Evidence map›Paper›PMID 37488286›Full record

Trial reportNature medicine2023

First-line pyrotinib in advanced HER2-mutant non-small-cell lung cancer: a patient-centric phase 2 trial.

Si-Yang Maggie Liu, Hai-Yan Tu, Xue-Wu Wei, Hong-Hong Yan, Xiao-Rong Dong, Jiu-Wei Cui, Zhen Zhou, Chong-Rui Xu, Ming-Ying Zheng, Yang-Si Li and 20 more

2 registry-linked trialsAbstract readClinical Trial, Phase II
PubMed Publisher
In one paragraph

Trial report in Nature medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 33 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed, 1 pooled it
14.7field-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.

NCT03574402 phase2unknown statusnot on this map

An Open-label, Multi-center, Phase II Umbrella Study to Assess Efficacy of Targeted Therapy or Immunotherapy Directed by Next Generation Sequencing (NGS) in Chinese Patients With Advanced NSCLC (TRUMP)

TypeinterventionalSponsorGuangdong Association of Clinical TrialsRan2018 to 2024Enrolled400ConditionsCarcinoma, Non-Small-Cell LungArmsAvitinib Maleate, Afatinib, Crizotinib, X-396, Chidamide
NCT03605602 unknown statusnot on this map

TRUMPRWS: A Non-interventional Study on Genetic Variants and Its Clinical Relevance in Chinese Patients With Advanced NSCLC (TRUMPRWS)

Typeobservational_patient_registrySponsorGuangdong Association of Clinical TrialsRan2018 to 2024Enrolled2,700ConditionsNon-Small Cell Carcinoma of Lung, TNM Stage 4ArmsNo treatment is included in this protocol.
3 · Its place in the literature

Who cites it

33 citing papers in PubMed, 1 synthesis or guideline pooled it, 57 citations in OpenAlex.

  1. Pooled it
  2. Plasma Metabolic Profiles-Based Prediction of Induction Chemotherapy Efficacy in Nasopharyngeal Carcinoma: Results of a Bidirectional Clinical Trial.Clinical cancer research : an official journal of the American Association for Cancer Research · 2024
    Trial
  3. Review
  4. Review
  5. Review
  6. Review
  7. Article
  8. Article
  9. Review
  10. [Advances in Targeted Therapy for Advanced Non-small Cell Lung Cancer 
with HER2 Mutation].Zhongguo fei ai za zhi = Chinese journal of lung cancer · 2025
    Review
  11. Article
  12. Review
  13. Review
  14. Review
  15. Article
  16. Observational
  17. HER2-Selective Tyrosine Kinase Inhibitor, Zongertinib (BI 1810631), in Patients With Advanced/Metastatic Solid Tumors WithJournal of clinical oncology : official journal of the American Society of Clinical Oncology · 2025
    Article
  18. Article
  19. Article
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

30 authors at 13 institutions in 2 countries.

