Small Cell Lung Cancer ( SCLC )NCT07565532
Establishment of a Prospective Clinical Cohort of Small Cell Lung Cancer Patients Receiving Radiotherapy-Involved Comprehensive Treatment
An observational study of Small Cell Lung Cancer ( SCLC ) and Radiotherapy, run by Shanghai Chest Hospital at 1 site in China.
Trial summary
By establishing a prospective clinical cohort for small cell lung cancer (SCLC) and systematically collecting high-quality real-world data integrating clinical, imaging, pathological, and molecular dimensions, this study aims to enable personalized treatment for distinct SCLC subtypes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer ( SCLC ), Radiotherapy, Immunotherapy
- What is being tested?
- radiatherapy, and chemotherapy with or without immunotherapy as clinical practice
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2026to 31 Mar 2030
- How long will I take part?
- 2 Years
- 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: Patients diagnosed with small-cell lung cancer
Who may be able to join
- Inclusion Criteria for Limited-Stage Small Cell Lung Cancer (LS-SCLC):
- 1. Voluntary signed informed consent according to clinical routine practice. 2. Histologically and radiologically confirmed, previously untreated limited-stage SCLC (according to the Veterans Administration Lung Study Group staging system).
- 3. Age ≥ 18 years. 4. Life expectancy ≥ 8 weeks. 5. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1. 6. At least one documented efficacy assessment. 7. At least one measurable lesion as confirmed by the investigator according to RECIST (iRECIST 2017) criteria.
- 8. Adequate organ and bone marrow function, with laboratory tests performed within 7 days prior to the first dose meeting the following criteria (without receiving any blood components, hematopoietic growth factors, albumin, or other corrective therapies considered by the investigator within 14 days prior to laboratory assessments):
- Hematology: Hemoglobin (Hb) ≥ 90 g/L, absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L, platelet count (PLT) ≥ 90 × 10⁹/L.
- Biochemistry: Serum creatinine (Cr) ≤ 1.5 × upper limit of normal (ULN); serum total bilirubin (TBIL) ≤ 1.5 × ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 × ULN in patients without liver metastases, or ≤ 5.0 × ULN in patients with liver metastases; serum albumin (ALB) ≥ 25 g/L.
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- Coagulation: International normalized ratio (INR) ≤ 1.5 × ULN; prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (for patients receiving prophylactic anticoagulation, the INR and APTT values should be judged by the treating physician or investigator to be within a safe and effective therapeutic range).
- 9. Pulmonary function test showing FEV₁ > 0.75 L. 10. No evidence of severe interstitial lung disease confirmed by CT or PET/CT prior to treatment.
- 11. No prior or concurrent primary malignancy at other sites. 12. No requirement for PD-L1 expression level.
- Inclusion Criteria for Extensive-Stage Small Cell Lung Cancer (ES-SCLC):
- 1. Voluntary signed informed consent according to clinical routine practice. 2. Histologically confirmed SCLC with complete staging workup showing extensive-stage disease (according to the Veterans Administration Lung Study Group staging system).
- 3. Age ≥ 18 years. 4. Life expectancy ≥ 8 weeks. 5. At least one documented efficacy assessment. 6. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-2. 7. Adequate organ and bone marrow function, with laboratory tests performed within 7 days prior to the first dose meeting the following criteria (without receiving any blood components, hematopoietic growth factors, albumin, or other corrective therapies considered by the investigator within 14 days prior to laboratory assessments):
- Hematology: Hemoglobin (Hb) ≥ 90 g/L, absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L, platelet count (PLT) ≥ 90 × 10⁹/L.
- Biochemistry: Serum creatinine (Cr) ≤ 1.5 × upper limit of normal (ULN); serum total bilirubin (TBIL) ≤ 1.5 × ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 × ULN in patients without liver metastases, or ≤ 5.0 × ULN in patients with liver metastases; serum albumin (ALB) ≥ 25 g/L.
