---
title: "Neoadjuvant serplulimab plus chemotherapy achieves high MPR in locally advanced squamous NSCLC"
id: "frontiers-in-immunology-2-neoadjuvant-serplulimab-combined-with-chemotherapy-in-locally-advanced-driver"
canonical_url: "https://medichelpline.com/clinical-feed/frontiers-in-immunology-2-neoadjuvant-serplulimab-combined-with-chemotherapy-in-locally-advanced-driver"
content_type: "clinical_feed_article"
specialty: "Infectious Disease"
source_name: "Frontiers in Immunology"
source_url: "https://www.frontiersin.org/articles/10.3389/fimmu.2026.1882282"
published_at: "2026-09-24T00:00:00.000Z"
evidence_level: "Journal Feed"
license: "CC-BY-NC-4.0 / Informational Use"
---
# Neoadjuvant serplulimab plus chemotherapy achieves high MPR in locally advanced squamous NSCLC
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/frontiers-in-immunology-2-neoadjuvant-serplulimab-combined-with-chemotherapy-in-locally-advanced-driver
- **Specialty:** [Infectious Disease](https://medichelpline.com/clinical-feed/infectious-disease.md)
- **Primary Source:** Frontiers in Immunology
- **Source URL:** [Original Journal Publication](https://www.frontiersin.org/articles/10.3389/fimmu.2026.1882282)
- **Published At:** 2026-09-24T00:00:00.000Z
- **Evidence Rating:** Journal Feed
## Executive GIST (TL;DR)
- This multicenter real-world study evaluated neoadjuvant **serplulimab** (300 mg Q3W) combined with platinum–taxane chemotherapy in 30 patients with locally advanced, driver gene–negative squamous non–small cell lung cancer (sq-NSCLC). - Patients were identified from electronic medical records and followed prospectively; all had resectable or potentially resectable stage I–III disease and no actionable genomic alterations by NGS. - Primary endpoint was **major pathological response (MPR)**; secondary endpoints included **pathological complete response (pCR)**, **objective response rate (ORR)**, event-free survival (EFS), overall survival (OS), and safety. - Median age was 64; 96.7% were male; 86.7% had stage III disease; PD-L1 TPS <1% in 76.7%. - Most patients received two cycles of neoadjuvant therapy; taxane was most often nab‑paclitaxel and platinum most often nedaplatin. - Radiologic ORR in the full analysis set (n = 30) was 80.0% (95% CI, 61.4–92.3%) and disease control rate was 96.7%. - Of 28 patients who underwent surgery with pathology (PPS), **MPR** was 57.1% (95% CI, 39.1–72.5%) and **pCR** was 28.6% (95% CI, 15.3–47.1%); R0 resection rate was 92.9%. - Observed MPR was significantly higher than historical neoadjuvant chemotherapy benchmarks (57.1% vs 8.9% and 11.0%; P < 0.001, one‑sample threshold test). - Median EFS was 29.97 months with a 12‑month EFS rate of 91.8% (95% CI, 81.4–100%); OS data remain immature. - Safety was manageable: grade 3 adverse events occurred in 6.7% of patients; no grade 4–5 events or perioperative immune‑related complications were reported. - Exploratory analyses identified lower post-treatment neutrophil-to-lymphocyte ratio (NLR < 3) positively correlated with MPR, while advanced T stage (T3–T4) was negatively associated. - Study limitations include single‑arm real‑world design, small sample size (planned n = 30), limited follow-up for survival, and lack of randomized comparator; details beyond reported outcomes were not provided in the source.
