Evidence map›Paper›PMID 34530760›Full record

ArticleBMC cancer2021

Pyrotinib combined with thalidomide in advanced non-small-cell lung cancer patients harboring HER2 exon 20 insertions (PRIDE): protocol of an open-label, single-arm phase II trial.

Xinghao Ai, Zhengbo Song, Hong Jian, Zhen Zhou, Zhiwei Chen, Yongfeng Yu, Ziming Li, Shun Lu

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC cancer, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04382300 (Safety and Efficacy of Pyrotinib Combined With Thalidomide in Advanced Non-Small-Cell Lung Cancer With HER2 Exon 20 Insertions), which is not on this map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
1.1field-weighted citation impact, top 20% 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.

NCT04382300 phase2unknown statusnot on this map

Safety and Efficacy of Pyrotinib Combined With Thalidomide in Advanced Non-Small-Cell Lung Cancer With HER2 Exon 20 Insertions: A Prospective, Single-arm, Open-label Phase II Study

TypeinterventionalSponsorShanghai Chest HospitalRan2020 to 2023Enrolled39ConditionsNon-small-cell Lung CancerArmspyrotinib combined with thalidomide
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 14 citations in OpenAlex.

  1. Pooled it
  2. [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
  3. Article
  4. Review
  5. Article
  6. Article
  7. Article
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

8 authors at 3 institutions in 1 country.

Xinghao AiDepartment of Oncology, Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, No.241 West Huaihai Road, Shanghai, 200030, China.
Zhengbo SongDepartment of Clinical Trial, The Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), No.1 East Banshan Road, Hangzhou, 310022, Zhejiang, China.
Hong JianDepartment of Oncology, Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, No.241 West Huaihai Road, Shanghai, 200030, China.
Zhen ZhouDepartment of Oncology, Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, No.241 West Huaihai Road, Shanghai, 200030, China.
Zhiwei ChenDepartment of Oncology, Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, No.241 West Huaihai Road, Shanghai, 200030, China.
Yongfeng YuDepartment of Oncology, Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, No.241 West Huaihai Road, Shanghai, 200030, China.
Ziming LiDepartment of Oncology, Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, No.241 West Huaihai Road, Shanghai, 200030, China.
Shun LuDepartment of Oncology, Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, No.241 West Huaihai Road, Shanghai, 200030, China. shunlu@sjtu.edu.cn.
Shanghai Jiao Tong University · CNShanghai Chest Hospital · CNZhejiang Cancer Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundStandard therapy for human epidermal growth factor receptor 2 (HER2)-mutant non-small-cell lung cancer (NSCLC) is lacking. The clinical benefits with pan-HER inhibitors (afatinib, neratinib, and dacomitinib), anti-HER2 antibody drug conjugate (ADC) trastuzumab emtansine, and an emerging irreversible tyrosine kinase inhibitor (TKI) poziotinib were modest. Another new ADC trastuzumab deruxtecan showed encouraging outcomes, but only phase I study was completed. Pyrotinib, another emerging irreversible epidermal growth factor receptor (EGFR)/HER2 dual TKI, has been approved in HER2-positive breast cancer in 2018 in China. It has shown promising antitumor activity against HER2-mutant NSCLC in phase II trials, but pyrotinib-related diarrhea remains an issue. The antiangiogenic and immunomodulatory drug thalidomide is a cereblon-based molecular glue that can induce the degradation of the IKAROS family transcription factors IKZF1 and IKZF3. The use of thalidomide can also decrease gastrointestinal toxicity induced by anti-cancer therapy.

methodsThis is an open-label, single-arm phase II trial. A total of 39 advanced NSCLC patients with HER2 exon 20 insertions and ≤ 2 lines of prior chemotherapy will be recruited, including treatment-naïve patients who refuse chemotherapy. Patients are allowed to have prior therapy with immune checkpoint inhibitors and/or antiangiogenic agents. Those who have prior HER2-targeting therapy or other gene alterations with available targeted drugs are excluded. Eligible patients will receive oral pyrotinib 400 mg once daily and oral thalidomide 200 mg once daily until disease progression or intolerable toxicity. The primary endpoint is objective response rate. DISCUSSION: The addition of thalidomide to pyrotinib is expected to increase the clinical benefit in advanced NSCLC patients with HER2 exon 20 insertions, and reduce the incidence of pyrotinib-related diarrhea. We believe thalidomide is the stone that can hit two birds.

trial registrationClinicalTrials.gov Identifier: NCT04382300 . Registered on May 11, 2020.

Indexed as

AcrylamidesAminoquinolinesAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Non-Small-Cell LungErb-b2 Receptor Tyrosine KinasesLung NeoplasmsThalidomideAngiogenesis InhibitorsChinaClinical Trials, Phase II as TopicDiarrheaDrug Administration ScheduleExonsHumansIkaros Transcription FactorMutationAcrylamidesAminoquinolinesAngiogenesis InhibitorsERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesIkaros Transcription FactorIKZF1 protein, humanIKZF3 protein, humanProtein Kinase InhibitorspyrotinibThalidomideHuman epidermal growth factor receptor 2Non-small-cell lung cancerProtocolPyrotinibThalidomide

Identifiers

PMID34530760
PMCPMC8444597
OpenAlexW3199012069

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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.