Evidence map›Paper›PMID 27959700›Full record

Trial reportThe New England journal of medicine2017

Osimertinib or Platinum-Pemetrexed in EGFR T790M-Positive Lung Cancer.

Tony S Mok, Yi-Long Wu, Myung-Ju Ahn, Marina C Garassino, Hye R Kim, Suresh S Ramalingam, Frances A Shepherd, Yong He, Hiroaki Akamatsu, Willemijn S M E Theelen and 8 more

13 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
In one paragraph

Trial report in The New England journal of medicine, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 13 registered trials, which are not on this map. Cited by 1,886 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1,886citing papers in PubMed, 7 pooled it
262.4field-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.

NCT02151981 phase3completednot on this map

A Phase III, Open Label, Randomized Study of AZD9291 Versus Platinum-Based Doublet Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Whose Disease Has Progressed With Previous Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and Whose Tumours Harbour a T790M Mutation Within the Epidermal Growth Factor Receptor Gene (AURA3).

TypeinterventionalSponsorAstraZenecaRan2014 to 2023Enrolled421ConditionsAnticancer TreatmentArmsChemotherapy, Cross-over to Osimertinib
NCT03382795 phase2unknown statusnot on this mapstarted 2018, after this paper: background citation

Retreatment With 1st Generation EGFR TKIs in Sensitizing EGFR Mutation Positive Non-Squamous Cell Carcinoma Patients Who Previously Treated With EGFR TKI and Cytotoxic Chemotherapy

TypeinterventionalSponsorKorea University Guro HospitalRan2018 to 2023Enrolled63ConditionsEGFR Positive Non-small Cell Lung CancerArmsEGFR
NCT03532698 unknown statusnot on this mapstarted 2020, after this paper: background citation

Prospective Observational Trial to Evaluate the Efficacy of the Combination of Osimertinib and Aspirin in Patients With Disease Progression to 3st Generation Epidermal Growth Factor Receptor-tyrosine Kinase Inhibitor(EGFR-TKI) Osimertinib

TypeobservationalSponsorDaping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityRan2020 to 2022Enrolled100ConditionsNon-Small Cell Lung Cancer Stage IIIB, Non-small Cell Lung Cancer Stage IV, EGFR T790MArmsAspirin, Osimertinib
NCT03543683 phase2completednot on this mapstarted 2018, after this paper: background citation

A Multi-center, Prospective, Non-randomized, Open-label Study of the Efficacy and Safety of Osimertinib Combined With Aspirin in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer Who Are T790M-positive and Resistant to First-generation Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors.

TypeinterventionalSponsorDaping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityRan2018 to 2024Enrolled115ConditionsNon-Small Cell Lung Cancer Stage IIIB, Non-small Cell Lung Cancer Stage IV, EGFR T790MArmsOsimertinib, Aspirin
NCT03858491 early_phase1completednot on this mapstarted 2020, after this paper: background citation

Pharmacokinetic Boosting of Osimertinib in Patients With Non-small Cell Lung Cancer.

TypeinterventionalSponsorAcademisch Ziekenhuis MaastrichtRan2020 to 2021Enrolled11ConditionsNon Small Cell Lung CancerArmsCobicistat
NCT04029350 phase2unknown statusnot on this mapstarted 2019, after this paper: background citation

A Multi-center, One-arm, Phase II Trial of Anlotinib Combined With Osimertinib as the Second-line Treatment in Stage IIIb-IV NSCLC With Confirmed EGFRm and T790M.

TypeinterventionalSponsorTianjin Medical University Cancer Institute and HospitalRan2019 to 2021Enrolled53ConditionsNon Small Cell Lung CancerArmsAnlotinib Combined With Osimertinib
NCT04105153 completednot on this mapstarted 2019, after this paper: background citation

Real-world Analysis of Workup at Disease Progression and Implementation of Osimertinib for EGFR+ NSCLC

TypeobservationalSponsorThoraxklinik-Heidelberg gGmbHRan2019 to 2019Enrolled400ConditionsEGFR Positive Non-small Cell Lung Cancer
NCT04136535 phase2recruitingnot on this mapstarted 2021, after this paper: background citation

A Multicenter, Randomized, Phase II Study of Pemetrexed and Carboplatin With or Without Anlotinib Hydrochloride for Advanced or Locally-advanced Osimertinib-resistant Non-squamous Non-small Cell Lung Cancer (ALTER-L031)

TypeinterventionalSponsorFudan UniversityRan2021 to 2026Enrolled105ConditionsNSCLC Stage IVArmsPemetrexed, Carboplatin, Anlotinib
NCT04141644 phase1active not recruitingnot on this mapstarted 2020, after this paper: background citation

A Phase Ib Study to Evaluate the Safety and Efficacy of Osimertinib in Combination With Ipilimumab in Patients With EGFR Mutated Non-Small-Cell Lung Cancer Tumors

TypeinterventionalSponsorUniversity of UtahRan2020 to 2028Enrolled24ConditionsNon-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor Receptor (Disorder)ArmsIpilimumab, Osimertinib
NCT04184921 phase2completednot on this mapstarted 2019, after this paper: background citation