## Clinical Analysis & Structured Key Points
Frontiers | Neoadjuvant serplulimab combined with chemotherapy in locally advanced driver gene-negative squamous NSCLC: a multicenter observational study ORIGINAL RESEARCH article Front. Immunol. , 24 September 2026 Sec. Cancer Immunity and Immunotherapy Volume 17 - 2026 | https://doi.org/10.3389/fimmu.2026.1882282 Published in Frontiers in Immunology Cancer Immunity and Immunotherapy 7 impact factor 11.3 citescore Part of a Research Topic Neoadjuvant or perioperative immunotherapy in oncology: A new paradigm shift Submission open 9526 views 9 articles Editor & Reviewers Edited by M G Maria Grazia Vitale Reviewed by J B Joseph Barbi X H Xin Huang Outline Figures and Tables Figure 1 View in article Figure 2 View in article Table 1 Baseline characteristics of included patients. . View in article Table 2 Patterns of neoadjuvant treatment and surgical management. View in article Table 3 Radiologic responses. View in article Table 4 Pathological responses. View in article Table 5 Safety profile of patients. View in article Table 6 Univariate and multivariate regression analysis of clinical factors associated with MPR. View in article ORIGINAL RESEARCH article Front. Immunol. , 24 September 2026 Sec. Cancer Immunity and Immunotherapy Volume 17 - 2026 | https://doi.org/10.3389/fimmu.2026.1882282 Neoadjuvant serplulimab combined with chemotherapy in locally advanced driver gene-negative squamous NSCLC: a multicenter observational study N L Nanlong Lin 1,2 † Z Y Zeru Yang 3 † F Y Fengqiang Yu 1,2 J L Jianbo Lin 1,2 * 1. Department of Thoracic Surgery, First Affiliated Hospital of Fujian Medical University, Fuzhou, China 2. Department of Thoracic Surgery, National Regional Medical Center, Binhai Campus of the First Affiliated Hospital, Fujian Medical University, Fuzhou, China 3. Fujian Medical University, Fuzhou, China See more Article metrics View details Abstract Background: Previous evidence demonstrated that neoadjuvant chemo-immunotherapy provides significant prognostic benefits for non-small cell lung cancer (NSCLC). While the efficacy of serplulimab, an anti-PD-1 monoclonal antibody, has been well established in advanced driver gene-negative NSCLC in the ASTRUM-004 trial, its efficacy in the neoadjuvant setting remains unclear. This real-world study aims to evaluate the efficacy and safety of neoadjuvant serplulimab plus chemotherapy in patients with locally advanced squamous NSCLC, with a particular focus on pathological response outcomes. Methods: This was a multicenter, retrospective–prospective, real-world observational study. Electronic medical records were retrospectively reviewed to identify eligible patients with locally advanced squamous NSCLC who received at least 1 cycle of neoadjuvant serplulimab (300 mg, Q3W) combined with platinum–taxane chemotherapy. Prospective follow-up was conducted to complete courses and outcomes. The primary endpoint was major pathologic response (MPR), and the secondary endpoints included pathological complete response (pCR), objective response rate (ORR), event-free survival (EFS), overall survival (OS), and safety. Results: Thirty patients were included (median age 64 years; 96.7% male; 86.7% stage III). Most patients received two cycles of neoadjuvant therapy (46.67%), and 80% achieved a radiologic ORR (95% CI, 61.4–92.3%). Surgery was performed on 28 patients (93.33%), with MPR and pCR achieved in 57.1% (95% CI, 39.1–73.5%) and 28.6% (95% CI, 15.3–47.1%), respectively, and an R0 resection rate of 92.9%. Compared with the historical chemotherapy group, the observed MPR was significantly higher (57.1% vs 8.9% and 11.0%; P 0.05). Table 1 Characteristic Overall (n = 30)* MPR (n = 16) Non-MPR (n = 12) P value Age (years), median(range) 64.00 (54–81) 66 (56–81) 64.00 (54–72) 0.279 Age (years), n (%) 0.136 0.05). Table 2 Characteristic Overall (N = 30)* MPR (N = 16) Non-MPR (N = 12) p (MPR vs non-MPR) Taxane regimen, n (%) 0.826 Nab-paclitaxel 20 (66.67) 10 (62.50) 9 (75.00) Paclitaxel 7 (23.33) 5 (31.25) 2 (16.67) Paclitaxel liposome 3 (10.00) 1 (6.25) 1 (8.33) Platinum regimen, n (%) 0.754 Cisplatin 3 (10.00) 1 (6.25) 2 (16.67) Carboplatin 1 (3.33) 1 (6.25) 0 (0.00) Nedaplatin 26 (86.67) 14 (87.50) 10 (83.33) Neoadjuvant cycles, n (%) 1.000 1 1 (3.33) 0 (0.00) 0 (0.00) 2 14 (46.67) 8 (50.00) 5 (41.67) 3 11 (36.67) 6 (37.50) 5 (41.67) >3 4 (13.33) 2 (12.50) 2 (16.67) Last dose to surgery (weeks), median (range) 6.22 (3.57,15.14) 6.00 (3.57,10.43) 6.86 (4.43,15.14) 0.427 Last dose to surgery interval (weeks), n (%) 0.691 3-6 14 (46.67) 9 (56.25) 5 (41.67) 6-8 8 (26.67) 4 (25.00) 4 (33.33) >8 6 (20.00) 3 (18.75) 3 (25.00) Surgical resection performed*, n (%) 28 (93.3) 16 (100.0) 12 (100.0) Blood loss (mL), median(range) 100 (50,300) 100 (50,150) 150 (50,300) 0.077 Patterns of neoadjuvant treatment and surgical management. *One patient has not yet undergone surgery, and one patient had missing surgical information. 3.3 Radiologic and pathological responses All 30 patients had evaluable radiologic assessments. In the FAS (n=30), two patients (6.67%) achieved complete response (CR) and 22 (73.33%) achieved partial response (PR), with one patient experiencing disease progression (PD), resulting in an ORR of 80.00% (95% CI, 61.43–92.29%) and a DCR of 96.67% (95% CI, 82.78–99.92%) ( Table 3 ). Notably, the proportion of radiologic responders was significantly higher in the MPR group than in the non-MPR group ( P = 0.01). Table 3 Characteristic Total (n = 30)* MPR (n = 16) non-MPR (n = 12) P value Best response 0.01 CR 2 (6.67) 2 (12.50) PR 22 (73.33) 14 (87.50) 7 (58.33) SD 5 (16.67) 4 (33.33) PD 1 (3.33) 1 (8.33) ORR (CR+PR) 24 (80.00) 16 (100.00) 7 (58.33) 95% CI 61.43-92.29 79.41-100.00 27.67-84.83 DCR(CR+PR+SD) 29(96.67) 16(100.00) 11(91.67) 95% CI 82.78-99.92 79.41-100.00 61.52-99.79 Radiologic responses. *One patient has not yet undergone surgery, and one patient had missing surgical information. ORR, objective response rate; DCR, disease control rate; CR, complete response; PR, partial response; SD, stable disease. Pathological responses are shown in Table 4 . Among 28 patients in the PPS set, MPR and pCR were achieved respectively in 16 (57.14%; 95% CI, 39.07–72.49%) and 8 (28.57%; 95% CI, 15.25–47.06%) patients, with R0 resection in 92.86%. Pathologic total downstaging was noted in 71.43% (95% CI, 52.94–84.75%), including T-stage downstaging in 89.29% and N-stage downstaging in 82.14%. The findings in sensitivity Set A were comparable to those observed in the PPS population, with similar MPR and pCR rates (57.14% [95% CI, 36.55–75.53%] and 28.57% [95% CI, 13.81–49.96%]), respectively, and a consistent frequency of pathologic downstaging (76.19%; 95% CI, 54.91-89.37%). Additionally, pathologic downstaging was more frequently observed in patients who achieved MPR than in those without MPR (PPS set, P = 0.044), and a similar trend was observed in the sensitivity Set A ( P = 0.006, Supplementary Figure S2A, B ). Table 4 PPS set Sensitivity Set A Characteristic, n (%) Total (N = 28) 95% CI Total (N = 21) 95% CI R0 26 (92.86) 77.35-98.02 20 (95.24) 77.33-99.15 MPR 16 (57.14) 39.07-73.49 12 (57.14) 36.55-75.53 PCR 8 (28.57) 15.25-47.06 6 (28.57) 13.81-49.96 Postoperative Downstaging, n (%) total downstaging 20 (71.43) 52.94-84.75 16 (76.19) 54.91-89.37 T downstaging 25 (89.29) 72.80-96.29 18 (85.71) 65.36-95.02 N downstaging 23 (82.14) 64.41-92.12 19 (90.48) 71.09-97.35 Pathological responses. PPS, patients who underwent surgery with evaluable pathology (n = 28); Sensitivity Set A, stage II–III patients with
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