Non-Small Cell Lung Cancer
Conditions
Interventions
Experimental group:Iparomlimab/Tuvonralimab: 5 mg/kg, intravenous infusion, Day 1, Q3W. Chemotherapy will be administered after the completion of Iparomlimab/Tuvonralimab treatment.
Albumin-bound pacl
or 125 mg/m2, intravenous infusion, Day 1 and Day 8, Q3W.
Pemetrexed: 500 mg/m2, intravenous infusion, Day 1, Q3W.
Cisplatin: 75 mg/m2, intravenous infusion, Day 1, Q3W.
Carboplatin: AUC=5-6, intraven
Sponsors
The Affiliated Hospital of Fudan University, Hua Shan
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Patients meeting all the following inclusion criteria are eligible for enrollment in this study: Able to understand and agree to comply with the study requirements and assessment schedule, and voluntarily sign the written informed consent form (ICF). Patients aged 18 years or older. Patients with histologically or cytologically confirmed NSCLC, and cytologically confirmed cancer cells in cerebrospinal fluid, diagnosed as leptomeningeal metastasis of NSCLC. There is no restriction on the anti-tumor treatment regimens used by patients before the diagnosis of leptomeningeal metastasis, such as immunotherapy, chemotherapy, targeted drugs, anti-angiogenesis, traditional Chinese medicine, etc., and all can be included. Patients who have previously received PD-(L)1/CTLA4 inhibitor treatment must have discontinued the medication for 1 year or more. For patients with non-squamous NSCLC, gene detection must clarify the positive status of driver genes such as EGFR/ALK/ROS1. For patients with positive driver genes, the following conditions must be met: a. EGFR-TKI treatment-resistant patients must undergo further gene detection. If there are positive mutations in other driver genes (such as MET, RET, etc.), they must be resistant to targeted therapy for that target before enrollment. Among them, if there is a T790M mutation after first-generation EGFR-TKI treatment resistance, they must be resistant to third-generation EGFR-TKI treatment. b. Patients with other positive driver genes must be resistant to available targeted therapy drugs. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2 are eligible. Patients with a score of 3-4 due to neurological symptoms caused by leptomeningeal metastasis are also allowed to be included. Adequate organ and marrow function, defined as follows: a. Hematology (no blood products, hematopoietic growth factors, granulocyte colony-stimulating factors, erythropoiesis-stimulating agents, or anemia-correcting drugs used within 14 days before the first use of the study drug): i. Absolute neutrophil count >= 1.5×10^9/L. ii. Hemoglobin (HGB) >= 90 g/L. iii. Platelet count (PLT) >= 90×10^9/L. b. Biochemistry: i. Total bilirubin (TBIL) = 30 mL/min (Cockcroft-Gault formula). c. Coagulation function: i. International normalized ratio (INR) = 12 weeks. Patients with reproductive potential must agree to use effective contraception during the study period and for 120 days after the last dose of treatment.
Exclusion criteria
Exclusion criteria: Patients meeting any of the following criteria will be excluded from this study: Patients with conditions related to cancer or meningeal disease that require urgent intervention, and have not yet been clinically managed or stabilized prior to enrollment. Respiratory syndrome (dyspnea >= CTCAE grade 2), uncontrolled pleural effusion (including pleural effusion, ascites, and pericardial effusion). A history of allergy to apalutamide or any of its components, or the presence of contraindications to treatment. A history of allergy to paclitaxel, platinum, gemcitabine, docetaxel, pemetrexed, or any of their components, or resistance or intolerance to treatment, or the presence of any contraindications to these drugs. Patients who have previously received or are currently receiving any of the following treatments: a) Use of immunosuppressive drugs or systemic corticosteroids for the purpose of immunosuppression within 2 weeks before the first use of the study drug (dose >10 mg/day prednisone or equivalent); patients using inhaled or topical corticosteroids and those receiving adrenal corticosteroid replacement therapy with a dose >10 mg/day prednisone or equivalent are allowed, as are patients with hypothyroidism receiving replacement therapy. b) Vaccination with a live attenuated vaccine within 4 weeks before the first use of the study drug, or planned administration of live or attenuated vaccines during the study period. c) Major surgery or severe trauma within 4 weeks before the first use of the study drug. d) Uncontrolled hypertension (systolic blood pressure >= 140 mmHg or diastolic blood pressure >90 mmHg despite optimal medical therapy). Uncontrolled hypertension. Patients with any active autoimmune disease or a history of autoimmune disease, including but not limited to: interstitial pneumonia, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (patients receiving hormone replacement therapy may be considered for inclusion); patients with psoriasis requiring only topical ointments and not affecting quality of life, or childhood asthma/allergy that has completely resolved and requires no intervention in adulthood, may be considered for inclusion, but patients requiring medical intervention with bronchodilators are excluded. A history of immunodeficiency, including positive HIV test results, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation or allogeneic bone marrow transplantation. Presence of uncontrolled cardiac clinical symptoms or diseases, including but not limited to: NYHA class II or higher heart failure, unstable angina, myocardial infarction within the past year, and clinically significant supraventricular or ventricular arrhythmias that are not controlled or poorly controlled after clinical intervention. Severe infection (CTCAE > grade 2) within 4 weeks before the first use of the study drug, such as severe pneumonia requiring hospitalization, bacteremia, infectious complications, etc.; baseline chest imaging suggesting active pulmonary inflammation, presence of signs and symptoms of infection within 14 days before the first use of the study drug, or need for oral or intravenous antibiotic therapy (excluding prophylactic use of antibiotics). Active tuberculosis infection identified by history or CT scan, or a history of active tuberculosis infection within the past year, or a history of active tuberculosis infection more than 1 year ago th
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OS; | — |
Secondary
| Measure | Time frame |
|---|---|
| iORR;iPFS;iDoR;PFS;ORR;DoR; | — |
Countries
China
Contacts
Public ContactXiaohua Liang
The Affiliated Hospital of Fudan University, Hua Shan
Outcome results
None listed