Evidence map›Paper›PMID 34184418›Full record

Trial reportCancer communications (London, England)2021

Bevacizumab biosimilar LY01008 compared with bevacizumab (Avastin) as first-line treatment for Chinese patients with unresectable, metastatic, or recurrent non-squamous non-small-cell lung cancer: A multicenter, randomized, double-blinded, phase III trial.

Yuankai Shi, Kaijian Lei, Yuming Jia, Bingqiang Ni, Zhiyong He, Minghong Bi, Xicheng Wang, Jianhua Shi, Ming Zhou, Qian Sun and 66 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Cancer communications (London, England), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03533127 (A Phase III Study Comparing Efficacy and Safety of LY01008 and Bevacizumab Combined With Paclitaxel and Carboplatin for Treatment of Naïve Subjects With Metastatic or Recurrent Nonsquamous Non-small Cell Lung Cancer), which is not on this map. Cited by 16 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 4 pooled it
1.9field-weighted citation impact, top 11% 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.

NCT03533127 phase3unknown statusnot on this map

A Phase III Study Comparing Efficacy and Safety of LY01008 and Bevacizumab Combined With Paclitaxel and Carboplatin for Treatment of Naïve Subjects With Metastatic or Recurrent Nonsquamous Non-small Cell Lung Cancer

TypeinterventionalSponsorLuye Pharma Group Ltd.Ran2017 to 2020Enrolled648ConditionsNon Small Cell Lung Cancer, Non Small Cell Lung Cancer Metastatic, Non Small Cell Lung Cancer RecurrentArmsLY01008, Bevacizumab
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 4 syntheses or guidelines pooled it, 25 citations in OpenAlex.

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  2. Biosimilar monoclonal antibodies for cancer treatment in adults.The Cochrane database of systematic reviews · 2024
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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

76 authors at 20 institutions in 2 countries.

