Efficacy and safety of neoadjuvant camrelizumab plus albumin-bound paclitaxel and carboplatin in stage II–IIIB lung squamous cell carcinoma: a single-arm, single-center, phase II trial

Background This study evaluated the preliminary efficacy and safety of neoadjuvant camrelizumab combined with albumin-bound paclitaxel and carboplatin in patients with stage II–IIIB lung squamous cell carcinoma (LUSC). Methods This prospective, single-arm, single-center phase II study enrolled 18 patients who received two to four cycles of neoadjuvant therapy, followed by surgery when feasible. Major Pathological Response (MPR) rate was the primary endpoint, and pathological response and safety were also assessed. Results All 18 patients were male, with a median age of 67 years. Fifteen patients underwent surgery, of whom 14 (93.3%) achieved R0 resection. The major pathological response (MPR) rate was 53.3% (8/15), including a pathological complete response (pCR) rate of 33.3% (5/15). Conversion from video-assisted thoracoscopic surgery to open thoracotomy was required in eight patients (53.3%), primarily because of severe pleural adhesions. No 30- or 90-day postoperative deaths or grade 5 adverse events occurred. After a median follow-up of 28.5 months, one recurrence was observed among the 15 surgical patients, whereas all three patients who did not undergo surgery had died. The estimated 1- and 2-year overall survival rates were 94.4% and 88.1%, respectively; the estimated 1- and 2-year DFS rates were both 100%. Conclusions Neoadjuvant camrelizumab combined with albumin-bound paclitaxel and carboplatin showed preliminary antitumor activity in patients with stage II–IIIB LUSC. However, the small sample size, single-arm design, and limited follow-up preclude definitive conclusions regarding efficacy and long-term benefit. Larger prospective controlled studies with longer follow-up are warranted. Trial registration: Chinese Clinical Trial Registry (ChiCTR); identifier: ChiCTR2200060165. Public website: https://www.chictr.org.cn/ .