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新辅助化免治疗手术切除N3局部晚期非小细胞肺癌（NEO-SURG）
Neoadjuvant chemo-immunotherapy and surgical resection in locally advanced non-small cell lung cancer with N3 lymph node involvement (NEO-SURG)
Cemiplimab（IgG4 + PD-1抗体）
neoadjuvant cemiplimab 350mg IV plus histology-specific chemotherapy every 3 weeks for 4 cycles prior to planned surgical resection followed by adjuvant radiotherapy (optional) and 1 year of adjuvant cemiplimab.
Background:
The emergence of neoadjuvant and peri-operative chemoimmunotherapy in locally-advanced non-small cell lung cancer (NSCLC) has revolutionized the treatment of resectable NSCLC. Importantly, in multiple phase III trials, patients with multi-station N2 disease derive profound benefit from neoadjuvant chemoimmunotherapy. NSCLC with N3 involvement has been excluded from neoadjuvant/perioperative studies, as these cancers have historically been considered unresectable and treated with definitive chemoradiotherapy (CRT) followed by durvalumab. However, CRT is associated with high rates of treatment-related adverse events and most patients experience disease relapse within 2 years. Whether patients with select N3 lymph node-positive NSCLC may benefit from neoadjuvant chemo-immunotherapy followed by surgery is an important unaddressed question. This phase II trial seeks to evaluate the feasibility and clinical utility of neoadjuvant chemoimmunotherapy followed by surgery in patients with locally-advanced stage III B/C NSCLC with select N3 involvement.
Methods:
This phase II, multi-center, single-arm study is evaluating neoadjuvant chemoimmunotherapy in patients with stage III B/C NSCLC with contralateral mediastinal or ipsilateral supraclavicular (N3) lymph node involvement. Select eligibility criteria include: ECOG performance status 0-1, pathologically-confirmed contralateral mediastinal or ipsilateral supraclavicular N3 disease, ≤2 involved lymph node stations, primary tumor appropriate for resection per multi-disciplinary review (any T stage), physical fitness for resection, wild-type EGFR/ALK. Patients will receive neoadjuvant cemiplimab 350mg IV plus histology-specific chemotherapy every 3 weeks for 4 cycles prior to planned surgical resection followed by adjuvant radiotherapy (optional) and 1 year of adjuvant cemiplimab. The primary endpoint is pCR rate defined by IASLC consensus guidelines. Secondary endpoints include objective response rate (per RECIST v1.1), R0 resection rate, major pathologic response (≤10% viable tumor) rate, disease-free survival and overall survival. A total of 21 patients will be enrolled. A Simon-2 stage design will be used such that 12 patients will be enrolled initially and, if at least one pCR is observed, the trial will proceed to the second stage with enrollment of an additional 9 patients. This design yields a type I error rate of 5% and power of 80% when the true pCR rate is 20%. In addition, a Pocock stopping rule at 5% type I error will be deployed to assess feasibility of surgical resection. The study will be halted for futility if 8 of the first 12 patients do not proceed with surgical resection.
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