Establishment of a Prospective Clinical Cohort of Small Cell Lung Cancer Patients Receiving Radiotherapy-Involved Comprehensive Treatment

NCT07565532 | Recruiting

• 1 other identifier: IS26056
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Small Cell Lung Cancer (SCLC); Radiotherapy; Immunotherapy; Personalized Cancer Treatment

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  up to 12 months after the last participant entry

Secondary Outcomes (5)

• Distant Metastasis-Free Survival

  up to 12 months after the last participant entry

• Locoregional Recurrence-Free Survival (LRFS)

  up to 12 months after the last participant entry

• Objective Response Rate (ORR)

  up to 12 months after the last participant entry

• Disease Control Rate (DCR)

  up to 12 months after the last participant entry

• Local Control Rate (LCR)

  up to 12 months after the last participant entry

Other Outcomes (1)

• Exploratory Endpoint

  up to 12 months after the last participant entry

Study Arms (1)

SCLC Clinical Cohort

Radiation: radiatherapy, and chemotherapy with or without immunotherapy as clinical practice

Interventions

radiatherapy, and chemotherapy with or without immunotherapy as clinical practice RADIATION

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.

SCLC Clinical Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with small-cell lung cancer

You may qualify if:

• \. 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).
• \. 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.
• \. 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).
• \. 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.
• \. No prior or concurrent primary malignancy at other sites. 12. No requirement for PD-L1 expression level.
• \. 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).
• \. 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).
• \. 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Shanghai Chest Hospital: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples for routine blood tests, liver and kidney function assessment, and peripheral blood mononuclear cell (PBMC) / plasma isolation for biomarker analysis (e.g., PD-L1, TMB, ctDNA). Urine samples for routine urinalysis. Tissue samples (if clinically available) from diagnostic or biopsy procedures for pathological diagnosis and biomarker evaluation.

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Drug Therapy; Immunotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Immunomodulation; Biological Therapy

Central Study Contacts

Xuwei Cai, Ph.D

CONTACT

02122200000; birdhome2000@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 4, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): March 31, 2030
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)