Extensive-stage Small-cell Lung CancerNCT07173946
Prospective Observational Study on ES-SCLC
An observational study of Extensive-stage Small-cell Lung Cancer and Small Cell Lung Cancer, run by Peking Union Medical College Hospital.
Trial summary
Study Title: A Real-World Study on Extensive-Stage Small Cell Lung Cancer (ES-SCLC) What is this study about? This research aims to learn more about how patients with extensive-stage small cell lung cancer (ES-SCLC) are treated in real-world hospital settings and how they respond to those treatments. 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, Small Cell Lung Cancer
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to Dec 2028
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (age ≥18 years) with histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC), defined as stage IV according to the AJCC 9th edition cancer staging system, who are scheduled to receive any antitumor therapy (including chemotherapy, immunotherapy, etc.). Participants must provide informed consent and be willing to comply with treatment and follow-up procedures.
Who may be able to join
- Aged 18 years or above
- Histologically or cytologically confirmed diagnosis of small cell lung cancer, classified as extensive stage (AJCC 9th Edition Stage IV).
- Signed informed consent, good compliance, and willingness to undergo treatment and follow-up.
- Intended to receive any anticancer treatment, including chemotherapy or immunotherapy.
Who cannot join
- Lack of definitive histological diagnosis
- Patients with limited-stage small cell lung cancer
- Expected survival < 3 months
- Inability to undergo regular follow-up.
About this study
Official title: Extensive-Stage Small Cell Lung Cancer (ES-SCLC) Prospective, Multicenter, Observational Cohort Study
Study Title: A Real-World Study on Extensive-Stage Small Cell Lung Cancer (ES-SCLC) What is this study about? This research aims to learn more about how patients with extensive-stage small cell lung cancer (ES-SCLC) are treated in real-world hospital settings and how they respond to those treatments. While new drugs like immunotherapies have shown promise in clinical trials, this study will observe their effectiveness and safety in everyday practice. The goal is to improve future treatment strategies for everyone with this disease.
What will I need to do if I join? This is an observational study. This means your doctors will decide your treatment plan as they normally would. The research team will not assign you any new or experimental treatments.
Read more
You will be asked to allow the researchers to collect information from your medical records about your diagnosis, treatment, and health status.
You will need to agree to regular follow-up visits (about every 3 months) by phone or clinic visit so we can track your health over time.
Optional Part: You may choose to provide extra blood and tissue samples (often taken during your routine care) for deeper laboratory research. Scientists will use these samples to try to grow "mini-tumors" (organoids) in the lab to study the disease and test drug responses. You can still participate in the main study even if you decline this part.
What are the benefits? You will receive more structured and consistent follow-up care. If you participate in the optional sample collection, you will receive a 100 RMB subsidy and a personal report on how your mini-tumor reacted to different drugs (this is for informational purposes only and not to guide your treatment).
Your participation will help doctors better understand ES-SCLC and improve care for future patients.
What are the risks or inconveniences? The main inconvenience is the time needed for follow-up visits. If you choose to provide tissue samples, the biopsy procedure itself carries standard risks (like pain, bleeding, or infection), which your doctor will manage carefully.
Your participation is completely voluntary. You can leave the study at any time without giving a reason, and it will not affect your relationship with your doctors or the quality of your medical care.
- Being tested
- Standard of Care Anti-tumor Therapy
- 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.
Standard of Care Anti-tumor TherapyOther
This is an observational cohort study. There is no intervention assigned by the study protocol. Treatment strategies (including but not limited to chemotherapy, immunotherapy, radiotherapy, and local interventional therapy) are determined solely by the treating physician based on clinical practice guidelines and individual patient circumstances.Patients will receive real-world anti-tumor treatments as prescribed by their physicians. Common treatments for extensive-stage small cell lung cancer (ES-SCLC) may include platinum-etoposide chemotherapy, immune checkpoint inhibitors (such as anti-PD-L1/PD-1 antibodies), radiotherapy, and other therapies per standard clinical practice. The study will observe and record these treatments and their outcomes.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Secondary outcomes (3)
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.
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.
