Non-small cell lung cancer
Conditions
Interventions
Experimental group:Camrelizumab combined with albumin-bound paclitaxel
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in this study and sign the Inform consent form (ICF); 2. Patients with an ECOG PS score of >=2 points or an age of >=70 years old, or other patients who meet the contraindications of platinum-based dual-drug chemotherapy and are considered unsuitable for platinum-based dual-drug chemotherapy by doctors. 3. Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), and patients at stage IIB -IIIC/IV who are inoperable or undergo radical chemoradiotherapy and judged according to the 9th edition of the International Society for the Study of Lung Cancer (IASLC) Thoracic Tumor Staging Manual; 4. No known EGFR-sensitive mutations or ALK-positive /ROS mutations; 5. No previous systemic treatment for locally advanced/metastatic NSCLC has been received. Chemotherapy and/or radiotherapy are allowed to be used as part of neoadjuvant/adjuvant therapy, with the requirement that the local disease recurs after adjuvant therapy and the interval from the end of the previous chemotherapy to recurrence is 6 months or longer; 6. Within 4 weeks before enrollment, imaging assessment (CT or MRI) was conducted, and there was at least one measurable target lesion (according to the RECIST v1.1 criteria); 7. The expected survival period is >=12 weeks; 8. The functions of important organs meet the following requirements: (1) Blood routine: White blood cell count (WBC) >=2.0× 10^9 /L; Neutrophil count (ANC) >=1.5× 10^9 /L; Platelet count (PLT) >=80× 10^9 /L; Hemoglobin content (HGB) >=9.0 g/dL (no blood transfusion or blood products within 14 days, and no correction using G-CSF and other hematopoietic stimulating factors); (2) Liver function: For patients without liver metastasis, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) should be =45 mL/min (used) (Cockcroft/Gault formula) Urine protein (UPRO) < (++), or 24-hour urine protein quantity < 1.0g; (4) Coagulation function: The International normalized ratio (INR) <=1.5 and the activated partial thromboplastin time (APTT) <=1.5 ULN; If the patient is undergoing anticoagulant therapy, as long as PT or APTT is within the expected therapeutic range of the anticoagulant, please refer to the relevant drug instructions for details. 9. Non-surgical sterilization or female patients of childbearing age must undergo a serum pregnancy test within 7 days before the first medication, and the result must be negative. And it must be in the non-lactation period. Female patients of childbearing age or male patients whose partners are female patients of childbearing age must agree to use efficient contraceptive methods during the study period and within 6 months after the last administration of the study drug.
Exclusion criteria
Exclusion criteria: 1. Histologically confirmed NSCLC with mixed small cell lung cancer components; 2. Have a history of allergy to the components of the drug under study; 3. Have received anti-PD -(L)1, CTLA-4 treatment or other immune checkpoint inhibitors in the past; 4. Patients with other severe concurrent diseases during the six-month period prior to enrollment (myocardial infection, severe or unstable angina pectoris, coronary or peripheral artery bypass surgery, New York Heart Association (NYHA) heart failure at grade 3 or 4, persistent ischemic attack, at least grade 2 peripheral neuropathy, mental or neurological disorders that prevent patients from understanding the trial) Not meeting the inclusion criteria; 5. Severe infections (CTCAE > grade 2) occurred within 4 weeks before enrollment, such as infectious complications requiring treatment, bacteremia, severe pneumonia, etc. If there are symptoms and signs of infection within 2 weeks before the first use of the drug and oral or intravenous antibiotic treatment is required (excluding the situation of preventive antibiotic use); 6. Palliative radiotherapy was received within 7 days before the first administration. For patients who have received palliative radiotherapy 7 days before the first administration, all of the following conditions must be met to be enrolled: there are currently no radiotherapy-related toxic reactions, no need to take glucocorticoids, and radiation pneumonitis is excluded; 7. Known epidermal growth factor receptor (EGFR) activating mutations (exon 19 deletion, exon 21 mutation L858R) or ALK or ROS1 gene rearrangements; 8. There is interstitial pneumonia or pneumonia or active pulmonary tuberculosis that requires systemic intravenous therapy; 9. Receive one or more other anti-tumor treatments simultaneously; 10. Suffering from congenital or acquired immune deficiency, such as being infected with the Human Immunodeficiency Virus (HIV); Have the following poorly controlled infectious diseases: active hepatitis B virus (HBsAg positive and HBV DNA>=500IU/ml or 1000copies/ml) or hepatitis C virus (hepatitis C antibody positive and HCV-RNA higher than the detection limit of the analytical method); Active tuberculosis or currently receiving anti-tuberculosis treatment; 11. Currently participating in interventional clinical research treatment, or having received other research drugs or studies within 4 weeks before enrollment; 12. Follow-up cannot be conducted as per the plan due to psychological, family, social or geographical reasons; Patients with symptomatic brain metastases or leptomeningeal metastases will be excluded. a.C If symptomatic brain metastases have been treated and magnetic resonance imaging (MRI) shows no progression within 28 days from the end of treatment to the first use of camrelizumab (with a minimum requirement of 4 weeks or longer), and within at least 2 weeks before the first use of the study drug, Patients with brain metastases who do not need to use immunosuppressive doses of systemic corticosteroids (prednisone equivalent dose exceeding 10 milligrams per day) can be admitted. b. Requirements for subjects with brain metastases who have not received local treatment in the past: If there are no neurological symptoms related to brain metastases and no need for corticosteroid hormone treatment, patients with brain metastases can be included. 14. If a patient needs to use systemic glucocorticoids (with an equivalent daily dose of prednisone exceeding 10 mill
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival, PFS;The 1 -year overall survival;Overall survival, OS;Disease control rate, DCR;Duration of Response, DoR;Safety; | — |
Countries
China
Contacts
Public ContactYan Yan; Xinai Wu
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed