OncoMatch/Clinical Trials/NCT06449313
Neoadjuvant Chemo-Immunotherapy and Surgical Resection in Locally Advanced Non-small Cell Lung Cancer With N3 Lymph Node or Other High Risk Features
Is NCT06449313 recruiting? Yes, currently enrolling (Sep 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 select N3 lymph node involvement or other high-risk subsets in which there is no consensus on resectability. 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
Treatments studied
Immunotherapy
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: ALK wild-type
Required: EGFR wild-type
Disease stage
Required: Stage III (other)
stage 3 Non-Small Cell Lung Cancer (NSCLC) as assessed per the 8th American Joint Committee on Cancer (AJCC)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic therapy for index lung cancer
Any prior systemic therapy for index lung cancer, including immunotherapy, chemotherapy.
Cannot have received: immune checkpoint inhibitor
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; platelets ≥ 100 x 10^9/L (100,000/uL) without transfusion; hemoglobin ≥ 90 g/L (9.0 g/dL) (transfusion permitted)
Kidney function
Creatinine clearance ≥ 45 mL/min (Cockcroft-Gault or other validated formula/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: ... (see full text for details)
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
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06449313 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require ALK?
Yes, ALK wild-type is a required biomarker for enrollment.
Does this trial require EGFR?
Yes, EGFR wild-type is a required biomarker for enrollment.
What disease stage is eligible?
Stage III is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages