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.
Aged 18 years or older.
Pathologically confirmed extensive-stage small cell lung cancer (ES-SCLC) (AJCC 9th edition, Stage IV).
Previously received first-line platinum-based systemic chemotherapy and experienced recurrence or progression during first-line treatment or within ≤ 6 months after completion of first-line treatment.
Availability of sufficient tumor tissue or malignant serous effusion for organoid culture.
Mixed tumor pathology or lack of histological confirmation.
Previous receipt of second-line or higher systemic anti-tumor therapy for ES-SCLC.
Symptomatic or progressive brain metastases, or meningeal metastases.
History of other malignant tumors that are progressive or require active treatment within the past 5 years.
Peking Union Medical College Hospital
Lead sponsor