Evidence map›Paper›PMID 38309287›Full record

Trial reportThe Lancet. Respiratory medicine2024

First-line penpulimab combined with paclitaxel and carboplatin for metastatic squamous non-small-cell lung cancer in China (AK105-302): a multicentre, randomised, double-blind, placebo-controlled phase 3 clinical trial.

Hua Zhong, Shengjie Sun, Jianhua Chen, Ziping Wang, Yanqiu Zhao, Guojun Zhang, Gongyan Chen, Ming Zhou, Jianying Zhou, Yingying Du and 34 more

Abstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase III
PubMed Publisher
In one paragraph

Trial report in The Lancet. Respiratory medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 46 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
46citing papers in PubMed, 7 pooled it
19.7field-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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

46 citing papers in PubMed, 7 syntheses or guidelines pooled it, 47 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

44 authors at 20 institutions in 1 country.

Hua ZhongDepartment of Respiratory and Critical Care Medicine, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Shengjie SunDepartment of Oncology, The Fifth Medical Center of PLA General Hospital, Beijing, China.
Jianhua ChenDepartment of Thoracic Oncology, Hunan Cancer Hospital, Changsha, China.
Ziping WangDepartment of Thoracic Oncology, Peking University Cancer Hospital and Institute, Beijing, China.
Yanqiu ZhaoDepartment of Oncology, Henan Cancer Hospital, Zhengzhou, China.
Guojun ZhangDepartment of Respiratory, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.
Gongyan ChenFirst Ward of Respiratory Medicine, Harbin Medical University Cancer Hospital, Harbin, China.
Ming ZhouDepartment of Thoracic Surgery, Affiliated Cancer Hospital and Institute of Guangzhou Medical University, Guangzhou, China.
Jianying ZhouDepartment of Respiratory, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.
Yingying DuDepartment of Oncology, The First Affiliated Hospital of Anhui Medical University, Hefei, China.
Lin WuDepartment of Thoracic Oncology, Hunan Cancer Hospital, Changsha, China.
Zhi XuDepartment of Respiratory, Xinqiao Hospital of Army Medical University, Chongqing, China.
Xiaodong MeiDepartment of Respiratory and Critical Care Medicine, Anhui Provincial Hospital, Heifei, China.
Weidong ZhangDepartment of Respiratory, Hunan Provincial People's Hospital, Changsha, China.
Jingdong HeDepartment of Oncology, Huai'an First People's Hospital, Huai'an, China.
Jiuwei CuiDepartment of Oncology, The First Hospital of Jilin University, Changchun, China.
Zhihong ZhangDepartment of Respiratory, Anhui Cancer Hospital, Hefei, China.
Hui LuoDepartment of Thoracic Oncology Radiotherapy, Jiangxi Cancer Hospital, Nanchang, China.
Weiyou LiuDepartment of Respiratory and Critical Care Medicine, The First Affiliated Hospital of Gannan Medical University, Ganzhou, China.
Meili SunDepartment of Oncology, Jinan Central Hospital, Jinan, China.
Jingxun WuDepartment of Oncology, The First Affiliated Hospital of Xiamen University, Xiamen, China.
Yongchun ShenDepartment of Respiratory and Critical Care Medicine, West China Hospital of Sichuan University, Chengdu, China.
Shucai ZhangDepartment of Oncology, Beijing Chest Hospital, Capital Medical University, Beijing, China.
Nong YangDepartment of Medical Oncology, Lung Cancer and Gastrointestinal Unit, Hunan Cancer Hospital, Changsha, China.
Mengzhao WangDepartment of Respiratory and Critical Care Medicine, Peking Union Medical College Hospital, Beijing, China.
Junguo LuDepartment of Respiratory, Nantong Tumor Hospital, Nantong, China.
Kai LiDepartment of Thoracic Oncology, Tianjin Medical University Cancer Hospital, Tianjin, China.
Weirong YaoDepartment of Oncology, Jiangxi Provincial People's Hospital, Nanchang, China.
Qian SunDepartment of Oncology, Henan Provincial Chest Hospital, Zhengzhou, China.
Hongmei YueDepartment of Respiratory and Critical Care Medicine, The First Hospital of Lanzhou University, Lanzhou, China.
Lin WangDepartment of Oncology, Hainan General Hospital, Haikou, China.
Sheng YeDepartment of Oncology, The First Affiliated Hospital of Sun Yat sen University, Guangzhou, China.
Bin LiDepartment of Oncology, Xiangya Hospital of Central South University, Changsha, China.
Xibin ZhuangDepartment of Respiratory and Critical Care Medicine, Quanzhou First Hospital, Quanzhou, China.
Yueyin PanDepartment of Chemotherapy Oncology, Anhui Provincial Hospital, Hefei, China.
Min ZhangDepartment of Respiratory and Critical Care Medicine, Ganzhou People's Hospital, Ganzhou, China.
Yongqian ShuDepartment of Oncology, Jiangsu Province Hospital, Nanjing, China.
Zhiyong HeDepartment of Thoracic Oncology, Fujian Cancer Hospital, Fuzhou, China.
Lei PanDepartment of Respiratory and Critical Care Medicine, Beijing Shijitan Hospital, CMU, Beijing, China.
Yang LingDepartment of Oncology, Changzhou Cancer Hospital, Changzhou, China.
Shengming LiuDepartment of Respiratory and Critical Care Medicine, The First Affiliated Hospital of Jinan University, Guangzhou, China.
Qi ZhangDepartment of Respiratory, The First Hospital of Jiaxing, Jiaxing, China.
Shunchang JiaoDepartment of Oncology, The Fifth Medical Center of PLA General Hospital, Beijing, China. Electronic address: jiaosc@vip.sina.com.
Baohui HanDepartment of Respiratory and Critical Care Medicine, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China. Electronic address: hanbaohui@csco.org.cn.
Anhui Provincial Hospital · CNHunan Cancer Hospital · CNChinese PLA General Hospital · CNAnhui Medical University · CNBeijing Shijitan Hospital · CNCapital Medical University · CNCentral South University · CNChinese Academy of Medical Sciences & Peking Union Medical College · CNFirst Affiliated Hospital of Gannan Medical University · CNFirst Affiliated Hospital of Jinan University · CNFirst Affiliated Hospital of Xiamen University · CNFirst Affiliated Hospital of Zhengzhou University · CNFirst Affiliated Hospital Zhejiang University · CNFirst Hospital of Jiaxing · CNFujian Provincial Cancer Hospital · CNGanzhou People's Hospital · CNGuangzhou Medical University · CNHainan General Hospital · CNHangzhou Cancer Hospital · CNHenan Cancer Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPenpulimab is a novel programmed death (PD)-1 inhibitor. This study aimed to establish the efficacy and safety of first line penpulimab plus chemotherapy for advanced squamous non-small-cell lung cancer.

methodsThis multicentre, randomised, double-blind, placebo-controlled, phase 3 clinical trial enrolled patients with locally advanced or metastatic squamous non-small-cell lung cancer from 74 hospitals in China. Eligible participants were aged 18-75 years, had histologically or cytologically confirmed locally advanced (stage IIIb or IIIc) or metastatic (stage IV) squamous non-small-cell lung cancer, were ineligible to complete surgical resection and concurrent or sequential chemoradiotherapy, had an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, did not have previous systemic chemotherapy for locally advanced or metastatic non-small-cell lung cancer, and had one or more measurable lesions according to RECIST (version 1.1). Participants were randomly assigned (1:1) to receive intravenous penpulimab 200 mg or placebo (excipient of penpulimab injection), plus paclitaxel 175 mg/m

findingsBetween Dec 20, 2018, and Oct 10, 2020, 485 patients were screened, and 350 participants were randomly assigned (175 in the penpulimab group and 175 in the placebo group). Of 350 participants, 324 (93%) were male and 26 (7%) were female, and 347 (99%) were of Han ethnicity. In the final analysis (June 1, 2022; median follow-up, 24·7 months [IQR 0-41·4]), the penpulimab group showed an improved progression-free survival compared with the placebo group, both in the intention-to-treat population (median 7·6 months, 95% CI 6·8--9·6 vs 4·2 months, 95% CI 4·2-4·3; HR 0·43, 95% CI 0·33-0·56; p<0·0001) and in the PD-L1-positive subgroup (8·1 months, 5·7-9·7 vs 4·2 months, 4·1-4·3; HR 0·37, 0·27-0·52, p<0·0001). Grade 3 or worse treatment-emergent adverse events occurred in 120 (69%) 173 patients in the penpulimab group and 119 (68%) of 175 in the placebo group.

interpretationPenpulimab plus chemotherapy significantly improved progression-free survival in patients with advanced squamous non-small-cell lung cancer compared with chemotherapy alone. The treatment was safe and tolerable. Penpulimab combined with paclitaxel and carboplatin is a new option for first-line treatment in patients with this advanced disease.

fundingThe National Natural Science Foundation of China, Shanghai Municipal Health Commission, Chia Tai Tianqing Pharmaceutical, Akeso.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsCarboplatinCarcinoma, Non-Small-Cell LungLung NeoplasmsPaclitaxelAdultAgedAntibodies, Monoclonal, HumanizedChinaDouble-Blind MethodFemaleHumansMaleMiddle AgedProgression-Free SurvivalTreatment OutcomeAntibodies, Monoclonal, HumanizedCarboplatinPaclitaxel

Identifiers

PMID38309287
OpenAlexW4391407963

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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.