- Coagulation: International normalized ratio (INR) ≤ 1.5 × ULN; prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (for patients receiving prophylactic anticoagulation, the INR and APTT values should be judged by the treating physician or investigator to be within a safe and effective therapeutic range).
- 8. No severe concurrent medical illness. 9. Forced expiratory volume in one second (FEV₁) > 0.75 L. 10. For patients with prior radiotherapy to the primary lesion, the current radiotherapy target is limited to metastatic lesions.
- 11. No prior or concurrent primary malignancy at other sites. 12. No requirement for PD-L1 expression level. 13. For patients with limited-stage SCLC who previously received curative-intent treatment, upon recurrence or metastasis, if complete staging workup is available and this is their first use of immunotherapy, they may still be considered for inclusion in the extensive-stage cohort.
Who cannot join
- Exclusion Criteria for Limited-Stage Small Cell Lung Cancer (LS-SCLC):
- Histologically confirmed non-small cell lung cancer (NSCLC).
- No efficacy assessment record, or missing efficacy assessment data.
- Presence of other primary malignancies; history of allogeneic organ transplantation.
- Major surgery (excluding diagnostic biopsy) within 4 weeks prior to the first dose.
- History of substance abuse (e.g., drug addiction), long-term alcoholism, or AIDS or HIV carrier.
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- Active autoimmune disease, or history of autoimmune disease with potential for relapse.
- Current systemic corticosteroid therapy (e.g., equivalent to >10 mg prednisone daily) or use of any other form of immunosuppressive therapy within 14 days prior to the first dose.
- Prior treatment with any antibody/drug targeting T-cell co-regulatory proteins (immune checkpoints), including but not limited to PD-1, PD-L1, CTLA-4, TIM-3, and LAG-3.
- Interstitial lung disease (ILD) or history of ILD requiring corticosteroid therapy.
- History of idiopathic pulmonary fibrosis (IPF), drug-induced pneumonitis, organizing pneumonia (e.g., bronchiolitis obliterans), idiopathic pneumonia, or evidence of active pneumonitis on screening chest CT.
- Receipt of live vaccine within 28 days prior to the first dose of study drug.
- Any other disease or condition that contraindicates chemoradiotherapy, including but not limited to active infection, within 6 months post-myocardial infarction, symptomatic heart disease (including unstable angina, congestive heart failure, or uncontrolled arrhythmias), and immunosuppressive therapy.
- Unresolved toxicity of Grade 2 or higher (according to CTCAE version 5.0).
- Pregnant or breastfeeding women; men or women of childbearing potential who are unwilling to use adequate contraceptive measures.
- Evidence of inherited bleeding diathesis or coagulation disorders.
- Prior history of malignancy (excluding skin cancer, or in situ breast cancer, oral cancer, or cervical cancer with life expectancy >3 years).
- Exclusion Criteria for Extensive-Stage Small Cell Lung Cancer (ES-SCLC):
- Pulmonary carcinoid or non-small cell lung cancer, unless transformed SCLC is ruled out.
- No efficacy assessment record, or missing efficacy assessment data.
- History of severe anaphylactic/allergic reaction to humanized antibodies or fusion proteins.
- Acute exacerbation of chronic obstructive pulmonary disease (COPD) or other pulmonary diseases requiring hospitalization.
- Active or prior autoimmune disease (within the past 2 years) or history of primary immunodeficiency.
- Progression after immunotherapy; prior or concurrent diagnosis of any other malignancy, excluding non-melanoma skin cancer or carcinoma in situ of the cervix.
- Any other disease or condition that contraindicates chemoradiotherapy, including but not limited to active infection, within 6 months post-myocardial infarction, symptomatic heart disease (including unstable angina, congestive heart failure, or uncontrolled arrhythmias), or immunosuppressive therapy.
- Unresolved toxicity of Grade 2 or higher (according to CTCAE version 5.0).
- Current or prior history of autoimmune disease or immunodeficiency, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, and rheumatoid arthritis.
- History of idiopathic pulmonary fibrosis (IPF), organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonia; or evidence of active pneumonitis on chest CT scan. Patients with a history of radiation pneumonitis (fibrosis) within the radiation field may be enrolled.
