Perioperative Cemiplimab for Resectable Non-Small Cell Lung Cancer With High PD-L1 (NCT07450183)
Phase II Trial of Perioperative Cemiplimab in Patients With Resectable Non-small Cell Lung Cancer and PD-L1 ≥50%
🩺 Plain-English Summary (8th-Grade Level)
This is a single arm phase II trial enrolling patients with stage II-IIIA non-small cell lung cancer whose disease is deemed amenable for surgical resection and has a PD-L1 level of ≥50%. Patients will receive cemiplimab for 3 cycles followed by surgical resection. The primary endpoint evaluated by the study is the amount of residual tumor in the resected tissue after 3 cycles of cemiplimab. After surgery, all patients will receive additional 10 cycles of cemiplimab and the treating oncologist will decide on the need of administering chemotherapy prior to that.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (17 items) and avoid the listed exclusions (30 items).
Location: Henry Ford Health — Detroit, Michigan
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Patients showing evidence of any distant metastases during screening.
- Patients with tumors with known actionable EGFR gene mutations, ALK, RET or ROS1 gene translocations
- Any condition that requires ongoing/continuous corticosteroid therapy (\>10 mg prednisone/day or anti-inflammatory equivalent) within 1 week prior to the first dose of study medication. Participants who require a brief course of steroids (up to 2 days in the week before enrollment) or physiologic replacement are not excluded.
- Significant renal or hepatic impairment.
- Presence of cardiovascular disease, as defined by: a. New York Heart Association heart failure classifications of Class II, III, or IV; or myocardial infarction, or acute coronary syndrome within 12 months of first dose of study medication; or b. Transient ischemic attack or stroke within 1 year
- Scheduled elective surgery or other procedures requiring general anaesthesia during the trial.
- Participant with life expectancy of less than 6 months or is inappropriate for placebo medication.
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
- Ongoing or recent evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments within the last 2 years. Note: The following are not exclusionary: vitiligo, childhood asthma that has resolved, endocrinopathies (such as hypothyroidism or type 1 diabetes) that require only hormone replacement, or psoriasis that does not require systemic treatment.
- Any infection requiring hospitalization or treatment with IV anti-infectives within 2 weeks of first dose of study medication
- Uncontrolled infection with HIV, hepatitis B or hepatitis C infection, diagnosis of immunodeficiency, and/or tuberculosis (active or latent).
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Henry Ford Health — Detroit, Michigan
📞 Contact the Study Coordinator
Phone: (313) 625-7634
Email: faburo1@hfhs.org
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
- 💵 Compensation indicated: Patients will receive cemiplimab for 3 cycles followed by surgical resection.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.