A Multicenter, Prospective, Non-randomized, Open-label Study on the Efficacy and Safety of Osimertinib Combined With Aspirin as First-line Treatment for Patients With Locally Advanced or Metastatic EGFR-positive Non-small Cell Lung Cancer (NSCLC)

TypeinterventionalSponsorDaping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityRan2019 to 2024Enrolled216ConditionsLung Cancer Non-small Cell Stage IVArmsAspirin 100mg, Osimertinib 80 MG
NCT04619563 phase2unknown statusnot on this mapstarted 2020, after this paper: background citation

A Single-arm Exploratory Clinical Study of Anlotinib Hydrochloride Combined With Docetaxel in EGFR Mutations Advanced Non Small Cell Lung Cancer Patients Who Have Progressed After Targeted Therapy and Chemotherapy

TypeinterventionalSponsorShandong Cancer Hospital and InstituteRan2020 to 2022Enrolled42ConditionsNon Small Cell Lung CancerArmsAnlotinib Hydrochloride plus Docetaxel
NCT05998993 nanot yet recruitingnot on this mapstarted 2023, after this paper: background citation

Phase II Study to Evaluate the Efficacy and Safety of SBRT as an Adjunctive Intervention for Oligoresidual Disease in EGFR Mutant NSCLC With First-Line Osimertinib Treatment

TypeinterventionalSponsorCentro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento AnguloRan2023 to 2028Enrolled35ConditionsEGF-R Positive Non-Small Cell Lung Cancer, Non Small Cell Lung Cancer, EGFR Exon 19 Deletion, EGFR Exon 21 MutationArmsStereotactic Body Radiation Therapy SBRT
NCT07361705 phase1recruitingnot on this mapstarted 2026, after this paper: background citation

An Open-Label, Multicentre, Phase 1 Clinical Study to Evaluate the Safety and Efficacy of Zorifertinib Combined With Osimertinib in Patients With Advanced Non-Small Cell Lung Cancer With Meningeal Progression After Osimertinib Treatment

TypeinterventionalSponsorAlpha Biopharma (Jiangsu) Co., Ltd.Ran2026 to 2028Enrolled42ConditionsPatients With Advanced Non-small Cell Lung Cancer With Meningeal Progression After Osimertinib TreatmentArmsZorifertinib and Osimertinib Combination Therapy
3 · Its place in the literature

Who cites it

1,886 citing papers in PubMed, 7 syntheses or guidelines pooled it, 3,266 citations in OpenAlex.

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  15. Neoadjuvant Osimertinib for ResectableJournal of clinical oncology : official journal of the American Society of Clinical Oncology · 2025
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  19. Venous and arterial thromboembolic events associated with osimertinib in patients with lung cancer: a study by the thrombosis and cancer group of the spanish society of medical oncology (SEOM).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
    Article
  20. Article

1,826 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors at 6 institutions in 11 countries.

