Pilot Study on Evolocumab with Nivolumab and Ipilimumab for New Patients with Advanced Lung Cancer

Inclusion Criteria

• Must have a confirmed diagnosis of advanced non-small cell lung cancer (NSCLC) that cannot be cured or is at stage 4.
• No previous chemotherapy, radiation, or targeted therapy for the current diagnosis of advanced NSCLC. Previous treatment for early-stage NSCLC is allowed if completed more than 6 months before joining the study.
• PD-L1 expression less than 50%.
• Good overall health with a performance status score of 0 or 1.
• Age 18 years or older.
• No active invasive cancer in the past 2 years, except for non-melanoma skin cancer.
• No autoimmune disease that would prevent receiving nivolumab.
• Must have a core needle biopsy tissue sample available for research.
• No excessive risk for biopsy procedures as determined by the doctor.
• Must undergo a 'research only' biopsy if not needed for diagnosis.
• Must sign a written informed consent form.
• Safety lab results must be within normal ranges.

Exclusion Criteria

• Currently participating in another study or received an investigational treatment within 4 weeks of starting this study.
• History of active tuberculosis (TB).
• Allergic reactions to nivolumab, ipilimumab, or evolocumab.
• No accessible site for biopsy.
• Receiving other anti-tumor treatments.
• Previous treatment with PD1, PDL1, or PDL2 inhibitors.
• Received a PCSK9 inhibitor within 90 days before the study.
• Active, symptomatic brain metastases unless treated and stable.
• Active Hepatitis B or C infections.
• Unable to comply with study procedures.
• Active infection requiring treatment that would affect tolerance to therapy.
• History of non-infectious lung inflammation.
• Known HIV infection.
• Active autoimmune disease requiring treatment in the past 2 years.
• Symptomatic interstitial lung disease.
• Immunodeficiency or receiving immunosuppressive therapy within 7 days before the study.
• Pregnant or breastfeeding, or planning to conceive during the study.
• Major surgery within two weeks before the study.
• Recent heart attack or uncontrolled heart conditions.
• Psychiatric or substance abuse disorders affecting study participation.
• Prisoners or involuntarily detained individuals.
• Taking more than 10 mg of prednisone daily or equivalent.