1225P - Perioperative serplulimab and chemotherapy in patients with resectable squamous non-small cell lung cancer: An open-label, single-arm, phase II trial

Background

Neoadjuvant and adjuvant immunotherapy provides benefit for patients with non-small cell lung cancer (NSCLC). However, there is a lack of studies specifically investigating the perioperative used of immunotherapy in squamous NSCLC.

Methods

This open-label, single-arm, phase II trial was conducted to evaluate the efficacy of perioperative serplulimab in patients with resectable squamous NSCLC. Eligible patients were aged from 18 to 75 and diagnosed with stage II-IIIA lung squamous cell carcinoma. Patients were given with intravenous serplulimab (300mg), in combination with (nab-) paclitaxel and carboplatin in 21-day cycles. Neoadjuvant therapy consisted of 2-3 cycles, while adjuvant therapy comprised 1-2 cycles, with a total of 4 cycles. The primary endpoint was major pathological response (MPR), defined as 10% or less viable tumor cells in the resected specimen.

Results

A total of 30 patients were enrolled. Among them, 16 (53.3%) patients had stage IIIA disease. Surgical resection was performed in 29 (97%) patients, with R0 resection achieved in 28 (93.3%) patients. MPR was observed in 23 (76.7%, 95%CI: 57.3-89.4%) patients, and pathological complete response (pCR) occurred in 15 (50%, 95%CI: 31.7-68.3%) patients. Neutropenia was the most prevalent grade 3-4 adverse events (13 [43%] of 30 patients). The clearance of circulating tumor DNA following neoadjuvant treatment was found to be a significant predictor of pCR (P=0.007), with a sensitivity of 78.6% and specificity of 76.9%.

Table: 1225P

Clinicopathologic characteristics of enrolled patients

∗ 29 patients underwent surgical resection.

Conclusions

Neoadjuvant and adjuvant serplulimab plus platin-based chemotherapy could be a promising treatment for resectable squamous NSCLC, yielding high MPR and pCR rates, with manageable adverse events (Funded by Shanghai Henlius Biotech and Burning Rock Biotech, NCT05775796).

Clinical trial identification

Protocol Number: HLX10IIT21, ECTOP-1013; NCT05775796.

Editorial acknowledgement

Legal entity responsible for the study

Haiquan Chen.

Funding

Shanghai Henlius Biotech and Burning Rock Biotech.

Disclosure

All authors have declared no conflicts of interest.