OncoMatch/Clinical Trials/NCT06449313
Neoadjuvant Chemo-Immunotherapy and Surgical Resection in Locally Advanced Non-small Cell Lung Cancer With N3 Lymph Node Involvement
Is NCT06449313 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Cemiplimab-Rwlc for non-small cell lung cancer stage iii.
Treatment: Cemiplimab-Rwlc — The goal of this clinical trial is to learn about neoadjuvant cemiplimab with histology-specific chemotherapy followed by resection and adjuvant cemiplimab in stage 3 non-small cell lung cancer (NSCLC) with contralateral mediastinal or ipsilateral supraclavicular lymph node (N3) involvement.. The main question it aims to answer is whether patients with stage 3 NSCLC with involvement of lymph nodes can undergo surgery to remove the cancer after receiving treatment with chemotherapy + immunotherapy. Participants will receive FDA-approved chemotherapy called platinum-doublet chemotherapy together with an immunotherapy drug targeting the immune marker PD-1 called cemiplimab. Patients will receive a 3 drug combination for 4 total treatments given every 3 weeks before surgery. After surgery, patients will have the option to undergo radiation therapy if it is recommended by their treatment team. After this, they will receive cemiplimab every 3 weeks for one year.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: ALK wild-type
Required: EGFR wild-type
Disease stage
Required: Stage 3B, 3C (8th American Joint Committee on Cancer (AJCC))
stage 3 B/C Non-Small Cell Lung Cancer (NSCLC) as assessed per the 8th American Joint Committee on Cancer (AJCC) with pathologically-confirmed contralateral mediastinal or ipsilateral supraclavicular (N3) lymph node involvement
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic therapy
Any prior systemic therapy for index lung cancer, including immunotherapy, chemotherapy.
Cannot have received: immune checkpoint blockade therapy
Any prior use of an immune checkpoint blockade therapy including agents directed against CTLA-4, PD-1, and PD-L1.
Lab requirements
Blood counts
ANC ≥ 1.0 x 10^9/L (1000/uL) without G-CSF; Platelet count ≥ 100 x 10^9/L (100,000/uL) without transfusion; Hemoglobin ≥ 90 g/L (9.0 g/dL) (transfusion allowed)
Kidney function
Creatinine clearance ≥ 45 mL/min (Cockcroft-Gault or other validated formula or 24hr urine collection)
Liver function
AST and ALT ≤ 3 x ULN; serum bilirubin ≤ 2.0 x ULN (≤ 3 x ULN for Gilbert disease)
Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 21 days prior to initiation of study treatment
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Lombardi Comprehensive Cancer Center, Georgetown University · Washington D.C., District of Columbia
- Washington University School of Medicine-Sitemen Cancer Center · St Louis, Missouri
- UVA Comprehensive Cancer Center · Charlottesville, Virginia
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