Si-Yang Maggie Liu *Department of Hematology, The First Affiliated Hospital, Jinan University, Guangzhou, China.
Hai-Yan Tu *Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, China.
Xue-Wu Wei *Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, China.ORCID http://orcid.org/0000-0001-6865-8923
Hong-Hong YanGuangdong Lung Cancer Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, China.
Xiao-Rong DongCancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Jiu-Wei CuiCancer Center, The First Hospital of Jilin University, Jilin University, Changchun, China.
Zhen ZhouShanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiaotong University, Shanghai, China.
Chong-Rui XuGuangdong Lung Cancer Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, China.ORCID http://orcid.org/0000-0002-3474-2809
Ming-Ying ZhengGuangdong Lung Cancer Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, China.
Yang-Si LiGuangdong Lung Cancer Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, China.
Zhen WangGuangdong Lung Cancer Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, China.
Xiao-Yan BaiGuangdong Lung Cancer Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, China.
An-Na LiGuangdong Lung Cancer Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, China.
Yue-Li SunGuangdong Lung Cancer Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, China.
Jie HuangGuangdong Lung Cancer Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, China.
Jia-Xin LinGuangdong Lung Cancer Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, China.
E E KeGuangdong Lung Cancer Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, China.
Bing-Fei XuGuangdong Lung Cancer Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, China.
Chang LuGuangdong Lung Cancer Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, China.ORCID http://orcid.org/0000-0001-6504-6083
Yingying DuDepartment of Oncology, The First Affiliated Hospital of Anhui Medical University, Hefei, China.
Yuan ChenDepartment of Oncology, Tongji Hospital, Tongji, Medical College, Huazhong, University of Science and Technology, Wuhan, China.
Rui MaMedical Oncology Department of Thoracic Cancer, Liaoning Cancer Hospital, Shenyang, China.
Bu-Hai WangDepartment of Oncology, Northern Jiangsu People's Hospital, Yangzhou, China.
Shun-Dong CangDepartment of Oncology, Henan Provincial People's Hospital, Zhengzhou, China.
Bin-Chao WangGuangdong Lung Cancer Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, China.
Hua-Jun ChenGuangdong Lung Cancer Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, China.
Jin-Ji YangGuangdong Lung Cancer Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, China.
Yangqiu LiDepartment of Hematology, The First Affiliated Hospital, Jinan University, Guangzhou, China. yangqiuli@hotmail.com.ORCID http://orcid.org/0000-0002-0974-4036
Qing ZhouGuangdong Lung Cancer Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, China. gzzhouqing@126.com.ORCID http://orcid.org/0000-0002-0478-176X
Yi-Long WuGuangdong Lung Cancer Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, China. syylwu@live.cn.ORCID http://orcid.org/0000-0002-3611-0258
Guangdong Academy of Medical Sciences · CNGuangzhou University of Chinese Medicine · CNNorthern Jiangsu People's Hospital · CNAnhui Medical University · CNFirst Affiliated Hospital of Jinan University · CNHenan Provincial People's Hospital · CNJilin University · CNJinan University · CNLiaoning Cancer Hospital & Institute · CNMinistry of Education · MEShanghai Chest Hospital · CNTongji Hospital · CNUnion Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

To explore targeted treatment options in patients with non-small-cell lung cancer (NSCLC) with rare genetic mutations in the context of a patient-centric clinical trial, we initiated, in parallel, a phase 2 adaptive umbrella trial consisting of a criteria-fulfilled (CF) cohort and a compassionate use (CU) cohort under expanded eligibility criteria, and a prospective real-world study (RWS). Here, we present efficacy and safety data from 48 patients with treatment-naive, advanced HER2-mutant NSCLC treated with the pan-HER receptor tyrosine kinase inhibitor pyrotinib (CF and CU cohorts) or physician's therapy of choice (RWS cohort). In the phase 2 trial CF cohort (n = 28), the primary endpoint was reached with an objective response rate of 35.7% after pyrotinib treatment. Secondary endpoints included disease control rate (89.3%), median progression-free survival (PFS) (7.3 months), median overall survival (OS) (14.3 months) and toxicity, which was acceptable, with grade 3 or 4 treatment-related adverse events occurring in three patients (10.7%). The phase 2 trial CU cohort (n = 12) showed an objective response rate of 16.7%, disease control rate of 83.4%, median PFS of 4.7 months and median OS of 14.2 months after pyrotinib treatment. The RWS cohort (n = 8) had no responses to physician's therapy of choice, while median PFS and OS were 3.0 and 12.2 months, respectively. Phase 2 umbrella trial, clinicaltrials.gov identifier: NCT03574402 . RWS, clinicaltrials.gov identifier: NCT03605602 .

Indexed as

Carcinoma, Non-Small-Cell LungLung NeoplasmsAcrylamidesAminoquinolinesHumansPatient-Centered CareProspective StudiesAcrylamidesAminoquinolinespyrotinib

Identifiers

PMID37488286
OpenAlexW4385197399

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.