Tony S MokFrom the State Key Laboratory in Oncology in South China, Sir Y.K. Pao Centre for Cancer, Department of Clinical Oncology, Chinese University of Hong Kong, Hong Kong (T.S.M.), the Division of Pulmonary Oncology, Guangdong Lung Cancer Institute, Guangdong General Hospital, and Guangdong Academy of Medical Sciences, Guangzhou (Y.-L.W.), and the Department of Respiratory Disease, Daping Hospital, Third Military Medical University, Chongqing (Y.H.) - all in China; the Department of Medicine, Division of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, (M.-J.A.), and the Yonsei Cancer Center, Department of Internal Medicine, Division of Medical Oncology, Yonsei University College of Medicine (H.R.K.), Seoul, South Korea; the Thoracic Oncology Unit, Medical Oncology Department, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico, Istituto Nazionale dei Tumori, Milan (M.C.G.); the Department of Hematology and Medical Oncology, Emory University School of Medicine, Winship Cancer Institute, Atlanta (S.S.R.); the Department of Medical Oncology and Haematology, Princess Margaret Cancer Centre, Toronto (F.A.S.); the Third Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan (H.A.); the Department of Thoracic Oncology, the Netherlands Cancer Institute, Plesmanlaan, Amsterdam (W.S.M.E.T.); the Clinical Research Unit, Division of Cancer Services, St. George Hospital, Kogarah, NSW, Australia (C.K.L.); the Department of Hematology-Oncology, Johann Wolfgang Goethe University Medical Center, Frankfurt am Main, Germany (M.S.); AstraZeneca, Cambridge, United Kingdom (A.T., H.M., M.M., S.G.); and the Department of Thoracic-Head and Neck Medical Oncology, University of Texas M.D. Anderson Cancer Center, Houston (V.A.P.).
Yi-Long WuFrom the State Key Laboratory in Oncology in South China, Sir Y.K. Pao Centre for Cancer, Department of Clinical Oncology, Chinese University of Hong Kong, Hong Kong (T.S.M.), the Division of Pulmonary Oncology, Guangdong Lung Cancer Institute, Guangdong General Hospital, and Guangdong Academy of Medical Sciences, Guangzhou (Y.-L.W.), and the Department of Respiratory Disease, Daping Hospital, Third Military Medical University, Chongqing (Y.H.) - all in China; the Department of Medicine, Division of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, (M.-J.A.), and the Yonsei Cancer Center, Department of Internal Medicine, Division of Medical Oncology, Yonsei University College of Medicine (H.R.K.), Seoul, South Korea; the Thoracic Oncology Unit, Medical Oncology Department, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico, Istituto Nazionale dei Tumori, Milan (M.C.G.); the Department of Hematology and Medical Oncology, Emory University School of Medicine, Winship Cancer Institute, Atlanta (S.S.R.); the Department of Medical Oncology and Haematology, Princess Margaret Cancer Centre, Toronto (F.A.S.); the Third Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan (H.A.); the Department of Thoracic Oncology, the Netherlands Cancer Institute, Plesmanlaan, Amsterdam (W.S.M.E.T.); the Clinical Research Unit, Division of Cancer Services, St. George Hospital, Kogarah, NSW, Australia (C.K.L.); the Department of Hematology-Oncology, Johann Wolfgang Goethe University Medical Center, Frankfurt am Main, Germany (M.S.); AstraZeneca, Cambridge, United Kingdom (A.T., H.M., M.M., S.G.); and the Department of Thoracic-Head and Neck Medical Oncology, University of Texas M.D. Anderson Cancer Center, Houston (V.A.P.).
Myung-Ju AhnFrom the State Key Laboratory in Oncology in South China, Sir Y.K. Pao Centre for Cancer, Department of Clinical Oncology, Chinese University of Hong Kong, Hong Kong (T.S.M.), the Division of Pulmonary Oncology, Guangdong Lung Cancer Institute, Guangdong General Hospital, and Guangdong Academy of Medical Sciences, Guangzhou (Y.-L.W.), and the Department of Respiratory Disease, Daping Hospital, Third Military Medical University, Chongqing (Y.H.) - all in China; the Department of Medicine, Division of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, (M.-J.A.), and the Yonsei Cancer Center, Department of Internal Medicine, Division of Medical Oncology, Yonsei University College of Medicine (H.R.K.), Seoul, South Korea; the Thoracic Oncology Unit, Medical Oncology Department, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico, Istituto Nazionale dei Tumori, Milan (M.C.G.); the Department of Hematology and Medical Oncology, Emory University School of Medicine, Winship Cancer Institute, Atlanta (S.S.R.); the Department of Medical Oncology and Haematology, Princess Margaret Cancer Centre, Toronto (F.A.S.); the Third Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan (H.A.); the Department of Thoracic Oncology, the Netherlands Cancer Institute, Plesmanlaan, Amsterdam (W.S.M.E.T.); the Clinical Research Unit, Division of Cancer Services, St. George Hospital, Kogarah, NSW, Australia (C.K.L.); the Department of Hematology-Oncology, Johann Wolfgang Goethe University Medical Center, Frankfurt am Main, Germany (M.S.); AstraZeneca, Cambridge, United Kingdom (A.T., H.M., M.M., S.G.); and the Department of Thoracic-Head and Neck Medical Oncology, University of Texas M.D. Anderson Cancer Center, Houston (V.A.P.).
