ADC Mechanisms in HER2/TROP2 NSCLC Using Patient-Derived Organoids
Official title: Study on the Mechanism of ADC Drug Evaluation Based on Immune Co-culture of Lung Cancer Organoids
Run by Guangzhou Institute of Respiratory Disease · NCT07610616 · Data updated 2026-11-12
This study tests how antibody-drug conjugates work in HER2- or TROP2-positive non-small cell lung cancer using organoid models made from patient tumors.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 100 Years |
| Sex | All |
| Enrollment | 10 (estimated) |
| Sponsor | Guangzhou Institute of Respiratory Disease Academic / other |
| Drugs / interventions | Trastuzumab, immunotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Status | Recruiting |
| Started | December 28, 2025 |
| Main results expected | October 1, 2027 |
| Study ends | October 1, 2027 |
| Registry record updated | May 28, 2026 |
| Trial ID | NCT07610616 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with NSCLC whose patient-derived organoids show strong HER2 or TROP2 expression and who are either receiving or eligible for Trastuzumab deruxtecan therapy.
✕Probably not a fit
Patients without matched organoids or with low HER2/TROP2 expression, or those not receiving ADC therapy, may see limited or no benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Researchers build patient-derived organoid and immune cell co-cultures from NSCLC tissue to test antibody-drug conjugates. They measure tumor cell killing, drug uptake, immune cell cytotoxicity, and single-cell gene changes to understand how ADCs behave with different target expressions and immune environments. The work includes dose–response analyses and explores combinations of ADCs with immuno-oncology strategies under clinically relevant drug exposures. The study uses resected tumors and pleural effusions, validating organoid fidelity and stratifying by HER2 and TROP2 levels to interpret responses. Outcomes aim to reveal mechanistic insights that could guide personalized ADC therapy in NSCLC.
Why it matters
Potential benefit: If successful, this approach could help identify which patients are most likely to benefit from ADC therapies and inform combination strategies.
How similar studies have gone: Prior studies in ADC mechanisms using organoid or co-culture models have shown biologically meaningful signals, supporting this approach as a plausible pathway to guide therapy.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China Recruiting
Study contacts
- Principal investigator: Chengzhi Zhou, PhD — The First Affiliated Hospital of Guangzhou Medical University
- Study coordinator: Chengzhi Professor Zhou, PhD
- Email: 13560351186@163.com
- Phone: 13560351186
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.