Actively Recruiting
Phase II Study of Neoadjuvant Dual Checkpoint Blockade With Cemiplimab and Fianlimab in Resectable Non-Small Cell Lung Cancer
Led by Mayo Clinic · Updated on 2026-02-24
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a fixed dose combination of cemiplimab and fianlimab given before surgery to treat patients with stage IB to IIIB non-small cell lung cancer (NSCLC). This phase II trial aims to see how well these immunotherapy drugs, which help the immune system attack cancer and may stop tumor growth and spread, work in patients with specific PD-L1 expression levels. The study focuses on measuring the major pathologic response rate, which means how much the tumor is reduced after treatment, along with survival and other outcomes. Participants receive cemiplimab and fianlimab intravenously over 30 minutes on the first day of each 21-day treatment cycle. They may receive up to three cycles if there is no disease progression or unacceptable side effects. Before treatment, patients undergo MRI scans, and during the study, tissue and blood samples are collected along with CT and PET/CT scans. After completing the study treatment, patients may have standard surgery to remove the cancer. Participants are followed closely with visits at 90 days after treatment, then every three months for two years, and every six months up to five years after surgery. Researchers will assess tumor response, survival rates, surgical outcomes, and side effects. The study also includes biomarker analyses from tissue and blood samples to better understand treatment effects and disease progression. This long-term follow-up helps monitor safety and disease status over time.
CONDITIONS
Brief Title
Cemiplimab and Fianlimab Before Surgery for the Treatment of Stage IB-IIIB Non-Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically or cytologically confirmed stage IB-IIIB (N2) non-small cell lung cancer
- Tumors classified as T4 based on size only if larger than 7 cm
- Known pathologic status of suspicious or enlarged lymph nodes
- PD-L1 expression of 1% or higher by tumor proportion score
- Complete surgical resection deemed achievable by thoracic surgeon
- Measurable disease per RECIST v1.1 criteria
- ECOG performance status of 0 or 1
- Adequate pulmonary function with specified FEV1 or DLCO values
- Hemoglobin of 8.0 g/dL or higher
- Absolute neutrophil count of 1500/mm3 or higher
- Platelet count of 100,000/mm3 or higher
- Total bilirubin less than or equal to 1.5 times upper limit of normal
- ALT and AST less than or equal to 3 times upper limit of normal
- Coagulation tests within normal limits or on stable anticoagulant therapy
- Creatinine clearance of 45 ml/min or higher
- Negative pregnancy test for persons of childbearing potential
- Provide written informed consent
- Willing to provide mandatory blood and tissue specimens
- Willing to return for follow-up during active monitoring phase
You will not qualify if you...
- Pregnant, nursing, or unwilling to use effective contraception during and up to 6 months after the last dose
- Presence of targetable tumor alterations such as EGFR, ALK, or ROS1
- Unresectable or metastatic disease
- Prior systemic anti-cancer therapy or radiation for the same cancer
- Interstitial lung disease or recent pneumonitis requiring immunosuppressive treatment
- History of autoimmune disease or syndromes requiring systemic steroids or immunosuppressive drugs, with exceptions
- Current use of systemic corticosteroids over 10 mg daily or other immunosuppressive medications within 14 days prior to registration
- Organ transplantation
- Recent myocardial infarction (within 6 months), severe heart failure, or immune-related myocarditis
- Uncontrolled infections, psychiatric illness, or other conditions limiting study compliance
- Uncontrolled HIV, hepatitis B or C infection unless controlled per specific criteria
- Use of other investigational agents for the primary malignancy
- Other severe systemic illnesses or concurrent diseases interfering with safety assessment
- Prior or concurrent malignancies interfering with study assessments
- Known hypersensitivity to active substances 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) including MRI and other imaging assessments
Duration - Up to 9 weeks
Participants receive cemiplimab and fianlimab intravenously every 21 days for up to 3 cycles unless disease progression or unacceptable toxicity occurs. Tissue and blood samples are collected during this period.
3 infusion visits every 3 weeks and additional visits for tissue and blood sample collection
Duration - Duration varies based on individual surgical scheduling
Participants may undergo standard-of-care surgical resection following completion of study treatment.
1 surgical procedure visit
Duration - Up to 5 years
Participants are followed up to monitor recovery, survival, and disease status after surgery. Follow-up visits occur at 90 days post-treatment, then every 3 months for 2 years, and every 6 months up to 5 years.
Visits every 3 months for 2 years, then every 6 months for up to 3 additional years
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
C
Clinical Trials Referral Office
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here