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.
Age ≥ 18 years at time of signing the informed consent form (ICF).
Pathologically-confirmed contralateral mediastinal or ipsilateral supraclavicular (N3) lymph node involvement. Primary tumor and involved lymph nodes should otherwise be deemed appropriate for resection/removal with curative intent as assessed by the treating surgeon prior to study enrollment.
Pathologically-confirmed T4N2 NSCLC.
Pathologically-confirmed T4inv with any N.
NSCLC with histology containing any of the following: large cell neuroendocrine carcinoma, small cell lung cancer.
Tumor with direct invasion of: mediastinum, diaphragm, heart, great vessels, trachea, esophagus, vertebral body, or carina.
Any other tumor characteristic making it not suitable for resection as determined by treating surgeon.
Tumor with direct invasion of: myocardium, trachea, esophagus, vertebral body, or carina.
Georgetown University
Lead sponsor
Regeneron Pharmaceuticals
Collaborator