Combining two drugs to treat advanced lung cancer that hasn't responded to previous treatments
A Phase II Study of PCSK9 Inhibitor Alirocumab and PD-1 Inhibitor Cemiplimab in Patients With Metastatic, Refractory To Prior Anti PD-1 Non-small Cell Lung Cancer: TOP2201
This study is testing if combining two drugs, alirocumab and cemiplimab, can help people with advanced lung cancer who haven't responded to previous treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Drugs / interventions | chemotherapy, alirocumab, cemiplimab |
| Locations | 2 sites (Tampa, Florida and 1 other locations) |
| Trial ID | NCT05553834 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of combining the anti-PCSK9 antibody alirocumab with the anti-PD-1 antibody cemiplimab in patients with metastatic non-small cell lung cancer (NSCLC) who have not responded to prior PD-1 therapy. The study aims to determine if this combination can enhance anti-tumor activity and lead to clinical responses in this challenging patient population. Participants must have measurable disease and meet specific eligibility criteria, including prior treatment history and performance status.
Who should consider this trial
Good fit: Ideal candidates include patients with recurrent or metastatic NSCLC who have progressed after prior PD-1 directed therapy.
Not a fit: Patients who have previously been treated with PCSK9 inhibitors or have significant cardiac issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new treatment option for patients with advanced lung cancer who have limited alternatives.
How similar studies have performed: While the combination of these specific agents is novel, previous studies have shown promise in targeting immune checkpoint resistance in cancer treatment.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Tampa, Florida and 1 other locations
- Moffitt Cancer Center — Tampa, Florida, United States (Recruiting)
- Duke University — Durham, North Carolina, United States (Recruiting)
Study contacts
- Study coordinator: Scott Antonia, MD
- Email: scott.antonia@duke.edu
- Phone: 919 681 9509
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.