- Pregnant or breastfeeding women; men or women of childbearing potential who are unwilling to use adequate contraceptive measures.
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, Shanghai Municipality, 200030
Xuwei Cai, Ph.D, 86+021-22200000, chestgcp@126.com
About this study
By establishing a prospective clinical cohort for small cell lung cancer (SCLC) and systematically collecting high-quality real-world data integrating clinical, imaging, pathological, and molecular dimensions, this study aims to enable personalized treatment for distinct SCLC subtypes. Furthermore, by evaluating the influence of radiotherapy timing, dose and fractionation, and target selection on efficacy and toxicity, we aim to identify the optimal radio-immunotherapy combination regimen that maximizes the synergistic effect in SCLC patients.
- Conditions
- Small Cell Lung Cancer ( SCLC ), Radiotherapy, Immunotherapy, Personalized Cancer Treatment
- Being tested
- radiatherapy, and chemotherapy with or without immunotherapy as clinical practice
- Keywords
- Small Cell Lung Cancer (SCLC), Radiotherapy, Immunotherapy, Personalized Cancer Treatment
- 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.
radiatherapy, and chemotherapy with or without immunotherapy as clinical practiceRadiation
This is an observation study. This study adopted different timing of radio-immunotherapy combination, fractionation schedules, radiation doses, irradiation sites, PCI, and various types of immune checkpoint inhibitors.
| Study group | Role | What they receive |
|---|---|---|
| SCLC Clinical Cohort | Not described Receives: Radiation: radiatherapy, and chemotherapy with or without immunotherapy as clinical practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
The time from the start of study treatment to the first occurrence of disease progression or death from any cause, whichever occurs first.
Measured: up to 12 months after the last participant entry
Overall Survival (OS)
The time from the start of study treatment to death from any cause or the data cut-off date.
Measured: up to 12 months after the last participant entry
Secondary outcomes (5)
Distant Metastasis-Free Survival
the time from the date of diagnosis to the first occurrence of distant metastasis. For patients with extensive-stage small cell lung cancer (ES-SCLC) who already have distant metastasis at baseline, DMFS is defined as the time to new distant organ metastasis or new distant lesions. Patients who have not developed distant metastasis by the last follow-up are censored.
Measured: up to 12 months after the last participant entry
Locoregional Recurrence-Free Survival (LRFS)
The time from the date of diagnosis to the first locoregional disease progression. Patients who have not experienced locoregional events by the last follow-up are censored.
Measured: up to 12 months after the last participant entry
Objective Response Rate (ORR)
The percentage of patients achieving a best overall response of complete response (CR) or partial response (PR) during the study period. The evaluable population includes patients with baseline imaging and at least one response assessment (or documented record).
Measured: up to 12 months after the last participant entry
Disease Control Rate (DCR)
The percentage of patients achieving a best overall response of CR, PR, or stable disease (SD). The evaluable population includes patients with baseline imaging and at least one response assessment (or documented record).
Measured: up to 12 months after the last participant entry
Local Control Rate (LCR)
The start of radiotherapy to the first objective progression within the irradiated target volume, or death, or the last follow-up date.
Measured: up to 12 months after the last participant entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start1 Apr 2026
- Primary completion31 Mar 2029 (estimated)
- Study completion31 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung Cancer ( SCLC )Studies of the same condition, open and under way.
- More trials run by Shanghai Chest 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
- 500 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xuwei Cai, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07565532
- Sponsor's protocol ID
- IS26056
- Status last verified
- Apr 2026
- First submitted
- 27 Apr 2026
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of a Prospective Clinical Cohort of Small Cell Lung Cancer Patients Receiving Radiotherapy-Involved Comprehensive Treatment
- ClinicalTrials.gov ID
- NCT07565532
- Acronym / sponsor ID
- IS26056
- Conditions
- Small Cell Lung Cancer ( SCLC ), Radiotherapy, Immunotherapy, Personalized Cancer Treatment
- Keywords
- Small Cell Lung Cancer (SCLC), Radiotherapy, Immunotherapy, Personalized Cancer Treatment
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 31 Mar 2030 (estimated)
- First posted
- 4 May 2026 (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.
