Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-25 @ 2:37 AM
NCT ID:
NCT05553834
Eligibility Criteria:
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05553834
Study Brief:
Protocol Section:
NCT05553834