ Time Frame: from day 0 to day 30 ]
    Cell viability test


Secondary Outcome Measures :
  1. Identify non-responders to osimertinib in vitro [ Time Frame: from day 0 to day 30 ]
    Cell viability test



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients with non small cell lung cancer of any stage undergoing surgical resection at the Nancy University Hospital
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-

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05136014


Locations
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France
Seitlinger
Vandoeuvre-lès-Nancy, Lorraine, France, 54500
Sponsors and Collaborators
Central Hospital, Nancy, France
Institut de Cancérologie de Lorraine
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Responsible Party: SEITLINGER Joseph, Principal Investigator, Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT05136014    
Other Study ID Numbers: 2021PI057
First Posted: November 26, 2021    Key Record Dates
Last Update Posted: November 26, 2021
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by SEITLINGER Joseph, Central Hospital, Nancy, France:
tyrosine kinase inhibitors
Lung adenocarcinoma
EGFR activating mutation
KRAS Mutation-related tumors
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Adenocarcinoma
Adenocarcinoma of Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type