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

Part of paid clinical trials in Detroit, Michigan.

Sponsor
Henry Ford Health System
Study ID
NCT07450183
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Lung Cancer (NSCLC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cemiplimab — DRUG
    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.
  • Adjuvant chemotherapy — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jun 1, 2026
Status verified
Feb 2026
Primary completion
Dec 1, 2027
Completion
Dec 1, 2027

Study Design

Enrollment
33 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Perioperative Cemiplimab
    Patients receive neoadjuvant cemiplimab 350 mg IV every 3 weeks for 3 cycles, followed by surgical resection, then adjuvant cemiplimab 350 mg IV every 3 weeks for 10 cycles. Treating oncologists may administer histology-matched adjuvant chemotherapy (up to 4 cycles) before adjuvant cemiplimab per investigator discretion.

Primary Outcome Measure

Pathologic Complete Response Rate [ Time Frame: At surgical resection visit ]

Locations (1)

FacilityCityStateZIPSite coordinators
Henry Ford HealthDetroitMichigan48202
Fawzi Abu Rous, MD
[email protected]
313-625-7634

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By research site
Henry Ford Health· Detroit, MI

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