Combined Statin and PD-1/PD-L1 Inhibitors in Treating Non-small Cell Lung Cancer

Korábbi kezelés

• Currently participating in interventional clinical research treatment, or received other research drugs or used research devices within 4 weeks before the first administration
• The study was receiving systemic glucocorticoid treatment (excluding local glucocorticoids by nasal spray, inhalation or other means) or any other form of immunosuppressive therapy within 7 days before the first administration; Note: It is allowed to use glucocorticoid with physiological dose (prednisone ≤ 10mg/day or equivalent)

Más betegség

• Within 5 years or at the same time, there are other active malignancies. Cured limited tumors, such as skin base cell carcinoma, skin squamous carcinoma, superficial bladder cancer, prostate in situ cancer, cervical in situ cancer, etc. can be included in the group
• Active autoimmune diseases requiring systemic treatment (such as the use of disease relieving drugs, glucocorticoids or immunosuppressants) occurred within 2 years before the first administration
• Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation
• People who are allergic to any component of the drug
• People with multiple factors affecting oral medicine (such as inability to swallow, gastrointestinal resection, significant digestive system diseases that may interfere with absorption, metabolism or excretion, such as chronic diarrhea or intestinal obstruction)

Egyéb

• According to the instructions of statins, there are contraindications to the use of statins

• Histopathology or hemology diagnostics of phase IIIB or IV (AJCC Version 8) NSCLC that cannot be surgicalor-able or radiotherapy
• Not applicable to EGFR/ALK/ROS1 targeted therapy
• Within 4 weeks prior to randomization, at least one measurable target lesions assessed by irRC in accordance with RECIST 1.1 requirements
• Patients have never received PD-1/PD-L1/CTLA-4 inhibitors treatment throughout the body for phase IIIB or IV NSCLC
• Patient have indications for statins
• The ECOG PS score for 7 days prior to the first drug use of the study drug was 0 or 1
• The expected lifetime is more than 12 weeks
• The main organ function sits well, i.e. meets the following criteria (no blood transfusion, albumin, recombinant human platelet production or Colony-stimulating factor (CSF) treatment within 14 days prior to the first drug use in this study)