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Testing antibody-drug conjugates on lab-grown lung cancer tissue with immune cells

Studies how antibody-drug conjugates act on HER2- or TROP2-positive non-small cell lung cancer.

Key facts

Who runs it
Guangzhou Institute of Respiratory Disease
Where
Guangzhou, ChinaSee the site
Trial code
Registry title
Study on the Mechanism of ADC Drug Evaluation Based on Immune Co-culture of Lung Cancer Organoids
Status
Recruiting
People taking part
10 people, planned
Started
28 Dec 2025
Expected to end
1 Oct 2027
Type of study
Observational
Treatments tested
  • Antibody-drug conjugate (ADC) combination therapy
Record updated
28 May 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with non-small cell lung cancer who have lab-grown tumour samples (organoids) with matched immune cells, and who are getting or about to get trastuzumab deruxtecan (T-DXd).

Age
18 years or older (up to 100 years)
Sex
All sexes
Disease stage
Non-small cell lung cancer. Tumour samples show strong or weak HER2 and TROP2 staining.
Earlier treatment
Currently having, or scheduled to have, trastuzumab deruxtecan (T-DXd).
Biomarker or test result
HER2 and TROP2 levels measured by immunohistochemistry. Strong staining goes to the experimental group, weak staining to the negative control group.

Main reasons for not taking part

  • Small cell lung cancer
  • No matched tumour organoids, tumour-infiltrating lymphocytes or blood immune cells available
  • Any reason that rules out T-DXd treatment
  • Other serious illness with expected survival under 3 months
  • Pregnant or breastfeeding women

The registry criteria, word for word

Show all 11 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 100 years old?

Where in China

  • The First Affiliated Hospital of Guangzhou Medical UniversityGuangzhou, ChinaContact: chengzhi Professor Zhou, PhDTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The group in the trial

  • HER2 Positive OrTROP2 Positive non-small cell lung cancer

    The abundance of HER2 or TROP2 target expression was determined by immunohistochemistry and categorized into strongly positive and weakly positive groups, representing the experimental group and negative control group, respectively. Using an immunococulture system based on patient-derived organoids, the in vitro activity of antibody-drug conjugates (ADCs)-including trastuzumab emtansine (an approved ADC administered intravenously)-that are either approved or currently in clinical trials was evaluated. In parallel, clinical patients provided ex vivo cytological assay results indicating their sensitivity to ADC therapy.

    Treatment: Antibody-drug conjugate (ADC) combination therapy

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Study on the Mechanism of ADC Drug Evaluation Based on Immune Co-culture of Lung Cancer Organoids
Plain-language title
Testing antibody-drug conjugates on lab-grown lung cancer tissue with immune cellsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 13 November 2026.
Fit questions
Built from NCT07610616, who can take part
Record updated
28 May 2026