Neoadjuvant Chemo-Immunotherapy and Surgical Resection in Locally Advanced Non-small Cell Lung Cancer With N3 Lymph Node Involvement
Eligible age
18+ yrs
Accepts
All genders
Locations
3 states
Healthy volunteers
No
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About this study
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.
Sponsor: Georgetown University
You may qualify if…
- ✓ 1. Age ≥ 18 years at time of signing the informed consent form (ICF).
- ✓ 2. Histologically or cytologically confirmed 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.
- ✓ 3. Primary tumor appropriate for resection with curative intent as assessed by the treating surgeon prior to study enrollment.
- ✓ 4. Absence of major associated pathologies and co-morbidities that elevate surgery risk to a prohibitive level, as assessed by treating surgeon prior to study enrollment.
- ✓ 5. Pulmonary function capacity capable of tolerating the lung resection proposed by the treating surgeon.
- ✓ 6. EGFR, ALK, wild-type assessed via any CLIA-certified tissue testing platform. Documentation of EGFR and ALK status is not required for pure squamous NSCLC histology.
- ✓ 7. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
- ✓ 8. Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 21 days prior to initiation of study treatment:
You may not qualify if…
- ✕ 1. NSCLC with histology containing any of the following: large cell neuroendocrine carcinoma, small cell lung cancer.
- ✕ 2. Primary tumor not deemed appropriate for surgical resection as assessed by treating surgeon.
- ✕ 1. Tumor with direct invasion of: mediastinum, diaphragm, heart, great vessels, trachea, esophagus, vertebral body, or carina.
- ✕ 2. Any other tumor characteristic making it not suitable for resection as determined by treating surgeon.
- ✕ 3. Any prior systemic therapy for index lung cancer, including immunotherapy, chemotherapy.
- ✕ 4. History of malignancy requiring systemic therapy within 2 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death as assessed and confirmed by the study PI. (Patients with a history of stage I NSCLC treated with resection or radiotherapy are eligible for inclusion.)
- ✕ 5. Active or history of clinically significant autoimmune disease that, in the opinion of the investigator, could compromise the health and safety of the patient if treated with anti-PD1 immunotherapy. Notable exceptions include:
- ✕ 1. Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone.
Where it's recruiting
Source: ClinicalTrials.gov · NCT06449313 · last updated 2026-06-10