NCT07450183

Perioperative Cemiplimab for Resectable Non-Small Cell Lung Cancer With High PD-L1

Phase II Trial of Perioperative Cemiplimab in Patients With Resectable Non-small Cell Lung Cancer and PD-L1 ≥50%

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: Henry Ford Health System · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Lung Cancer (NSCLC)

Interventions

Type	Name	Description
DRUG	Cemiplimab	Cemiplimab 350 mg IV every 3 weeks for 3 neoadjuvant cycles, followed by surgical resection, then 10 adjuvant cycles of cemiplimab at the same dose and schedule.
DRUG	Adjuvant chemotherapy	Up to 4 cycles of histology-matched platinum-based adjuvant chemotherapy may be administered after surgery, at the treating oncologist's discretion, prior to starting adjuvant cemiplimab.

Timeline

• Start date: 2026-06-01
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2026-03-04
• Last updated: 2026-03-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study