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.
Single group
Cemiplimab-Rwlc
Drug350 mg every 3 weeks, intravenously, on day 1 of a 21 day cycle for 4 cycles, then every 3 weeks after surgery for 1 year.
Pathologic complete response (pCR) rate
Pathologic complete response (pCR): 0% viable tumor in primary tumor and resected lymph nodes.
Objective Response Rate (ORR)
Defined as imaging response according to RECIST v1.1 (Eisenhauer et al. 2009).
Rate of R0 Resection
Rate of R0 Resection: Defined as percentage of patients undergo complete tumor resection with negative margins.
Major pathologic response (MPR) rate
MPR Rate: Defined as the percentage of patients with resection specimen that shows ≤10% viable tumor in resected lung and lymph nodes
Disease-free Survival (DFS)
DFS: Time from first dose of neoadjuvant treatment to documented disease recurrence. Where possible, date of pathologic confirmation of recurrence should be used over date of radiographic imaging showing findings concerning for recurrence.
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Georgetown University
Lead sponsor
Regeneron Pharmaceuticals
Collaborator