Marina C GarassinoFrom the State Key Laboratory in Oncology in South China, Sir Y.K. Pao Centre for Cancer, Department of Clinical Oncology, Chinese University of Hong Kong, Hong Kong (T.S.M.), the Division of Pulmonary Oncology, Guangdong Lung Cancer Institute, Guangdong General Hospital, and Guangdong Academy of Medical Sciences, Guangzhou (Y.-L.W.), and the Department of Respiratory Disease, Daping Hospital, Third Military Medical University, Chongqing (Y.H.) - all in China; the Department of Medicine, Division of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, (M.-J.A.), and the Yonsei Cancer Center, Department of Internal Medicine, Division of Medical Oncology, Yonsei University College of Medicine (H.R.K.), Seoul, South Korea; the Thoracic Oncology Unit, Medical Oncology Department, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico, Istituto Nazionale dei Tumori, Milan (M.C.G.); the Department of Hematology and Medical Oncology, Emory University School of Medicine, Winship Cancer Institute, Atlanta (S.S.R.); the Department of Medical Oncology and Haematology, Princess Margaret Cancer Centre, Toronto (F.A.S.); the Third Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan (H.A.); the Department of Thoracic Oncology, the Netherlands Cancer Institute, Plesmanlaan, Amsterdam (W.S.M.E.T.); the Clinical Research Unit, Division of Cancer Services, St. George Hospital, Kogarah, NSW, Australia (C.K.L.); the Department of Hematology-Oncology, Johann Wolfgang Goethe University Medical Center, Frankfurt am Main, Germany (M.S.); AstraZeneca, Cambridge, United Kingdom (A.T., H.M., M.M., S.G.); and the Department of Thoracic-Head and Neck Medical Oncology, University of Texas M.D. Anderson Cancer Center, Houston (V.A.P.).
Hye R KimFrom the State Key Laboratory in Oncology in South China, Sir Y.K. Pao Centre for Cancer, Department of Clinical Oncology, Chinese University of Hong Kong, Hong Kong (T.S.M.), the Division of Pulmonary Oncology, Guangdong Lung Cancer Institute, Guangdong General Hospital, and Guangdong Academy of Medical Sciences, Guangzhou (Y.-L.W.), and the Department of Respiratory Disease, Daping Hospital, Third Military Medical University, Chongqing (Y.H.) - all in China; the Department of Medicine, Division of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, (M.-J.A.), and the Yonsei Cancer Center, Department of Internal Medicine, Division of Medical Oncology, Yonsei University College of Medicine (H.R.K.), Seoul, South Korea; the Thoracic Oncology Unit, Medical Oncology Department, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico, Istituto Nazionale dei Tumori, Milan (M.C.G.); the Department of Hematology and Medical Oncology, Emory University School of Medicine, Winship Cancer Institute, Atlanta (S.S.R.); the Department of Medical Oncology and Haematology, Princess Margaret Cancer Centre, Toronto (F.A.S.); the Third Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan (H.A.); the Department of Thoracic Oncology, the Netherlands Cancer Institute, Plesmanlaan, Amsterdam (W.S.M.E.T.); the Clinical Research Unit, Division of Cancer Services, St. George Hospital, Kogarah, NSW, Australia (C.K.L.); the Department of Hematology-Oncology, Johann Wolfgang Goethe University Medical Center, Frankfurt am Main, Germany (M.S.); AstraZeneca, Cambridge, United Kingdom (A.T., H.M., M.M., S.G.); and the Department of Thoracic-Head and Neck Medical Oncology, University of Texas M.D. Anderson Cancer Center, Houston (V.A.P.).
Suresh S RamalingamFrom the State Key Laboratory in Oncology in South China, Sir Y.K. Pao Centre for Cancer, Department of Clinical Oncology, Chinese University of Hong Kong, Hong Kong (T.S.M.), the Division of Pulmonary Oncology, Guangdong Lung Cancer Institute, Guangdong General Hospital, and Guangdong Academy of Medical Sciences, Guangzhou (Y.-L.W.), and the Department of Respiratory Disease, Daping Hospital, Third Military Medical University, Chongqing (Y.H.) - all in China; the Department of Medicine, Division of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, (M.-J.A.), and the Yonsei Cancer Center, Department of Internal Medicine, Division of Medical Oncology, Yonsei University College of Medicine (H.R.K.), Seoul, South Korea; the Thoracic Oncology Unit, Medical Oncology Department, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico, Istituto Nazionale dei Tumori, Milan (M.C.G.); the Department of Hematology and Medical Oncology, Emory University School of Medicine, Winship Cancer Institute, Atlanta (S.S.R.); the Department of Medical Oncology and Haematology, Princess Margaret Cancer Centre, Toronto (F.A.S.); the Third Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan (H.A.); the Department of Thoracic Oncology, the Netherlands Cancer Institute, Plesmanlaan, Amsterdam (W.S.M.E.T.); the Clinical Research Unit, Division of Cancer Services, St. George Hospital, Kogarah, NSW, Australia (C.K.L.); the Department of Hematology-Oncology, Johann Wolfgang Goethe University Medical Center, Frankfurt am Main, Germany (M.S.); AstraZeneca, Cambridge, United Kingdom (A.T., H.M., M.M., S.G.); and the Department of Thoracic-Head and Neck Medical Oncology, University of Texas M.D. Anderson Cancer Center, Houston (V.A.P.).
Frances A ShepherdFrom the State Key Laboratory in Oncology in South China, Sir Y.K. Pao Centre for Cancer, Department of Clinical Oncology, Chinese University of Hong Kong, Hong Kong (T.S.M.), the Division of Pulmonary Oncology, Guangdong Lung Cancer Institute, Guangdong General Hospital, and Guangdong Academy of Medical Sciences, Guangzhou (Y.-L.W.), and the Department of Respiratory Disease, Daping Hospital, Third Military Medical University, Chongqing (Y.H.) - all in China; the Department of Medicine, Division of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, (M.-J.A.), and the Yonsei Cancer Center, Department of Internal Medicine, Division of Medical Oncology, Yonsei University College of Medicine (H.R.K.), Seoul, South Korea; the Thoracic Oncology Unit, Medical Oncology Department, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico, Istituto Nazionale dei Tumori, Milan (M.C.G.); the Department of Hematology and Medical Oncology, Emory University School of Medicine, Winship Cancer Institute, Atlanta (S.S.R.); the Department of Medical Oncology and Haematology, Princess Margaret Cancer Centre, Toronto (F.A.S.); the Third Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan (H.A.); the Department of Thoracic Oncology, the Netherlands Cancer Institute, Plesmanlaan, Amsterdam (W.S.M.E.T.); the Clinical Research Unit, Division of Cancer Services, St. George Hospital, Kogarah, NSW, Australia (C.K.L.); the Department of Hematology-Oncology, Johann Wolfgang Goethe University Medical Center, Frankfurt am Main, Germany (M.S.); AstraZeneca, Cambridge, United Kingdom (A.T., H.M., M.M., S.G.); and the Department of Thoracic-Head and Neck Medical Oncology, University of Texas M.D. Anderson Cancer Center, Houston (V.A.P.).
