Small Cell Lung Cancer
Conditions
Interventions
Treatment group:Thoracic radiotherapy and PD1/PD-L1 maintenance
Control group:PD1/PD-L1 maintenance
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Sign the informed consent form 2. Male or female aged >=18 years and =3 months 9. Adequate hematologic and end-organ function, as defined by the following laboratory test results, obtained within 14 days prior to the first dose of study treatment: Absolute neutrophil count (ANC) >1.5×10^9/L (1500/L) (not treated with granulocyte colony-stimulating factor); Lymphocyte count >=0.5×10^9/L (500/µL); platelet count > = 100×10^9/L (100,000/microlitre) (in the absence of blood transfusion); hemoglobin > = 90 g/L (9.0 g/dL); Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) =60mL/min (calculated using the Cockcroft-Gault formula); albumin > = 25 g/L (2.5 g/dL); For anticoagulation-naïve patients: international normalized ratio (INR) and activated partial thromboplastin time (aPTT) <=1.5×ULN; Pulmonary function tests: forced expiratory volume in one second (FEV1) greater than 50% of normal predicted value, and diffusing capacity of carbon monoxide lung greater than 40% of normal predicted value; 10. For patients receiving anticoagulant therapy: stable anticoagulation regimen 11. Negative human immunodeficiency virus (HIV) test result at screening 12. Negative hepatitis B surface antigen (HBsAg) test result at screening, if HBsAg test is positive, normal function is required, and HBV-DNA does not exceed 1000 copies/ml (200IU/ml) or higher than the lower limit of detection, whichever is higher 13. Positive hepatitis B surface antibody (HBsAb) test result at screening, or negative HBsAb at screening with any of the following conditions: Hepatitis B virus core antibody (HBcAb) is negative; Positive HBcAb test result and subsequent negative hepatitis B virus (HBV) DNA test result (as defined by local laboratory); Patients with a negative HBsAg test result, a negative HBsAb test result, and a positive HBcAb test result must undergo HBV DNA testing; 14. Patients with a negative hepatitis C virus (HCV) antibody test result at screening, or a positive HCV antibody test result at screening, followed by a negative HCVRNA test result and a positive HCV antibody test result, must undergo HCVRNA testing; 15. For women of childbearing potential: agree to abstinence (refrain from heterosexual intercourse) or use contraception. 16. For men: Agree to abstain from sexual intercourse (not to have heterosexual intercourse) or use condoms, and agree to refrain from donating sperm 17. Patients must submit a sample of tumor tissue prior to treatment during the study. Any available tumor tissue sample is available. Tissue samples may be provided after selection.
Exclusion criteria
Exclusion criteria: 1. During PD-1/PD-L1 monoclonal antibody combined with chemotherapy, complete response (CR) or tumor progression (PD) 2. Central nervous system (CNS) metastases that are symptomatic, untreated, or in an active progressive state Patients who are treated with a CNS lesion and are asymptomatic who are eligible for this study if they meet all of the following criteria: Measurable lesions that meet the definition of RECISTv1.1 are present outside the CNS; The patient has no history of intracranial hemorrhage or intraspinal hemorrhage; Patient has not received stereotactic radiotherapy within 7 days prior to the start of study treatment, whole-brain radiation therapy within 14 days prior to the start of study treatment, or has not undergone neurosurgical resection within 28 days prior to the start of study treatment; Patients do not require ongoing corticosteroid therapy for CNS disease. Treatment with stable doses of anticonvulsant medications is permitted. Metastases are confined to the cerebellum or supratentorial region (i.e., not metastasized to the midbrain, pons, medulla, or spinal cord); There is no evidence of progression between completion of CNS topical therapy and initiation of study treatment; Patients with asymptomatic central nervous system metastases newly identified at screening, after receiving radiation therapy and/or surgery, are eligible to participate in this study; 3. History of leptomeningeal disease 4. Total number of liver metastases>= 3 or a single liver metastases greater than 3cm 5. Uncontrolled tumor-related pain: Patients requiring analgesics who have a stable analgesic regimen at the time of enrollment in this study; Treatment of extrathoracic lesions (e.g., bone metastases or metastases causing nerve compression) that are symptomatic and eligible for palliative radiotherapy should be completed prior to enrollment. Patients should recover from side effects of radiation therapy. Topical treatment of metastatic lesions that are now asymptomatic but may lead to functional deficits or intractable pain with further growth should be considered, as appropriate, prior to enrollment. 6. Poorly controlled pleural effusion, pericardial effusion, or ascites requiring repeated drainage (once a month or more often) 7. Poorly controlled or symptomatic hypercalcemia (ionized calcium> 1.5 mmol/L, calcium > 12 mg/dL or corrected calcium >ULN) 8. Presence of active or prior autoimmune disease or immunodeficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener's granulomatous disease, Sjögren's syndrome, Guillain-Barré syndrome, or multiple sclerosis (see Appendix for a more comprehensive list of autoimmune diseases and immunodeficiencies), with the following exceptions: Patients with a history of autoimmune hypothyroidism who are receiving thyroid replacement therapy are eligible for this study; Patients with type I diabetes mellitus treated with insulin regimens and glycemic control are eligible for this study; Patients with eczema, psoriasis, lichen simplex chronica, or vitiligo with only skin symptoms (e.g.: patients with psoriatic arthritis excluded) are eligible for this study if all of the following are met: The area covered by the rash must < 10% of body surface area; Disease control at baseline with only topical weak-potency corticosteroids; No acute exacerbation of
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;ORR;DOR; | — |
Countries
China
Contacts
Public ContactYaping Xu
Shanghai Pulmonary Hospital
Outcome results
None listed