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.
Age ≥ 18 years
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.
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
Single group
Biospecimen Collection
Procedure/SurgeryUndergo tissue and blood sample collection
Cemiplimab
Biological/VaccineGiven IV
Fianlimab
Biological/VaccineGiven IV
Magnetic Resonance Imaging
Procedure/SurgeryUndergo MRI
Surgical Procedure
Procedure/SurgeryUndergo SOC surgery
Computed Tomography
Procedure/SurgeryUndergo CT and PET/CT
Positron Emission Tomography
Procedure/SurgeryUndergo PET/CT
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.
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.
Event-free survival (EFS)
Defined as the time from study entry to any progression of disease precluding surgery, progression or recurrence of disease after surgery, progression of disease in the absence of surgery, or death from any cause (whichever occurs first).
Overall survival (OS)
Defined as the time from study entry to death from any cause.
Disease-free survival (DFS)
Defined as the time from surgery to the first of either disease recurrence or death from any cause.
Overall response rate (ORR)
Will be calculated based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. A tumor response is defined to be either a complete response or partial response noted as the objective status during neoadjuvant treatment.
Click on the lead sponsor to view all of their trials.
