Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06918132

Cemiplimab and Fianlimab Before Surgery for the Treatment of Stage IB-IIIB Non-Small Cell Lung Cancer

Led by Mayo Clinic · Updated on 2026-02-24

60

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This phase II trial tests how well a fixed dose combination (FDC) of cemiplimab and fianlimab before surgery (neoadjuvant) works in treating patients with stage IB-IIIB non-small cell lung cancer (NSCLC). The current standard of care (SOC) for NSCLC is to give chemotherapy and immunotherapy before going to surgery to have the cancer removed (neoadjuvant therapy). Immunotherapy with monoclonal antibodies, such as cemiplimab and fianlimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving a FDC of cemiplimab and fianlimab before surgery may kill more tumor cells in treating patients with stage IB-IIIB NSCLC.

CONDITIONS

Official Title

Cemiplimab and Fianlimab Before Surgery for the Treatment of Stage IB-IIIB Non-Small Cell Lung Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Histologically or cytologically confirmed stage IB-IIIB (N2) non-small cell lung cancer per AJCC 8th Edition
  • T4 tumors eligible only if based solely on size > 7 cm
  • Known lymph node status for suspicious or enlarged nodes
  • PD-L1 expression 1% or higher by tumor proportion score
  • PD-L1 groups: 1% to less than 50% (Group A), 50% or higher (Group B)
  • Complete surgical resection achievable as determined by thoracic surgeon
  • Measurable disease per RECIST v1.1, excluding lesions in previously irradiated areas and disease measurable only by physical exam
  • ECOG performance status 0 or 1
  • Adequate pulmonary function with FEV1 ≥ 1.0 L or > 40% predicted post-op and DLCO > 40% predicted
  • Hemoglobin ≥ 8.0 g/dL within 15 days prior to registration
  • Absolute neutrophil count ≥ 1500/mm³ within 15 days prior to registration
  • Platelet count ≥ 100,000/mm³ within 15 days prior to registration
  • Total bilirubin ≤ 1.5 times upper limit of normal within 15 days prior to registration
  • ALT and AST ≤ 3 times upper limit of normal within 15 days prior to registration
  • PT/INR/aPTT ≤ 1.5 times upper limit of normal or within target if on anticoagulants within 15 days prior to registration
  • Creatinine clearance ≥ 45 ml/min within 15 days prior to registration
  • Negative pregnancy test within 8 days prior to registration for persons of childbearing potential
  • Written informed consent provided
  • Willingness to provide mandatory blood and tissue specimens for research
  • Willingness to return to enrolling institution for follow-up during active monitoring phase
Not Eligible

You will not qualify if you...

  • Pregnant or nursing persons
  • Persons of childbearing potential or able to father a child unwilling to use effective contraception during study and 6 months after last dose
  • Presence of EGFR, ALK, or ROS1 targetable alterations in tumor
  • Unresectable or metastatic disease
  • Prior systemic anti-cancer therapy or radiation for the same cancer
  • Interstitial lung disease or active noninfectious pneumonitis requiring immune-suppressive steroids or pneumonitis within last 5 years
  • Autoimmune diseases including inflammatory bowel disease
  • Syndromes requiring systemic steroids or immunosuppressive drugs except specific exceptions such as vitiligo or controlled hypothyroidism
  • Use of systemic corticosteroids > 10 mg prednisone equivalent or other immunosuppressive medications within 14 days prior to registration
  • Organ transplantation
  • Recent myocardial infarction within 6 months, congestive heart failure needing maintenance therapy, or prior immune-related myocarditis
  • Uncontrolled non-cardiac illnesses including active infection, psychiatric/social issues, dyspnea at rest needing continuous oxygen, or other conditions limiting study compliance
  • Uncontrolled HIV, hepatitis B or C infections or immunodeficiency related to chronic infection, except patients with controlled infections under specialist care
  • Use of other investigational agents for primary malignancy
  • Severe concurrent diseases or co-morbid systemic illnesses interfering with safety or efficacy assessment
  • Prior or concurrent malignancy potentially interfering with study assessments
  • Known hypersensitivity to study drugs or excipients
  • Receipt of live vaccine within 30 days prior to registration

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Mayo Clinic in Rochester

Rochester, Minnesota, United States, 55905

Actively Recruiting

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Research Team

C

Clinical Trials Referral Office

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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