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

NCT07106528 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2025-08-06

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-31
Primary Completion
2027-12-31
Completion
2028-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07106528 on ClinicalTrials.gov