Yuankai ShiDepartment of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, Beijing, 100021, P. R. China.ORCID 0000-0002-3342-4964
Kaijian LeiDepartment of Oncology, Yibin Second People's Hospital, Yibin, Sichuan, 644000, P. R. China.
Yuming JiaDepartment of Oncology, Yibin Second People's Hospital, Yibin, Sichuan, 644000, P. R. China.
Bingqiang NiDepartment of Oncology, Liuzhou People's Hospital, Liuzhou, Guangxi, 545006, P. R. China.
Zhiyong HeDepartment of Thoracic Oncology, Fujian Provincial Cancer Hospital, Fuzhou, Fujian, 350014, P. R. China.
Minghong BiOncology Department, the First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, 233030, P. R. China.
Xicheng WangDepartment of Oncology, the First Affiliated Hospital of Guangdong Pharmaceutical University, Guangzhou, Guangdong, 510030, P. R. China.
Jianhua ShiDepartment of Internal medicine, Linyi Cancer Hospital, Linyi, Shandong, 276002, P. R. China.
Ming ZhouDepartment of Thoracic Surgery, the Affiliated Cancer Hospital of Guangzhou Medical University, Guangzhou, Guangdong, 510095, P. R. China.
Qian SunDepartment of Internal Medicine-Oncology/Department of thoracic oncology, Henan Chest Hospital, Zhengzhou, Henan, 450003, P. R. China.
Guolei WangDepartment of Internal Medicine-Oncology/Department of thoracic oncology, Henan Chest Hospital, Zhengzhou, Henan, 450003, P. R. China.
Dongji ChenThe Second Department of Radiotherapy, Wuwei Cancer Hospital of Gansu Province, Wuwei, Gansu, 730000, P. R. China.
Yongqian ShuDepartment of Oncology, the People's Hospital of Jiangsu Province, Nanjing, Jiangsu, 210000, P. R. China.ORCID 0000-0003-2103-0877
Lianke LiuDepartment of Oncology, the People's Hospital of Jiangsu Province, Nanjing, Jiangsu, 210000, P. R. China.
Zhongliang GuoRespiratory Medicine Department, Shanghai East Hospital, Shanghai, 200120, P. R. China.
Yong LiuThe Second Department of Internal Medicine-Oncology, Xuzhou Central Hospital, Xuzhou, Jiangsu, 221009, P. R. China.
Junquan YangOncology Department, Tangshan People's Hospital, Tangshan, Hebei, 063001, P. R. China.
Ke WangRespiratory Medicine Department, West China Hospital of Sichuan University, Chengdu, Sichuan, 610041, P. R. China.
Ke XiaoThoracic Surgery, the Second Affiliated Hospital of Shantou University Medical College, Shantou, Guangdong, 515051, P. R. China.
Lin WuInternal Medicine-Oncology, Hunan Cancer Hospital, Changsha, Hunan, 410013, P. R. China.
Tienan YiDepartment of Oncology, Xiangyang Central Hospital, Xiangyang, Hubei, 441021, P. R. China.
Debin SunRespiratory Department, Lishui Central Hospital, Lishui, Zhejiang, 323000, P. R. China.
Mafei KangOncology Department, The Affiliated Hospital of Guilin Medical College, Guilin, Guangxi, 541001, P. R. China.
Tianjiang MaInternal Medicine-Oncology, Luohe Central Hospital, Luohe, Henan, 462000, P. R. China.
Yimin MaoRespiratory Department, the First Affiliated Hospital of Henan University of Science and Technology, Luoyang, Henan, 471003, P. R. China.
Jinsheng ShiOncology Department, Cangzhou People's Hospital, Cangzhou, Hebei, 061000, P. R. China.
Tiegang TangOncology Department, Xiangtan Central Hospital, Xiangtan, Hunan, 411100, P. R. China.
Yan WangDepartment of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, Beijing, 100021, P. R. China.
Puyuan XingDepartment of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, Beijing, 100021, P. R. China.
Dongqing LvRespiratory Department, Taizhou Hospital of Zhejiang Province, Taizhou, Zhejiang, 317000, P. R. China.
Wangjun LiaoDepartment of Oncology, Nanfang Hospital of Southern Medical University, Guangzhou, Guangdong, 510515, P. R. China.
Zhiguo LuoDepartment of Oncology, Taihe Hospital of Shiyan City, Shiyan, Hubei, 442000, P. R. China.
Bin WangRespiratory Department, Huzhou Central Hospital, Huzhou, Zhejiang, 313003, P. R. China.
Xiaohong WuInternal Medicine-Oncology, the Fourth People's Hospital of Wuxi City, Wuxi, Jiangsu, 214062, P. R. China.
Xiaoli ZhuDepartment of Oncology, Zhongda Hospital of Southeast University, Nanjing, Jiangsu, 210009, P. R. China.
Shuhua HanDepartment of Oncology, Zhongda Hospital of Southeast University, Nanjing, Jiangsu, 210009, P. R. China.
Qisen GuoThe Second Department of Internal Medicine, Shandong Cancer Hospital, Jinan, Shandong, 250117, P. R. China.
Rongyu LiuRespiratory Department, the First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, 230022, P. R. China.
Zhiwei LuRespiratory Department, The First Affiliated Hospital of Wannan Medical College, Wuhu, Anhui, 241001, P. R. China.
Jianyong ZhangThe Second Department of Respiratory Medicine, the Affiliated Hospital of Zunyi Medical College, Zunyi, Guizhou, 563099, P. R. China.
Jian FangThe Second Department of thoracic oncology, Beijing Cancer Hospital, Beijing, 100142, P. R. China.
Changlu HuDepartment of Oncology, Anhui Cancer Hospital, Hefei, Anhui, 233004, P. R. China.
Yinghua JiOncology Department, the First Affiliated Hospital of Xinxiang Medical College, Xinxiang, Henan, 453100, P. R. China.
Guolong LiuDepartment of Oncology, the First People's Hospital of Guangzhou, Guangzhou, Guangdong, 510180, P. R. China.
Hong LuOncology Department, Huaihe Hospital of Henan University, Kaifeng, Henan, 475000, P. R. China.
Dedong WuDepartment of Oncology and Hematology, The First People's Hospital of Zhengzhou, Zhengzhou, Henan, 450004, P. R. China.
Junhong ZhangOncology Department, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, 430071, P. R. China.
Shuyang ZhuRespiratory Department, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, 221006, P. R. China.
Zheng LiuThe Third Department of Oncology, Handan Central Hospital, Handan, Hebei, 056001, P. R. China.
Wensheng QiuOncology Department, The Affiliated Hospital of Qingdao University, Qingdao, Shandong, 266011, P. R. China.
Feng YeOncology Department, the First Affiliated Hospital of Xiamen University, Xiamen, Fujian, 361003, P. R. China.
Yan YuThe Sixth Department of Internal Medicine, the Affiliated Cancer Hospital of Harbin Medical University, Harbin, Heilongjiang, 150081, P. R. China.
Yanqiu ZhaoRespiratory Department, Henan Cancer Hospital, Zhengzhou, Henan, 450008, P. R. China.
Qinhong ZhengInternal Medicine-Oncology, Quzhou People's Hospital, Quzhou, Zhejiang, 324000, P. R. China.
Jun ChenLung tumor surgery Department, General Hospital of Tianjin Medical University, Tianjin, 300052, P. R. China.
Zhanyu PanIntegrated Traditional Chinese and Western Medicine Department, Tianjin Cancer Hospital, Tianjin, 300060, P. R. China.
Yiping ZhangDepartment of Thoracic Cancer, Zhejiang Cancer Hospital, Hangzhou, Zhejiang, 310022, P. R. China.
Wenjuan LianDepartment of Oncology, Xi'an Chest Hospital, Xi'an, Shanxi, 710061, P. R. China.
Bo JiangSpecial Medical Treatment, Yunnan Cancer Hospital, Kunming, Yunnan, 650106, P. R. China.
Bo QiuDepartment of Oncology, Zhuzhou Central Hospital, Zhuzhou, Hunan, 412007, P. R. China.
Guojun ZhangRespiratory Department, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, 450052, P. R. China.
Hua ZhangSecond Department of Cancer Center, The First Affiliated Hospital of Xinjiang Medical University, Urumqi, Xinjiang, 830054, P. R. China.
Yanju ChenInternal Medicine-Oncology, Hainan Provincial People's Hospital, Haikou, Hainan, 570311, P. R. China.
Yuan ChenOncology Department, Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, 430030, P. R. China.
Hongbing DuanThoracic Surgery, Zhongshan Hospital Affiliated to Xiamen University, Xiamen, Fujian, 361004, P. R. China.
Manxiang LiRespiratory Department, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shanxi, 710061, P. R. China.
Shengming LiuRespiratory Department, The First Affiliated Hospital of Jinan University, Guangzhou, Guangdong, 510632, P. R. China.
Lijun MaOncology Department, Shanghai Tongren Hospital, Shanghai, 200336, P. R. China.
Hongming PanInternal Medicine-Oncology, Shaoyifu Hospital Affiliated to Medical College of Zhejiang University, Hangzhou, Zhejiang, 310016, P. R. China.
Xia YuanInternal Medicine-Oncology, Huizhou Central People's Hospital, Huizhou, Guangdong, 516008, P. R. China.
Xueli YuanOncology Department, the Fourth Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, 150001, P. R. China.
Yulong ZhengRespiratory Department, Huai'an Second People's Hospital, Huai'an, Jiangsu, 223002, P. R. China.
Emei GaoClinical Research Center of Luye Pharma Group Ltd, Luye Life Sciences Group, Beijing, 100025, P. R. China.
Li ZhaoClinical Research Center of Luye Pharma Group Ltd, Luye Life Sciences Group, Beijing, 100025, P. R. China.
Shumin WangClinical Research Center of Luye Pharma Group Ltd, Luye Life Sciences Group, Beijing, 100025, P. R. China.
Can WuClinical Research Center of Luye Pharma Group Ltd, Luye Life Sciences Group, Beijing, 100025, P. R. China.
Luye Pharma (China) · CNHarbin Medical University · CNTarget (United States) · USGovernment of Jiangsu Province · CNHenan Provincial Chest Hospital · CNSecond People’s Hospital of Yibin · CNWuhan University · CNXiangyang Central Hospital · CNXuzhou Medical College · CNZhongda Hospital Southeast University · CNAffiliated Hospital of Guilin Medical College · CNAnhui Medical University · CNAnhui Provincial Hospital · CNFirst Affiliated Hospital of Bengbu Medical College · CNFirst Affiliated Hospital of Guangdong Pharmaceutical University · CNFirst Affiliated Hospital of Henan University of Science and Technology · CNFirst Affiliated Hospital of Jinan University · CNFirst Affiliated Hospital of Wannan Medical College · CNFirst Affiliated Hospital of Xiamen University · CNFirst Affiliated Hospital of Xi'an Jiaotong University · CN

