Evidence map›Paper›PMID 33544337›Full record

Trial reportTargeted oncology2021

Osimertinib Versus Comparator EGFR TKI as First-Line Treatment for EGFR-Mutated Advanced NSCLC: FLAURA China, A Randomized Study.

Ying Cheng, Yong He, Wei Li, He-Long Zhang, Qing Zhou, Buhai Wang, Chunling Liu, Andrew Walding, Matilde Saggese, Xiangning Huang and 3 more

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Targeted oncology, 2021. 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 113 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
113citing papers in PubMed, 8 pooled it
15.9field-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.

NCT02296125 phase3completednot on this map

A Phase III, Double-blind, Randomised Study to Assess the Safety and Efficacy of AZD9291 Versus a Standard of Care Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor as First Line Treatment in Patients With Epidermal Growth Factor Receptor Mutation Positive, Locally Advanced or Metastatic Non Small Cell Lung Cancer.

TypeinterventionalSponsorAstraZenecaRan2014 to 2025Enrolled674ConditionsLocally Advanced or Metastatic EGFR Sensitising Mutation Positive Non Small Cell Lung CancerArmsAZD9291 80 mg/40 mg + placebo, Placebo Erlotinib 150/100mg, Placebo Gefitinib 250 mg, Erlotinib 150/100 mg, Gefitinib 250 mg
NCT06102928 narecruitingnot on this mapstarted 2023, after this paper: background citation

A Prospective, Multicenter, Single-arm Clinical Study of the Combination of Anlotinib and Aumolertinib in the First-line Treatment of Advanced Non-small Cell Lung Cancer With EGFR 21L858R Mutation

TypeinterventionalSponsorKunming Medical UniversityRan2023 to 2026Enrolled30ConditionsNon-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor ReceptorArmsCombined therapy of anlotinib and aumolertinib
3 · Its place in the literature

Who cites it

113 citing papers in PubMed, 8 syntheses or guidelines pooled it, 159 citations in OpenAlex.

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53 more citing papers are in PubMed but not listed here.

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

13 authors at 10 institutions in 3 countries.

Ying ChengDepartment of Medical Oncology, Jilin Provincial Cancer Hospital, Changchun, 130000, China. jl.cheng@163.com.ORCID 0000-0001-9908-597X
Yong HeRespiratory Disease, Daping Hospital, Chongqing, China.
Wei LiThe First Hospital of Jilin University, Changchun, Jilin, China.
He-Long ZhangTangdu Hospital of Fourth Military Medical University, Xi'an, Shaanxi, China.
Qing ZhouGuangdong Lung Cancer Institute, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China.
Buhai WangDepartment of Oncology of Subei People's Hospital, Yangzhou University, Yangzhou, Jiangsu, China.
Chunling LiuTumor Hospital, Xinjiang Medical University, Urumqi, China.
Andrew WaldingGlobal Medicines Development, GMED Oncology, AstraZeneca, Cambridge, UK.
Matilde SaggeseGlobal Medicines Development, GMED Oncology, AstraZeneca, Cambridge, UK.
Xiangning HuangGlobal Medicines Development, GMED Oncology, AstraZeneca, Cambridge, UK.
Minhao FanGlobal Medicines Development, AstraZeneca, Shanghai, China.
Jia WangGlobal Medicines Development, AstraZeneca, Shanghai, China.
Suresh S RamalingamWinship Cancer Institute, Emory University School of Medicine, Atlanta, GA, USA.
AstraZeneca (United Kingdom) · GBShanghai Innovative Research Center of Traditional Chinese Medicine · CNAir Force Medical University · CNDaping Hospital · CNEmory University · USGuangdong Academy of Medical Sciences · CNJilin Province Tumor Hospital · CNJilin University · CNXinjiang Medical University · CNYangzhou University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn the global FLAURA study, first-line osimertinib, a third-generation irreversible tyrosine kinase inhibitor (TKI) of epidermal growth factor receptor (EGFR), significantly improved progression-free survival (PFS) and overall survival (OS) versus comparator EGFR TKIs in patients with EGFR mutation-positive (EGFRm) advanced non-small-cell lung cancer (NSCLC).

objectiveThe FLAURA China study assessed first-line osimertinib in Chinese patients with EGFRm advanced NSCLC (NCT02296125).

methodsFLAURA China was a double-blind, randomized, phase III study. Adults from mainland China with previously untreated EGFRm (Exon 19 deletion or L858R) advanced NSCLC were enrolled in the global study or a China-only study under the same protocol; 136 patients were randomized to osimertinib (80 mg once daily [od]; n = 71) or comparator EGFR TKI (gefitinib or erlotinib; all sites selected gefitinib 250 mg od; n = 65). Patients were randomized and allocated to treatment groups by a central computer system. Treatment continued until disease progression, unacceptable toxicity, or withdrawal of consent. The primary endpoint was investigator-assessed PFS; OS was a secondary endpoint.

resultsAll 136 randomized patients were analyzed. Osimertinib extended median PFS by 8.0 months versus comparator EGFR TKI (17.8 vs. 9.8 months; hazard ratio [HR] 0.56; 95% confidence interval [CI] 0.37-0.85). Median OS was 33.1 months in the osimertinib group versus 25.7 months in the comparator group (HR 0.85; 95% CI 0.56-1.29). At 3 years, 20% of patients on osimertinib and 8% on the comparator remained on randomized treatment. Grade 3 or higher adverse events (AEs) were reported in 54 and 28% of patients in the osimertinib and comparator groups, respectively, driven by increased local reporting of laboratory- and disease-related AEs. No new safety signals were identified.

conclusionsFirst-line osimertinib treatment resulted in a clinically meaningful PFS and OS benefit versus comparator EGFR TKI in Chinese patients with EGFRm advanced NSCLC. Safety data were consistent with the known safety profile of osimertinib. CLINICAL

trial registrationClinicalTrials.gov NCT02296125, registered 20 November 2014.

Indexed as

AcrylamidesAdultAgedAged, 80 and overAniline CompoundsCarcinoma, Non-Small-Cell LungChinaDouble-Blind MethodErbB ReceptorsFemaleHumansIndolesLung NeoplasmsMaleMiddle AgedMutationAcrylamidesAniline CompoundsEGFR protein, humanErbB ReceptorsIndolesosimertinibProtein Kinase InhibitorsPyrimidines

Identifiers

PMID33544337
PMCPMC7935816
OpenAlexW3128870202

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.