NCT07610616Recruiting
Study on the Mechanism of ADC Drug Evaluation Based on Immune Co-culture of Lung Cancer Organoids
Source: ClinicalTrials.gov · Last updated 28 May 2026
Brief summary (registry, in English)
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 features. The integrated approach provided cell-based evidence of ADC potency and revealed mechanistic insights-including immune-mediated cytotoxicity pathways and intracellular trafficking-supporting the rational design of clinical trials. These findings established a foundation for precision immunotherapy strategies and offered a mechanistic rationale for patient selection in HER2/TROP2-positive lung cancer.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 10 (estimated)
- First submitted
- 12 May 2026
- Start date
- 28 Dec 2025
- Primary completion date
- 1 Oct 2027
- Lead sponsor
- Guangzhou Institute of Respiratory Disease
- Diseases
- Lung cancer
- NCT number
- NCT07610616
What you commit to
- Study type: Observational
- Planned participants: 10
- From 28 Dec 2025 to the primary completion date, 1 Oct 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- PDOs derived from patients with pathologically confirmed small cell lung cancer (SCLC).
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Guangzhou Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.