Evidence map›Paper›PMID 42114951›Full record

Trial reportJournal for immunotherapy of cancer2026

Simplified perioperative serplulimab and chemotherapy for resectable squamous NSCLC: a phase II trial with biomarker analysis.

Fangqiu Fu, Haoxuan Wu, Chaoqiang Deng, Haiqing Chen, Qingyuan Huang, Chongze Yuan, Xusheng Ding, Ting Ye, Yaodong Zhou, Sufeng Chen and 10 more

Registry-linked trialAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Journal for immunotherapy of cancer, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05775796 (A Single-arm, Multicenter, and Phase II Clinical Study to Evaluate the Efficacy and Safety of Serplulimab Combined With Chemotherapy in Neoadjuvant and Adjuvant Treatment of Resectable Stage II-IIIA NSCLC), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05775796 phase2completednot on this map

A Single-arm, Multicenter, and Phase II Clinical Study to Evaluate the Efficacy and Safety of Serplulimab Combined With Chemotherapy in Neoadjuvant and Adjuvant Treatment of Resectable Stage II-IIIA NSCLC

TypeinterventionalSponsorFudan UniversityRan2023 to 2025Enrolled30ConditionsNon-small Cell Lung Cancer, Stage II-IIIA, Immunotherapy, Neoadjuvant TherapyArmsSerplulimab and Chemotherapy
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors.

Fangqiu Fu *Department of Thoracic Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.
Haoxuan Wu *Department of Thoracic Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.
Chaoqiang Deng *Department of Thoracic Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.
Haiqing ChenDepartment of Thoracic Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.
Qingyuan HuangDepartment of Thoracic Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.
Chongze YuanDepartment of Thoracic Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.
Xusheng DingDepartment of Thoracic Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.
Ting YeDepartment of Thoracic Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.
Yaodong ZhouDepartment of Thoracic Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.ORCID http://orcid.org/0000-0001-7685-721X
Sufeng ChenDepartment of Thoracic Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.
Yihua SunDepartment of Thoracic Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.ORCID http://orcid.org/0000-0002-5287-0601
Yawei ZhangInstitute of Thoracic Oncology, Fudan University, Shanghai, China.
Jiaqing XiangDepartment of Thoracic Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.
Shengping WangInstitute of Thoracic Oncology, Fudan University, Shanghai, China.
Yuan LiInstitute of Thoracic Oncology, Fudan University, Shanghai, China.
Bing LiBurning Rock Biotech, Guangzhou, Guangdong, China.
Yi LuBurning Rock Biotech, Guangzhou, Guangdong, China.
Yang ZhangDepartment of Thoracic Surgery, Fudan University Shanghai Cancer Center, Shanghai, China hqchen1@yahoo.com huhong0997@163.com fduzhangyang1987@hotmail.com.
Hong HuDepartment of Thoracic Surgery, Fudan University Shanghai Cancer Center, Shanghai, China hqchen1@yahoo.com huhong0997@163.com fduzhangyang1987@hotmail.com.
Haiquan ChenDepartment of Thoracic Surgery, Fudan University Shanghai Cancer Center, Shanghai, China hqchen1@yahoo.com huhong0997@163.com fduzhangyang1987@hotmail.com.ORCID http://orcid.org/0000-0001-7846-257X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeSquamous non-small cell lung cancer (sq-NSCLC) is a distinct subtype of NSCLC. This exploratory, phase II study investigated the feasibility and efficacy of a four-cycle perioperative regimen combining serplulimab with a taxane (paclitaxel or nab-paclitaxel) and carboplatin in patients with resectable stage II-IIIA sq-NSCLC.

methodsThis investigator-initiated, single-arm, phase II exploratory trial (NCT05775796) enrolled patients with histologically confirmed, resectable clinical stage II-IIIA squamous NSCLC. Patients received two to three cycles of neoadjuvant serplulimab plus taxane-carboplatin, followed by curative-intent surgery and one to two cycles of adjuvant treatment. The primary endpoint was major pathological response (MPR). Secondary endpoints included pathological complete response (pCR), R0 resection rate, overall response rate (ORR), safety, event-free survival (EFS), and overall survival (OS).

resultsA total of 30 patients without actionable driver alterations were enrolled and 29 underwent surgery. The median age was 65 years, and most were male smokers (n=28, 93.33%). Surgery was performed in 29 patients, and R0 resection was achieved in 96.55% (28/29) of the surgically resected patients. Among all enrolled patients, MPR and pCR rates were 76.67% and 50.00%, respectively. Based on radiological assessments during the neoadjuvant phase, the ORR was 73.33% (95% CI 54.11% to 87.72%). Grade ≥3 treatment-related adverse events were predominantly hematologic and were generally manageable. Long-term EFS and OS data are not yet mature. Additionally, exploratory minimal residual disease analysis using circulating tumor DNA (ctDNA) in 27 patients showed a strong correlation between ctDNA clearance and pCR (p=0.004), suggesting ctDNA as a promising biomarker for immunochemotherapy response.

conclusionsA four-cycle perioperative regimen of serplulimab combined with taxane-carboplatin demonstrated promising MPR and pCR rates with an acceptable safety profile in patients with resectable sq-NSCLC. Long-term follow-up and future phase III trials are warranted to confirm these exploratory findings. TRIAL REGISTRATION NUMBER: NCT05775796.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorCarcinoma, Non-Small-Cell LungCarcinoma, Squamous CellLung NeoplasmsAgedAlbuminsAntibodies, Monoclonal, HumanizedCarboplatinFemaleHumansMaleMiddle AgedNeoadjuvant TherapyPaclitaxelPathologic Complete Response130-nm albumin-bound paclitaxelAlbuminsAntibodies, Monoclonal, HumanizedBiomarkers, TumorCarboplatinPaclitaxelserplulimabImmune Checkpoint InhibitorLung CancerMinimal residual disease - MRDNeoadjuvant

Identifiers

PMID42114951
PMCPMC13182475

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.