Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Duke University
With
Regeneron Pharmaceuticals
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Histologically documented recurrent and/or metastatic non-small cell lung cancer
Progression after prior PD-1 directed therapy (as monotherapy or in combination with chemotherapy and/or anti-CTLA4, or anti-VEGF agents) - defined as investigator assessed progression from prior treatment
If molecularly altered NSCLC including EGFR, ALK, ROS1, MET exon 14, RET, BRAF, NTRK, progression on prior targeted therapy is required
Measurable disease by RECIST 1.1
ECOG Performance Status 0 or 1
Signed written informed consent
Minimum of 4 weeks from any other experimental anti-cancer therapies or prior PD-1 treatment
Meet all the laboratory criteria per protocol
You may not be if
Prior treatment with PCSK9 inhibitors
Cardiac issues including MI, uncontrolled arrhythmia, symptomatic angina pectoris, active ischemia, or cardiac failure not controlled by medications.
Uncontrolled diabetes mellitus, defined as HbA1c \> 10
Major surgery less than 4 weeks prior to study enrollment
Another malignant condition diagnosed within 3 years of study enrollment
Intolerance to prior PD-1/L1 treatment including discontinuation for severe or recurrent severe toxicity (including myocarditis or other myocardiotoxity, encephalitis, colitis, diarrhea, pancreatitis, hypo/hyperthyroidism, hypopituitarism, adrenal insufficiency, rash, autonomic neuropathy, myasthenia gravis, Guillain-Barre, myositis/polymyositis, hepatitis, Type 1 Diabetes, thrombocytopenia) or developed an immune checkpoint blockade related immune adverse event that was refractory to steroids and required additional systemic immunosuppressive medication.
Known history of HIV seropositivity or known acquired immunodeficiency syndrome (AIDS)
Additional exclusion criterion as per listed in the protocol
