Evidence map›Paper›PMID 39174542›Full record

Trial reportNature communications2024

Sintilimab in combination with stereotactic body radiotherapy and granulocyte-macrophage colony-stimulating factor in metastatic non-small cell lung cancer: The multicenter SWORD phase 2 trial.

Jianjiao Ni, Xiaofei Wang, Lin Wu, Xinghao Ai, Qian Chu, Chengbo Han, Xiaorong Dong, Yue Zhou, Yechun Pang, Zhengfei Zhu

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Nature communications, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04106180 (An Open-label, Multicenter, Phase II Single Arm Trial of SBRT in Combination With Sintilimab and GM-CSF for the Treatment of Advanced NSCLC), which is not on this map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing 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.

NCT04106180 phase2unknown statusnot on this map

An Open-label, Multicenter, Phase II Single Arm Trial of SBRT in Combination With Sintilimab and GM-CSF for the Treatment of Advanced NSCLC

TypeinterventionalSponsorFudan UniversityRan2019 to 2023Enrolled63ConditionsNSCLC Stage IVArmsGM-CSF, Sintilimab, SBRT
3 · Its place in the literature

Who cites it

16 citing papers in PubMed.

  1. Trial
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  6. Observational
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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

10 authors.

Jianjiao NiDepartment of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.
Xiaofei WangDepartment of Biostatistics & Bioinformatics, Duke University School of Medicine, Durham, NC, USA.
Lin WuThe Second Department of Thoracic Oncology, Hunan Cancer Hospital, The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.ORCID 0000-0001-7078-7767
Xinghao AiShanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China.
Qian ChuDepartment of Oncology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.ORCID 0000-0001-8192-7630
Chengbo HanDepartment of Oncology, Shengjing Hospital of China Medical University, Shenyang, China.
Xiaorong DongCancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Yue ZhouDepartment of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.
Yechun PangDepartment of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.
Zhengfei ZhuDepartment of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China. fuscczzf@163.com.ORCID 0000-0001-7537-3619

Funding

Shanghai Municipal Health Bureau (Shanghai Municipal Public Health Bureau) 20194Y0501
6 · The paper itself

Abstract

This single-arm, multicenter, phase 2 trial (NCT04106180) investigated the triple combination of sintilimab (anti-PD1 antibody), stereotactic body radiotherapy (SBRT) and granulocyte-macrophage colony-stimulating factor (GM-CSF) in metastatic non-small cell lung cancer (NSCLC). With a median follow-up of 32.1 months, 18 (36.7%, 90% CI 25.3%-49.5%) of the 49 evaluable patients had an objective response, meeting the primary endpoint. Secondary endpoints included out-of-field (abscopal) response rate (ASR), progression-free survival (PFS), overall survival (OS), and treatment-related adverse events (TRAEs). The ASR was 30.6% (95% CI 18.3%-45.4%). The median PFS and OS were 5.9 (95% CI 2.5-9.3) and 18.4 (95% CI 9.7-27.1) months, respectively. Any grade and grade 3 TRAEs occurred in 44 (86.3%) and 6 (11.8%) patients, without grade 4-5 TRAEs. Moreover, in pre-specified biomarker analyses, SBRT-induced increase of follicular helper T cells (Tfh) in unirradiated tumor lesions and patient's blood, as well as of circulating IL-21 levels, was found associated with improved prognosis. Taken together, the triple combination therapy was well tolerated with promising efficacy and Tfh may play a critical role in SBRT-triggered anti-tumor immunity in metastatic NSCLC.

Indexed as

Antibodies, Monoclonal, HumanizedCarcinoma, Non-Small-Cell LungGranulocyte-Macrophage Colony-Stimulating FactorLung NeoplasmsRadiosurgeryAdultAgedAged, 80 and overCombined Modality TherapyFemaleHumansMaleMiddle AgedNeoplasm MetastasisProgression-Free SurvivalAntibodies, Monoclonal, HumanizedGranulocyte-Macrophage Colony-Stimulating Factorsintilimab

Identifiers

PMID39174542
PMCPMC11341907

What OpenQuestion holds

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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.