NSCLC
Conditions
Interventions
SABR combined with Serplulimab treatment group:Slulizumab immunotherapy combined with SABR
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Voluntarily participate in clinical research; 2.Male or female subjects aged >=18 years at the time of signing the informed consent form (ICF); 3.Cytologically confirmed early-stage T1-3N0 NSCLC, allowing patients with multiple primary lesions or isolated parenchymal lung recurrence; 4.At least one measurable target lesion assessed by the investigator according to RECIST v1.1 within 4 weeks prior to the first dose; 5.ECOG performance status (PS) score of 0-2; 6.Medically inoperable or unwilling to undergo surgery based on multidisciplinary evaluation; 7.Lung lesions suitable for SABR treatment; 8.Expected survival time >=12 weeks; 9.Good function of vital organs, meeting all protocol criteria [no transfusions, albumin, recombinant human thrombopoietin, or colony-stimulating factor (CSF) treatments within 14 days prior to the first dose in this study]; 10.Female subjects must have a negative serum pregnancy test within 14 days prior to the first dose and agree to use effective contraception during the treatment period and for 6 months after treatment. Breastfeeding is not allowed during treatment. Male subjects must agree to use contraception during the treatment period; 11.Male subjects must meet the following requirements: agree to abstain from sexual intercourse (avoid heterosexual activity) or use contraception as specified: if the partner is of childbearing potential or is already pregnant, the male subject must maintain abstinence or use a condom during the study treatment period and for at least 6 months after the last dose of study medication to prevent embryo exposure to the drug. Periodic abstinence (e.g., calendar method, ovulation method, basal body temperature, or post-ovulation contraception) and withdrawal (coitus interruptus) are not considered acceptable contraceptive methods.
Exclusion criteria
Exclusion criteria: 1.History of severe allergic reaction to any monoclonal antibody (NCI-CTCAE 5.0 grade >3); 2.Subjects who have previously received treatment with other immune checkpoint inhibitors, such as PD-1, PD-L1, CTLA-4, etc; 3.Known contraindications to radiotherapy in the patient; 4.Unable to meet the minimum requirements for SABR planned target coverage and key structure dose limitations (refer to the SABR treatment planning section); 5.Any active infection requiring systemic antimicrobial treatment within 14 days prior to the first dose; 6.History of myocardial infarction, poorly controlled arrhythmia (including QTc interval >=450 ms for males and >=470 ms for females) within 6 months prior to the first dose (QTc interval calculated using the Fridericia formula); or NYHA class III-IV heart failure; or left ventricular ejection fraction 1.5 mmol/L ionized calcium, or calcium >12 mg/dL, or corrected serum calcium >ULN); 8.Subjects with a history of interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-induced pneumonia, or severely impaired lung function, who in the investigator's judgment may interfere with the detection and management of suspected drug-related pulmonary toxicity during screening or prior to enrollment; 9.Subjects with hepatitis B (HBsAg positive and detectable HBV-DNA indicating viral replication); or hepatitis C (HCV antibody positive and detectable HCV-RNA indicating viral replication); or positive syphilis screening (specific antibody positive, non-specific antibody negative, and confirmed as non-active infection based on clinical judgment); or known history of HIV positivity or positive HIV screening; 10.Subjects with known active or suspected autoimmune diseases. Subjects in a stable condition who do not require systemic immunosuppressive treatment are allowed to enroll; 11.Subjects with a history of another active malignancy within the past 5 years or concurrent active malignancy. Subjects with localized tumors that have been cured for more than 5 years, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, localized prostate cancer, cervical carcinoma in situ, and ductal carcinoma in situ of the breast, may be eligible for enrollment; 12.Subjects who have received live vaccines or attenuated vaccines within 28 days prior to the first dose, or have plans to receive such vaccines during the study period; however, inactivated virus vaccines for seasonal influenza are allowed; 13.Subjects who have received radical radiotherapy within 3 months prior to the first dose; 14.Subjects with spinal cord compression that has not been effectively treated with surgery and/or radiotherapy; 15.Subjects with deep vein thrombosis, currently using anticoagulant or antiplatelet therapy, or with a history of deep vein thrombosis or severe bleeding caused by the use of anti-angiogenic drugs; 16.Subjects with poorly controlled blood pressure (defined as a blood pressure of >=160/100 mmHg despite optimal hypertension treatment); 17.Subjects who have undergone major surgery within 28 days prior to the first dose (major surgery is defined in this study as a surgery that requires at least 3 weeks of recovery time before the subject can begin the study treatment); 18.Subjects currently par
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;local control;Distant metastasis;Treatment-related adverse reactions; | — |
Countries
China
Contacts
Public ContactXu Yaping
Shanghai Pulmonary Hospital
Outcome results
None listed