OncoMatch/Clinical Trials/NCT06918132
Cemiplimab and Fianlimab Before Surgery for the Treatment of Stage IB-IIIB Non-Small Cell Lung Cancer
Is NCT06918132 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Cemiplimab and Fianlimab for lung non-small cell carcinoma.
Treatment: Cemiplimab · Fianlimab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: PD-L1 (CD274) expression ≥ 1% by tumor proportion score (TPS) using immunohistochemistry (IHC) (≥ 1% TPS)
PD-L1 expression ≥ 1% by tumor proportion score (TPS) using immunohistochemistry (IHC)
Excluded: EGFR targetable alteration
Presence of targetable alterations [Epiderman Growth Factor Receptor (EGFR), anaplastic lymphoma kinase (ALK), receptor tyrosine kinase (ROS1)] in tumor
Excluded: ALK targetable alteration
Presence of targetable alterations [Epiderman Growth Factor Receptor (EGFR), anaplastic lymphoma kinase (ALK), receptor tyrosine kinase (ROS1)] in tumor
Excluded: ROS1 targetable alteration
Presence of targetable alterations [Epiderman Growth Factor Receptor (EGFR), anaplastic lymphoma kinase (ALK), receptor tyrosine kinase (ROS1)] in tumor
Disease stage
Required: Stage IB, II, IIIA, IIIB
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic anti-cancer therapy
Prior systemic anti-cancer therapy or radiation therapy for the same cancer being studied in this protocol
Cannot have received: radiation therapy
Prior systemic anti-cancer therapy or radiation therapy for the same cancer being studied in this protocol
Lab requirements
Blood counts
Hemoglobin ≥ 8.0 g/dL; Absolute neutrophil count (ANC) ≥ 1500/mm^3; Platelet count ≥ 100,000/mm^3
Kidney function
Calculated creatinine clearance ≥ 45 ml/min using the Cockroft-Gault formula
Liver function
Total bilirubin ≤ 1.5 x upper limit of normal (ULN); ALT and AST ≤ 3 x ULN
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); Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (obtained ≤ 15 days prior to registration); Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 3 x ULN (obtained ≤ 15 days prior to registration); Calculated creatinine clearance ≥ 45 ml/min using the Cockroft-Gault formula (obtained ≤ 15 days prior to registration)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mayo Clinic in Rochester · Rochester, Minnesota
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