SMARCA4 deficient non-small cell lung cancer, SMARCA4-dNSCLC
Conditions
Interventions
Experimental group:Ivoximab: 20 mg/kg, q3 W Administered as a 60-minute (/-10 min) intravenous infusion. For subjects who are unable to tolerate the 60-minute infusion, the infusion time can be extend
Sponsors
Liaoning Provincial Cancer Hospital (Liaoning Provincial Cancer Institute)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily join this study and sign the informed consent form; 2. Age: 18-75 years old, male or female; 3. Confirmed pathological type of SMARCA4 deletion NSCLC by histopathology or cytopathology, and diagnosed as stage IIIB-IV according to the International Association for the Study of Lung Cancer (IASLC) 9th edition staging criteria, that is, locally advanced (the tumor lesion must be assessed by the investigator to be inoperable or radiotherapy) or metastasis; 4. ECOG physical condition score 0-1; 5. Have measurable tumor target lesions (meet RECIST 1.1 criteria); 6. Expected survival> 3 months; 7. Good organ function as determined by the following requirements: hematology (no use of any blood components and cell growth factor supportive therapy within 7 days prior to initiation of study treatment): absolute neutrophil ANC > = 1.5 ×10^9/L (1,500/mm3); Platelet count >=100 × 10^9/L (100,000/mm^3); Hemoglobin >=90 g/L. Renal: Creatinine clearance* (CrCl) calculated >=50 mL/min CrCl will be calculated using the Cockcroft-Gault formula CrCl (mL/min) = {(140 - age) × weight (kg) × F}/ (SCr (mg/dL) × 72) where F = 1 for males and F = 0.85 for females; SCr = serum creatinine. Urine protein =28 g/L d) Coagulation function: International normalized ratio (INR) and activated partial thromboplastin time (APTT) =50%. 8. Female subjects of childbearing potential must have a urine or serum pregnancy test within 3 days before the first dose (if the urine pregnancy test result cannot be confirmed to be negative, a serum pregnancy test is required, and the serum pregnancy result shall prevail) and the result is negative.
Exclusion criteria
Exclusion criteria: 1.Diagnosis of malignant diseases other than NSCLC within 3 years prior to the first dose; 2.Currently participating in interventional clinical research treatment; 3.Previously received systemic antitumor therapy; 4.Palliative local treatment of nontarget lesions was administered within 2 weeks before the first dose;received non-specific immunomodulatory therapy (such as interleukin, interferon, thymosin, tumor necrosis factor, etc., excluding IL-11 for thrombocytopenia) within 2 weeks before the first dose;Received proprietary Chinese medicines with anti-lung cancer indications drugs within 1 week before the first administration; 5.An active autoimmune disease requiring systemic treatment has occurred within 2 years prior to initial administration; 6.Active or prior history of a definite inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis, or chronic diarrhea). 7.Diagnosis of immunodeficiency;Known history of human immunodeficiency virus (HIV) infection; Currently receiving systemic glucocorticoid therapy or other immunosuppressive agents; 8.Known active pulmonary tuberculosis (TB);Clinical examination should be excluded in patients with suspected active TB; Known active syphilis infection. 9.History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 10.History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease; 11.Active infection requiring systemic therapy; 12.Untreated subjects with active hepatitis B (HBsag-positive and HBV-DNA of more than 1000 copies per milliliter (200 IU per milliliter) or above the upper limit of the normal range) and, for those with hepatitis B, were required to receive anti-HBV therapy for the duration of the study treatment; Subjects with active hepatitis C (positive for HCV antibodies and HCV-RNA levels above the lower limit of detection). 13.Had undergone a major surgical procedure or major trauma within 30 days before or within 30 days after the first dose (at the discretion of the investigator); Minor local procedures (excluding peripherally inserted central catheters and implantation of venous-access ports) had been performed within 3 days before the first dose; 14.Present brain stem, meningeal metastases, spinal cord metastases, or compression; 15.Known active CNS metastases; Participants with previously treated brain metastases may participate provided they are radiologically stable, (ie, without evidence of progression) for at least 2 weeks, are clinically stable and have not required steroid treatment for at least 3 days before the first dose of study intervention; asymptomatic brain metastases were allowed; 16.Tumor invades the surrounding important organs (such as aorta, heart and pericardium, superior vena cava, trachea, esophagus, etc.) or there is a risk of esophagotracheal fistula or esophagopleural fistula; 17.Clinically uncontrollable pleural effusion/abdominal/pericardial effusion; 18.The presence of any uncontrolled systemic disease,including but not limited to symptomatic congestive heart failure (New York Heart Association functional class 2 or higher), unstable angina, acute myocardial ischemia, uncontrolled arrhythmia, decompensated cirrhosis, nephrotic syndrome, uncontrolled metabolic disorders, severe active peptic ulcer disease, or gastritis;mental illness/social condition that would limit compliance with study requirements or affect the partici
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progress Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event;Quality of Life Assessment;Objective Response Rate;Disease Control Rate;Durationg of relief;Time to Response;Overall Survival; | — |
Countries
China
Contacts
Public ContactYuan Liang
Liaoning Provincial Cancer Hospital (Liaoning Provincial Cancer Institute)
Outcome results
None listed