Yong HeFrom the State Key Laboratory in Oncology in South China, Sir Y.K. Pao Centre for Cancer, Department of Clinical Oncology, Chinese University of Hong Kong, Hong Kong (T.S.M.), the Division of Pulmonary Oncology, Guangdong Lung Cancer Institute, Guangdong General Hospital, and Guangdong Academy of Medical Sciences, Guangzhou (Y.-L.W.), and the Department of Respiratory Disease, Daping Hospital, Third Military Medical University, Chongqing (Y.H.) - all in China; the Department of Medicine, Division of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, (M.-J.A.), and the Yonsei Cancer Center, Department of Internal Medicine, Division of Medical Oncology, Yonsei University College of Medicine (H.R.K.), Seoul, South Korea; the Thoracic Oncology Unit, Medical Oncology Department, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico, Istituto Nazionale dei Tumori, Milan (M.C.G.); the Department of Hematology and Medical Oncology, Emory University School of Medicine, Winship Cancer Institute, Atlanta (S.S.R.); the Department of Medical Oncology and Haematology, Princess Margaret Cancer Centre, Toronto (F.A.S.); the Third Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan (H.A.); the Department of Thoracic Oncology, the Netherlands Cancer Institute, Plesmanlaan, Amsterdam (W.S.M.E.T.); the Clinical Research Unit, Division of Cancer Services, St. George Hospital, Kogarah, NSW, Australia (C.K.L.); the Department of Hematology-Oncology, Johann Wolfgang Goethe University Medical Center, Frankfurt am Main, Germany (M.S.); AstraZeneca, Cambridge, United Kingdom (A.T., H.M., M.M., S.G.); and the Department of Thoracic-Head and Neck Medical Oncology, University of Texas M.D. Anderson Cancer Center, Houston (V.A.P.).
Hiroaki AkamatsuFrom the State Key Laboratory in Oncology in South China, Sir Y.K. Pao Centre for Cancer, Department of Clinical Oncology, Chinese University of Hong Kong, Hong Kong (T.S.M.), the Division of Pulmonary Oncology, Guangdong Lung Cancer Institute, Guangdong General Hospital, and Guangdong Academy of Medical Sciences, Guangzhou (Y.-L.W.), and the Department of Respiratory Disease, Daping Hospital, Third Military Medical University, Chongqing (Y.H.) - all in China; the Department of Medicine, Division of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, (M.-J.A.), and the Yonsei Cancer Center, Department of Internal Medicine, Division of Medical Oncology, Yonsei University College of Medicine (H.R.K.), Seoul, South Korea; the Thoracic Oncology Unit, Medical Oncology Department, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico, Istituto Nazionale dei Tumori, Milan (M.C.G.); the Department of Hematology and Medical Oncology, Emory University School of Medicine, Winship Cancer Institute, Atlanta (S.S.R.); the Department of Medical Oncology and Haematology, Princess Margaret Cancer Centre, Toronto (F.A.S.); the Third Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan (H.A.); the Department of Thoracic Oncology, the Netherlands Cancer Institute, Plesmanlaan, Amsterdam (W.S.M.E.T.); the Clinical Research Unit, Division of Cancer Services, St. George Hospital, Kogarah, NSW, Australia (C.K.L.); the Department of Hematology-Oncology, Johann Wolfgang Goethe University Medical Center, Frankfurt am Main, Germany (M.S.); AstraZeneca, Cambridge, United Kingdom (A.T., H.M., M.M., S.G.); and the Department of Thoracic-Head and Neck Medical Oncology, University of Texas M.D. Anderson Cancer Center, Houston (V.A.P.).
Willemijn S M E TheelenFrom the State Key Laboratory in Oncology in South China, Sir Y.K. Pao Centre for Cancer, Department of Clinical Oncology, Chinese University of Hong Kong, Hong Kong (T.S.M.), the Division of Pulmonary Oncology, Guangdong Lung Cancer Institute, Guangdong General Hospital, and Guangdong Academy of Medical Sciences, Guangzhou (Y.-L.W.), and the Department of Respiratory Disease, Daping Hospital, Third Military Medical University, Chongqing (Y.H.) - all in China; the Department of Medicine, Division of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, (M.-J.A.), and the Yonsei Cancer Center, Department of Internal Medicine, Division of Medical Oncology, Yonsei University College of Medicine (H.R.K.), Seoul, South Korea; the Thoracic Oncology Unit, Medical Oncology Department, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico, Istituto Nazionale dei Tumori, Milan (M.C.G.); the Department of Hematology and Medical Oncology, Emory University School of Medicine, Winship Cancer Institute, Atlanta (S.S.R.); the Department of Medical Oncology and Haematology, Princess Margaret Cancer Centre, Toronto (F.A.S.); the Third Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan (H.A.); the Department of Thoracic Oncology, the Netherlands Cancer Institute, Plesmanlaan, Amsterdam (W.S.M.E.T.); the Clinical Research Unit, Division of Cancer Services, St. George Hospital, Kogarah, NSW, Australia (C.K.L.); the Department of Hematology-Oncology, Johann Wolfgang Goethe University Medical Center, Frankfurt am Main, Germany (M.S.); AstraZeneca, Cambridge, United Kingdom (A.T., H.M., M.M., S.G.); and the Department of Thoracic-Head and Neck Medical Oncology, University of Texas M.D. Anderson Cancer Center, Houston (V.A.P.).
