Trials / Not Yet Recruiting
Not Yet RecruitingNCT07106528
Organoid-guided vs Topotecan Therapy in Relapsed Extensive-Stage Small Cell Lung Cancer
Organoid-Based Drug Sensitivity Model Guided Personalized Precision Treatment for Extensive-Stage Small Cell Lung Cancer: A Prospective, Multicenter, Randomized Controlled Trial
- Status
- Not Yet Recruiting
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 128 (estimated)
- Sponsor
- Peking Union Medical College Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Extensive-stage Small Cell Lung Cancer (ES-SCLC)
- Extensive-stage Small Cell Lung Cancer (SCLC)
- Small Cell Lung Cancer ( SCLC )
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Organoid Drug Sensitivity Testing-Guided Therapy | Personalized drug selection (chemotherapy/targeted therapy/immunotherapy) based on ex vivo organoid drug response testing |
| DRUG | Topotecan | Intravenous topotecan 1.25 mg/m² daily on days 1-5 of each 21-day cycle |
Timeline
- Start date
- 2025-08-01
- Primary completion
- 2027-12-01
- Completion
- 2028-12-01
- First posted
- 2025-08-06
- Last updated
- 2025-08-06
Source: ClinicalTrials.gov record NCT07106528. Inclusion in this directory is not an endorsement.