Evidence map›Paper›PMID 33962566›Full record

Trial reportBMC cancer2021

Thoracic radiotherapy and concurrent almonertinib for unresectable stage III EGFR-mutated non-small-cell lung cancer: a phase 2 study.

Lucheng Zhu, Changlin Zou, Zhanchun Zhang, Jianfang Wang, Li Yang, Chuangzhou Rao, Zhiping Yang, Jiafeng Liang, Bing Xia, M A Shenglin

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report 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 NCT04636593 (Almonertinib With Concurrent Radiotherapy in The Treatment of Unresectable, Stage Ⅲ Non-small-cell Lung Cancer Harboring EGFR Mutations), which is not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 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.

NCT04636593 phase2unknown statusnot on this map

Almonertinib With Concurrent Radiotherapy in The Treatment of Unresectable, Stage Ⅲ Non-small-cell Lung Cancer Harboring EGFR Mutations: A PhaseⅡCohort Study

TypeinterventionalSponsorFirst People's Hospital of HangzhouRan2020 to 2022Enrolled43ConditionsNon Small Cell Lung Cancer, Stage III NSCLC, EGFR Activating MutationArmsAlmonertinib
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Review
  7. Review
  8. Review
  9. 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

10 authors.

Lucheng ZhuDepartment of Thoracic Oncology, Key Laboratory of Clinical Cancer Pharmacology and Toxicology Research of Zhejiang Province, Affiliated Hangzhou Cancer Hospital, Zhejiang University School of Medicine, Hangzhou, 310002, People's Republic of China.
Changlin ZouDepartment of Radiotherapy, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, 325100, People's Republic of China.
Zhanchun ZhangDepartment of Radiotherapy, Ningbo Medical Center Lihuili Hospital, Ningbo, 315100, People's Republic of China.
Jianfang WangDepartment of Radiotherapy, Shaoxing People's Hospital (Shaoxing Hospital, Zhejiang University School of Medicine), Shaoxing, 312000, People's Republic of China.
Li YangDepartment of Pulmonary & Critical Care Medicine, Shulan (Hangzhou) Hospital, Affiliated to Zhejiang Shuren University Shulan International Medical college, Hangzhou, 310022, People's Republic of China.
Chuangzhou RaoDepartment of Radiotherapy & Chemotherapy,Hwa Mei Hospital, University of Chinese Academy of Sciences, Ningbo, 315010, People's Republic of China.
Zhiping YangDepartment of Oncology, Affiliated Hospital of Jiaxing University, The First Hospital of Jiaxing, Jiaxing, 314000, People's Republic of China.
Jiafeng LiangDepartment of Thoracic Oncology, Key Laboratory of Clinical Cancer Pharmacology and Toxicology Research of Zhejiang Province, Affiliated Hangzhou Cancer Hospital, Zhejiang University School of Medicine, Hangzhou, 310002, People's Republic of China.
Bing XiaDepartment of Thoracic Oncology, Key Laboratory of Clinical Cancer Pharmacology and Toxicology Research of Zhejiang Province, Affiliated Hangzhou Cancer Hospital, Zhejiang University School of Medicine, Hangzhou, 310002, People's Republic of China. bingxia_hzch@163.com.
M A ShenglinDepartment of Thoracic Oncology, Key Laboratory of Clinical Cancer Pharmacology and Toxicology Research of Zhejiang Province, Affiliated Hangzhou Cancer Hospital, Zhejiang University School of Medicine, Hangzhou, 310002, People's Republic of China. zdsymsl0807@zju.edu.cn.

Funding

Huilan Welfare Foundations HL-HS2020-84-2
6 · The paper itself

Abstract

backgroundConcurrent chemo-radiotherapy remains the standard treatment in unresectable stage III non-small-cell lung cancer (NSCLC) patients. Several studies have shown a potential value of concurrent epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) with thoracic radiotherapy in EGFR-mutated population, but a high risk of radiation pneumonitis raised a major concern. This study intends to explore the safety and efficacy of concurrent almonertinib, a new third-generation EGFR-TKI, with radiotherapy in locally advanced EGFR-mutated NSCLC patients.

methodsLocally advanced NSCLC patients harboring sensitive EGFR mutation will be included in this study. A radiotherapy plan will be made for each patient before treatment, and the lung V20 will be calculated. Patients with lung V20 ≥ 28% were enrolled in induction group (arm A), which almonertinib was given for 2 months followed by concurrent radiotherapy; patients with lung V20 < 28% were enrolled in concurrent group (arm B), which almonertinib was given concurrent with thoracic radiotherapy. The primary endpoint is the incidence of grade ≥ 3 radiation pneumonitis within 6 months post-radiotherapy, and the secondary endpoints are local control rate, progression-free survival, and overall survival. DISCUSSION: The safety and efficacy of third-generation EGFR-TKI concurrent with thoracic radiotherapy in locally advanced EGFR-mutated NSCLC is still unknown. We propose to conduct this phase 2 study evaluating the safety especially the radiation pneumonitis within 6 months post-radiotherapy. This trial protocol has been approved by the Ethics committee of Hangzhou cancer hospital. The ethics number is HZCH-2020-030.

trial registrationclinicaltrials.gov, NCT04636593 . Registered 19 November 2020 - Retrospectively registered.

Indexed as

ChemoradiotherapyMutationAcrylamidesCarcinoma, Non-Small-Cell LungErbB ReceptorsHumansIndolesLung NeoplasmsNeoplasm StagingProtein Kinase InhibitorsPyrimidinesAcrylamidesaumolertinibEGFR protein, humanErbB ReceptorsIndolesProtein Kinase InhibitorsPyrimidinesAlmonertinibEGFR-TKILocally advanced NSCLCRadiation pneumonitisRadiotherapy

Identifiers

PMID33962566
PMCPMC8103745

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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.