Clinical Trial

Organoid-guided vs Topotecan Therapy in Relapsed Extensive-Stage Small Cell Lung Cancer

Not Yet Recruiting Phase 2/3
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Summary
This study aims to provide personalized treatment options for patients with extensive-stage small cell lung cancer (SCLC) whose disease has worsened after initial chemotherapy. Researchers will use a novel approach called "tumor organoid drug sensitivity testing": A small sample of the patient's tumor (from biopsy or fluid) is grown into miniature 3D tumor models ("organoids") in the lab. These organoids are exposed to various FDA-approved second-line drugs (including chemotherapy and newer targeted/immunotherapy drugs if available). The most effective drug for each patient's organoids will be recommended for their treatment. 128 participants will be randomly assigned to one of two groups:Experimental Group: Receive organoid-guided personalized therapy; Control Group: Receive standard second-line chemotherapy (Topotecan). The study will compare: How long the cancer remains controlled (Progression-Free Survival); Overall survival time; Treatment response rates and side effects. Potential benefits: May identify more effective treatments for individual patients; Could extend time without cancer progression. Risks: Organoid testing requires an additional tumor biopsy/fluid collection; Possible side effects from second-line drugs.
Trial Details
NCT Number NCT07106528
Lead Sponsor Peking Union Medical College Hospital
Conditions Extensive-stage Small Cell Lung Cancer (ES-SCLC), Extensive-stage Small Cell Lung Cancer (SCLC), Small Cell Lung Cancer ( SCLC )
Enrollment 128 participants
Start Date 2025-08
Primary Completion 2027-12 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2025-08-06