Evidence map›Paper›PMID 42458439›Full record

Observational studyBMC medicine2026

Real-world serplulimab plus chemotherapy for extensive-stage small cell lung cancer in china: an external validation of ASTRUM-005 trial.

Lin Wu, Chengping Hu, Wenzhong Su, Hui Zhu, Wei Hong, Haichuan Su, Yan Yu, Tao Luo, Zhigang Liu, Zhentian Liu and 5 more

Registry-linked trialAbstract readObservational StudyMulticenter Study
PubMed Publisher
In one paragraph

Observational study in BMC medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06748495 (Real-world First-line Serplulimab-based Immunochemotherapy for Extensive-stage Small Cell Lung Cancer), 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.

NCT06748495 active not recruitingnot on this map

Real-world First-line Serplulimab-based Immunochemotherapy for Extensive-stage Small Cell Lung Cancer: the Multicenter ASTRUM-005R Study

Typeobservational_patient_registrySponsorHunan Cancer HospitalRan2024 to 2025Enrolled600ConditionsExtensive-stage Small Cell Lung Cancer (ES-SCLC)
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  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

15 authors.

Lin Wu *The Department of Thoracic Medical Oncology, Hunan Cancer Hospital/The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, 410031, Hunan Province, China. wulin-calf@vip.163.com.ORCID http://orcid.org/0000-0001-7078-7767
Chengping Hu *Department of Respiratory Medicine, Xiangya Hospital, Central South University, Changsha, 410008, Hunan Province, China. huchengp28@126.com.
Wenzhong Su *Department of Respiratory Medicine, Shanxi Cancer Hospital, Taiyuan, 030000, China.
Hui ZhuDepartment of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Science, Jinan, 250117, China.
Wei HongDepartment of Chest Oncology, Zhejiang Cancer Hospital, Hangzhou, 310022, China.
Haichuan SuDepartment of Oncology, Tangdu Hospital, Air Force Medical University, Xi'an, 710038, China.
Yan YuHarbin Medical University Cancer Hospital, Harbin, 150081, China.
Tao LuoDepartment of Respiratory and Critical Care Medicine, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, 221004, China.
Zhigang LiuCancer Center, Guangdong Engineering Research Center of Boron Neutron Therapy and Application in Malignant Tumors, Dongguan Key Laboratory of Precision Diagnosis and Treatment for Tumors, The Tenth Affiliated Hospital, Southern Medical University (Dongguan People's Hospital), Dongguan, 523059, China.
Zhentian LiuDepartment of Thoracic Medical Oncology, Jiangxi Cancer Hospital, Nanchang, 330001, China.
Qing PuDepartment of Medical Oncology, The First Affiliated Hospital of Guangxi Medical University, Nanning, 530022, China.
Caixia WangChemotherapy Department of Oncology Center, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, 250021, China.
Xuhong MinDepartment of Oncology Radiotherapy, Anhui Chest Hospital, Hefei, 230000, China.
Hui GuoDepartment of Medical Oncology, The Second Affiliated Hospital of Xi'an, Jiaotong University, Xi'an, 710004, China.
Yifei ChenDepartment of Respiratory Medicine, Shanxi Cancer Hospital, Taiyuan, 030000, China.

Funding

Hunan Cancer Hospital Climb Plan ZX2020005-5Hunan Provincial Health High-Level Talent Scientific Research Project R2023125National Key Clinical Specialty Scientific Research Project Z2023098Science and Technology Innovation Program of Hunan Province 2023SK4024
6 · The paper itself

Abstract

backgroundIn the randomized phase 3 ASTRUM-005 trial, adding serplulimab to chemotherapy improved survival in extensive-stage small cell lung cancer (ES-SCLC), but whether these results generalize to routine practice remains uncertain. To evaluate the real-world effectiveness and safety of first-line serplulimab plus chemotherapy in China and to benchmark outcomes against the pivotal trial using a matching-adjusted indirect comparison (MAIC).

methodsThis nationwide, observational study enrolled ES-SCLC patients treated with serplulimab and investigator-selected chemotherapy across 14 sites in China. For subsequent analyses, patients were grouped by alignment with the ASTRUM-005 trial regimen: an RCT-regimen cohort and a real-world regimen cohort. The primary endpoints were overall survival (OS) and real-world progression-free survival (rwPFS); secondary endpoints included objective response rate (ORR) and safety. The MAIC weighted eligible real-world patients to the aggregate baseline profile of the pivotal trial.

resultsAmong 635 patients, the median OS was 17.20 months (95% CI, 15.43-19.77) and the median rwPFS was 8.17 months (95% CI, 7.40-9.20). The ORR was 69.05%, with comparable efficacy observed between RCT-regimen and real-world cohorts. Poor performance status and liver metastases independently predicted higher mortality. In the MAIC, OS in the RCT-regimen cohort was comparable to the serplulimab arm of the pivotal ASTRUM-005 trial (weighted log-rank P = 0.784). Safety was manageable and consistent with known profiles.

conclusionsThis large-scale real-world study confirms the efficacy of serplulimab plus chemotherapy and tolerability in diverse ES-SCLC population, supporting the external validity and generalizability of the pivotal ASTRUM-005 trial results. CLINICAL

trial registrationClinicalTrials.gov (NCT06748495).

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsLung NeoplasmsSmall Cell Lung CarcinomaAdultAgedChinaFemaleHumansMaleMiddle AgedTreatment OutcomeAntibodies, Monoclonal, HumanizedChemoimmunotherapyExtensive-stage small cell lung cancer (ES-SCLC)Immunotherapy maintenanceReal-world evidence (RWE)Serplulimab

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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.