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NCT05136014: OS-TUMOVASC

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 Last updated 26 November 2021
What this trial tests

trial testing Collection of surgical waste in Lung Cancer in 200 participants. Status unknown.

Timeline
1 November 2021
Primary endpoint
1 November 2021
1 November 2022

Quick facts

Lead sponsorCentral Hospital, Nancy, France
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment200
Start date1 November 2021
Primary completion1 November 2021
Estimated completion1 November 2022
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

Central Hospital, Nancy, France

Who can join

18 and older, any sex, with Lung Cancer or Lung Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Organoids: The current status and biomedical applications.
    Yang S, Hu H, Kung H, Zou R, et al · · 2023 · cited 162× · PMID 37215622 · DOI 10.1002/mco2.274
  2. Clinical translation of patient-derived tumour organoids- bottlenecks and strategies.
    Foo MA, You M, Chan SL, Sethi G, et al · · 2022 · cited 61× · PMID 35272694 · DOI 10.1186/s40364-022-00356-6
  3. Organoids: development and applications in disease models, drug discovery, precision medicine, and regenerative medicine.
    Yao Q, Cheng S, Pan Q, Yu J, et al · · 2024 · cited 40× · PMID 39309690 · DOI 10.1002/mco2.735
  4. The application of patient-derived organoid in the research of lung cancer.
    Li Y, Gao X, Ni C, Zhao B, et al · · 2023 · cited 29× · PMID 36696006 · DOI 10.1007/s13402-023-00771-3
  5. Tumour organoids and assembloids: Patient-derived cancer avatars for immunotherapy.
    Mei J, Liu X, Tian HX, Chen Y, et al · · 2024 · cited 25× · PMID 38664597 · DOI 10.1002/ctm2.1656
  6. Lung Organoids-The Ultimate Tool to Dissect Pulmonary Diseases?
    Bosáková V, De Zuani M, Sládková L, Garlíková Z, et al · · 2022 · cited 25× · PMID 35912110 · DOI 10.3389/fcell.2022.899368
  7. Lung Cancer Organoids: The Rough Path to Personalized Medicine.
    Rossi R, De Angelis ML, Xhelili E, Sette G, et al · · 2022 · cited 21× · PMID 35954367 · DOI 10.3390/cancers14153703
  8. A systematic review on the culture methods and applications of 3D tumoroids for cancer research and personalized medicine.
    Kalla J, Pfneissl J, Mair T, Tran L, et al · · 2025 · cited 13× · PMID 38806997 · DOI 10.1007/s13402-024-00960-8

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