Evidence map›Paper›PMID 39715755›Full record

Trial reportSignal transduction and targeted therapy2024

Toripalimab plus chemotherapy for first line treatment of advanced non-small cell lung cancer (CHOICE-01): final OS and biomarker exploration of a randomized, double-blind, phase 3 trial.

Jia Zhong, Kailun Fei, Lin Wu, Baolan Li, Zhijie Wang, Ying Cheng, Xiaoling Li, Xicheng Wang, Liang Han, Xiaohong Wu and 61 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase III
In one paragraph

Trial report in Signal transduction and targeted therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03856411 (A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-center Clinical Study to Evaluate the Efficacy and Safety of Toripalimab Injection), which is not on this map. Cited by 26 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 7 pooled it
–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.

NCT03856411 phase3completednot on this map

A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-center Clinical Study to Evaluate the Efficacy and Safety of Toripalimab Injection (JS001) or Placebo Combined With First-line Standard Chemotherapy in Treatment-naive Advanced Non-small Cell Lung Cancer (NSCLC)

TypeinterventionalSponsorShanghai Junshi Bioscience Co., Ltd.Ran2019 to 2023Enrolled465ConditionsTreatment-naive Advanced Non-small Cell Lung CancerArmsTORIPALIMAB INJECTION (JS001 ) combine with chemotherapy
3 · Its place in the literature

Who cites it

26 citing papers in PubMed, 7 syntheses or guidelines pooled it.

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  10. Progress in management of advanced clear-cell renal cell carcinoma.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
    Review
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  15. Current and future immunotherapies for NSCLC.Journal of hematology & oncology · 2026
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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

71 authors.

Jia Zhong *State Key Laboratory of Molecular Oncology, CAMS Key Laboratory of Translational Research on Lung Cancer, Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Kailun Fei *State Key Laboratory of Molecular Oncology, CAMS Key Laboratory of Translational Research on Lung Cancer, Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Lin WuHunan Cancer Hospital, The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.ORCID 0000-0001-7078-7767
Baolan LiBeijing Chest Hospital, Capital Medical University, Beijing, China.
Zhijie WangState Key Laboratory of Molecular Oncology, CAMS Key Laboratory of Translational Research on Lung Cancer, Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Ying ChengJilin Cancer Hospital, Changchun, China.
Xiaoling LiLiaoning Cancer Hospital & Institute, Shenyang, China.
Xicheng WangThe First Affiliated Hospital, School of Clinical Medicine of Guangdong Pharmaceutical University, Guangzhou, China.
Liang HanXuzhou Central Hospital, Xuzhou, China.
Xiaohong WuJiangnan University Affiliated Hospital, Wuxi, China.
Yun FanCancer Hospital of the University of Chinese Academy of Sciences, Hangzhou, China.ORCID 0000-0003-1755-0175
Yan YuHarbin Medical University Cancer Hospital, Harbin, China.
Dongqing LvTaizhou Hospital of Zhejiang Province, Linhai, China.
Jianhua ShiLinyi Cancer Hospital, Linyi, China.
Jianjin HuangThe Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China.
Shaozhang ZhouGuangxi Medical University Affiliated Tumor Hospital, Nanning, China.
Baohui HanShanghai Chest Hospital, Shanghai, China.
Guogui SunTangshan People's Hospital, Tangshan, China.
Qisen GuoShangdong Cancer Hospital, Jinan, China.
Youxin JiQingdao Central Hospital, Qingdao, China.
Xiaoli ZhuZhongda Hospital Southeast University, Nanjing, China.
Sheng HuHubei Cancer Hospital, Wuhan, China.
Wei ZhangThe First Affiliated Hospital of Nanchang University, Nanchang, China.
Qiming WangHenan Cancer Hospital, Zhengzhou, China.
Yuming JiaThe Second People's Hospital of Yibin, Yibin, China.
Ziping WangPeking University Cancer Hospital, Beijing, China.
Yong SongJinling Hospital, Nanjing University School of Medicine, Nanjing, China.
Jingxun WuThe First Affiliated Hospital of Xiamen University, Xiamen, China.
Meiqi ShiJiangsu Cancer Hospital, Nanjing, China.
Xingya LiThe First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.
Zhigang HanAffiliated Tumor Hospital of Xinjiang Medical University, Urumqi, China.
Yunpeng LiuThe First Hospital of China Medical University, Shenyang, China.
Zhuang YuThe Affiliated Hospital of Qingdao University, Qingdao, China.
An-Wen LiuThe Second Affiliated Hospital of Nanchang University, Nanchang, China.
Xiuwen WangQilu Hospital of Shandong University, Jinan, China.
Caicun ZhouShanghai Pulmonary Hospital, Shanghai, China.
Diansheng ZhongTianjin Medical University General Hospital, Tianjin, China.
Liyun MiaoAffiliated Drum Tower Hospital, Medical School of Nanjing University, Nanjing, China.
Zhihong ZhangAnhui Provincial Cancer Hospital, Hefei, China.
Hui ZhaoThe Second Hospital of Anhui Medical University, Hefei, China.
Jun YangThe Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.
Dong WangArmy Medical Center of PLA, Daping Hospital, Daping, China.
Yingyi WangPeking Union Medical College Hospital, Beijing, China.
Qiang LiShanghai East Hospital of Tongji University, Shanghai, China.
Xiaodong ZhangNantong Tumor Hospital, Nantong, China.
Mei JiThe First People's Hospital of Changzhou, Changzhou, China.
Zhenzhou YangThe Second Affiliated Hospital of Chongqing University, Chongqing, China.
Jiuwei CuiThe First Hospital of Jilin University, Jilin, China.
Beili GaoRuijin Hospital Shanghai Jiaotong University, School of Medicine, Shanghai, China.
Buhai WangSubei People's Hospital of Jiangsu Province, Yanghzou, China.
Hu LiuAnhui Provincial Cancer Hospital, Hefei, China.
Lei NieShaanxi Provincial Cancer Hospital, Xian, China.
Mei HeShanxi Provincial People's Hospital, Taiyuan, China.
Shi JinCancer Hospital of Chinese Academy of Medical Sciences, Shenzhen Center, Shenzhen, China.
Wei GuNanjing First Hospital, Nanjing, China.
Yongqian ShuThe First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Tong ZhouChangZhou Cancer Hospital, Changzhou, China.
Jian FengAffiliated Hospital of Nantong University, Nantong, China.
Xinmei YangJiaxing No. 1 Hospital, Jiaxing, China.
Cheng HuangFujian Cancer Hospital, Fuzhou, China.
Bo ZhuXinqiao Hospital of Army Medical University, Chongqing, China.
Yu YaoFirst Affiliated Hospital of Xi'an Jiaotong University, Xian, China.
Sheng YaoTopAlliance Biosciences, Rockville, MD, USA.
Jianjun YuTopAlliance Biosciences, Rockville, MD, USA.
Shang Li CaiBurning Rock Biotech, Guangdong, China.ORCID 0000-0002-5063-5712
Yiran CaiBurning Rock Biotech, Guangdong, China.
Jiachen XuState Key Laboratory of Molecular Oncology, CAMS Key Laboratory of Translational Research on Lung Cancer, Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Wei ZhuangState Key Laboratory of Molecular Oncology, CAMS Key Laboratory of Translational Research on Lung Cancer, Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Xianmin LuoShanghai Junshi Biosciences, Shanghai, China.
Jianchun DuanState Key Laboratory of Molecular Oncology, CAMS Key Laboratory of Translational Research on Lung Cancer, Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. duanjianchun79@163.com.
Jie WangState Key Laboratory of Molecular Oncology, CAMS Key Laboratory of Translational Research on Lung Cancer, Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. zlhuxi@163.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

