The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Phase
Observational
Started
2022-10-15
Last updated
2024-03-12
Condition(s) studied
Lung Cancer
Investigational drug(s) / intervention(s)
immunotherapy
immunotherapy: statin combined with immunotherapy
Study summary
This prospective observational study was designed to evaluate the safety and efficacy of PD-1/PD-L1 inhibitors in combination with statins compared with treatment with PD-1/PD-L1 inhibitors alone in advanced NSCLC patients. Participants will receive either immunotherapy + statin or immunotherapy until progressive disease (PD) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Treatment can be continued until persistent radiographic PD or symptomatic deterioration.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
* 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)
Exclusion Criteria:
* 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
* Currently participating in interventional clinical research treatment, or received other research drugs or used research devices within 4 weeks before the first administration
* 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
* 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)
* Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation
* According to the instructions of statins, there are contraindications to the use of statins
* 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)
Primary outcome measure(s)
objective response rate — three years Refers to the proportion of patients whose tumor shrinkage reaches a certain amount and remains for a certain period of time, including CR + PR cases
progression-free survival — three years Patients with oncological diseases have a period of time from the start of treatment to the observation of disease progression or death due to any cause
Trial sites (1)
Facility
City
Region
Status
The Fourth Affiliated Hospital of Zhejiang University
Yiwu
Zhejiang
More The Fourth Affiliated Hospital of Zhejiang University School of Medicine trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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