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RecruitingNCT06406608Updated May 9, 2024

Patient-derived Organoid Drug Sensitivity Guided Treatment for Drug-resistant Recurrent Non-Small Cell Lung Cancer

An interventional study of Chemotherapy and targeted-therapy guided by organoid drug sensitivity test in Non-small Cell Lung Cancer, sponsored by Henan Cancer Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-05-09.

Sponsored by Henan Cancer Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as recruiting.
  • Started Apr 2024; still recruiting 2 years 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

This study aims to enroll non-small cell lung cancer patients who have undergone at least two rounds of standard treatment for drug resistance/recurrence. Patient-derived Organoid will be established, and drug sensitivity test will be conducted to intervene in the selection of clinical treatment plans. Efficacy evaluation and prognosis analysis will also be conducted. It is hoped that this study will provide a basis for the development of personalized treatment plans.

Read the detailed description

Twenty patients with drug-resistant/relapsed non-small cell lung cancer who met the inclusion criteria were enrolled in the study after signing an informed consent form. Tumor samples were obtained through clinical puncture, and qualified samples were subjected to organoid modeling. Perform drug sensitivity test on the established lung cancer organoids. The drugs used are all that have been marketed and applied in clinical practice. According to the results of organoid drug sensitivity analysis, the patient received a treatment plan with relatively sensitive drugs. Follow up prognostic data and relevant clinical information of enrolled patients, conduct statistical analysis on the consistency between drug sensitivity test results and patient treatment response, and evaluate the clinical effectiveness of treatment plans guided by organoid drug sensitivity results.

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Conditions studied

  • Non-small Cell Lung Cancer
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 20 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Henan Cancer Hospital is the lead sponsor of 228 studies on the registry; 130 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age ≥18 and ≤75 years old (calculated based on the date of signing informed consent);
  2. Diagnosed as drug-resistant/relapsed non-small cell lung cancer;
  3. After at least two systemic treatments and the disease progresses;
  4. According to the efficacy evaluation criteria of solid tumors (RECIST 1.1), at least one lesion that has not received radiation therapy, has not received other local therapies, and can obtain tumor tissue (can be from a single lesion source or multiple lesions combined) is used for organoid establishment;
  5. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-1;
  6. Expected survival time>3 months;
  7. Before a tumor sample can be taken, there must be a record of disease progression on imaging after the previous treatment.;
  8. The patient has informed consent and signed a written consent form;
  9. The patients had good compliance and willingly followed the study plan, including scheduled visits, treatments, laboratory tests, and other research steps.

Exclusion criteria

Exclusion Criteria:

  1. Extremely weakened overall condition, unable to tolerate bronchoscopy examination;
  2. Patients with acute suppurative inflammation of the respiratory tract accompanied by high fever, acute asthma attacks, and ongoing hemoptysis;
  3. Have a history of interstitial lung disease, non infectious pneumonia or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung disease, etc
  4. Patients with active leptomeningeal disease or brain metastasis;
  5. Diagnosed with other malignant diseases other than NSCLC within 5 years prior to initial administration (excluding curative basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or curative resection of carcinoma in situ);
  6. Have a history of immunodeficiency, including positive HIV serum tests;
  7. Active hepatitis B without treatment (defined as HBsAg positive and HBV-DNA copy number detected is greater than the upper limit of normal value in the laboratory of the research center);
  8. The presence of any serious or uncontrollable systemic diseases;
  9. Pregnant or lactating female patients;
  10. The researchers believe that patients who are not suitable to participate in this study.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Organoid-Guided therapy

    All patients will be included in a single-arm. Participants will undergo biopsy of tumor tissue for subsequent organoid generation and drug sensitivity tests.

    Other: Chemotherapy and targeted-therapy guided by organoid drug sensitivity test

Interventions

  • OtherChemotherapy and targeted-therapy guided by organoid drug sensitivity test

    This study conducts drug sensitivity tests on various clinically approved drugs. The most sensitive drug for the patient is selected for treatment. This study aims to evaluate the clinical effectiveness of treatment plans guided by organoid drug sensitivity tests.

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What researchers measure

Primary outcomes

  1. Objective Response Rate

    Percentage of patient's measurable disease who have achieved either complete response (CR) or partial response (PR) according to RECIST 1.1.

    Time frame: 1-2 years

Secondary outcomes

  1. Progressive free survival

    The time from initiation of treatment to the occurrence of disease progression or death.

    Time frame: 1-2 years

  2. Overall survival time

    The time from the date of randomization to the date of death for any cause. Patients will be followed until their date of death or until final database closure.

