Non-Small Cell Lung Cancer
Conditions
Interventions
Treatment group:Cadonilimab Injection
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1? Subject age >=18 years. 2?Must have Eastern Cooperative Oncology Group (ECOG) performance status score of 0- 1 (Oken et al. 1982). 3?Histologically confirmed Stage IIIB-IIIC or Stage IV NSCLC that is not suitable for radical surgery or radiation therapy. The histology of the tumor must be non-squamous or squamous cell.Progress during or after first-line immunotherapy (anti-PD-1) combined with chemotherapy. 4?The patient needs to provide a genetic test report, and the genetic report shows that the driver gene is negative, that is, there is no EFGR sensitive gene mutation, no ALK or ROS1 gene fusion, no BRAF V600E sensitive gene mutation, and no RET gene fusion; if the patient cannot provide a genetic test report, then tumor tissue that meets the requirements needs to be provided for genetic testing. 5?Brain MRI confirms tumor metastasis to brain parenchyma. There must be at least one measurable lesion in the brain lesion and the lesion diameter>=10mm; 6?Patients with asymptomatic brain metastases or brain metastases with intracranial hypertension symptoms controlled after dehydration treatment can continue to take medication at the time of enrollment or during the study period to maintain stable symptoms. 7?Must have life expectancy of at least 3 months. 8?The patient had at least one measurable target lesion as assessed by the investigator according to RECIST v1.1 within 4 weeks before the first dose. 9?Patients are allowed to be treated with steroids (dexamethasone). When patients with dexamethasone = 1.0×109/L (1,500/mm3);b. Platelet count (PLT)>= 80×109/L (100,000/mm3);c. Hemoglobin (HB)>=80 g/L. ? Kidney: a. Serum creatinine=50 mL/min (calculated using Cockcroft-Gault formula, CrCl (mL/min) = {(140 -age) × weight (kg) × F}/ (SCr(mg/dL) × 72), where F=1 for men and F=0.85 for women;SCr = serum creatinine);b. Urine protein =25g/L. ? Coagulation function: International normalized ratio (INR) and activated partial thromboplastin time (APTT)=50%. 11?Female patients of childbearing potential must agree to remain abstinent or use non-hormonal contraceptive methods during treatment and for 3 months after the last dose of study treatment.A woman is considered to have childbearing potential if she is after menarche, has not reached postmenopausal status (amenorrhea for 12 consecutive months, with no clear cause other than menopause), and has not undergone surgical sterilization (ovaries and/or uterus removal). 12?Male patients must agree to remain abstinent or use condoms and agree not to donate sperm.For female partners of childbearing potential or pregnant female partners, men must remain abstinent or use condoms during treatment and for 3 months after the last dose of study treatment to avoid exposing the embryo. During this period, men
Exclusion criteria
Exclusion criteria: 1?The patient suffered from metastases in the brain stem, midbrain, pons, and medulla or lesions causing obstructive hydrocephalus. 2?Patients with neurological symptoms, including patients receiving dexamethasone>4mg daily, will not be eligible for this study. 3?Excluding spinal metastases and spinal cord compression subjects who cannot be treated radically with surgery and/or radiotherapy. 4?Patients who have undergone surgical treatment for brain or spinal disease within the previous 14 days. 5?The patient has a history of severe allergy to any monoclonal antibody(NCI-CTCAE 5.0 grade greater than grade 3) ; or a history of hypersensitivity to docetaxel. 6?Patients develop any active infection requiring systemic anti-infective treatment within 14 days before the first dose. 7?Within 6 months before the first dose, the patient experienced myocardial infarction, poorly controlled arrhythmia (including QTc interval>=450 ms in men and >=470 ms in women)(QTc interval calculated based on Fridericia's formula); or Class III-IV cardiac dysfunction according to NYHA standards or left ventricular ejection fraction =2 peripheral neuropathy. 8?Patient has uncontrollable or symptomatic hypercalcemia (>1.5 mmol/L ionized calcium or calcium>12 mg/dL or corrected serum calcium>ULN). 9?Subjects who have had interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severe impairment of lung function, etc. in the past and at screening, which may interfere with the detection and management of suspected drug-related pulmonary toxicity in the investigator's judgment. 10?Patients with hepatitis B [hepatitis B surface antigen (HBsAg) is positive and HBV-DNA detection indicates virus replication]; or patients with hepatitis C [hepatitis C virus (HCV) antibodies are positive and HCV-RNA detection indicates virus replication]; or syphilis screening is positive (except for those with positive specific antibody test, negative non-specific antibody test and confirmed to be inactive infection based on clinical judgment); or a known history of positive human immunodeficiency virus (HIV) or positive HIV screening. 11?The subject had known active or suspected autoimmune disease. However, subjects whose disease is stable and do not require systemic immunosuppressants are allowed to be enrolled. 12?The patient also suffered from other active malignant tumors within 5 years. However, if patients have been cured for more than 5 years for localized tumors, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, prostate cancer in situ, cervical cancer in situ, and breast cancer in situ, can be enrolled. 13?Patients with other active malignancies within 5 years. However, if localized tumors that have been cured for more than 5 years, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, prostate cancer in situ, cervical cancer in situ, and breast cancer in situ, can be enrolled. 14?The patient had received radical radiotherapy within 3 months before the first dose, or received whole-brain radiotherapy to the brain. 15?Persons with poor blood pressure control (poor control is defined as: blood pressure still>=160/100mmHg under the best hypertension treatment regimen). 16?The patient had undergone major surgery within 28 days before the first dose (the definition of major surgery in this stu
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| intracranial progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| intracranial objective response rate;objective response rate;progression-free survival;overall survival;Neurocognitive Function Assessment (MMSE Scale);safety; | — |
Countries
China
Contacts
Public ContactJie Zhang
Shanghai Pulmonary Hospital
Outcome results
None listed