Evidence map›Paper›PMID 31605792›Full record

Trial reportJournal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer2020

Programmed Cell Death Ligand 1 Expression in Untreated EGFR Mutated Advanced NSCLC and Response to Osimertinib Versus Comparator in FLAURA.

Helen Brown, Johan Vansteenkiste, Kazuhiko Nakagawa, Manuel Cobo, Thomas John, Craig Barker, Alexander Kohlmann, Alexander Todd, Matilde Saggese, Juliann Chmielecki and 3 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02296125 (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.), which is not on this map. Cited by 40 papers.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed
4.5field-weighted citation impact, top 5% 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
3 · Its place in the literature

Who cites it

40 citing papers in PubMed, 59 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. Review
  5. Exon-levelTranslational lung cancer research · 2025
    Article
  6. Metabolic tumor volume onTranslational lung cancer research · 2025
    Article
  7. Article
  8. Article
  9. Article
  10. Review
  11. Article
  12. Review
  13. Article
  14. Article
  15. Article
  16. Top 20Lung Cancer (Auckland, N.Z.) · 2024
    Article
  17. Adjuvant radiotherapy after brain metastasectomy: analysis of consecutive cohort of 118 patients from real world practice.Reports of practical oncology and radiotherapy : journal of Greatpoland Cancer Center in Poznan and Polish Society of Radiation Oncology · 2024
    Article
  18. Article
  19. Article
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 7 institutions in 6 countries.

Helen BrownPrecision Medicine, Oncology R&D, AstraZeneca, Cambridge, United Kingdom.
Johan VansteenkisteRespiratory Oncology Unit (Respiratory Diseases), University Hospital KU Leuven, Leuven, Belgium.
Kazuhiko NakagawaDepartment of Medical Oncology, Kindai University Faculty of Medicine, Osaka, Japan.
Manuel CoboMedical Oncology Department, University Regional Hospital of Málaga, IBIMA, Málaga, Spain.
Thomas JohnOlivia Newton-John Cancer Research Institute, Austin Health, Melbourne, Victoria, Australia.
Craig BarkerPrecision Medicine, Oncology R&D, AstraZeneca, Cambridge, United Kingdom.
Alexander KohlmannPrecision Medicine, Oncology R&D, AstraZeneca, Cambridge, United Kingdom.
Alexander ToddOncology Biometrics, Oncology, AstraZeneca, Cambridge, United Kingdom.
Matilde SaggeseGlobal Medicines Development, Oncology, AstraZeneca, Cambridge, United Kingdom.
Juliann ChmieleckiTranslational Medicine, Oncology, AstraZeneca, Waltham, Massachusetts.
Aleksandra MarkovetsTranslational Medicine, Oncology, AstraZeneca, Waltham, Massachusetts.
Marietta ScottPrecision Medicine, Oncology R&D, AstraZeneca, Cambridge, United Kingdom.
Suresh S RamalingamEmory University School of Medicine, Winship Cancer Institute, Atlanta, Georgia. Electronic address: suresh.ramalingam@emory.edu.
AstraZeneca (United Kingdom) · GBAstraZeneca (United States) · USEmory University · USHospital Regional Universitario de Málaga · ESKindai University · JPKU Leuven · BEOlivia Newton-John Cancer Wellness & Research Centre · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionEGFR mutated (EGFRm) NSCLC tumors occasionally express programmed cell death ligand 1 (PD-L1), although frequency and clinical relevance are not fully characterized. We report PD-L1 expression in patients with EGFRm advanced NSCLC and association with clinical outcomes following treatment with osimertinib or comparator EGFR tyrosine kinase inhibitors in the FLAURA trial (phase III, NCT02296125).

methodsOf 231 tissue blocks available from the screened population (including EGFRm-positive and -negative samples), 197 had sufficient tissue for PD-L1 testing using the SP263 (Ventana, Tucson, Arizona) immunohistochemical assay. Tumor cell (TC) staining thresholds of PD-L1 TC greater than or equal to 1%, TC greater than or equal to 25%, and TC greater than or equal to 50% were applied. Progression-free survival (PFS) was investigator-assessed, per Response Evaluation Criteria in Solid Tumor, version 1.1, according to PD-L1 expressors (TC ≥ 1%) or negatives (TC < 1%) in randomized patients.

resultsPD-L1 staining was successful in 193 of 197 patient formalin-fixed paraffin-embedded blocks; of these, 128 of 193 were EGFRm-positive and 106 of 128 patients were randomized to treatment (osimertinib: 54; comparator: 52). At the PD-L1 TC greater than or equal to 25% threshold, 8% (10 of 128) of EGFRm-positive tumors expressed PD-L1 versus 35% (23 of 65) of EGFRm-negative tumors. With the TC greater than or equal to 1% threshold, 51% (65 of 128) versus 68% (44 of 65) were mutation-positive and -negative, respectively, and with the TC greater than or equal to 50% threshold, 5% (7 of 128) versus 28% (18 of 65), were mutation-positive and -negative, respectively. For PD-L1 expressors (TC ≥ 1%), median PFS was 18.4 months with osimertinib and 6.9 months with comparator (hazard ratio = 0.30; 95% confidence interval: 0.15-0.60). For PD-L1-negative patients (TC < 1%), median PFS was 18.9 months with osimertinib and 10.9 months with comparator (hazard ratio = 0.37; 95% confidence interval: 0.17-0.74).

conclusionsClinical benefit with osimertinib was unaffected by PD-L1 expression status.

Indexed as

Antineoplastic AgentsLung NeoplasmsAcrylamidesAniline CompoundsApoptosisB7-H1 AntigenErbB ReceptorsHumansIndolesLigandsMutationPyrimidinesAcrylamidesAniline CompoundsAntineoplastic AgentsB7-H1 AntigenEGFR protein, humanErbB ReceptorsIndolesLigandsosimertinibPyrimidinesEGFR mutatedFLAURANSCLCOsimertinibProgrammed death ligand 1

Identifiers

PMID31605792
OpenAlexW2979699053

What OpenQuestion holds

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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.