    Time frame: 2 years

07

Study locations

1 of 1 sites recruiting
  • Henan Cancer Hospital
    Zhengzhou, Henan 450003, China
    Recruiting
08

References and documents

Publications

  • Carney DN. Lung cancer--time to move on from chemotherapy. N Engl J Med. 2002 Jan 10;346(2):126-8. doi: 10.1056/NEJM200201103460211. No abstract available. PubMed 11784881 ↗
  • Kashima J, Kitadai R, Okuma Y. Molecular and Morphological Profiling of Lung Cancer: A Foundation for "Next-Generation" Pathologists and Oncologists. Cancers (Basel). 2019 Apr 29;11(5):599. doi: 10.3390/cancers11050599. PubMed 31035693 ↗
  • Zhang Z, Yang S, Ma Y, Zhou H, Wu X, Han J, Hou J, Hao L, Spicer JD, Koh YW, Provencio M, Reguart N, Mitsudomi T, Wang Q. Consistency of recommendations for the diagnosis and treatment of non-small cell lung cancer: a systematic review. Transl Lung Cancer Res. 2021 Jun;10(6):2715-2732. doi: 10.21037/tlcr-21-423. PubMed 34295672 ↗
  • Muto S, Inomata S, Yamaguchi H, Mine H, Takagi H, Watanabe M, Ozaki Y, Inoue T, Yamaura T, Fukuhara M, Okabe N, Matsumura Y, Hasegawa T, Osugi J, Hoshino M, Higuchi M, Shio Y, Suzuki H. [Resistance Mechanisms to Immune Checkpoint Inhibitor and Its Overcome with Focus on beta-Catenin in Lung Cancer]. Gan To Kagaku Ryoho. 2022 Sep;49(9):928-931. Japanese. PubMed 36156007 ↗
  • Seidlitz T, Merker SR, Rothe A, Zakrzewski F, von Neubeck C, Grutzmann K, Sommer U, Schweitzer C, Scholch S, Uhlemann H, Gaebler AM, Werner K, Krause M, Baretton GB, Welsch T, Koo BK, Aust DE, Klink B, Weitz J, Stange DE. Human gastric cancer modelling using organoids. Gut. 2019 Feb;68(2):207-217. doi: 10.1136/gutjnl-2017-314549. Epub 2018 Apr 27. PubMed 29703791 ↗
  • Romero-Calvo I, Weber CR, Ray M, Brown M, Kirby K, Nandi RK, Long TM, Sparrow SM, Ugolkov A, Qiang W, Zhang Y, Brunetti T, Kindler H, Segal JP, Rzhetsky A, Mazar AP, Buschmann MM, Weichselbaum R, Roggin K, White KP. Human Organoids Share Structural and Genetic Features with Primary Pancreatic Adenocarcinoma Tumors. Mol Cancer Res. 2019 Jan;17(1):70-83. doi: 10.1158/1541-7786.MCR-18-0531. Epub 2018 Aug 31. PubMed 30171177 ↗
  • Li M, Izpisua Belmonte JC. Organoids - Preclinical Models of Human Disease. N Engl J Med. 2019 Feb 7;380(6):569-579. doi: 10.1056/NEJMra1806175. No abstract available. PubMed 30726695 ↗
  • Kim SY, Kim SM, Lim S, Lee JY, Choi SJ, Yang SD, Yun MR, Kim CG, Gu SR, Park C, Park AY, Lim SM, Heo SG, Kim H, Cho BC. Modeling Clinical Responses to Targeted Therapies by Patient-Derived Organoids of Advanced Lung Adenocarcinoma. Clin Cancer Res. 2021 Aug 1;27(15):4397-4409. doi: 10.1158/1078-0432.CCR-20-5026. Epub 2021 Jun 3. PubMed 34083237 ↗
  • Wang HM, Zhang CY, Peng KC, Chen ZX, Su JW, Li YF, Li WF, Gao QY, Zhang SL, Chen YQ, Zhou Q, Xu C, Xu CR, Wang Z, Su J, Yan HH, Zhang XC, Chen HJ, Wu YL, Yang JJ. Using patient-derived organoids to predict locally advanced or metastatic lung cancer tumor response: A real-world study. Cell Rep Med. 2023 Feb 21;4(2):100911. doi: 10.1016/j.xcrm.2022.100911. Epub 2023 Jan 18. PubMed 36657446 ↗
  • Drost J, Clevers H. Organoids in cancer research. Nat Rev Cancer. 2018 Jul;18(7):407-418. doi: 10.1038/s41568-018-0007-6. PubMed 29692415 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06406608
Lead sponsor
Henan Cancer Hospital
Collaborators
Kingbio Medical (Beijing) Co., Ltd.
Responsible party
Sponsor
First posted
May 9, 2024
Start date
Apr 16, 2024
Primary completion
Dec 16, 2025 (estimated)
Completion
Jun 16, 2026 (estimated)
Last update
May 9, 2024

Study contacts

Qiming Wang, PhD
Contact
qimingwang1006@126.com
+8613783590691
Qiming Wang, PhD
principal investigator · Henan Cancer Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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