NSCLC
Conditions
Interventions
Experimental group:After 4 cycles of Camrelizumab combined with chemotherapy, Camrelizumab combined with Recaticimab was maintained
Sponsors
First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients are at least 18 years old at the time of signing the informed consent, both male and female. 2. Patients with histologically or cytologically confirmed non-small cell lung cancer (NSCLC) and stage IIIB/IIIC/IV of inoperable and radical radiochemotherapy (as determined by the IASLC Manual on Thoracic Tumor Staging, 9th Edition). 3. The patient has not previously received systemic treatment for advanced/metastatic NSCLC. Chemotherapy and/or radiotherapy are allowed to be used as part of neoadjuvant/adjuvant therapy. 4. Have at least one measurable target lesion according to RECIST 1.1. Imaging evaluation of the tumor was performed within 28 days before the first dose. 5.ECOG PS score: 0-1. 6. Expected survival >=3 months. 7. All screening period laboratory tests shall be performed in accordance with the protocol requirements, and the values of the laboratory tests performed by the screening shall meet the following criteria: (1) Blood routine examination: (no blood transfusion, no G-CSF, no drug correction within 14 days prior to screening) 1) Hemoglobin (HB) >=90 g/L; 2) Neutrophil count absolute value (ANC) >=1.5×10^9/L; 3) Platelet count (PLT) >=100×10^9/L; 4) White blood cell count (WBC) >=4.0×10^9/L and =30 g/L; 9)Cr=60 mL/min (Cockcroft-Gault formula); 10)APTT<=1.5ULN, while INR or PT<=1.5ULN (not receiving anticoagulation therapy). 8. Fertile female subjects must have had a negative blood pregnancy test within 7 days prior to the first dosing, are not breastfeeding, and must consent to use effective contraception during the trial period and within 6 months after the last dosing of the study drug; Male subjects whose partners are fertile women should be surgically sterilized or agree to use effective contraception during the trial period and for 6 months after the last administration of the study drug, and sperm donation is not allowed during the study period. 9.With my consent and signed informed consent, I am willing and able to comply with planned visits, research treatments, laboratory tests and other test procedures.
Exclusion criteria
Exclusion criteria: 1. Pathology of NSCLC patients with small cell lung cancer components. 2. Patients with known EGFR sensitivity mutations or ALK positive /ROS1 mutations. 3. Patients who have previously received PD-(L)1 or CTLA-4 treatment. 4. Patients with active central nervous system (CNS) metastasis. Patients may participate in the study if their CNS metastases can be adequately treated, such as if clinical stability (MRI) has been maintained for at least 4 weeks, and the patient's neurological and other clinical symptoms return to baseline at least 2 weeks prior to initial medication (other than residual signs or symptoms related to CNS treatment). In addition, patients with corticosteroid related clinical symptoms who received a stable or gradually decreasing dose of =500IU/ml or 1,000 copies/ml) or viral hepatitis C (HCV antibody positive and HCV-RNA above the lower detection limit of analytical methods); Have active TB or are currently receiving anti-TB treatment; 8. There is past or present objective evidence of idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, tissue pneumonia (such as bronchitis, vasculitis obliterans), drug-induced pneumonia, active pneumonia on CT examination, or severe impairment of lung function; 9. Cardiac function and disease meet one of the following conditions, considered by the investigators to be clinically significant, obvious abnormal arrhythmias not suitable for inclusion in this study, including but not limited to complete left bundle branch conduction abnormalities, degree II atrioventricular block; 12-lead electrocardiogram (ECG) measurement, QTc interval >=450ms for male and >=470ms for female; New York Heart Society (NYHA) grade >=3 cardiac insufficiency or heart color ultrasound: left ventricular ejection fraction (LVEF) Grade 2) occurred within 4 weeks prior to enrollment, such as infection complications, bacteremia, severe pneumonia, etc., requiring treatment; Patients with signs and symptoms of infection within 2 weeks prior to first use of the drug that require oral or intravenous antibiotic treatment (excluding cases of prophylactic antibiotic use) who require systemic antibiotic use due to an infection; 11. Diagnosed with immune deficiency or receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy not directly related to tumor treatment within 7 days prior to study enrollment; Physiological doses of glucocorticoids (<=10 mg/ day of prednisone or equivalent) are permitted; 12. Other malignancies developed within 5 years prior to admission, excluding adequately treatable cervical carcinoma in situ, basal cell or squamous cell sk
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 12-month PFS rate;Overall survival;Disease control rate;During of response;Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Progression free survival; | — |
Countries
China
Contacts
Public ContactBin Jia; Yanru Qin
First Affiliated Hospital of Zhengzhou University
Outcome results
None listed