recurrent or metastatic SMARCA4-deficient non-small cell lung cancer
Conditions
Interventions
Experimental group:iparomlimab and tuvonralimab combined with docetaxel
Sponsors
Dongguan People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Subjects voluntarily participate and sign the Informed Consent Form (ICF), and are able to comply with the study procedures; 2. Age >=18 years at the time of signing the informed consent, with no gender restriction; 3. Pathologically confirmed SMARCA4-deficient NSCLC by histology or cytology, diagnosed as stage IV according to the 9th edition of the International Association for the Study of Lung Cancer (IASLC) staging system; 4. Investigator determines at least one measurable lesion according to RECIST v1.1 criteria; 5. Patients who have progressed after first-line standard treatment, including but not limited to platinum-based doublet chemotherapy, or platinum-based doublet chemotherapy combined with bevacizumab, or PD-1/PD-L1 drugs combined with platinum-based doublet chemotherapy; 6. ECOG performance status: 0-2, with expected survival >=12 weeks; 7. During screening, ensure that the values meet the following requirements: (No use of any blood components, cell growth factors, leukocyte-increasing drugs, platelet-increasing drugs, or anemia-correcting drugs within 14 days prior to laboratory tests): (1) Complete blood count: Absolute neutrophil count (ANC) >= 1.5 × 10^9/L, platelet count (PLT) >= 90 × 10^9/L, hemoglobin (Hb) >= 90 g/L; (2) Liver function: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 30 g/L; (3) Renal function: Serum creatinine (Cr) = 50 mL/min (calculated using the standard Cockcroft-Gault formula); (4) Coagulation function: Activated partial thromboplastin time (APTT) = 2, a 24-hour urine protein test is required, and if the result is = 50%; 8. Female subjects must not be breastfeeding, and pregnancy test results must be negative; 9. Subjects of childbearing potential must agree to use effective contraception from the time of signing the informed consent form until 180 days after the last dose.
Exclusion criteria
Exclusion criteria: 1. Known history of severe allergy to any monoclonal antibody or any component within its preparation; 2. Currently participating in and receiving investigational treatment, or having participated in investigational drug studies or received investigational treatment or devices within 4 weeks prior to the first dose of study treatment; 3. Having any other active malignancy within 5 years prior to first dosing. Cured localized tumors, such as basal cell carcinoma, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, carcinoma in situ of the cervix, carcinoma in situ of the breast, etc., are not subject to time restrictions; 4. Previous treatment with anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibodies or any other antibodies targeting T cell co-stimulatory or checkpoint pathways (such as OX40, CD137, etc.), unless the patient received such therapy for the disease more than 5 years ago and the disease has been clinically cured within the last 5 years; 5. Presence of brain metastases (patients with asymptomatic brain metastases or symptomatic brain metastases that have been treated and stable for >=4 weeks can be included); 6. Active autoimmune disease requiring systemic treatment (i.e., disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years prior to enrollment (including but not limited to: myasthenia gravis, systemic lupus erythematosus, interstitial pneumonia, uveitis, ulcerative colitis, autoimmune hepatitis, hypophysitis, systemic vasculitis, nephritis, hyperthyroidism, hypothyroidism, mixed connective tissue disease, etc.); patients with vitiligo or childhood asthma that has fully resolved and requires no intervention in adulthood may be included; asthma requiring medical intervention with bronchodilators cannot be included; replacement therapies (such as thyroid hormone, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency) are not considered systemic treatment; 7. Active pulmonary tuberculosis, radiation pneumonitis, drug-induced pneumonitis, or other diseases, symptoms, or signs seriously affecting lung function during the screening period; 8. Requirement for long-term or high-dose use of nonsteroidal drugs (aspirin >=325 mg) or anticoagulant therapy; 9. Gastrointestinal diseases of clinical significance, including but not limited to a history of gastrointestinal bleeding or perforation, acute pancreatitis, and other related conditions; 10. Coexisting cardiovascular and cerebrovascular diseases, including but not limited to: (1) Heart failure = class 2 according to the New York Heart Association (NYHA) criteria; (2) Severe/unstable angina; (3) Myocardial infarction, cerebrovascular accident, or aortic aneurysm requiring surgical repair within 6 months prior to the first administration; (4) Atrial fibrillation and supraventricular or ventricular arrhythmias requiring treatment; (5) Symptomatic superior vena cava syndrome; (6) QTc interval >450 ms (male); QTc interval >470 ms (female); (7) Hypertension not well controlled by antihypertensive medication, such as systolic blood pressure >=140 mmHg and/or diastolic blood pressure =90 mmHg, or a history of hypertensive crisis or hypertensive encephalopathy; 11. Hereditary or acquired bleeding tendency or coagulation disorder; 12. Presence of uncontrolled pleural effusion, pericardial effusion, or ascites requiring drainage; 13. Active infection or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of Response;Disease Control Rate;Progression-Free Survival;Overall Survival;Safety;Quality of Life ; | — |
Countries
China
Contacts
Public ContactGuanming Jiang
Dongguan People's Hospital
Outcome results
None listed