Lung cancer
Conditions
Interventions
D-BACE:None
Sponsors
Guangdong Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Sign a written informed consent form Male or female, at least 18 years old or of legal age Eastern Cooperative Oncology Group (ECOG) performance status <= 1 Measurable lesions according to RECIST version 1.1 The subject must be able to provide a specimen containing tumor tissue or obtain a newly resected tumor biopsy tissue sample Pathologically confirmed unresectable stage II-IV N0-N1 small cell lung cancer For central laboratory PD-L1 IHC testing during the screening period: Prior to treatment, formalin-fixed, paraffin-embedded (FFPE) tissue blocks or unstained tumor tissue slides and related pathology reports must be submitted for biomarker evaluation. Tumor tissue specimens may be either freshly collected or archived samples collected within 6 months prior to enrollment. The tissue must be from core needle biopsy, excisional biopsy, or incisional biopsy sections. Freshly cut paraffin sections (PD-L1 testing should be performed within 7 days after sectioning) should be stored and transported protected from light. Fresh tissue is recommended to be fixed in 10% neutral buffered formalin for 24 to 48 hours. The subject's lung function or other organ functions, as assessed by a surgeon, must be sufficient to tolerate local surgical treatment. Adequate organ function assessment and laboratory screening must be performed within 7 days prior to treatment. Reproductive Status: Women of childbearing potential must have a negative pregnancy test (serum or urine) within 72 hours before treatment initiation. Women must not be breastfeeding. Female patients must use appropriate contraception during the treatment period and for 6 months after the last dose of treatment (i.e., 30 days of an ovulation cycle plus the time required for 5 half-lives of the drug). Male subjects must agree to use appropriate contraception during the treatment period and for 7 months after the last dose of treatment (i.e., 90 days of sperm turnover duration plus the time required for 5 half-lives of the drug). Additionally, male subjects must refrain from sperm donation during this period.
Exclusion criteria
Exclusion criteria: Patients with stage I SCLC who have previously received systemic anti-tumor treatments such as ICIs, targeted therapy, or chemotherapy are not eligible for enrollment. Patients with active known or suspected autoimmune diseases are excluded, except for those with type 1 diabetes, hypothyroidism requiring only hormone replacement therapy, skin diseases (such as vitiligo, psoriasis, or alopecia) that do not require systemic treatment, or other conditions that are not expected to recur without external triggers. Patients with active hepatitis B (positive HBsAg test result) or hepatitis C (positive HCV RNA test result) are not eligible. However, patients with a history of HBV infection or resolved HBV infection (defined as positive HBcAb and negative HBsAg) can participate in the study. These patients must provide HBV DNA test results before enrollment. HBV carriers or those requiring antiviral treatment are not eligible. Patients with positive HCV antibodies can only participate if their HCV RNA PCR test result is negative. Patients with a history of HIV positivity or AIDS, any arterial thrombosis within 6 months, deep vein thrombosis, pulmonary embolism, or any other severe thromboembolic event within 3 months, uncontrolled angina pectoris, arrhythmia, or congestive heart failure, other active malignancies within 5 years (except for adequately treated cervical carcinoma in situ, basal cell carcinoma, squamous cell skin cancer, superficial bladder cancer, prostate cancer, or breast carcinoma in situ), local treatment contraindications as determined by the investigator (including surgery or interventional procedures), severe or uncontrolled medical conditions, mental illness or other conditions that may lead to non-compliance with treatment, a history of severe hypersensitivity reactions to other monoclonal antibodies, unwillingness to sign the informed consent form, or unwillingness to undergo follow-up are not eligible for the study. Bone Marrow Function: Total white blood cell count 1.5 times the upper limit of normal (ULN). b. In the case of liver metastasis: AST and ALT > 5×ULN, total bilirubin > 1.5×ULN. Coagulation Function: Coagulation abnormalities, defined as an international normalized ratio (INR) or prothrombin time (PT) > 1.5×ULN; or, if the subject is receiving anticoagulant therapy, PT outside the intended therapeutic range of the anticoagulant drug. Renal Function: Urine protein > 2+, or 24-hour urine protein quantification > 1g; serum creatinine > 1.5×ULN or calculated creatinine clearance (CrCl) < 50 mL/min (using the Cockcroft-Gault formula). Female: CrCl = ([140 - age] × weight (kg) × 0.85) / (72 × serum creatinine (mg/dL)). Male: CrCl = ([140 - age] × weight (kg) × 1.00) / (72 × serum creatinine (mg/dL)). Allergy and Adverse Drug Reactions History of hypersensitivity reactions to other monoclonal antibodies. History of allergy or hypersensitivity to any component of the investigational drug. Other Exclusion Criteria Subjects who are incarcerated or under compulsory detention. Subjects involuntarily confined for treatment of psychiatric or physical illnesses (e.g., infectious diseases). The eligibility criteria for this study have been carefully considered to ensure the safety of the research subjects and the validity of the study results. Subjects must fully meet all eligibility criteri
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival period; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete pathological remission rate;Event-free survival period;Overall survival period; | — |
Countries
China
Contacts
Public ContactWei Cui
Guangdong Provincial People's Hospital
Outcome results
None listed