A randomized double-blind phase 3 trial (CHOICE-01, NCT03856411) demonstrated that combining toripalimab with chemotherapy substantially improves progression-free survival (PFS) in advanced non-small cell lung cancer (NSCLC) patients without pretreatment. This study presents the prespecified final analysis of overall survival (OS) and biomarkers utilizing circulating tumor DNA (ctDNA) and tissue-based sequencing. Additionally, the analysis revealed a higher median overall survival (OS, 23.8 months) in the toripalimab group than that in the control group (17.0 months). (HR = 0.69, 95%CI: 0.57-0.93, nominal P = 0.01). This survival benefit was particularly notable in the non-squamous subgroup. As the first phase 3 study to perform both baseline tissue whole-exome sequencing (WES) and peripheral blood ctDNA testing, we investigated efficacy predictive biomarkers based on both tissue and ctDNA, Genomic sequencing of ctDNA showed high concordance with tumor tissue independently confirmed that individuals exhibiting a high tumor mutational burden, as well as mutations in the FA-PI3K-Akt and IL-7 signaling pathways benefited more from the toripalimab treatment. Furthermore, a ctDNA response observed on cycle 3 day 1, was associated with improved clinical outcomes for patients treated with the combination therapy. In conclusion, Toripalimab plus chemotherapy yields significant improvements in OS as a first-line treatment. The study highlights the utility of ctDNA as a proxy for tumor tissue, providing novel prospects for predicting efficacy of immuno-chemotherapy through continuous ctDNA monitoring.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorCarcinoma, Non-Small-Cell LungLung NeoplasmsAdultAgedCirculating Tumor DNADouble-Blind MethodFemaleHumansMaleMiddle AgedAntibodies, Monoclonal, HumanizedBiomarkers, TumorCirculating Tumor DNAtoripalimab

Identifiers

PMID39715755
PMCPMC11666711

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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.