Chee K LeeFrom the State Key Laboratory in Oncology in South China, Sir Y.K. Pao Centre for Cancer, Department of Clinical Oncology, Chinese University of Hong Kong, Hong Kong (T.S.M.), the Division of Pulmonary Oncology, Guangdong Lung Cancer Institute, Guangdong General Hospital, and Guangdong Academy of Medical Sciences, Guangzhou (Y.-L.W.), and the Department of Respiratory Disease, Daping Hospital, Third Military Medical University, Chongqing (Y.H.) - all in China; the Department of Medicine, Division of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, (M.-J.A.), and the Yonsei Cancer Center, Department of Internal Medicine, Division of Medical Oncology, Yonsei University College of Medicine (H.R.K.), Seoul, South Korea; the Thoracic Oncology Unit, Medical Oncology Department, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico, Istituto Nazionale dei Tumori, Milan (M.C.G.); the Department of Hematology and Medical Oncology, Emory University School of Medicine, Winship Cancer Institute, Atlanta (S.S.R.); the Department of Medical Oncology and Haematology, Princess Margaret Cancer Centre, Toronto (F.A.S.); the Third Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan (H.A.); the Department of Thoracic Oncology, the Netherlands Cancer Institute, Plesmanlaan, Amsterdam (W.S.M.E.T.); the Clinical Research Unit, Division of Cancer Services, St. George Hospital, Kogarah, NSW, Australia (C.K.L.); the Department of Hematology-Oncology, Johann Wolfgang Goethe University Medical Center, Frankfurt am Main, Germany (M.S.); AstraZeneca, Cambridge, United Kingdom (A.T., H.M., M.M., S.G.); and the Department of Thoracic-Head and Neck Medical Oncology, University of Texas M.D. Anderson Cancer Center, Houston (V.A.P.).
Martin SebastianFrom the State Key Laboratory in Oncology in South China, Sir Y.K. Pao Centre for Cancer, Department of Clinical Oncology, Chinese University of Hong Kong, Hong Kong (T.S.M.), the Division of Pulmonary Oncology, Guangdong Lung Cancer Institute, Guangdong General Hospital, and Guangdong Academy of Medical Sciences, Guangzhou (Y.-L.W.), and the Department of Respiratory Disease, Daping Hospital, Third Military Medical University, Chongqing (Y.H.) - all in China; the Department of Medicine, Division of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, (M.-J.A.), and the Yonsei Cancer Center, Department of Internal Medicine, Division of Medical Oncology, Yonsei University College of Medicine (H.R.K.), Seoul, South Korea; the Thoracic Oncology Unit, Medical Oncology Department, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico, Istituto Nazionale dei Tumori, Milan (M.C.G.); the Department of Hematology and Medical Oncology, Emory University School of Medicine, Winship Cancer Institute, Atlanta (S.S.R.); the Department of Medical Oncology and Haematology, Princess Margaret Cancer Centre, Toronto (F.A.S.); the Third Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan (H.A.); the Department of Thoracic Oncology, the Netherlands Cancer Institute, Plesmanlaan, Amsterdam (W.S.M.E.T.); the Clinical Research Unit, Division of Cancer Services, St. George Hospital, Kogarah, NSW, Australia (C.K.L.); the Department of Hematology-Oncology, Johann Wolfgang Goethe University Medical Center, Frankfurt am Main, Germany (M.S.); AstraZeneca, Cambridge, United Kingdom (A.T., H.M., M.M., S.G.); and the Department of Thoracic-Head and Neck Medical Oncology, University of Texas M.D. Anderson Cancer Center, Houston (V.A.P.).
Alison TempletonFrom the State Key Laboratory in Oncology in South China, Sir Y.K. Pao Centre for Cancer, Department of Clinical Oncology, Chinese University of Hong Kong, Hong Kong (T.S.M.), the Division of Pulmonary Oncology, Guangdong Lung Cancer Institute, Guangdong General Hospital, and Guangdong Academy of Medical Sciences, Guangzhou (Y.-L.W.), and the Department of Respiratory Disease, Daping Hospital, Third Military Medical University, Chongqing (Y.H.) - all in China; the Department of Medicine, Division of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, (M.-J.A.), and the Yonsei Cancer Center, Department of Internal Medicine, Division of Medical Oncology, Yonsei University College of Medicine (H.R.K.), Seoul, South Korea; the Thoracic Oncology Unit, Medical Oncology Department, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico, Istituto Nazionale dei Tumori, Milan (M.C.G.); the Department of Hematology and Medical Oncology, Emory University School of Medicine, Winship Cancer Institute, Atlanta (S.S.R.); the Department of Medical Oncology and Haematology, Princess Margaret Cancer Centre, Toronto (F.A.S.); the Third Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan (H.A.); the Department of Thoracic Oncology, the Netherlands Cancer Institute, Plesmanlaan, Amsterdam (W.S.M.E.T.); the Clinical Research Unit, Division of Cancer Services, St. George Hospital, Kogarah, NSW, Australia (C.K.L.); the Department of Hematology-Oncology, Johann Wolfgang Goethe University Medical Center, Frankfurt am Main, Germany (M.S.); AstraZeneca, Cambridge, United Kingdom (A.T., H.M., M.M., S.G.); and the Department of Thoracic-Head and Neck Medical Oncology, University of Texas M.D. Anderson Cancer Center, Houston (V.A.P.).
Helen MannFrom the State Key Laboratory in Oncology in South China, Sir Y.K. Pao Centre for Cancer, Department of Clinical Oncology, Chinese University of Hong Kong, Hong Kong (T.S.M.), the Division of Pulmonary Oncology, Guangdong Lung Cancer Institute, Guangdong General Hospital, and Guangdong Academy of Medical Sciences, Guangzhou (Y.-L.W.), and the Department of Respiratory Disease, Daping Hospital, Third Military Medical University, Chongqing (Y.H.) - all in China; the Department of Medicine, Division of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, (M.-J.A.), and the Yonsei Cancer Center, Department of Internal Medicine, Division of Medical Oncology, Yonsei University College of Medicine (H.R.K.), Seoul, South Korea; the Thoracic Oncology Unit, Medical Oncology Department, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico, Istituto Nazionale dei Tumori, Milan (M.C.G.); the Department of Hematology and Medical Oncology, Emory University School of Medicine, Winship Cancer Institute, Atlanta (S.S.R.); the Department of Medical Oncology and Haematology, Princess Margaret Cancer Centre, Toronto (F.A.S.); the Third Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan (H.A.); the Department of Thoracic Oncology, the Netherlands Cancer Institute, Plesmanlaan, Amsterdam (W.S.M.E.T.); the Clinical Research Unit, Division of Cancer Services, St. George Hospital, Kogarah, NSW, Australia (C.K.L.); the Department of Hematology-Oncology, Johann Wolfgang Goethe University Medical Center, Frankfurt am Main, Germany (M.S.); AstraZeneca, Cambridge, United Kingdom (A.T., H.M., M.M., S.G.); and the Department of Thoracic-Head and Neck Medical Oncology, University of Texas M.D. Anderson Cancer Center, Houston (V.A.P.).
