non-small cell lung cancer
Conditions
Interventions
Experimental group:Retlirafusp alfa + Apatinib + Platinum-based chemotherapy
Sponsors
The first affiliated hospital of anhui medical university
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >= 18 years old, gender not limited; 2. Pathologically confirmed non-small cell lung cancer by histology or cytology; 3. TNM stage IIIb-IV (according to the 9th edition of the International Union Against Cancer/American Joint Committee on Cancer Cancer Staging System); 4.No EGFR sensitive mutation and no ALK fusion or ROS1 gene rearrangement; 5.No previous systemic treatment for advanced/metastatic NSCLC. Systemic therapy and/or radiotherapy as part of neoadjuvant/adjuvant treatment is allowed, provided that the treatment was completed at least 12 months before the diagnosis of advanced or metastatic disease; 6.It is recommended to provide tumor tissue samples (archived or freshly obtained tissue samples without radiotherapy, excluding needle aspiration cytology samples (without complete tissue structure, only suspension or cell smear), brush samples, pleural effusion cell sediment, and bronchoalveolar lavage fluid samples) for central laboratory testing of PD-L1 expression. 7. At least one measurable lesion according to RECIST 1.1 criteria; 8.Performance status score (ECOG PS score): 0-1; 9.Expected survival >= 3 months; 10. Good major organ function, that is, the relevant examination indicators within 14 days before enrollment meet the following requirements: hemoglobin >= 90 g/L (no blood transfusion within 14 days); neutrophil count > 1.5×10^9/L; platelet count >= 100×10^9/L; total bilirubin = 60 mL/min (Cockcroft-Gault formula); 11.Women of childbearing age must undergo serum pregnancy testing within 3 days before the first dose and the result must be negative. Women of childbearing age and male subjects whose partners are of childbearing age must agree to use highly effective contraceptive methods during the study and for 180 days after the last administration of the study drug; 12. Understand the study procedures and contents, and voluntarily sign the written informed consent form.
Exclusion criteria
Exclusion criteria: 1.Subjects diagnosed with other pathological types of non-small cell lung cancer, including those with squamous adenocarcinoma and those with NSCLC containing small cell lung cancer components; 2. Subjects with known EGFR sensitive mutations, ALK fusion, and ROS1 rearrangement; 3. Subjects who can undergo surgical resection or radical radiotherapy; 4. Subjects who have received previous chemotherapy or other systemic treatment for stage IIIb-IV disease; 5. Subjects with tumor lesions invading major blood vessels and having a significant risk of bleeding (such as central type lung squamous carcinoma); 6. Subjects with active central nervous system (CNS) metastases. If the CNS metastases of the subjects can be adequately treated, such as when the clinical stability (detected by MRI) has been maintained for at least 4 weeks, and the neurological symptoms of the subjects can recover to the baseline level (excluding residual signs or symptoms related to CNS treatment) at least 2 weeks before the first administration of the drug, they can participate in the study. Additionally, if the subjects use corticosteroid hormones to treat related clinical symptom; 7. Subjects with active, known or suspected autoimmune diseases. Subjects in a stable state and not requiring systemic immunosuppressive therapy are allowed to be enrolled, such as those with type I diabetes, hypothyroidism that only requires hormone replacement therapy, or skin diseases that do not require systemic treatment (e.g., vitiligo, psoriasis or alopecia); 8. Those with congenital or acquired immune system deficiencies, such as individuals infected with the Human Immunodeficiency Virus (HIV); 9. Diagnosis of immunodeficiency or use of systemic glucocorticoid therapy (not directly related to tumor treatment) or any other form of immunosuppressive therapy within 7 days prior to enrollment in the study; Administration of physiological doses of glucocorticoids (= 10 mg/day of prednisone or equivalent drugs) is permitted; 10. Have the following poorly controlled infectious diseases: active hepatitis B (with positive HBsAg and HBV DNA >= 500 IU/ml or 1000 copies/ml) or hepatitis C (with positive hepatitis C antibody and HCV-RNA above the detection limit of the analytical method); active tuberculosis or currently undergoing anti-tuberculosis treatment; 11. There is a previous or current history of idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation-induced pneumonia, organizing pneumonia (such as bronchitis, obliterative arteritis), drug-induced pneumonia, active pneumonia detected by CT examination, or objective evidence of severe impairment of lung function; 12. Uncontrolled pleural effusion, pericardial effusion, or ascites may require repeated drainage (once a month or more frequently). Patients may be allowed to have a catheter inserted. 13. Poor control of hypertension (systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg) allows for the administration of antihypertensive treatment to achieve the above parameters; 14. Before initiating the treatment, patients must have experienced major cardiovascular diseases (such as New York Heart Association heart diseases (rated as grade II or higher), myocardial infarction, or cerebrovascular events), unstable arrhythmias or unstable angina pectoris within the previous 3 months. Patients known to have coronary artery disease, arrhythmias, or congestive heart failure but not meeting the abov
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety;Objective Response Rate;Disease Control Rate;Overall Survival; | — |
Countries
China
Contacts
Public ContactWang Hua
The first affiliated hospital of anhui medical university
Outcome results
None listed