Phase II Single Arm Study of Neoadjuvant Dual Checkpoint Blockade With Programmed Death-ligand 1 (PD1) and Lymphocyte Activation Gene 3 (LAG-3) Inhibition in Resectable Non-Small Cell Lung Cancer (N-PLANC)
Mayo Clinic
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.
Description
PRIMARY OBJECTIVES: I. To assess efficacy of neoadjuvant cemiplimab and fianlimab in patients with resectable/early-stage NSCLC with programmed death-ligand 1 (PD-L1) 1-49%, as measured by rate of major pathologic response (MPR) (defined as ≤ 10% viable tumor cells in resected tumor and lymph nodes). II. To assess efficacy of neoadjuvant cemiplimab and fianlimab in patients with resectable/early-stage NSCLC with PD-L1 ≥ 50%, as measured by rate of major pathologic response (MPR). SECONDARY OBJECTIVES: I. Assess the following endpoints (overall and by PD-L1 subsets): event-free survival (EF…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 expressio…
Interventions
- ProcedureBiospecimen Collection
Undergo tissue and blood sample collection
- BiologicalCemiplimab
Given IV
- BiologicalFianlimab
Given IV
- ProcedureMagnetic Resonance Imaging
Undergo MRI
- ProcedureSurgical Procedure
Undergo SOC surgery
- ProcedureComputed Tomography
Undergo CT and PET/CT
- ProcedurePositron Emission Tomography
Location
- Mayo Clinic in RochesterRochester, Minnesota