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

NCT06406608 | Recruiting DMC

• 1 other identifier: 2024-107
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

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.

  1-2 years

Secondary Outcomes (2)

• Progressive free survival

  1-2 years

• Overall survival time

  2 years

Study Arms (1)

Organoid-Guided therapy

EXPERIMENTAL

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

Chemotherapy and targeted-therapy guided by organoid drug sensitivity test OTHER

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.

Organoid-Guided therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 and ≤75 years old (calculated based on the date of signing informed consent);
• Diagnosed as drug-resistant/relapsed non-small cell lung cancer;
• After at least two systemic treatments 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 0-1;
• Expected survival time\>3 months;
• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Henan Cancer Hospital: lead
• Kingbio Medical (Beijing) Co., Ltd.: collaborator

Study Sites (1)

Henan Cancer Hospital

Zhengzhou, Henan, 450003, China

RECRUITING

Related Publications (10)

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  PMID: 11784881 BACKGROUND

• 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.

  PMID: 31035693 BACKGROUND

• 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.

  PMID: 34295672 BACKGROUND

• 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.

  PMID: 36156007 BACKGROUND

• 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.

  PMID: 29703791 BACKGROUND

• 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.

  PMID: 30171177 BACKGROUND

• 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.

  PMID: 30726695 BACKGROUND

• 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.

  PMID: 34083237 BACKGROUND

• 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.

  PMID: 36657446 BACKGROUND

• Drost J, Clevers H. Organoids in cancer research. Nat Rev Cancer. 2018 Jul;18(7):407-418. doi: 10.1038/s41568-018-0007-6.

  PMID: 29692415 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Qiming Wang, PhD

  Henan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qiming Wang, PhD

CONTACT

+8613783590691; qimingwang1006@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 9, 2024
• Study Start: April 16, 2024
• Primary Completion: December 16, 2025
• Study Completion (Estimated): June 16, 2026
• Last Updated: May 9, 2024

Record last verified: 2024-04

Locations

CN (1)