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Active, Not Recruiting

NCT Number: NCT05092009

Lung Cancer Organoids and Patient Derived Tumor Xenografts

Extra tissue will be taken from patient during a procedure in standard of care. Also, through an existing line, 10ml of extra blood will be drawn. From this material the investigator will try to establish matched normal and primary human lung cancer organoids.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Zuyderland Medical Center, Heerlen, Netherlands

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About this study

Lung (tumor) material obtained from biopsies or surgical resection material that is not needed by the pathologist for diagnosis (i.e. to stage the patient or to perform molecular diagnosis) will be collected and used for the generation of matched normal and lung cancer organoids and/or PDX.

Biopsy material: Patients with (suspected) lung cancer will undergo a bronchoscopy or endobronchial ultrasound guided transbronchial needle aspiration (EBUS/EUS-TBNA) bronchoscopy for the collection of a lung / lymph node biopsy. Biopsies are collected according to standard of care procedures for i.e. the initial diagnosis and staging of lung cancer, and molecular profiling of recurrent tumors. During the standard of care biopsy procedure, an extra biopsy (lung and/or lymph node) will be collected and used for the generation of lung (cancer) organoids:

  • Bronchoscopy: biopsy-derived lung (tumor) tissue from endobronchial tumors
  • EBUS/EUS-TBNA bronchoscopy: cytology-derived lung (tumor) cells from mediastinal lymph nodes

A 10 ml blood sample will only be collected at the moment blood must be drawn according to standard of care procedures or when the patient has received an intravenous drip. The patient therefore does not require to undergo additional procedures.

Resection material: Patients who are selected to undergo surgical removal of a primary lung cancer will be included. The (tumor) material that will be used to make organoids and PDX will be derived from remaining healthy and tumor tissue that is not needed for the pathologist to make a diagnosis, to stage the patient or to perform a molecular diagnosis. The patient therefore does not require to undergo additional treatments or procedures. A 10 ml blood sample will be collected at the moment blood must be drawn pre-operatively according to standard of care procedures or from the intravenous drip the patient will receive before start surgery. The patient therefore does not require to undergo additional procedures.

Collection of clinical data: Clinical data will be collected from existing standard of care data:

  • Histology
  • Date diagnosis lung cancer
  • TNM classification (eight edition)
  • If performed, molecular analysis data such as Epidermal Growth Factor Receptor (EGFR) mutation, Anaplastic Lymphoma Kinase (ALK) translocation, Kirsten Rat Sarcoma (KRAS) viral oncogene homolog mutation etc. (Type of test, results)
  • PD-L1 status if available. If available, type of test and PD-L1%
  • Type, dose, and date of treatment the patient received before and/or after the collection tumor biopsy (chemotherapy, radiotherapy, tyrosine kinase inhibitors, immunotherapy). If applicable, also the date and dose of all cycles.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients selected to undergo primary surgical resection of a primary lung cancer. All types of resection are eligible, e.g. wedge resection, segmental resection, lobectomy, pneumonectomy.
  • All patients with (suspected) lung cancer that will undergo a bronchoscopy or endobronchial ultrasound guided transbronchial needle aspiration (EBUS/EUS-TBNA) bronchoscopy.

Exclusion criteria

There are no exclusion criteria

Treatment and study plan

Tissue and blood

Other

Tissue and blood will be derived from patient during a standard of care procedure

Primary outcomes

  1. Lung cancer organoids

    Time frame: 1 year

    Establishing matched normal and primary human lung cancer organoids from patient-derived (tumor) tissue material by establishing long term culturing and bio-banking conditions for matched normal and primary lung cancer organoids from patient-derived lung (tumor) material. From these, we will In the established organoids we will:

    • the rate of proliferation and cell death (turnover) will be calculated
  2. Lung cancer organoids

    Time frame: 1 year

    Establishing matched normal and primary human lung cancer organoids from patient-derived (tumor) tissue material by establishing long term culturing and bio-banking conditions for matched normal and primary lung cancer organoids from patient-derived lung (tumor) material. From these, we will In the established organoids we will:

    • the size distribution of the organoids
  3. Lung cancer organoids

    Time frame: 1 year

    Establishing matched normal and primary human lung cancer organoids from patient-derived (tumor) tissue material by establishing long term culturing and bio-banking conditions for matched normal and primary lung cancer organoids from patient-derived lung (tumor) material. From these, we will In the established organoids we will:

    • determine the frequency of primary, secondary and tertiary organoid formation

Secondary outcomes

  1. Oncogenetic drivers

    Time frame: 1 year

    To define oncogenic drivers in lung cancer organoids

  2. Tumor heterogeneity

    Time frame: 1 year

    To investigate the stability of (epi-) genetic and phenotypic tumor heterogeneity of cultured organoids compared to a primary/secondary biopsy

  3. Molecular biology

    Time frame: 1 year

    To predict sensitivity and to get insight in the molecular biology of the response to immunotherapy, radiotherapy, cytotoxic and targeted agents

  4. Treatment response

    Time frame: 1 year

    To compare treatment response in normal lung organoids and lung cancer organoids

  5. Xenografts

    Time frame: 1 year

    To establish and characterize patient-derived tumor xenografts

  6. Therapeutic approaches

    Time frame: 1 year

    To test novel therapeutic approaches in lung cancer organoids and clinically relevant PDX models, including radiotherapy combined with hypoxia activated prodrugs and immunotherapies

  7. Developing biomarkers

    Time frame: 1 year

    To develop biomarker(s) of tumor response to be able to select patients who will benefit from novel treatment strategies.

  8. Analysing blood

    Time frame: 1 year

    To analyze (ct)DNA in organoid-derived culture supernatants and corresponding patient-derived blood samples

  9. Analysing blood

    Time frame: 1 year

    To analyze metabolites in organoid-derived culture supernatants and corresponding patient-derived blood samples

  10. Analysing blood

    Time frame: 1 year

    To analyze RNA in organoid-derived culture supernatants and corresponding patient-derived blood samples

  11. Analysing blood

    Time frame: 1 year

    To analyze proteins in organoid-derived culture supernatants and corresponding patient-derived blood samples

  12. Analysing blood

    Time frame: 1 year

    To analyze microvesicles secreted by lung cancer cells in organoid-derived culture supernatants and corresponding patient-derived blood samples

Sponsors and collaborators

Lead sponsor

Maastricht Radiation Oncology

Other

Registry information

Acronym: IPON-3

Important dates

Study start
2022
Primary completion
2026
Study completion
2028
First posted
Oct 25, 2021
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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