Marcelo MarottiFrom the State Key Laboratory in Oncology in South China, Sir Y.K. Pao Centre for Cancer, Department of Clinical Oncology, Chinese University of Hong Kong, Hong Kong (T.S.M.), the Division of Pulmonary Oncology, Guangdong Lung Cancer Institute, Guangdong General Hospital, and Guangdong Academy of Medical Sciences, Guangzhou (Y.-L.W.), and the Department of Respiratory Disease, Daping Hospital, Third Military Medical University, Chongqing (Y.H.) - all in China; the Department of Medicine, Division of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, (M.-J.A.), and the Yonsei Cancer Center, Department of Internal Medicine, Division of Medical Oncology, Yonsei University College of Medicine (H.R.K.), Seoul, South Korea; the Thoracic Oncology Unit, Medical Oncology Department, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico, Istituto Nazionale dei Tumori, Milan (M.C.G.); the Department of Hematology and Medical Oncology, Emory University School of Medicine, Winship Cancer Institute, Atlanta (S.S.R.); the Department of Medical Oncology and Haematology, Princess Margaret Cancer Centre, Toronto (F.A.S.); the Third Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan (H.A.); the Department of Thoracic Oncology, the Netherlands Cancer Institute, Plesmanlaan, Amsterdam (W.S.M.E.T.); the Clinical Research Unit, Division of Cancer Services, St. George Hospital, Kogarah, NSW, Australia (C.K.L.); the Department of Hematology-Oncology, Johann Wolfgang Goethe University Medical Center, Frankfurt am Main, Germany (M.S.); AstraZeneca, Cambridge, United Kingdom (A.T., H.M., M.M., S.G.); and the Department of Thoracic-Head and Neck Medical Oncology, University of Texas M.D. Anderson Cancer Center, Houston (V.A.P.).
Serban GhiorghiuFrom the State Key Laboratory in Oncology in South China, Sir Y.K. Pao Centre for Cancer, Department of Clinical Oncology, Chinese University of Hong Kong, Hong Kong (T.S.M.), the Division of Pulmonary Oncology, Guangdong Lung Cancer Institute, Guangdong General Hospital, and Guangdong Academy of Medical Sciences, Guangzhou (Y.-L.W.), and the Department of Respiratory Disease, Daping Hospital, Third Military Medical University, Chongqing (Y.H.) - all in China; the Department of Medicine, Division of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, (M.-J.A.), and the Yonsei Cancer Center, Department of Internal Medicine, Division of Medical Oncology, Yonsei University College of Medicine (H.R.K.), Seoul, South Korea; the Thoracic Oncology Unit, Medical Oncology Department, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico, Istituto Nazionale dei Tumori, Milan (M.C.G.); the Department of Hematology and Medical Oncology, Emory University School of Medicine, Winship Cancer Institute, Atlanta (S.S.R.); the Department of Medical Oncology and Haematology, Princess Margaret Cancer Centre, Toronto (F.A.S.); the Third Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan (H.A.); the Department of Thoracic Oncology, the Netherlands Cancer Institute, Plesmanlaan, Amsterdam (W.S.M.E.T.); the Clinical Research Unit, Division of Cancer Services, St. George Hospital, Kogarah, NSW, Australia (C.K.L.); the Department of Hematology-Oncology, Johann Wolfgang Goethe University Medical Center, Frankfurt am Main, Germany (M.S.); AstraZeneca, Cambridge, United Kingdom (A.T., H.M., M.M., S.G.); and the Department of Thoracic-Head and Neck Medical Oncology, University of Texas M.D. Anderson Cancer Center, Houston (V.A.P.).
Vassiliki A PapadimitrakopoulouFrom the State Key Laboratory in Oncology in South China, Sir Y.K. Pao Centre for Cancer, Department of Clinical Oncology, Chinese University of Hong Kong, Hong Kong (T.S.M.), the Division of Pulmonary Oncology, Guangdong Lung Cancer Institute, Guangdong General Hospital, and Guangdong Academy of Medical Sciences, Guangzhou (Y.-L.W.), and the Department of Respiratory Disease, Daping Hospital, Third Military Medical University, Chongqing (Y.H.) - all in China; the Department of Medicine, Division of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, (M.-J.A.), and the Yonsei Cancer Center, Department of Internal Medicine, Division of Medical Oncology, Yonsei University College of Medicine (H.R.K.), Seoul, South Korea; the Thoracic Oncology Unit, Medical Oncology Department, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico, Istituto Nazionale dei Tumori, Milan (M.C.G.); the Department of Hematology and Medical Oncology, Emory University School of Medicine, Winship Cancer Institute, Atlanta (S.S.R.); the Department of Medical Oncology and Haematology, Princess Margaret Cancer Centre, Toronto (F.A.S.); the Third Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan (H.A.); the Department of Thoracic Oncology, the Netherlands Cancer Institute, Plesmanlaan, Amsterdam (W.S.M.E.T.); the Clinical Research Unit, Division of Cancer Services, St. George Hospital, Kogarah, NSW, Australia (C.K.L.); the Department of Hematology-Oncology, Johann Wolfgang Goethe University Medical Center, Frankfurt am Main, Germany (M.S.); AstraZeneca, Cambridge, United Kingdom (A.T., H.M., M.M., S.G.); and the Department of Thoracic-Head and Neck Medical Oncology, University of Texas M.D. Anderson Cancer Center, Houston (V.A.P.).
AURA3 Investigators
Army Medical University · CNChinese University of Hong Kong · CNSun Yat-sen University · CNSun Yat-sen University Cancer Center · CNAstraZeneca (United Kingdom) · GBThe University of Texas MD Anderson Cancer Center · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
Cancer Research UK 20465NCI NIH HHS P30 CA016672
6 · The paper itself

