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

ConditionsExtensive-stage Small Cell Lung Cancer (ES-SCLC)Extensive-stage Small Cell Lung Cancer (SCLC)Small Cell Lung Cancer ( SCLC )
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking Union Medical College Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Organoid Drug Sensitivity Testing-Guided Therapy

    Drug

    Personalized drug selection (chemotherapy/targeted therapy/immunotherapy) based on ex vivo organoid drug response testing

  • Topotecan

    Drug

    Intravenous topotecan 1.25 mg/m² daily on days 1-5 of each 21-day cycle

Treatment groups

128 Participants
are divided into 2 treatment groups
Group A: Organoid-Guided Personalized TherapyExperimental treatment 1 intervention
Group B: Standard Topotecan ChemotherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Progression-Free Survival (PFS)

From the date of randomization to the date of first recording of disease progression ( RECIST v1.1 ) or all-cause death, whichever occurred first.

Time frame
From date of randomization until the date of first documented progression (RECIST v1.1) or death from any cause, whichever occurs first, assessed up to 100 months.

Secondary outcomes

1

Overall Survival (OS)

From date of randomization until the date of death from any cause

Time frame
From date of randomization until the date of death from any cause, assessed up to 100 months.
2

Objective Response Rate (ORR)

From date of randomization until the date of first documented progression, assessed by RECIST v1.1 criteria at 6- to 8-week

Time frame
From date of randomization until the date of first documented progression, assessed by RECIST v1.1 criteria at 6- to 8-week intervals up to 100 months.
3

Duration of Response (DOR)

From date of first documented objective response (CR or PR per RECIST v1.1) until the date of first documented progression or death from any cause, whichever occurs first

Time frame
From date of first documented objective response (CR or PR per RECIST v1.1) until the date of first documented progression or death from any cause, whichever occurs first, assessed up to 100 months.
4

Grade ≥3 Adverse Events

The incidence of treatment-related adverse events ≥ grade 3 ( CTCAE v5.0 ).

Time frame
From date of first treatment administration until 3 months after last dose, assessed by CTCAE v5.0 criteria.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking Union Medical College Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: