Non-Small Cell Lung Cancer
Conditions
Interventions
Test group: serplulimab in combination with paclitaxel and platinum-based chemotherapy
Sponsors
Sichuan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign a written informed consent form. 2. Age >=18 years and =3 months. 5. Histologically or cytologically confirmed NSCLC with stable brain metastases, staged according to the AJCC Cancer Staging Manual, 8th Edition. 6. Patients with stable brain metastases who have not received any prior systemic therapy. 7. At least one measurable lesion in both the body and the brain according to RECIST v1.1. 8. Adequate organ function confirmed by the following criteria (test results must be provided within 14 days before the start of study treatment): a) Hematology (no blood transfusion or use of hematopoietic growth factors within 7 days prior to the start of study treatment): i. Absolute neutrophil count (ANC) >= 1.5 × 10?/L (1,500/mm³) ii. Platelet count >= 100 × 10?/L (100,000/mm³) iii. Hemoglobin >= 90 g/L b) Renal function: i. Serum creatinine = 28 g/L d) Coagulation function: i. International normalized ratio (INR) and activated partial thromboplastin time (APTT) <= 1.5 × ULN 9. Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 3 days prior to the first dose (if the urine pregnancy test result is not confirmed as negative, a serum pregnancy test will be required, and the serum result shall prevail). If a female subject of childbearing potential engages in sexual activity with a non-sterilized male partner, she must use acceptable contraceptive methods starting from screening and agree to continue using contraception for 120 days after the last dose of the study drug. The decision to discontinue contraception after this period should be discussed with the investigator. 10. If a non-sterilized male subject engages in sexual activity with a female partner of childbearing potential, he must use effective contraceptive methods from screening until 120 days after the last dose. The decision to discontinue contraception after this period should be discussed with the investigator. 11. The subject is willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study requirements.
Exclusion criteria
Exclusion criteria: 1. The subject has had any other malignancy within 5 years prior to enrollment, except for non-small cell lung cancer. Subjects who have had other malignancies that were cured by local treatment (e.g., basal or squamous cell skin cancer, superficial bladder cancer, or other in situ cancers) are not excluded. 2. The subject is enrolled in another clinical study, unless it is an observational, non-interventional study or in the follow-up phase of an interventional study. 3. The subject has previously received any anti-tumor drug therapy. 4. Imaging during the screening period shows tumor invasion or the presence of significant necrotic cavities, and the investigator determines that enrollment would pose a risk of bleeding. 5. The subject has a history of active autoimmune disease requiring systemic treatment within the past 2 years (e.g., treatment with disease-modifying agents, corticosteroids, or immunosuppressants). Replacement therapy (e.g., thyroid hormone, insulin, or physiological corticosteroid replacement for adrenal or pituitary insufficiency) is not considered systemic treatment. 6. The subject has a history of non-infectious pneumonia requiring systemic corticosteroid treatment or currently has non-infectious pneumonia. 7. The subject has brainstem leptomeningeal metastases, spinal metastases, or spinal cord compression. 8. The subject has active central nervous system (CNS) metastases. Subjects who have previously received treatment for brain metastases (e.g., surgery or radiotherapy) may be enrolled if they have been clinically stable for at least 2 weeks (from the first administration of the study drug) and have discontinued corticosteroids for at least 7 days prior to drug administration. Asymptomatic subjects with untreated brain metastases (i.e., no neurological symptoms, no need for corticosteroids, no lesion with a longest diameter >1.5 cm, and no significant perilesional edema) may also be enrolled. 9. The subject has uncontrolled pleural, peritoneal, or pericardial effusion. 10. The subject has uncontrolled comorbidities, including but not limited to decompensated cirrhosis, nephrotic syndrome, uncontrolled metabolic disturbances, severe active peptic ulcer disease or gastritis, or psychiatric/social conditions that may limit the subject’s ability to comply with the study requirements or provide written informed consent. 11. The subject has a history of myocarditis, cardiomyopathy, or malignant arrhythmia. Subjects who have had hospitalization for unstable angina, myocardial infarction, or congestive heart failure (New York Heart Association functional class >=2) within 12 months prior to the first dose, or vascular disease (e.g., aneurysm at risk of rupture), or other cardiac impairments that may affect the safety evaluation of the study drug (e.g., uncontrolled arrhythmia or myocardial ischemia) within 12 months prior to the first dose; subjects who have had esophageal-gastric varices, severe ulcers, non-healing wounds, gastrointestinal perforation, fistula, obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding within 6 months prior to the first dose; subjects who have had any arterial thromboembolic event, NCI CTCAE 5.0 Grade 3 or higher venous thromboembolic event, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy within 6 months prior to the first dose; subjects who have had an acute exacerbation of chronic obstructive
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival;Intracranial Progression-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;overall response rate; | — |
Countries
China
Contacts
Public ContactJin Zhou
Sichuan Cancer Hospital
Outcome results
None listed