Using organoids to predict treatment response in drug-resistant lung cancer

A Single-arm, Single-center Clinical Trial of Patient-derived Lung Cancer Organoids for Predicting Therapeutic Response in Patients With Multiline Drug-resistant Lung Cancer

This study is testing if mini versions of patients' lung tumors can help doctors find the best cancer treatments for people whose cancer hasn't responded to standard drugs.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Affiliated Hospital of Jiangnan University (Academic / other)
• Locations: 1 site (Wuxi, Jiangsu)
• Trial ID: NCT05669586 on ClinicalTrials.gov

What this trial studies

This clinical study evaluates the effectiveness of patient-derived organoids (PDOs) in predicting how well lung cancer patients will respond to various anticancer drugs. By creating personalized tumor models that closely resemble the original tumors, the study aims to identify tailored treatment regimens for patients who have not responded to standard therapies. The study is single-center and exploratory, focusing on the accuracy of PDOs in reflecting drug sensitivity and providing rapid feedback for clinical decision-making. The goal is to improve treatment outcomes for patients with multi-line drug-resistant lung cancer.

Who should consider this trial

Good fit: Ideal candidates include adults with non-small cell lung cancer who have progressed after multiple lines of standard therapy and have accessible tumor samples.

Not a fit: Patients with lung cancer who have not undergone multiple lines of therapy or those with other types of lung cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more effective and personalized treatment options for patients with resistant lung cancer.

How similar studies have performed: Other studies using organoid models for drug sensitivity testing have shown promising results, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Male or female patients: ≥18 years old.
2. For non-small cell lung cancer confirmed by histology or cytology, there is no standard protocol recommendation in the guidelines for disease progression after multiline standard therapy.
3. Expected survival ≥3 months.
4. Sign informed consent.
5. The patient is willing and able to adhere to the protocol during the study, including receiving treatment and scheduled visits and examinations, including follow-up.
6. Accessible to biopsy and/or surgery sample of metastasis and/or primitive tumour
7. At least one previously unirradiated lesion that can be accurately measured at baseline with longest diameter ≥ 10 mm (must have a short lymph node excluding axis ≥ 15 mm) according to RECIST criteria with computed tomography (CT), magnetic resonance imaging (MRI) or clinical examination for accurate repeated measures. Or an unevaluable lesion, including but not limited to pleural and ascites, bone metastasis, etc.

Exclusion Criteria:

1. Participated in clinical trials of other drugs within four weeks.
2. Histologically or cytologically confirmed small cell, large cell neuroendocrine or carcinoid.
3. Not accessible to biopsy and/or surgery sample.
4. Not enough lung tissue for a histological analysis or the remaining lung tissue is not enough to perform a routine pathological analysis.
5. There are clinical symptoms or diseases of the heart that cannot be well controlled, such as: NYHA class 2 or higher heart failure, unstable angina pectoris, myocardial infarction within 1 year, clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention of patients.
6. For female subjects: should be surgically sterilized, postmenopausal patients, or agree to use a medically approved contraceptive during the study treatment period and within 6 months after the end of the study treatment period; Serum or urine pregnancy test must be negative within 7 days and must be non-nursing. Male subjects: Patients who should be surgically sterilized, or who agree to use a medically-approved contraceptive method during the study treatment period and within 6 months after the end of the study treatment period.
7. The patient has active pulmonary tuberculosis, bacterial or fungal infection (≥ grade 2 of NCI-CTC, 3rd edition); HIV infection, HBV infection, HCV infection.

   Those who have a history of psychotropic substance abuse and cannot quit or have mental disorders.
8. The subject has any active autoimmune disease or has a history of autoimmune disease (such as the following, but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism, thyroid Reduced function; subjects with vitiligo or complete remission of asthma in childhood without any intervention in adulthood can be included; subjects with asthma requiring bronchodilator medical intervention are not included).
9. According to the judgment of the investigator, there are concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study.

Where this trial is running

Wuxi, Jiangsu

• Affiliated Hospital of Jiangnan University — Wuxi, Jiangsu, China (Recruiting)

Study contacts

• Principal investigator: quan liu, doctor — Affiliated Hospital of Jiangnan University
• Study coordinator: quan liu, doctor

Conditions Lung Cancer; Organoid