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Study on the Mechanism of ADC Drug Evaluation Based on Immune Co-culture of Lung Cancer Organoids

Recruitingn/aAges 18 Years - 100 YearsAllGuangzhou Institute of Respiratory Disease
NCT07610616 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

A case-control study was conducted to evaluate the efficacy and mechanism of action of antibody-drug conjugates (ADCs) in lung cancer, utilizing patient-derived organoid (PDO)-immune co-cultures. Focusing on HER2-positive and TROP2-positive non-small cell lung cancer (NSCLC) cases, ADC candidates were screened for in vitro activity based on organoid-immune interaction models. Key assessments included: Tumor killing efficiency, assessed by dose-response relationships; Drug internalization (cellular uptake), as a measure of penetration into cancer cells; Antibody-dependent cellular cytotoxicity (ADCC) and bystander effect, with negative control targets employed to delineate specificity; Single-cell RNA sequencing, to profile transcriptional alterations at single-cell resolution. Data demonstrated distinct ADC responses correlating with target expression and immune microenvironment featu

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age ≥ 18 years. * Availability of patient-derived organoids (PDOs) with matched autologous tumor-infiltrating lymphocytes (TILs) or peripheral blood mononuclear cells (PBMCs) from non-small cell lung cancer (NSCLC) cases. * Patients currently undergoing or scheduled to receive Trastuzumab deruxtecan (T-DXd) therapy who meet clinical eligibility criteria. * Provision of written informed consent. * PDOs exhibiting strong positive HER2 and TROP2 expression by immunohistochemistry (IHC) assigned to the experimental group. * PDOs exhibiting weak positive HER2 and TROP2 expression by IHC assigned to the negative control group. Exclusion Criteria: * PDOs derived from patients with pathologically confirmed small cell lung cancer (SCLC). * Unavailability of matched autologous PDOs, TILs, or PBMCs. * Presence of any contraindications to T-DXd treatment. * Presence of other serious comorbidities resulting in an estimated survival of \<3 months. * Pregnant or breastfeeding women.
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What it tests

  • Antibody-drug conjugate (ADC) combination therapy
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Where

1 site
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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