Evidence map›Paper›PMID 29874546›Full record

Trial reportJournal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer2018

A Phase II Study of Pembrolizumab in EGFR-Mutant, PD-L1+, Tyrosine Kinase Inhibitor Naïve Patients With Advanced NSCLC.

A Lisberg, A Cummings, J W Goldman, K Bornazyan, N Reese, T Wang, P Coluzzi, B Ledezma, M Mendenhall, J Hunt and 16 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02879994 (A Phase II Study of Pembrolizumab in EGFR Mutant, Tyrosine Kinase Inhibitor Naïve Treatment Patients With Advanced Non-Small Cell Lung Cancer), which is not on this map. Cited by 353 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
353citing papers in PubMed, 5 pooled it
46.6field-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.

NCT02879994 phase2completednot on this map

A Phase II Study of Pembrolizumab in EGFR Mutant, Tyrosine Kinase Inhibitor Naïve Treatment Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

TypeinterventionalSponsorJonsson Comprehensive Cancer CenterRan2016 to 2019Enrolled11ConditionsStage IIIA Non-Small Cell Lung Cancer, Stage IIIB Non-Small Cell Lung Cancer, Stage IV Non-Small Cell Lung CancerArmsLaboratory Biomarker Analysis, Pembrolizumab
3 · Its place in the literature

Who cites it

353 citing papers in PubMed, 5 syntheses or guidelines pooled it, 583 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Trial
  7. Journal for immunotherapy of cancer · 2025
    Trial
  8. Trial
  9. Trial
  10. Trial
  11. Trial
  12. Review
  13. Review
  14. Review
  15. Observational
  16. Article
  17. Article
  18. Article
  19. Immune Doublet Checkpoint Inhibition inJTO clinical and research reports · 2026
    Article
  20. Observational

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

26 authors at 1 institution in 1 country.

A LisbergDavid Geffen School of Medicine at the University of California Los Angeles, Los Angeles, California.
A CummingsDavid Geffen School of Medicine at the University of California Los Angeles, Los Angeles, California.
J W GoldmanDavid Geffen School of Medicine at the University of California Los Angeles, Los Angeles, California.
K BornazyanDavid Geffen School of Medicine at the University of California Los Angeles, Los Angeles, California.
N ReeseDavid Geffen School of Medicine at the University of California Los Angeles, Los Angeles, California.
T WangDavid Geffen School of Medicine at the University of California Los Angeles, Los Angeles, California.
P ColuzziDavid Geffen School of Medicine at the University of California Los Angeles, Los Angeles, California.
B LedezmaDavid Geffen School of Medicine at the University of California Los Angeles, Los Angeles, California.
M MendenhallDavid Geffen School of Medicine at the University of California Los Angeles, Los Angeles, California.
J HuntDavid Geffen School of Medicine at the University of California Los Angeles, Los Angeles, California.
B WolfDavid Geffen School of Medicine at the University of California Los Angeles, Los Angeles, California.
B JonesDavid Geffen School of Medicine at the University of California Los Angeles, Los Angeles, California.
J MadrigalDavid Geffen School of Medicine at the University of California Los Angeles, Los Angeles, California.
J HortonDavid Geffen School of Medicine at the University of California Los Angeles, Los Angeles, California.
M SpiegelDavid Geffen School of Medicine at the University of California Los Angeles, Los Angeles, California.
J CarrollDavid Geffen School of Medicine at the University of California Los Angeles, Los Angeles, California.
J GukasyanDavid Geffen School of Medicine at the University of California Los Angeles, Los Angeles, California.
T WilliamsDavid Geffen School of Medicine at the University of California Los Angeles, Los Angeles, California.
L SauerDavid Geffen School of Medicine at the University of California Los Angeles, Los Angeles, California.
C WellsDavid Geffen School of Medicine at the University of California Los Angeles, Los Angeles, California.
A HardyDavid Geffen School of Medicine at the University of California Los Angeles, Los Angeles, California.
P LinaresDavid Geffen School of Medicine at the University of California Los Angeles, Los Angeles, California.
C LimDavid Geffen School of Medicine at the University of California Los Angeles, Los Angeles, California.
L MaDavid Geffen School of Medicine at the University of California Los Angeles, Los Angeles, California.
C AdameDavid Geffen School of Medicine at the University of California Los Angeles, Los Angeles, California.
Edward B GaronDavid Geffen School of Medicine at the University of California Los Angeles, Los Angeles, California. Electronic address: egaron@mednet.ucla.edu.
University of California, Los Angeles · US

Funding

Women's CancersP30CA016042 · NCI · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Samuel Wheeler French · 1985 to 2026
$134.5M
A model for predicting response to PD-1 inhibitors in NSCLCR01CA208403 · NCI · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI GARON, EDWARD B · 2017 to 2021
$3.2M
NCI NIH HHS P30 CA016042NCI NIH HHS R01 CA208403
6 · The paper itself

Abstract

backgroundDespite the significant antitumor activity of pembrolizumab in NSCLC, clinical benefit has been less frequently observed in patients whose tumors harbor EGFR mutations compared to EGFR wild-type patients. Our single-center experience on the KEYNOTE-001 trial suggested that pembrolizumab-treated EGFR-mutant patients, who were tyrosine kinase inhibitor (TKI) naïve, had superior clinical outcomes to those previously treated with a TKI. As TKI naïve EGFR-mutants have generally been excluded from pembrolizumab studies, data to guide treatment decisions in this patient population is lacking, particularly in patients with programmed death ligand 1 (PD-L1) expression ≥50%.

methodsWe conducted a phase II trial (NCT02879994) of pembrolizumab in TKI naive patients with EGFR mutation-positive, advanced NSCLC and PD-L1-positive (≥1%, 22C3 antibody) tumors. Pembrolizumab was administered 200 mg every 3 weeks. The primary endpoint was objective response rate. Secondary endpoints included safety of pembrolizumab, additional pembrolizumab efficacy endpoints, and efficacy and safety of an EGFR TKI after pembrolizumab.

resultsEnrollment was ceased due to lack of efficacy after 11 of 25 planned patients were treated. Eighty-two percent of trial patients were treatment naïve, 64% had sensitizing EGFR mutations, and 73% had PD-L1 expression ≥50%. Only 1 patient had an objective response (9%), but repeat analysis of this patient's tumor definitively showed the original report of an EGFR mutation to be erroneous. Observed treatment-related adverse events were similar to prior experience with pembrolizumab, but two deaths within 6 months of enrollment, including one attributed to pneumonitis, were of concern.

conclusionsPembrolizumab's lack of efficacy in TKI naïve, PD-L1+, EGFR-mutant patients with advanced NSCLC, including those with PD-L1 expression ≥50%, suggests that it is not an appropriate therapeutic choice in this setting.

Indexed as

AdultAgedAntibodies, Monoclonal, HumanizedB7-H1 AntigenCarcinoma, Non-Small-Cell LungErbB ReceptorsFemaleHumansLung NeoplasmsMaleMiddle AgedMutationProtein Kinase InhibitorsAntibodies, Monoclonal, HumanizedB7-H1 AntigenCD274 protein, humanEGFR protein, humanErbB ReceptorspembrolizumabProtein Kinase InhibitorsEGFRNSCLCpembrolizumabprogrammed death 1 (PD-1)programmed death ligand 1tumor immunology

Identifiers

PMID29874546
PMCPMC6063769
OpenAlexW2889653218

What OpenQuestion holds

Textmetadata
LicenceTDM
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.