SCLC
Conditions
Interventions
Experimental group:PD-1 monoantibody and chemoradiotherapy
Control group:Standard chemoradiation
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Provision of written informed consent. 2. Age 18–75 years. 3. Histologically or cytologically confirmed small-cell lung cancer (SCLC). 4. No evidence of distant metastasis on PET–CT, CT, or MRI, with disease classified as limited-stage SCLC (stage I–III according to the eighth edition of the American Joint Committee on Cancer [AJCC] staging system). 5. No prior treatment for limited-stage SCLC, including chemotherapy, radiotherapy, or surgery. 6. At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) (lesions within a previously irradiated field may be considered measurable if they have demonstrated radiographic progression). 7. An Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1. 8. An estimated life expectancy of at least 12 weeks. 9. Male participants and female participants of childbearing potential must use effective contraception from the initiation of the first dose until 3 months after the last dose of the study treatment. 10. Adequate pulmonary function, defined as a forced expiratory volume in 1 second (FEV1) >60% of the predicted value and a diffusing capacity of the lung for carbon monoxide (DLCO) >60% of the predicted value. 11. Adequate organ function, as demonstrated by the following laboratory assessments performed within 28 days before the first dose of study treatment: 1) Hematologic function: • White blood cell count (WBC) >=3.0 × 10?/L • Absolute neutrophil count (ANC) >=1.5 × 10?/L • Platelet count (PLT) >=100 × 10?/L • Hemoglobin (HGB) >=90 g/L 2) Hepatic function: • Aspartate aminotransferase (AST) =60 mL/min 4) Coagulation function: • International normalized ratio (INR) <=1.5 • Activated partial thromboplastin time (APTT) <=1.5 × ULN 5) No clinically significant abnormalities on electrocardiography.
Exclusion criteria
Exclusion criteria: 1. Histological type and disease stage 1) Histologically confirmed combined small-cell lung cancer (SCLC) or non-small-cell lung cancer (NSCLC). 2) Extensive-stage SCLC (TxNxM1a/b). 2. Medical history and comorbidities 1) Any known active autoimmune disease. Patients with clinically stable conditions that do not require systemic immunosuppressive therapy may be eligible, including those with type 1 diabetes mellitus or hypothyroidism requiring only hormone replacement therapy, and those with dermatologic conditions not requiring systemic treatment. 2) Any concomitant condition requiring systemic glucocorticoid therapy at a dose equivalent to prednisone >10 mg/day, or use of immunosuppressive medications within 14 days before the first dose of study treatment. In the absence of active autoimmune disease, inhaled or topical glucocorticoids and physiologic corticosteroid replacement therapy for adrenal insufficiency are permitted. 3) Receipt of a tumor vaccine or other immune-activating anticancer treatment, such as interferons, interleukins, thymosin, or immune-cell therapy, within 1 month before the first dose of study treatment. 4) Current participation in another clinical trial or receipt of an investigational drug or other interventional treatment in another clinical trial within 4 weeks before the first dose of study treatment. 5) Major surgery or radiotherapy at a total dose of >30 Gy within 4 weeks before the first dose of study treatment. 6) Any other malignancy requiring treatment. Patients with basal-cell carcinoma of the skin, squamous-cell carcinoma of the skin, ductal carcinoma in situ of the breast, or cervical carcinoma in situ that has been treated with curative intent and requires no further treatment may be eligible. 7) A history of severe cardiovascular disease, including grade 2 or higher myocardial ischemia, myocardial infarction, poorly controlled arrhythmia, including a corrected QT interval (QTc) =480 ms, New York Heart Association class III or IV heart failure, or a left ventricular ejection fraction (LVEF) <50% on echocardiography. 8) A known history of allogeneic organ transplantation or allogeneic hematopoietic stem-cell transplantation. 9) Receipt of a live vaccine within 30 days before the first dose of study treatment. 3. Laboratory findings 1) Positive serum testing for human immunodeficiency virus (HIV). 2) Active hepatitis B, defined as hepatitis B surface antigen (HBsAg) positivity and an HBV DNA level =10³ copies/mL, or active hepatitis C, defined as positivity for both hepatitis C virus antibody and HCV RNA and requiring antiviral treatment. 4. Allergies and treatment-related adverse reactions 1) A history of allergy or hypersensitivity to monoclonal antibodies. 2) A history of allergic reactions or intolerance during infusion. 5. Pulmonary conditions A history of non-infectious pneumonitis or interstitial lung disease requiring systemic corticosteroid treatment. 6. Other conditions Any disease, abnormal laboratory finding, or other condition that, in the investigator’s judgment, could affect the interpretation of the study results, interfere with participation in the study, or make participation not in the best interests of the patient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR);Overall survival (OS);Progression-Free Survival (PFS);Safety Assessment; | — |
Countries
China
Contacts
Public ContactYaping Xu
Shanghai Pulmonary Hospital
Outcome results
None listed