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

Study acronym: N-PLANC
StatusRecruiting
PhasePhase 2
Started2025-05-02
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 43 months later Apr 29, 2027 → Dec 2, 2030
See other at-risk trials from Mayo Clinic

Amendment history

2026-10-02
Primary completion pushed: 2027-04-29 → 2030-12-02
Completion pushed: 2027-04-29 → 2033-12-02
2026-02-20
Study Status, Conditions, Arms and Interventions, Eligibility v3
InterventionsBiospecimen Collection (Procedure), Cemiplimab (Biological), Fianlimab (Biological), Magnetic Resonance Imaging (Procedure), Surgical…→Biospecimen Collection (Procedure), Cemiplimab (Biological), Computed Tomography (Procedure), Fianlimab (Biological), Magnetic Resonance…
Eligibility criteria+6 characters
[...] e 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 [...] ilator forced expiratory volume in 1 second (FEV1) of 1.0 L andor > 40% postoperative predicted value andor diffusing capacity of the lungs for carbon monoxide (DLCO) [...] tion) Calculated creatinine clearance ≥ 45 ml/min using the ChronicCockroft-Gault Kidney Disease Epidemiology (CKD-EPI) Creatinine Equationformula (obtained ≤ 15 days prior to [...] [...]
2025-12-05
Study Status v2
Re-verified, no change to tracked fields
2025-04-29
Not Yet Recruiting→Recruiting Study Status, Oversight, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2027-04-23→2027-04-29
Completion date2027-04-23→2027-04-29
Start dateestimated 2025-04-23→confirmed 2025-04-29
Study sitesdetails revised at 1 of 1 site
2025-04-07
Original filing
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.
Trial Details
NCT Number NCT06918132
Lead Sponsor Mayo Clinic
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
Enrollment 60 participants
Start Date 2025-05-02
Primary Completion 2030-12-02 (estimated)
Study Completion 2033-12-02 (estimated)
Updated on ClinicalTrials.gov 2026-10-01