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

NCT06918132 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: MC230202NCI-2025-0215323-011212
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Lung Non-Small Cell Carcinoma; Stage IB Lung Cancer AJCC v8; Stage II Lung Cancer AJCC v8; Stage IIIA Lung Cancer AJCC v8; Stage IIIB Lung Cancer AJCC v8

Outcome Measures

Primary Outcomes (2)

• Major pathologic response (MPR) rate (Group A)

  Will be defined as ≤ 10% viable tumor cells in resected tumor and lymph nodes. Will be conducted using two parallel Simon two-stage trial designs. Will be evaluated within the PD-L1 1-49% group.

  Up to 2 years

• MPR rate (Group B)

  Will be defined as ≤ 10% viable tumor cells in resected tumor and lymph nodes. Will be conducted using two parallel Simon two-stage trial designs. Will be evaluated within the PD-L1 ≥ 50% group.

  Up to 2 years

Secondary Outcomes (8)

• Event-free survival (EFS)

  Up to 5 years

• Overall survival (OS)

  Up to 5 years

• Disease-free survival (DFS)

  Up to 5 years

• Overall response rate (ORR)

  Up to 5 years

• Pathologic complete response (pCR) rate

  Up to 5 years

Study Arms (1)

Treatment (cemiplimab, fianlimab)

EXPERIMENTAL

Patients receive cemiplimab IV over 30 minutes on day 1 of each cycle and fianlimab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo MRI during screening, tissue sample collection on study, and blood sample collection, CT, and PET/CT throughout the study. Patients may undergo SOC surgery post-treatment.

Procedure: Biospecimen Collection; Biological: Cemiplimab; Biological: Fianlimab; Procedure: Magnetic Resonance Imaging; Procedure: Surgical Procedure; Procedure: Computed Tomography; Procedure: Positron Emission Tomography

Interventions

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI

Treatment (cemiplimab, fianlimab)

Computed Tomography PROCEDURE

Undergo CT and PET/CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, computerized axial tomogrpahy, Computerized Axial Tomography, Computerized Tomography, Computerized Tomography (CT) scan, CT, Ct Scan, Diagnostic CAT Scan

Treatment (cemiplimab, fianlimab)

Positron Emission Tomography PROCEDURE

Undergo PET/CT

Also known as: Medical Imaging, PET, Pet Scan, positron emission tomography scan

Treatment (cemiplimab, fianlimab)

Biospecimen Collection PROCEDURE

Undergo tissue and blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Treatment (cemiplimab, fianlimab)

Cemiplimab BIOLOGICAL

Given IV

Also known as: Cemiplimab RWLC, Cemiplimab-rwlc, Libtayo, REGN 2810, REGN-2810, REGN2810

Treatment (cemiplimab, fianlimab)

Fianlimab BIOLOGICAL

Given IV

Also known as: Anti-LAG-3 MoAb REGN3767, REGN 3767, REGN3767, WHO 11182

Treatment (cemiplimab, fianlimab)

Surgical Procedure PROCEDURE

Undergo SOC surgery

Also known as: Operation, Surgery, Surgery Type, Surgery, Not Otherwise Specified (NOS), Surgical, Surgical Intervention, Surgical Interventions, Surgical Procedures, Type of Surgery

Treatment (cemiplimab, fianlimab)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Disease characteristics:
• Histologically or cytologically confirmed stage IB-IIIB (N2) non-small cell lung cancer (NSCLC) per American Joint Committee on Cancer (AJCC) Cancer Staging Manual Eighth Edition
• T4 tumors will only be eligible if they are defined as T4 based only on their size (more than 7 cm). All other T4 tumors will be ineligible.
• Pathologic status of lymph nodes must be known for suspicious or enlarged lymph nodes. Note: suspicious or enlarged lymph nodes must be discussed with sponsor/principal investigator.
• PD-L1 expression ≥ 1% by tumor proportion score (TPS) using immunohistochemistry (IHC)
• Group A: PD-L1 expression ≥ 1% \< 50%
• Group B: PD-L1 expression ≥ 50%
• Complete surgical resection of the primary NSCLC must be deemed achievable by thoracic surgeon at screening
• Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 NOTE: Tumor lesions in a previously irradiated area are not considered measurable disease; Disease that is measurable by physical examination only is not eligible
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
• Adequate pulmonary function ascertained by treating surgeon obtained ≤ 30 days prior to registration. A pre- or post-bronchodilator forced expiratory volume in 1 second (FEV1) of 1.0 L or \> 40% postoperative predicted value or diffusing capacity of the lungs for carbon monoxide (DLCO) \> 40% predicted value are required prior to enrollment
• Hemoglobin ≥ 8.0 g/dL (obtained ≤ 15 days prior to registration)
• Absolute neutrophil count (ANC) ≥ 1500/mm\^3 (obtained ≤ 15 days prior to registration)
• Platelet count ≥ 100,000/mm\^3 (obtained ≤ 15 days prior to registration)

You may not qualify if:

• Any of the following because this study involves an investigational agent, the genotoxic, mutagenic, and teratogenic effects of which on the developing fetus and newborn are unknown:
• Pregnant persons
• Nursing persons
• Persons of childbearing potential or able to father a child who are unwilling to employ highly effective contraception during the study and up to 6 months after the last dose
• Presence of targetable alterations \[Epiderman Growth Factor Receptor (EGFR), anaplastic lymphoma kinase (ALK), receptor tyrosine kinase (ROS1)\] in tumor
• Unresectable or metastatic disease
• Active or history of the following:
• Prior systemic anti-cancer therapy or radiation therapy for the same cancer being studied in this protocol
• Interstitial lung disease (e.g., idiopathic pulmonary fibrosis or organizing pneumonia), or active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management, or pneumonitis within the last 5 years
• Autoimmune disease (including any history of inflammatory bowel disease)
• Any syndrome that required systemic steroids or immunosuppressive medications EXCEPTIONS: patients with vitiligo; resolved childhood asthma/atopy; residual hypothyroidism that requires only hormone replacement; or psoriasis not requiring systemic treatment, type-1 diabetes mellitus, or rheumatoid arthritis managed without disease modifying anti-rheumatic drugs or \>10 mg prednisone equivalent
• Patients requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications ≤14 days prior to registration.
• NOTE: Inhaled or topical steroids and adrenal replacement doses \< 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease
• Patients with organ transplantation
• History of myocardial infarction ≤ 6 months prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias; or prior immune-related myocarditis

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

Specimen Handling; cemiplimab; Magnetic Resonance Spectroscopy; Surgical Procedures, Operative; X-Rays

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Spectrum Analysis; Chemistry Techniques, Analytical; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Officials

• Kaushal Parikh, MBBS

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: April 9, 2025
• Study Start: April 29, 2025
• Primary Completion (Estimated): April 29, 2027
• Study Completion (Estimated): April 29, 2027
• Last Updated: February 24, 2026

Record last verified: 2026-02

Locations

US (1)