NSCLC
Conditions
Interventions
The first stage experimental group:Cadonilimab 15mg/kg +
Adenocarcinoma: Pemetrexed 500mg/m^2(NSQ) +
Cabo AUC5
or
Squamous cell carcinoma: albumin-paclitaxel 260mg/m^2(SQ) +
Cabo AUC5
The second stage experimental group:Cadonilimab 15mg/kg +
Adenocarcinoma: Pemetrexed 500mg/m^2(NSQ) +
Cabo AUC5
or
Squamous cell carcinoma: albumin-paclitaxel 260mg/m^2(SQ) +
Cabo AUC5
Sponsors
China-japan Union Hospital of Jilin University
Eligibility
Sex/Gender
All
Age
50 Years to 85 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria 1. Voluntary signing of a written informed consent form 2. Age 50 - 85 years old 3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 4. Histological or cytological confirmed stage IIIB/IIIC or IV NSCLC (AJCC 8th edition) 5. No previous systemic anti-tumor treatment for locally advanced/metastatic diseases 6. At least one measurable lesion (according to mRECIST v1.1 criteria), and suitable for repeated accurate measurement 7. Expected survival period >= 3 months 8. To determine good organ function, the following requirements must be met (please provide the test results within 14 days before the start of the treatment): a) Hematology (no use of any blood components or cell growth factors for treatment within 7 days before the start of the study treatment): i. Absolute neutrophil count (ANC) >= 1.5 × 10^9/L ii. Platelet count >= 100 × 10^9/L iii. Hemoglobin >= 90 g/L b) Kidney: i. Serum creatinine = 2+, and quantitative examination = 28 g/L d) Coagulation function: International normalized ratio (INR) and activated partial thromboplastin time (APTT) = 50% 9. For female subjects with reproductive capacity, a urine or serum pregnancy test must be conducted 3 days before the first administration of the drug (if the urine pregnancy test result cannot be confirmed as negative, a serum pregnancy test must be performed, and the serum test result shall prevail). The result must be negative. If a female subject with reproductive capacity has sexual intercourse with an unsterilized male partner, the subject must start using an acceptable contraceptive method from the screening stage and must agree to continue using the contraceptive method for 120 days after the last administration of the study drug; regarding whether to stop the contraception after this time point, it should be discussed with the researcher. 10. If an unsterilized male subject has sexual intercourse with a female subject with reproductive capacity, the subject must use an effective contraceptive method from the screening stage until 120 days after the last administration of the study drug; regarding whether to stop the contraception after this time point, it should be discussed with the researcher. 11. The subject is willing and able to comply with the visit schedule, treatment plan, laboratory tests, and other requirements of the study.
Exclusion criteria
Exclusion criteria: Any subject meeting any of the following criteria will be ineligible to participate in this study: 1. Except for small cell lung cancer, the subject had another malignant tumor within 3 years prior to enrollment. Subjects who have been cured of other malignant tumors through local treatment, such as basal or squamous cell carcinoma of the skin, superficial bladder cancer, cervical or breast carcinoma in situ, are not excluded. 2. At the same time, be enrolled in another clinical study, unless it is an observational, non-interventional clinical study or a follow-up study of an interventional study. 3. Has previously received treatment with PDL/PDL1/CTLA4 inhibitors; or has previously undergone other systemic anti-tumor treatments for non-small cell lung cancer (such as chemotherapy, targeted therapy, etc.). 4. There is expression of driver genes (including but not limited to EGFR/ALK/MET/RET). 5. Suffering from an active autoimmune disease that required systemic treatment in the past two years (such as treatment with disease-modifying drugs, corticosteroids, or immunosuppressants). Alternative treatments (such as thyroid hormone, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency) are not considered as systemic treatment. 6. Has a history of non-infectious pneumonia/interstitial lung disease that required systemic glucocorticoid treatment in the past, or currently has non-infectious pneumonia. 7. There are active central nervous system (CNS) metastatic lesions; Subjects who have previously received treatment for brain metastases (such as surgery or radiotherapy), provided that they have achieved clinical stability for at least two weeks after the treatment and the use of corticosteroids has been discontinued 7 days before the administration of the study drug, are eligible for inclusion; Untreated, asymptomatic brain metastasis subjects (i.e., without neurological symptoms, not requiring corticosteroids, with a long diameter of any brain metastasis lesion > 1.5 cm, and without significant edema around the brain metastasis lesion) can be included. 8. Currently, there are uncontrolled coexisting diseases, including but not limited to decompensated liver cirrhosis, nephrotic syndrome, severe active peptic ulcer disease or gastritis, or mental illnesses/situations that may limit the subject's compliance with the study requirements or affect their ability to provide written informed consent. 9. There is a history of myocarditis, cardiomyopathy, or malignant arrhythmia. Within 12 months prior to the first administration, there was unstable angina pectoris requiring hospitalization, myocardial infarction, congestive heart failure (classified as grade 2 or above according to the New York Heart Association functional classification) or vascular disease (such as an aortic aneurysm with a risk of rupture), or other cardiac impairments that may affect the safety evaluation of the study drug (such as uncontrolled arrhythmia, myocardial ischemia), and QTc (Fridericia method) > 450 msec (for males) or QTc (Fridericia method) > 470 msec (for females). 10. Within 4 weeks prior to the first administration, there was a severe infection, including but not limited to those accompanied by complications requiring hospitalization, sepsis, or severe pneumonia; and within 2 weeks prior to the first administration, systemic anti-infective treatment had been received (excluding antiviral treatment fo
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR; | — |
Countries
China
Contacts
Public ContactBai YuanSong
China-japan Union Hospital of Jilin University
Outcome results
None listed