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

NCT07450183 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2026-03-04

No results posted yet for this study

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

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.

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2027-12-01
Completion
2027-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07450183 on ClinicalTrials.gov