Extensive-stage Small Cell Lung Cancer (ES-SCLC)NCT07070011
Small Extracellular Vesicle miRNAs as Predictive Biomarkers for Immunochemotherapy Efficacy in Extensive-stage Small Cell Lung Cancer
An observational study of Extensive-stage Small Cell Lung Cancer (ES-SCLC), run by Shanghai Chest Hospital of Shanghai Jiao Tong University at 1 site in China.
Trial summary
This study aims to investigate the clinical value of small extracellular vesicle (sEV) miRNAs as predictive biomarkers for immunochemotherapy efficacy in extensive-stage small cell lung cancer (ES-SCLC). Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Extensive-stage Small Cell Lung Cancer (ES-SCLC)
- What is being tested?
- EC/EP + ICIs
- How many people
- 38 participants
- Where
- 1 siteChina
- Study dates
- 3 Jan 2023to 31 Dec 2026
- How long will I take part?
- 38 Days
- Phase
- Observational
- 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ES-SCLC (extensive-stage small cell lung cancer) patients with an ECOG performance status of 0-1 and no prior exposure to immunotherapy or chemotherapy.
Who may be able to join
- Requirements for patients enrolled in the project:
- The pathological diagnosis of the patient is ESSCLC;
- ECOG score 0 or 1；
- The patient is receiving immunotherapy combined with chemotherapy for the first time and has no history of chemotherapy treatment;
- Patients with complete clinical sample information who meet the inclusion requirements
Who cannot join
- Patients whose pathological diagnosis does not meet the requirements;
- Patients whose ECOG staging does not meet the requirements;
- Patients with a history of chemotherapy, immunotherapy, or immunotherapy combined with chemotherapy;
- Patients with incomplete clinical sample information and follow-up information;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Chest Hospital
Shanghai, 200030
Wei Zhang, MD, +86-021-62821990, zhwei2002@sjtu.edu.cn
About this study
This study aims to investigate the clinical value of small extracellular vesicle (sEV) miRNAs as predictive biomarkers for immunochemotherapy efficacy in extensive-stage small cell lung cancer (ES-SCLC). ES-SCLC represents a highly aggressive neuroendocrine malignancy, where the current standard first-line treatment combining immune checkpoint inhibitors with chemotherapy lacks predictive biomarkers for individualized therapeutic strategies.
A prospective observational cohort will be established at Shanghai Chest Hospital, enrolling treatment-naïve ES-SCLC patients. Distinct miRNA signatures differentiating responders from non-responders will be identified through pretreatment serum sEV miRNA sequencing and differential expression analysis. These findings may provide novel liquid biopsy biomarkers to guide personalized treatment strategies and optimize clinical decision-making in ES-SCLC management.
- Being tested
- EC/EP + ICIs
- Keywords
- small cell lung cancer, immunochemotherapy, sEV miRNAs, predictive biomarkers
- 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.
EC/EP + ICIsCombination product
Collect blood samples from patients with small cell lung cancer before receiving immunotherapy combined with chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Partial Response (PR), Stable Disease (SD) and Progressive Disease (PD). | Partial Response (PR): Defined as a reduction in the sum of the diameters of target lesions by ≥30% from baseline, in the absence of new lesions. This indicates effective treatment with significant tumor shrinkage.
Stable Disease (SD): Defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease (i.e., the sum of the diameters of target lesions shows a change ranging from a decrease of <30% to an increase of <20%), in the absence of new lesions. This indicates that the disease has not worsened, but a significant reduction in tumor burden has not been achieved.
Progressive Disease (PD): Defined as an increase in the sum of the diameters of target lesions by ≥20% (taking as reference the smallest sum on study), and/or the appearance of one or more new lesions. This signifies treatment failure, necessitating a modification of the therapeutic regimen. Receives: Combination Product: EC/EP + ICIs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor Response Status per RECIST 1.1
- Assessment Tool: RECIST 1.1 criteria ;
- Unit of Measure: Number of patients (n) and percentage (%) ;
- Data Aggregation Method: Calculation of proportions of patients in each response category (PR/SD/PD);
Definitions:
- Partial Response (PR): ≥30% reduction in the sum of diameters of target lesions from baseline (absence of new lesions) ;
- Stable Disease (SD): Change in the sum of diameters ranging from <30% reduction to <20% increase (absence of new lesions) ;
- Progressive Disease (PD): ≥20% increase in the sum of diameters (reference: smallest sum recorded) and/or appearance of new lesions ;
Measured: 6 to 8 weeks
Baseline Serum sEV miRNA Expression Levels
- Measurement Tool: Next-generation sequencing (NGS) ;
- Unit of Measure: Standardized expression values (CPM, Counts Per Million) ;
- Data Aggregation Method: Descriptive statistics (mean ± SD or median [IQR]) of expression levels by response groups ;
- Procedure:
- Pre-treatment serum collection ;
- sEV isolation ;
- miRNA extraction ;
- NGS sequencing ;
- Bioinformatic normalization (CPM) .
