A Phase II Trial of Perioperative Camrelizumab Plus Neoadjuvant Chemotherapy in Resectable Stage IIB-IIIB Lung...

This phase II trial investigated perioperative camrelizumab plus neoadjuvant chemotherapy for patients with stage IIB-IIIB lung squamous cell carcinoma (LUSC) and explored predictive biomarkers of treatment response. Patients received neoadjuvant camrelizumab (200 mg, Day 1) in combination with nab-paclitaxel (130 mg/m², Days 1 and 8) and carboplatin (area under the curve = 5, Day 1) every 3 weeks for two cycles, followed by surgery and adjuvant camrelizumab for 1 year. The primary endpoint was major pathological response (MPR) rate. Forty-five patients were treated, of whom 41 underwent surgery. Twenty-seven of 45 patients (60.0%) achieved MPR and 20 (44.4%) achieved pathological complete response (pCR). With a median follow-up of 37.5 months, the 3-year disease-free survival and overall survival rates were 65.9% and 68.7%, respectively. Among eight patients with stage IIIB disease, three (37.5%) achieved pCR. Baseline neutrophil percentage and smoking history were associated with MPR. T-cell receptor (TCR) sequencing revealed that three V-J gene pairs in TCR beta clones differed between the pCR and non-pCR groups. This study supports the application of perioperative immunotherapy combined with neoadjuvant chemotherapy in patients with resectable locally advanced LUSC. The identification of blood biomarkers for precise patient selection warrants further in-depth investigation.