non-small-cell lung cancer
Conditions
Interventions
Single arm:Anlotinib plus Benmelstobart (TQB2450) :
Anlotinib, 12 mg, po, qd, d1-14, 1 cycle in 3 weeks
Benmelstobart (TQB2450) monoclonal antibody, 1200 mg, iv, d1, 1 cycle in 3 weeks
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Subjects who voluntarily enroll in the study, sign an informed consent form, are compliant and cooperate with follow-up; 2. Age >= 18 years at the time of signing the informed consent form, male or female; 3. Locally advanced and advanced or recurrent Stage IIIB-IV NSCLC verified by histological examination or cytological examination, according to the 8th edition of the TNM Classification; 4. No sensitizing EGFR mutation, ALK fusion or ROS1 fusion; 5. No prior systemic antitumor therapy for locally advanced or advanced NSCLC, with disease progression in recurrent NSCLC occurring >6 months after the last treatment; 6. Not considered by the investigator to be candidates for any platinum-based two-agent chemotherapy due to poor physical status (ECOG PS of 2-3); or ECOG PS of 0-1with >= 70 years of age may be enrolled due to: (1) Substantial comorbidities; (2) Any contraindications to chemotherapy; 7. At least one measurable lesion according to RECIST 1.1; 8. Asymptomatic brain metastases after treatment are permitted to be enrolled; 9. Expected survival of not less than 8 weeks; 10. Women of childbearing potential (15-49 years of age) must have a negative serum pregnancy test within 7 days prior to initiation of treatment and agree to use a reliable method of contraception for the duration of the study up to 8 weeks after discontinuation of the drug; 11.Normal function of major organs should meet the following criteria: (1) Blood test criteria (no transfusion of blood and blood products within 14 days, no corrected with G-CSF and other hematopoietic stimulating factors): 1) Hemoglobin >= 90g/L; 2) Absolute neutrophil count >= 1.5x10^9/L; 3) Platelet >= 80x10^9/L; (2) Biochemical tests need to meet the following indicators: 1) Total bilirubin = 60 ml/min. (3) Urinary proteins < 2+; (4) Prothrombin time in patients who have not undergone anticoagulant therapy International normalized ratio (INR) <= 1.5, and partial thromboplastin time (APTT) <= 1.5 times upper limit of normal. Patients receiving full or parenteral anticoagulant therapy may enter a clinical trial as long as the dose of anticoagulant has been stable for at least 2 weeks prior to entry into a clinical study and the results of coagulation assay tests are within the limits imposed by local therapy.
Exclusion criteria
Exclusion criteria: 1. Large cell carcinoma and combined small cell lung cancer; 2. Age less than 70 years and ECOG PS of 0 or 1; 3. Active or untreated central nervous system metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic evaluation; 4. Uncontrolled tumor-related pain; 5. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage operations (monthly or more frequently); 6. Uncontrolled or symptomatic hypocalcemia (ionized calcium > 1.5 mmol/L or calcium > 12 mg/dL or corrected serum calcium > ULN); 7. Anti-tumor therapy by any modality within 4 weeks prior to enrollment, including radiotherapy, chemotherapy, molecularly targeted therapy, immunotherapy, and experimental therapies; 8. Treatment with systemic immunostimulants (including, but not limited to, interferon, interleukin 2, tumor necrosis factor) within 4 weeks prior to enrollment (use of cancer vaccines in prior therapy is permitted); 9. Use of any herbal medicine used for cancer control within 14 days prior to the first dose of study drug; 10. Any disease within 14 days prior to enrollment that necessitates systemic treatment with corticosteroids (prednisone >10 mg/day or equivalent) or other immunosuppressive medications [Patients may be enrolled if they are currently or have previously used any of the following steroid regimens: epinephrine-replacement steroids (prednisone =150 mmHg and diastolic blood pressure >=100 mmHg); (2) Patients with grade I or greater myocardial ischemia or myocardial infarction, cardiac arrhythmias (including QTc >=480ms) and grade >=2 congestive heart failure (New York Heart Association (NYHA) classification); (3) Abnormal coagulation (INR > 1.5 or prothrombin time (PT) > ULN+4 seconds or APTT > 1.5 ULN), bleed
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event;Objective response rate;Disease control rate;Duration of response;Overall survival; | — |
Countries
China
Contacts
Public ContactPanwen Tian
West China Hospital of Sichuan University
Outcome results
None listed