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Small Cell Lung CancerNCT06406660

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

A study testing Chemotherapy and targeted-therapy guided by organoid drug sensitivity test in people with Small Cell Lung Cancer, run by Henan Cancer Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study plans to enroll 20 patients with recurrent small cell lung cancer. 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Small Cell Lung Cancer
What is being tested?
Chemotherapy and targeted-therapy guided by organoid drug sensitivity test
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
16 Apr 2024to 16 Jun 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥18 and ≤75 years old (calculated based on the date of signing informed consent);
  • Diagnosed as recurrent small cell lung cancer;
  • After at least one systematic treatment and the disease progresses;
  • 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;
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-2;
  • Expected survival time≥3 months;
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  • Before a tumor sample can be taken, there must be a record of disease progression on imaging after the previous treatment.;
  • The patient has informed consent and signed a written consent form;
  • The patients had good compliance and willingly followed the study plan, including scheduled visits, treatments, laboratory tests, and other research steps.

Who cannot join

  • Extremely weakened overall condition, unable to tolerate bronchoscopy examination;
  • Patients with acute suppurative inflammation of the respiratory tract accompanied by high fever, acute asthma attacks, and ongoing hemoptysis;
  • Have a history of interstitial lung disease, non infectious pneumonia or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung disease, etc
  • Patients with active leptomeningeal disease or brain metastasis;
  • 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);
  • Have a history of immunodeficiency, including positive HIV serum tests;
Show all 10Show fewer
  • 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);
  • The presence of any serious or uncontrollable systemic diseases;
  • Pregnant or lactating female patients;
  • The researchers believe that patients who are not suitable to participate in this study.

Trial locations and contacts

1 site in 1 country.

Qiming Wang, PhD contact

+8613783590691

qimingwang1006@126.com

China1 site, 1 recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450003

    Qiming Wang, PhD, +8613783590691, qimingwang1006@126.com

    Recruiting

Other trials in China

About this study

This study plans to enroll 20 patients with recurrent small cell lung cancer. 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 recurrent 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.

Being tested
Chemotherapy and targeted-therapy guided by organoid drug sensitivity test
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Chemotherapy and targeted-therapy guided by organoid drug sensitivity testOther

    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.

Study groups in NCT06406660
Study groupRoleWhat they receive
Organoid-Guided therapyOtherAll patients will be included in a single-arm. Participants will undergo biopsy of tumor tissue for subsequent organoid generation and drug sensitivity tests.
Receives: Other: Chemotherapy and targeted-therapy guided by organoid drug sensitivity test

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1-2 years

Secondary outcomes (2)

  1. Progressive free survival

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

    Measured: 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.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2024
  2. Study start16 Apr 2024
  3. Primary completion16 Dec 2025 (estimated)
  4. Study completion16 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06406660
Sponsor's protocol ID
2024-108
Status last verified
Apr 2024
First submitted
6 May 2024
Last updated
9 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

  • Bogart JA, Waqar SN, Mix MD. Radiation and Systemic Therapy for Limited-Stage Small-Cell Lung Cancer. J Clin Oncol. 2022 Feb 20;40(6):661-670. doi: 10.1200/JCO.21.01639. Epub 2022 Jan 5.

    PubMed 34985935

  • Yang JJ, Yu D, White E, Lee DH, Blot W, Robien K, Sinha R, Park Y, Takata Y, Gao YT, Smith-Byrne K, Monninkhof EM, Kaaks R, Langhammer A, Borch KB, Al-Shaar L, Lan Q, Sorgjerd EP, Zhang X, Zhu C, Chirlaque MD, Severi G, Overvad K, Sacerdote C, Aune D, Johansson M, Smith-Warner SA, Zheng W, Shu XO. Prediagnosis Leisure-Time Physical Activity and Lung Cancer Survival: A Pooled Analysis of 11 Cohorts. JNCI Cancer Spectr. 2022 Mar 2;6(2):pkac009. doi: 10.1093/jncics/pkac009.

    PubMed 35603841

  • Iams WT, Porter J, Horn L. Immunotherapeutic approaches for small-cell lung cancer. Nat Rev Clin Oncol. 2020 May;17(5):300-312. doi: 10.1038/s41571-019-0316-z. Epub 2020 Feb 13.

    PubMed 32055013

  • Zugazagoitia J, Paz-Ares L. Extensive-Stage Small-Cell Lung Cancer: First-Line and Second-Line Treatment Options. J Clin Oncol. 2022 Feb 20;40(6):671-680. doi: 10.1200/JCO.21.01881. Epub 2022 Jan 5.

    PubMed 34985925

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing Chemotherapy and targeted-therapy guided by organoid drug sensitivity test in people with Small Cell Lung Cancer, run by Henan Cancer Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Qiming Wang, PhD (+8613783590691, qimingwang1006@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (time frame: 1-2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06406660, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.

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