By establishing a prospective clinical cohort for small cell lung cancer (SCLC) and systematically collecting high-quality real-world data integrating clinical, imaging, pathological, and molecular dimensions, this study aims to enable personalized treatment for distinct SCLC subtypes. Furthermore, by evaluating the influence of radiotherapy timing, dose and fractionation, and target selection on efficacy and toxicity, we aim to identify the optimal radio-immunotherapy combination regimen that maximizes the synergistic effect in SCLC patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SCLC Clinical Cohort | – | Radiation: radiatherapy, and chemotherapy with or without immunotherapy as clinical practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with small-cell lung cancer
Key inclusion criteria (17 listed)
- 1. Voluntary signed informed consent according to clinical routine practice. 2. Histologically and radiologically confirmed, previously untreated limited-stage SCLC (according to the Veterans Administration Lung Study Group staging system).
- 3. Age ≥ 18 years. 4. Life expectancy ≥ 8 weeks. 5. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1. 6. At least one documented efficacy assessment. 7. At least one measurable lesion as confirmed by the investigator according to RECIST (iRECIST 2017) criteria.
- 8. Adequate organ and bone marrow function, with laboratory tests performed within 7 days prior to the first dose meeting the following criteria (without receiving any blood components, hematopoietic growth factors, albumin, or other corrective therapies considered by the investigator within 14 days prior to laboratory assessments):
- Hematology: Hemoglobin (Hb) ≥ 90 g/L, absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L, platelet count (PLT) ≥ 90 × 10⁹/L.
- Biochemistry: Serum creatinine (Cr) ≤ 1.5 × upper limit of normal (ULN); serum total bilirubin (TBIL) ≤ 1.5 × ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 × ULN in patients without liver metastases, or ≤ 5.0 × ULN in patients with liver metastases; serum albumin (ALB) ≥ 25 g/L.
Key exclusion criteria (29 listed)
- Histologically confirmed non-small cell lung cancer (NSCLC).
- No efficacy assessment record, or missing efficacy assessment data.
- Presence of other primary malignancies; history of allogeneic organ transplantation.
- Major surgery (excluding diagnostic biopsy) within 4 weeks prior to the first dose.
- History of substance abuse (e.g., drug addiction), long-term alcoholism, or AIDS or HIV carrier.
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 |
|---|---|---|
| radiatherapy, and chemotherapy with or without immunotherapy as clinical practiceThis is an observation study. This study adopted different timing of radio-immunotherapy combination, fractionation schedules, radiation doses, irradiation sites, PCI, and various types of immune checkpoint inhibitors. | Radiation | SCLC Clinical Cohort |
Primary outcome
Progression-free survival (PFS)
Time frame: up to 12 months after the last participant entry
The time from the start of study treatment to the first occurrence of disease progression or death from any cause, whichever occurs first.
Overall Survival (OS)
Time frame: up to 12 months after the last participant entry
The time from the start of study treatment to death from any cause or the data cut-off date.
5 secondary outcomes
Distant Metastasis-Free Survival
Time frame: up to 12 months after the last participant entry
Locoregional Recurrence-Free Survival (LRFS)
Time frame: up to 12 months after the last participant entry
Objective Response Rate (ORR)
Time frame: up to 12 months after the last participant entry
Disease Control Rate (DCR)
Time frame: up to 12 months after the last participant entry
Local Control Rate (LCR)
Time frame: up to 12 months after the last participant entry
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 4 May 2026.
- 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 Small Cell Lung Cancer ( SCLC ) and Radiotherapy, run by Shanghai Chest Hospital 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 17 inclusion and 29 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 4 May 2026. 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 Xuwei Cai, Ph.D (02122200000, birdhome2000@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: up to 12 months after the last participant entry). 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 4 May 2026.