Lung Cancer
Conditions
Interventions
Experimental Group :Patients in the study were given oral vitamin K2 (MK4, 45 mg/day) during treatment with immune checkpoint inhibitors.
Sponsors
The Second Affiliated Hospital, Zhejiang University College of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years old, gender is not limited; 2. Pathologically confirmed lung cancer, including adenocarcinoma and squamous cell carcinoma, needs to be evaluated for preoperative neoadjuvant therapy indications (tumour diameter >=4cm, positive lymph node metastasis, PD-L1 test is positive expression), and is planned to receive neoadjuvant therapy including immune checkpoint inhibitors (platinum-based doublet chemotherapy combined with nivolumab/pembrolizumab/tislelizumab/durvalumab, etc., every 3 weeks, up to 4 cycles); 3. At least one measurable lesion according to version RECIST1.1 criteria. 4. Have adequate organ function, as defined below:1) Liver function: serum total bilirubin (TBIL) =60 mL/min(Calculated using the Cockcroft/Gault formula):Female: Ccr= (140-age) x weight (kg) x 0.85 /72 x serum creatinine (mg/dL)Male: Ccr= (140-age) x weight (kg) x 1.00 /72 x serum creatinine (mg/dL)Note: For patients aged >=65 years, or for patients with normal serum creatinine but creatinine clearance = 12 weeks. Female patients of childbearing potential or male patients whose sexual partners are women of childbearing potential are required to use effective contraception throughout the treatment period and for 180 days after the last dose of trial drug. 6. Sign a written informed consent form and be able to comply with the visits and related procedures specified in the protocol.
Exclusion criteria
Exclusion criteria: 1. History of allogeneic organ transplantation. 2. Active or past records of autoimmune or inflammatory diseases (including inflammatory bowel disease [such as colitis or Crohn's disease], diverticulitis [excluding diverticular disease], systemic lupus erythematosus, sarcoidosis, or Wegener's syndrome [e.g., granulomatosis with polyangiitis, Goodpasture's disease, rheumatoid arthritis, hypophysitis, and uveitis]). 3. Uncontrollable complications, including but not limited to: symptomatic congestive heart failure, uncontrolled diabetes, uncontrolled hypertension, unstable angina, uncontrolled arrhythmias, active ILD, severe chronic GI disease with diarrhea, or psychiatric/social conditions that may limit compliance with study requirements, significantly increase the risk of adverse events, or affect the subject's ability to provide written informed consent. 4. History of other primary malignant tumors, except for the following situations: (1) Malignant tumors treated with curative intent, with no known active disease for>=5 years before first administration, and with a low risk of recurrence; (2) Adequately treated non-melanoma skin cancer or malignant nevi without evidence of disease; (3) Adequately treated in situ cancer without evidence of disease. 5. History of meningeal carcinoma. 6. History of active primary immunodeficiency. 7. Active infections, including pulmonary tuberculosis (clinical evaluation including medical history, physical examination, and imaging results, as well as TB testing according to local practices), or positive human immunodeficiency virus (HIV1/2) antibodies. 8. Any unresolved NCI CTCAE grade>=2 toxicity from prior anticancer therapy, except for alopecia, dizziness, and laboratory values defined in the inclusion criteria. 9. Brain metastases or spinal cord compression (including asymptomatic and adequately treated disease). 10. Known allergic or hypersensitivity reactions to any study drug or any of its excipients. 11. Radiotherapy is not allowed prior to the study (including palliative radiotherapy). 12. Vaccination with a live attenuated vaccine within 30 days before first administration. 13. Major surgery within the previous 28 days. 14. Patients previously treated with immune-mediated therapy (including but not limited to other anti-PD-1, anti-PD-L1, or anti-CTLA-4 agents). 15. Prior local treatments, such as radioembolization. 16. Female patients who are pregnant or breastfeeding. 17. Patients deemed by the investigator as unlikely to comply with study procedures, restrictions, and requirements are not eligible to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival;Overall Survival;Duration of Response;Patient-Reported Outcomes; | — |
Countries
China
Contacts
Public ContactJunqiang Fan
The Second Affiliated Hospital Zhejiang University School of Medicine
Outcome results
None listed