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 posted15 Sep 2025
- Study startSep 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 CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 96 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
- NCT07173946
- Sponsor's protocol ID
- K8454
- Status last verified
- Aug 2025
- First submitted
- 8 Sep 2025
- Last updated
- 15 Sep 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 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extensive-Stage Small Cell Lung Cancer (ES-SCLC) Prospective, Multicenter, Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07173946
- Acronym / sponsor ID
- K8454
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 15 Sep 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.
Study Title: A Real-World Study on Extensive-Stage Small Cell Lung Cancer (ES-SCLC) What is this study about? This research aims to learn more about how patients with extensive-stage small cell lung cancer (ES-SCLC) are treated in real-world hospital settings and how they respond to those treatments. While new drugs like immunotherapies have shown promise in clinical trials, this study will observe their effectiveness and safety in everyday practice. The goal is to improve future treatment strategies for everyone with this disease.
What will I need to do if I join? This is an observational study. This means your doctors will decide your treatment plan as they normally would. The research team will not assign you any new or experimental treatments.
You will be asked to allow the researchers to collect information from your medical records about your diagnosis, treatment, and health status.
You will need to agree to regular follow-up visits (about every 3 months) by phone or clinic visit so we can track your health over time.
Optional Part: You may choose to provide extra blood and tissue samples (often taken during your routine care) for deeper laboratory research. Scientists will use these samples to try to grow "mini-tumors" (organoids) in the lab to study the disease and test drug responses. You can still participate in the main study even if you decline this part.
What are the benefits? You will receive more structured and consistent follow-up care. If you participate in the optional sample collection, you will receive a 100 RMB subsidy and a personal report on how your mini-tumor reacted to different drugs (this is for informational purposes only and not to guide your treatment).
Your participation will help doctors better understand ES-SCLC and improve care for future patients.
What are the risks or inconveniences? The main inconvenience is the time needed for follow-up visits. If you choose to provide tissue samples, the biopsy procedure itself carries standard risks (like pain, bleeding, or infection), which your doctor will manage carefully.
Your participation is completely voluntary. You can leave the study at any time without giving a reason, and it will not affect your relationship with your doctors or the quality of your medical care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (age ≥18 years) with histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC), defined as stage IV according to the AJCC 9th edition cancer staging system, who are scheduled to receive any antitumor therapy (including chemotherapy, immunotherapy, etc.). Participants must provide informed consent and be willing to comply with treatment and follow-up procedures.
Key inclusion criteria (4 listed)
- Aged 18 years or above
- Histologically or cytologically confirmed diagnosis of small cell lung cancer, classified as extensive stage (AJCC 9th Edition Stage IV).
- Signed informed consent, good compliance, and willingness to undergo treatment and follow-up.
- Intended to receive any anticancer treatment, including chemotherapy or immunotherapy.
Key exclusion criteria (4 listed)
- Lack of definitive histological diagnosis
- Patients with limited-stage small cell lung cancer
- Expected survival < 3 months
- Inability to undergo regular follow-up.
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 |
|---|---|---|
| Standard of Care Anti-tumor TherapyThis is an observational cohort study. There is no intervention assigned by the study protocol. Treatment strategies (including but not limited to chemotherapy, immunotherapy, radiotherapy, and local interventional therapy) are determined solely by the treating physician based on clinical practice guidelines and individual patient circumstances.Patients will receive real-world anti-tumor treatments as prescribed by their physicians. Common treatments for extensive-stage small cell lung cancer (ES-SCLC) may include platinum-etoposide chemotherapy, immune checkpoint inhibitors (such as anti-PD-L1/PD-1 antibodies), radiotherapy, and other therapies per standard clinical practice. The study will observe and record these treatments and their outcomes. | Other | – |
Primary outcome
Overall Survival (OS)
Time frame: From date of randomization until the date of death from any cause, assessed up to 100 months.
From date of randomization until the date of death from any cause
3 secondary outcomes
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.
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.
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 15 Sep 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?
An observational study of Extensive-stage Small-cell Lung Cancer and Small Cell Lung Cancer, 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 4 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: opening soon, as of the sponsor's last update on 15 Sep 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.
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?
Overall Survival (OS) (time frame: From date of randomization until the date of death from any cause, 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 15 Sep 2025.