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Perioperative Cemiplimab for Resectable Non-Small Cell Lung Cancer With High PD-L1 | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE2

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%

NCT07450183•Henry Ford Health System

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participant is willing and able to give informed consent for participation in the trial
•Male or Female, aged 18 years or above
•ECOG 0-1
•Patient diagnosed with early-stage resectable stage II to IIIA squamous or non-squamous, operable treatment naïve NSCLC with PD-L1 TPS ≥50%. Patients who are eligible for standard of care treatment are allowed as well as those who are ineligible for chemo, if they fit the rest of the criteria
•PD-L1 TPS ≥50% as assessed by DAKO 22C3 assay
•Adequate bone marrow function, as determined by hematological parameters:
•1. ANC ≥1.5 x 10\^9/L (1500/mm3)
•2. Hemoglobin ≥9.0 g/dL (5.59 mmol/L).
•3. Platelet count ≥75,000/mm³
•Adequate hepatic function, as determined by:
+7 more criteria

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.
+21 more criteria

Locations (1)

Henry Ford Health

Detroit, Michigan, United States

Key Dates

Start Date

June 1, 2026

Primary Completion Date

December 1, 2027

Completion Date

December 1, 2027

Last Updated

March 4, 2026

Enrollment

ESTIMATED participants

Conditions

Lung Cancer (NSCLC)

Interventions

Cemiplimab

DRUG

Adjuvant chemotherapy

DRUG

Magnetic Resonance Imaging of the Lung: Oncological Applications

NCT07486219

Lung Cancer (NSCLC)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 4, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Magnetic Resonance Imaging of the Lung: Oncological Applications

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

Practical Geriatric Assessment in Older Adults With Non-Small Cell Lung Cancer Undergoing Stereotactic Body Radiation Therapy

Engagement of Veterans With Lung Cancer

A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)

Study of Elironrasib and Daraxonrasib as Monotherapies and Combination Therapy in Participants With Advanced KRAS G12C Mutant Solid Tumors