Measured: Baseline (pre-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start3 Jan 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 38 participants (estimated)
- Target duration
- 38 Days
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital of Shanghai Jiao Tong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Zhang, Shanghai Chest Hospital of Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07070011
- Sponsor's protocol ID
- IS2109-(LGZ)
- Status last verified
- Jul 2025
- First submitted
- 2 Jun 2025
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Small Extracellular Vesicle miRNAs as Predictive Biomarkers for Immunochemotherapy Efficacy in Extensive-stage Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07070011
- Acronym / sponsor ID
- IS2109-(LGZ)
- Keywords
- small cell lung cancer, immunochemotherapy, sEV miRNAs, predictive biomarkers
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Shanghai Chest Hospital of Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 3 Jan 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 17 Jul 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 investigate the clinical value of small extracellular vesicle (sEV) miRNAs as predictive biomarkers for immunochemotherapy efficacy in extensive-stage small cell lung cancer (ES-SCLC). ES-SCLC represents a highly aggressive neuroendocrine malignancy, where the current standard first-line treatment combining immune checkpoint inhibitors with chemotherapy lacks predictive biomarkers for individualized therapeutic strategies.
A prospective observational cohort will be established at Shanghai Chest Hospital, enrolling treatment-naïve ES-SCLC patients. Distinct miRNA signatures differentiating responders from non-responders will be identified through pretreatment serum sEV miRNA sequencing and differential expression analysis. These findings may provide novel liquid biopsy biomarkers to guide personalized treatment strategies and optimize clinical decision-making in ES-SCLC management.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 38 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Partial Response (PR), Stable Disease (SD) and Progressive Disease (PD). | – | Combination Product: EC/EP + ICIsPartial Response (PR): Defined as a reduction in the sum of the diameters of target lesions by ≥30% from baseline, in the absence of new lesions. This indicates effective treatment with significant tumor shrinkage. Stable Disease (SD): Defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease (i.e., the sum of the diameters of target lesions shows a change ranging from a decrease of <30% to an increase of <20%), in the absence of new lesions. This indicates that the disease has not worsened, but a significant reduction in tumor burden has not been achieved. Progressive Disease (PD): Defined as an increase in the sum of the diameters of target lesions by ≥20% (taking as reference the smallest sum on study), and/or the appearance of one or more new lesions. This signifies treatment failure, necessitating a modification of the therapeutic regimen. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ES-SCLC (extensive-stage small cell lung cancer) patients with an ECOG performance status of 0-1 and no prior exposure to immunotherapy or chemotherapy.
Key inclusion criteria (5 listed)
- The pathological diagnosis of the patient is ESSCLC;
- ECOG score 0 or 1；
- The patient is receiving immunotherapy combined with chemotherapy for the first time and has no history of chemotherapy treatment;
- Patients with complete clinical sample information who meet the inclusion requirements
Key exclusion criteria (4 listed)
- Patients whose pathological diagnosis does not meet the requirements;
- Patients whose ECOG staging does not meet the requirements;
- Patients with a history of chemotherapy, immunotherapy, or immunotherapy combined with chemotherapy;
- Patients with incomplete clinical sample information and follow-up information;
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 |
|---|---|---|
| EC/EP + ICIsCollect blood samples from patients with small cell lung cancer before receiving immunotherapy combined with chemotherapy. | Combination product | Partial Response (PR), Stable Disease (SD) and Progressive Disease (PD). |
Primary outcome
Tumor Response Status per RECIST 1.1
Time frame: 6 to 8 weeks
* Assessment Tool: RECIST 1.1 criteria ; * Unit of Measure: Number of patients (n) and percentage (%) ; * Data Aggregation Method: Calculation of proportions of patients in each response category (PR/SD/PD); Definitions: * Partial Response (PR): ≥30% reduction in the sum of diameters of target lesions from baseline (absence of new lesions) ; * Stable Disease (SD): Change in the sum of diameters ranging from <30% reduction to <20% increase (absence of new lesions) ; * Progressive Disease (PD): ≥20% increase in the sum of diameters (reference: smallest sum recorded) and/or appearance of new lesions ;
Baseline Serum sEV miRNA Expression Levels
Time frame: Baseline (pre-treatment)
* Measurement Tool: Next-generation sequencing (NGS) ; * Unit of Measure: Standardized expression values (CPM, Counts Per Million) ; * Data Aggregation Method: Descriptive statistics (mean ± SD or median [IQR]) of expression levels by response groups ; * Procedure: 1. Pre-treatment serum collection ; 2. sEV isolation ; 3. miRNA extraction ; 4. NGS sequencing ; 5. Bioinformatic normalization (CPM) .
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 17 Jul 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Extensive-stage Small Cell Lung Cancer (ES-SCLC), run by Shanghai Chest Hospital of Shanghai Jiao Tong University at 1 site in China.
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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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?
Contact Wei Zhang, MD (+86-021-62821990, zhwei2002@sjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor Response Status per RECIST 1.1 (time frame: 6 to 8 weeks). The study lists 2 primary outcomes in all. 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 17 Jul 2025.