Evidence map›Paper›PMID 34650034›Full record

Trial reportSignal transduction and targeted therapy2021

Toripalimab plus chemotherapy as second-line treatment in previously EGFR-TKI treated patients with EGFR-mutant-advanced NSCLC: a multicenter phase-II trial.

Tao Jiang, Pingyang Wang, Jie Zhang, Yanqiu Zhao, Jianying Zhou, Yun Fan, Yongqian Shu, Xiaoqing Liu, Helong Zhang, Jianxing He and 15 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in Signal transduction and targeted therapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03924050 (A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase III Study of Pemetrexed + Platinum Chemotherapy With or Without Toripalimab), which is not on this map. Cited by 73 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
73citing papers in PubMed, 4 pooled it
10.1field-weighted citation impact, top 1% of its field
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.

NCT03924050 phase3completednot on this map

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase III Study of Pemetrexed + Platinum Chemotherapy With or Without Toripalimab (JS001) in Advanced Non-small Cell Lung Cancer (NSCLC) Participants With TKI-resistant EGFR-mutated Tumors

TypeinterventionalSponsorShanghai Junshi Bioscience Co., Ltd.Ran2019 to 2025Enrolled440ConditionsNon-small Cell Lung CancerArmsTORIPALIMAB INJECTION(JS001 )
3 · Its place in the literature

Who cites it

73 citing papers in PubMed, 4 syntheses or guidelines pooled it, 92 citations in OpenAlex.

  1. Pooled it
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  7. Tislelizumab plus chemotherapy for patients withJournal for immunotherapy of cancer · 2023
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  18. Immunotherapy in EGFR-mutant non-small cell lung cancer.Clinical and experimental medicine · 2025
    Review
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13 more citing papers are in PubMed but not listed here.

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

25 authors at 10 institutions in 2 countries.

Tao Jiang *Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China.ORCID 0000-0002-9205-8183
Pingyang Wang *State Key Laboratory of Cell Biology, Innovation Center for Cell Signaling Network, CAS Center for Excellence in Molecular Cell Science, Shanghai Institute of Biochemistry and Cell Biology, Chinese Academy of Sciences, University of Chinese Academy of Sciences, Shanghai, China.
Jie Zhang *Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China.
Yanqiu ZhaoHenan Cancer Hospital, Zhengzhou, China.
Jianying ZhouThe First Affiliated Hospital of Zhejiang University, Hangzhou, China.
Yun FanZhejiang Cancer Hospital, Hangzhou, China.
Yongqian ShuJiangsu Province Hospital, Nanjing, China.
Xiaoqing LiuThe Fifth Medical Center of PLA General Hospital, Beijing, China.
Helong ZhangTangdu Hospital, Fourth Military Medical University, Xi'an, China.
Jianxing HeThe First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.
Guanghui GaoShanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China.
Xiaoqian MuHenan Cancer Hospital, Zhengzhou, China.
Zhang BaoThe First Affiliated Hospital of Zhejiang University, Hangzhou, China.
Yanjun XuZhejiang Cancer Hospital, Hangzhou, China.
Renhua GuoJiangsu Province Hospital, Nanjing, China.
Hong WangThe Fifth Medical Center of PLA General Hospital, Beijing, China.
Lin DengTangdu Hospital, Fourth Military Medical University, Xi'an, China.
Ningqiang MaTangdu Hospital, Fourth Military Medical University, Xi'an, China.
Yalei ZhangThe First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.
Hui FengShanghai Junshi Biosciences Co. Ltd, Shanghai, China.
Sheng YaoShanghai Junshi Biosciences Co. Ltd, Shanghai, China.
Jiarui WuState Key Laboratory of Cell Biology, Innovation Center for Cell Signaling Network, CAS Center for Excellence in Molecular Cell Science, Shanghai Institute of Biochemistry and Cell Biology, Chinese Academy of Sciences, University of Chinese Academy of Sciences, Shanghai, China.
Luonan ChenShanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China. lnchen@sibs.ac.cn.
Caicun ZhouShanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China. caicunzhou_dr@163.com.ORCID 0000-0002-1072-9941
Shengxiang RenShanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China. harry_ren@126.com.
Tongji University · CNAir Force Medical University · CNCenter for Excellence in Molecular Cell Science · CNChinese PLA General Hospital · CNFirst Affiliated Hospital of Guangzhou Medical University · CNFirst Affiliated Hospital Zhejiang University · CNHenan Cancer Hospital · CNJiangsu Province Hospital · CNZhejiang Cancer Hospital · CNShanghaiTech University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This multicenter phase-II trial aimed to investigate the efficacy, safety, and predictive biomarkers of toripalimab plus chemotherapy as second-line treatment in patients with EGFR-mutant-advanced NSCLC. Patients who failed from first-line EGFR-TKIs and did not harbor T790M mutation were enrolled. Toripalimab plus carboplatin and pemetrexed were administrated every three weeks for up to six cycles, followed by the maintenance of toripalimab and pemetrexed. The primary endpoint was objective-response rate (ORR). Integrated biomarker analysis of PD-L1 expression, tumor mutational burden (TMB), CD8 + tumor-infiltrating lymphocyte (TIL) density, whole-exome, and transcriptome sequencing on tumor biopsies were also conducted. Forty patients were enrolled with an overall ORR of 50.0% and disease-control rate (DCR) of 87.5%. The median progression free survival (PFS) and overall survival were 7.0 and 23.5 months, respectively. The most common treatment-related adverse effects were leukopenia, neutropenia, anemia, ALT/AST elevation, and nausea. Biomarker analysis showed that none of PD-L1 expression, TMB level, and CD8 + TIL density could serve as a predictive biomarker. Integrated analysis of whole-exome and transcriptome sequencing data revealed that patients with DSPP mutation had a decreased M2 macrophage infiltration and associated with longer PFS than those of wild type. Toripalimab plus chemotherapy showed a promising anti-tumor activity with acceptable safety profiles as the second-line setting in patients with EGFR-mutant NSCLC. DSPP mutation might serve as a potential biomarker for this combination. A phase-III trial to compare toripalimab versus placebo in combination with chemotherapy in this setting is ongoing (NCT03924050).

Indexed as

AdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCarboplatinCarcinoma, Non-Small-Cell LungErbB ReceptorsFemaleGene Expression Regulation, NeoplasticHumansMaleMiddle AgedMutationPemetrexedProgression-Free SurvivalProtein Kinase InhibitorsAntibodies, Monoclonal, HumanizedCarboplatinEGFR protein, humanErbB ReceptorsPemetrexedProtein Kinase Inhibitorstoripalimab

Identifiers

PMID34650034
PMCPMC8517012
OpenAlexW3205552647

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.