Abstract

backgroundOsimertinib is an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) that is selective for both EGFR-TKI sensitizing and T790M resistance mutations in patients with non-small-cell lung cancer. The efficacy of osimertinib as compared with platinum-based therapy plus pemetrexed in such patients is unknown.

methodsIn this randomized, international, open-label, phase 3 trial, we assigned 419 patients with T790M-positive advanced non-small-cell lung cancer, who had disease progression after first-line EGFR-TKI therapy, in a 2:1 ratio to receive either oral osimertinib (at a dose of 80 mg once daily) or intravenous pemetrexed (500 mg per square meter of body-surface area) plus either carboplatin (target area under the curve, 5 [AUC5]) or cisplatin (75 mg per square meter) every 3 weeks for up to six cycles; maintenance pemetrexed was allowed. In all the patients, disease had progressed during receipt of first-line EGFR-TKI therapy. The primary end point was investigator-assessed progression-free survival.

resultsThe median duration of progression-free survival was significantly longer with osimertinib than with platinum therapy plus pemetrexed (10.1 months vs. 4.4 months; hazard ratio; 0.30; 95% confidence interval [CI], 0.23 to 0.41; P<0.001). The objective response rate was significantly better with osimertinib (71%; 95% CI, 65 to 76) than with platinum therapy plus pemetrexed (31%; 95% CI, 24 to 40) (odds ratio for objective response, 5.39; 95% CI, 3.47 to 8.48; P<0.001). Among 144 patients with metastases to the central nervous system (CNS), the median duration of progression-free survival was longer among patients receiving osimertinib than among those receiving platinum therapy plus pemetrexed (8.5 months vs. 4.2 months; hazard ratio, 0.32; 95% CI, 0.21 to 0.49). The proportion of patients with adverse events of grade 3 or higher was lower with osimertinib (23%) than with platinum therapy plus pemetrexed (47%).

conclusionsOsimertinib had significantly greater efficacy than platinum therapy plus pemetrexed in patients with T790M-positive advanced non-small-cell lung cancer (including those with CNS metastases) in whom disease had progressed during first-line EGFR-TKI therapy. (Funded by AstraZeneca; AURA3 ClinicalTrials.gov number, NCT02151981 .).

Indexed as

AcrylamidesAdultAgedAged, 80 and overAniline CompoundsAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Non-Small-Cell LungDisease-Free SurvivalErbB ReceptorsFemaleHumansIndolesLung NeoplasmsMaleMiddle AgedMutationAcrylamidesAniline CompoundsEGFR protein, humanErbB ReceptorsIndolesosimertinibPemetrexedPiperazinesPlatinumPyrimidines

Identifiers

PMID27959700
PMCPMC6762027
OpenAlexW2560717039

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