Extensive-stage Small Cell Lung Cancer (ES-SCLC)Phase 2/3NCT07106528
Organoid-guided vs Topotecan Therapy in Relapsed Extensive-Stage Small Cell Lung Cancer
A Phase 2/3 study testing Organoid Drug Sensitivity Testing-Guided Therapy and Topotecan in people with Extensive-stage Small Cell Lung Cancer (ES-SCLC) and Extensive-stage Small Cell Lung Cancer (SCLC), run by Peking Union Medical College Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extensive-stage Small Cell Lung Cancer (ES-SCLC), Extensive-stage Small Cell Lung Cancer (SCLC), Small Cell Lung Cancer ( SCLC )
- What is being tested?
- Organoid Drug Sensitivity Testing-Guided Therapy and Topotecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- No sites listed yet
- Study dates
- Aug 2025to Dec 2028
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Presence of measurable lesions based on RECIST 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
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- Adequate bone marrow and organ function, confirmed by baseline blood count, blood biochemistry, and urine biochemistry tests.
- Asymptomatic and stable central nervous system (CNS) metastases are allowed.
- Expected survival of at least 3 months.
- For male participants: Agreement to use effective contraception during treatment and for at least 180 days after the last dose of study treatment; prohibition of sperm donation during this period.
- For female participants: Not pregnant or breastfeeding, and meeting at least one of the following:
- Women of non-childbearing potential; or Agreement to use effective contraception during treatment and for at least 180 days after the last dose of study treatment; or Women of childbearing potential must have a negative serum or urine pregnancy test (with a minimum sensitivity of 25 IU/L or HCG equivalent units) within 72 hours before initiating treatment.
- Voluntary participation with signed informed consent and willingness to comply with study follow-up procedures.
Who cannot join
- 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.
- Presence of active infections, severe organ dysfunction, or other contraindications to anti-tumor treatment.
- Inability to obtain tumor tissue or insufficient malignant serous effusion for collection.
- Expected survival of less than 3 months.
- Inability to complete standardized clinical diagnosis/treatment or regular follow-up.
About this study
Official title: Organoid-Based Drug Sensitivity Model Guided Personalized Precision Treatment for Extensive-Stage Small Cell Lung Cancer: A Prospective, Multicenter, Randomized Controlled 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":
Read more
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 )
- Being tested
- Organoid Drug Sensitivity Testing-Guided Therapy, Topotecan
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Organoid Drug Sensitivity Testing-Guided TherapyDrug
Personalized drug selection (chemotherapy/targeted therapy/immunotherapy) based on ex vivo organoid drug response testing
TopotecanDrug
Intravenous topotecan 1.25 mg/m² daily on days 1-5 of each 21-day cycle
| Study group | Role | What they receive |
|---|---|---|
| Organoid-Guided Personalized Therapy | Experimental | Drug selection based on organoid drug sensitivity testing Receives: Drug: Organoid Drug Sensitivity Testing-Guided Therapy |
| Standard Topotecan Chemotherapy | Active comparator | Intravenous topotecan Receives: Drug: Topotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (4)
Overall Survival (OS)
From date of randomization until the date of death from any cause
Measured: From date of randomization until the date of death from any cause, assessed up to 100 months.
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
Measured: 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.
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
Measured: 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.
Grade ≥3 Adverse Events
The incidence of treatment-related adverse events ≥ grade 3 ( CTCAE v5.0 ).
Measured: From date of first treatment administration until 3 months after last dose, assessed by CTCAE v5.0 criteria.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study startAug 2025 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extensive-stage Small Cell Lung Cancer (ES-SCLC)Studies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07106528
- Sponsor's protocol ID
- K8538
- Status last verified
- Jul 2025
- First submitted
- 22 Jul 2025
- Last updated
- 6 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Organoid-Based Drug Sensitivity Model Guided Personalized Precision Treatment for Extensive-Stage Small Cell Lung Cancer: A Prospective, Multicenter, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07106528
- Acronym / sponsor ID
- K8538
- Conditions
- Extensive-stage Small Cell Lung Cancer (ES-SCLC), Extensive-stage Small Cell Lung Cancer (SCLC), Small Cell Lung Cancer ( SCLC )
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Aug 2025 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 6 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Organoid-Guided Personalized Therapy | Experimental | Drug: Organoid Drug Sensitivity Testing-Guided TherapyDrug selection based on organoid drug sensitivity testing |
| Standard Topotecan Chemotherapy | Active comparator | Drug: TopotecanIntravenous topotecan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
- Presence of measurable lesions based on RECIST 1.1.
Key exclusion criteria (8 listed)
- 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.
- Presence of active infections, severe organ dysfunction, or other contraindications to anti-tumor treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Organoid Drug Sensitivity Testing-Guided TherapyPersonalized drug selection (chemotherapy/targeted therapy/immunotherapy) based on ex vivo organoid drug response testing | Drug | Organoid-Guided Personalized Therapy |
| TopotecanIntravenous topotecan 1.25 mg/m² daily on days 1-5 of each 21-day cycle | Drug | Standard Topotecan Chemotherapy |
Primary outcome
Progression-Free Survival (PFS)
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.
From the date of randomization to the date of first recording of disease progression ( RECIST v1.1 ) or all-cause death, whichever occurred first.
4 secondary outcomes
Overall Survival (OS)
Time frame: From date of randomization until the date of death from any cause, assessed up to 100 months.
Objective Response Rate (ORR)
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.
Duration of Response (DOR)
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.
Grade ≥3 Adverse Events
Time frame: From date of first treatment administration until 3 months after last dose, assessed by CTCAE v5.0 criteria.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Organoid Drug Sensitivity Testing-Guided Therapy and Topotecan in people with Extensive-stage Small Cell Lung Cancer (ES-SCLC) and Extensive-stage Small Cell Lung Cancer (SCLC), run by Peking Union Medical College Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025.