Personalized treatment for recurrent small cell lung cancer using patient-derived organoids

Patient-derived Organoid Drug Sensitivity Guided Treatment for Recurrent Small Cell Lung Cancer

This study is testing if using mini versions of patients' tumors can help find the best personalized treatments for people with recurrent small cell lung cancer.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Henan Cancer Hospital (Government)
• Drugs / interventions: radiation
• Locations: 1 site (Zhengzhou, Henan)
• Trial ID: NCT06406660 on ClinicalTrials.gov

What this trial studies

This study aims to enroll 20 patients with recurrent small cell lung cancer to develop patient-derived organoids from tumor samples. These organoids will undergo drug sensitivity testing to guide the selection of personalized treatment plans. The study will evaluate the efficacy of the treatments based on the organoid responses and analyze prognostic data to assess the consistency between drug sensitivity results and patient outcomes. The ultimate goal is to enhance treatment effectiveness through tailored therapies based on individual tumor characteristics.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with recurrent small cell lung cancer who have experienced disease progression after at least one prior treatment.

Not a fit: Patients who are not diagnosed with recurrent small cell lung cancer or those who have not progressed after previous treatments 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 recurrent small cell lung cancer.

How similar studies have performed: While the use of organoids for drug sensitivity testing is a growing field, this specific approach for recurrent small cell lung cancer is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

1. Age ≥18 and ≤75 years old (calculated based on the date of signing informed consent);
2. Diagnosed as recurrent small cell lung cancer;
3. After at least one systematic treatment and the disease progresses;
4. According to the efficacy evaluation criteria of solid tumors (RECIST 1.1), at least one lesion that has not received radiation therapy, has not received other local therapies, and can obtain tumor tissue (can be from a single lesion source or multiple lesions combined) is used for organoid establishment;
5. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-2;
6. Expected survival time≥3 months;
7. Before a tumor sample can be taken, there must be a record of disease progression on imaging after the previous treatment.;
8. The patient has informed consent and signed a written consent form;
9. The patients had good compliance and willingly followed the study plan, including scheduled visits, treatments, laboratory tests, and other research steps.

Exclusion Criteria:

1. Extremely weakened overall condition, unable to tolerate bronchoscopy examination;
2. Patients with acute suppurative inflammation of the respiratory tract accompanied by high fever, acute asthma attacks, and ongoing hemoptysis;
3. Have a history of interstitial lung disease, non infectious pneumonia or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung disease, etc
4. Patients with active leptomeningeal disease or brain metastasis;
5. Diagnosed with other malignant diseases other than NSCLC within 5 years prior to initial administration (excluding curative basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or curative resection of carcinoma in situ);
6. Have a history of immunodeficiency, including positive HIV serum tests;
7. Active hepatitis B without treatment (defined as HBsAg positive and HBV-DNA copy number detected is greater than the upper limit of normal value in the laboratory of the research center);
8. The presence of any serious or uncontrollable systemic diseases;
9. Pregnant or lactating female patients;
10. The researchers believe that patients who are not suitable to participate in this study.

Where this trial is running

Zhengzhou, Henan

• Henan Cancer Hospital — Zhengzhou, Henan, China (Recruiting)

Study contacts

• Principal investigator: Qiming Wang, PhD — Henan Cancer Hospital
• Study coordinator: Qiming Wang, PhD

Conditions Small Cell Lung Cancer