Funding

China National Major Project for New Drug Innovation 2017ZX09304015Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences (CIFMS) 2016-I2M-1-001Luye Life Sciences Group, Beijing, ChinaLuye Pharma Group Ltd.
6 · The paper itself

Abstract

backgroundPrevious studies have demonstrated the preclinical pharmacological and toxicological consistency, and clinical pharmacokinetic equivalence of bevacizumab biosimilar LY01008 with reference bevacizumab (Avastin). This randomized controlled trial aimed to compare the efficacy and safety of LY01008 with Avastin in first-line treatment of Chinese patients with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC).

methodsStage IIIB-IV NSCLC patients with evaluable lesions, good physical status, and adequate organ functions from 67 centers across China were randomized in a ratio of 1:1 to receive LY01008 or Avastin 15 mg/kg intravenously in combination with paclitaxel/carboplatin (combined treatment) for 4-6 cycles, followed by maintenance monotherapy with LY01008 until disease progression, intolerable toxicity, or death. The primary endpoint was objective response rate (ORR) in accordance with Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 confirmed by independent radiological review committees (IRRC). Secondary endpoints included disease control rate (DCR), duration of response (DoR), progression-free survival (PFS), overall survival (OS), and safety. This study was registered in ClinicalTrials.gov (NCT03533127).

resultsBetween December 15

conclusionsLY01008 demonstrated similarity to Avastin in terms of efficacy and safety in Chinese patients with advanced or recurrent non-squamous NSCLC. LY01008 combined with paclitaxel/carboplatin is expected to become a new treatment option for unresectable, metastatic, or recurrent non-squamous NSCLC patients in the first-line setting.

Indexed as

Biosimilar PharmaceuticalsCarcinoma, Non-Small-Cell LungLung NeoplasmsAntineoplastic Combined Chemotherapy ProtocolsBevacizumabChinaHumansTreatment OutcomeBevacizumabBiosimilar Pharmaceuticalsanti-angiogenesisanti-VEGF monoclonal antibodyavastinbevacizumabbiosimilarLY01008non-small cell lung cancervascular endothelial growth factor

Identifiers

PMID34184418
PMCPMC8441057
OpenAlexW3176765587

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LicenceCC BY-NC-ND
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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.