Phase
Condition
N/ATreatment
N/AClinical Study ID
Ages 18-75 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- patients voluntarily enrolled in this study and signed the informed consent form (ICF). Good compliance and cooperation with follow-up.
- age: 18 to 75 years, both sexes.
- ECOG PS: 0 to 1 score.
- patients with non-small cell lung cancer clearly diagnosed by pathology, withmeasurable tumor lesions (oligometastases ≥10 mm in length, meeting mRECIST1.1criteria).
- subjects with clinical stage IV according to the 8th edition of the Clinical OncologyTNM staging Stage IV (≤5 oligometastases, ≤3 metastatic organs, and measurablemetastases) non-small cell lung cancer patients according to the 8th edition of TNMstaging.
- patients with stage IV clinical stage (number of oligometastases ≤ 5, metastatic organs ≤ 3, and measurable metastases) non-small cell lung cancer 6. vital organ function meetsthe following requirements (no blood components and cell growth are allowed 2 weeks priorto the start of study treatment) (No blood components or cell growth factors are allowed 2weeks prior to the start of study treatment).
(1) Routine blood tests must meet the following requirements.
- absolute neutrophil count (ANC) ≥ 1.5 x 109
- L.
- Hemoglobin (HB) ≥ 9 g/dL.
- Platelets (PLT) ≥ 100×109 /L.
- serum albumin (ALB) ≥ 2.8g/dL. (2) Biochemical examination shall comply with. a) total bilirubin (TBIL) ≤ 1.5 ULN. b) ALT, AST ≤ 2.5 UILN (if liver functionabnormalities due to liver metastases, then ≤ 5 ULN) b) ALT, AST ≤ 2.5 UILN (≤ 5 ULN ifliver function abnormalities are due to liver metastasis). c) serum creatinine sCr ≤ 1.5 ULN, endogenous creatinine clearance c) serum creatinine sCr ≤ 1.5 ULN and endogenous creatinine clearance ≥ 50 ml/min (Cockcroft-Gault formula).
- expected survival ≥ 3 months. 8. the patient is judged by the investigator to beamenable to treatment with kallikreinumab 9. the patient has no autoimmune disease. 10. thepatient has not received prior treatment with PD-1/PD-L1 inhibitors. 11. tissue or plasmagenetic testing for common lung cancer driver genes such as EGFR, ALK, ROS, RET, HER2, MET,BRAF negative, or no accessible targeted drugs or who are intolerant to targeted drugtherapy.
- Female subjects of childbearing potential should receive their first study drugadministration within 12. Female subjects of childbearing potential should have a urine orserum pregnancy test within 72 hours prior to the first study drug administration anddemonstrate 12. Female subjects of childbearing potential should have a negative urine orserum pregnancy test within 72 hours prior to the first dose of study drug and be willingto use validated methods during the trial until 3 months after the last administration ofcariolizumab. Male subjects whose partners are women of childbearing potential should usean effective method of contraception for the duration of the trial and for 3 months afterthe last administration of cariolizumab. Male subjects whose partners are women ofchildbearing potential should use an effective method of contraception during the trial andfor 3 months after the last administration of carreliximab
Exclusion
Exclusion Criteria:
- patients who do not meet the inclusion criteria for type of pathology and site ofprimary focus.
- with diffuse brain metastases and meningeal metastases
- have any active autoimmune disease or a history of autoimmune disease such as interstromal pneumonia, uveitis, enterocolitis, hepatitis, pituitary inflammation,vasculitis myocarditis, nephritis, hyperthyroidism, hypothyroidism (can be includedafter normal hormone replacement therapy). may be included after normalization of hormone replacement therapy).
- patients with asthma requiring medical intervention with bronchodilators
- patients with uncontrolled cardiac clinical symptoms or disease, such as. (1) NYHAclass II or higher heart failure. (2) Unstable angina pectoris. (3) Myocardialinfarction within 1 year. (4) Clinically significant supraventricular or ventriculararrhythmias requiring clinical (4) patients with clinically significantsupraventricular or ventricular arrhythmias requiring clinical intervention.
- active infection or unexplained fever of >38.5°C (0.5 mg/kg) during screening orbefore the first dose Fever >38.5°C (in the judgment of the investigator, subjectswith fever due to tumor fever can be enrolled).
- a known history or evidence of interstitial lung disease or active non-infectiouspneumonia
- have a congenital or acquired immune deficiency (e.g., HIV-infected), active HepatitisB (HBV-DNA ≥ 104 copies/mL) or Hepatitis C (Hepatitis C antibody positive and HCV-RNAabove the lower limit of detection for the assay).
- prior treatment with other PD-1 monoclonal antibodies or other immunotherapy againstPD-1/PDL1
- known hypersensitivity to macromolecular protein agents, or to any of the componentsof kareolizumab sensitization.
- Requirement for corticosteroids (>10 mg/day, prednisone) within 14 days prior to firstadministration of study drug.
10 mg/day, prednisone efficacy dose) or other immunosuppressive agents for systemic therapywithin 14 days prior to the first Subjects on systemic therapy with corticosteroids (> 10mg/day, prednisone efficacy dose) or other immunosuppressive agents within 14 days prior tofirst study drug administration. In the absence of active autoimmune disease In the absenceof active autoimmune disease, inhaled or topical steroids and adrenaline at doses >10mg/day, prednisone efficacy dose are allowed. Adrenocorticosteroid replacement at efficacious doses of prednisone. 12. have received anantitumor monoclonal antibody (mAb) within 4 weeks prior to the first administration ofstudy drug (mAb) within 4 weeks prior to the first administration of study drug, or adverseevents from previously received drugs have not Recovery (i.e., ≤ grade 1 or at baselinelevel). Note: Occurrence of ≤ grade 2 neuropathy or ≤ grade 2 alopecia. Note: Subjects with ≤ grade 2 neuropathy or ≤ grade 2 alopecia are excluded if the subjecthas undergone major surgery. If the subject has undergone major surgery, the toxic effects and/or complications of thesurgical intervention must be adequately addressed prior to initiation of treatment. Subjects who have undergone major surgery must have recovered sufficiently from the toxiceffects and/or complications of their surgical intervention prior to initiation oftreatment. 13. the subject is participating in another clinical study 14. the subject has received alive vaccine within 4 weeks prior to the first administration of the study drug and isallowed to receive injectable 14. Receipt of inactivated viral vaccine for seasonalinfluenza, by injection, but not receive live attenuated influenza vaccine administered viaintranasal route. 15. subjects who, in the judgment of the investigator, have other factorsthat may force them to terminate the other factors that, in the judgment of theinvestigator, may force him or her to terminate the study, such as other serious illnesses (including mental illness) requiring comorbid treatment, severely abnormal laboratory testvalues, family or social factors that circumstances that may affect the safety of thesubject or the collection of trial data. 16. other circumstances that, in the judgment of the investigator, make inclusion in thisstudy inappropriate
Study Design
Study Description
Connect with a study center
Sichuan Cancer Hospital & Institute
Chengdu, Sichuan 610041
ChinaActive - Recruiting

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