Evidence map›Paper›PMID 31195180›Full record

Trial reportJournal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer2019

SWOG S1400D (NCT02965378), a Phase II Study of the Fibroblast Growth Factor Receptor Inhibitor AZD4547 in Previously Treated Patients With Fibroblast Growth Factor Pathway-Activated Stage IV Squamous Cell Lung Cancer (Lung-MAP Substudy).

Charu Aggarwal, Mary W Redman, Primo N Lara, Hossein Borghaei, Philip Hoffman, Jeffrey D Bradley, Alfred J Newman, Marvin J Feldman, Katherine Minichiello, Jieling Miao and 5 more

Abstract readClinical Trial, Phase II
In one paragraph

Trial report in Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 58 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
58citing papers in PubMed, 3 pooled it
9.1field-weighted citation impact, top 2% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

58 citing papers in PubMed, 3 syntheses or guidelines pooled it, 90 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
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  6. Trial
  7. Phase II Study of AZD4547 in Patients With Tumors Harboring Aberrations in the FGFR Pathway: Results From the NCI-MATCH Trial (EAY131) Subprotocol W.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2020
    Trial
  8. Article
  9. Article
  10. Article
  11. Review
  12. Article
  13. Review
  14. Review
  15. Review
  16. Review
  17. Lung-MAP Next-Generation Sequencing Analysis of Advanced Squamous Cell Lung Cancers (SWOG S1400).Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer · 2024
    Article
  18. Review
  19. Review
  20. Targeting FGFR for cancer therapy.Journal of hematology & oncology · 2024
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors at 10 institutions in 1 country.

Charu AggarwalUniversity of Pennsylvania, Philadelphia, Pennsylvania. Electronic address: charu.aggarwal@uphs.upenn.edu.
Mary W RedmanSWOG Statistics and Data Management Center at Fred Hutchinson Cancer Research Center, Seattle, Washington.
Primo N LaraUniversity of California Davis Comprehensive Cancer Center, Sacramento, California.
Hossein BorghaeiFox Chase Cancer Center, Philadelphia, Pennsylvania.
Philip HoffmanUniversity of Chicago, Chicago, Illinois.
Jeffrey D BradleyWashington University Medical Center, St. Louis, Missouri.
Alfred J NewmanSoutheast Clinical Onc Research Consortium NCORP/ Novant Health Presbyterian Medical Center, Charlotte, North Carolina.
Marvin J FeldmanSinai Hospital Cancer Institute, Baltimore, Maryland.
Katherine MinichielloSWOG Statistics and Data Management Center at Fred Hutchinson Cancer Research Center, Seattle, Washington.
Jieling MiaoSWOG Statistics and Data Management Center at Fred Hutchinson Cancer Research Center, Seattle, Washington.
Philip C MackUniversity of California Davis Comprehensive Cancer Center, Sacramento, California.
Vassiliki A PapadimitrakopoulouMD Anderson Cancer Center, Houston, Texas.
Roy S HerbstYale Cancer Center, New Haven, Connecticut.
Karen KellyUniversity of California Davis Comprehensive Cancer Center, Sacramento, California.
David R GandaraFox Chase Cancer Center, Philadelphia, Pennsylvania.
Fred Hutch Cancer Center · USUC Davis Comprehensive Cancer CenterFox Chase Cancer Center · USNovant Health Presbyterian Medical Center · USSinai Hospital · USThe University of Texas MD Anderson Cancer Center · USUniversity of Chicago · USUniversity of Pennsylvania · USWashington University Medical Center · USYale Cancer Center · US

Funding

NRG Oncology Network Group Operations Center - GY9 BIQSFP Reports/BudgetsU10CA180868 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI NORMAN WOLMARK · 2014 to 2026
$206.8M
Member Site CoreU10CA180821 · NCI · BRIGHAM AND WOMEN'S HOSPITAL · PI Evanthia Galanis · 2014 to 2026
$177.3M
Project-006U10CA180820 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI Peter J ODwyer, MITCHELL D. SCHNALL · 2014 to 2026
$167.6M
SWOG Network Group Operations Center of the NCTNU10CA180888 · NCI · UNIVERSITY OF CALIFORNIA AT DAVIS · PI PRIMO N. LARA · 2014 to 2026
$152.1M
SWOG Statistics & Data Management Center complex - extension supplement for GY06U10CA180819 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Catherine M. Tangen · 2014 to 2026
$115.2M
Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
Kaiser Permanente NCI National Community Oncology Research Program, NCORPUG1CA189821 · NCI · KAISER FOUNDATION RESEARCH INSTITUTE · PI Jennifer Marie Suga · 2014 to 2026
$44.4M
Heartland Cancer Research NCORPUG1CA189830 · NCI · DECATUR MEMORIAL HOSPITAL · PI Bryan A. Faller · 2014 to 2026
$40.9M
Southeast Clinical Oncology Research Consortium, Inc. (SCOR)UG1CA189858 · NCI · SOUTHEAST CLINICAL ONCOL RES CONSORTIUM · PI Judith O Hopkins, William J Irvin · 2014 to 2026
$38.8M
Michigan Cancer Research Consortium NCORPUG1CA189971 · NCI · SAINT JOSEPH MERCY HEALTH SYSTEM · PI Tareq Al baghdadi · 2014 to 2026
$36.6M
Carle Cancer Center NCI Community Oncology Research Progran (NCORP)UG1CA189861 · NCI · CARLE FOUNDATION · PI KENDRITH Martin ROWLAND · 2014 to 2026
$20.4M
NCORP of the Carolinas (Greenville Health System NCORP)UG1CA189972 · NCI · PRISMA HEALTH - UPSTATE · PI Ki Young Chung · 2014 to 2026
$17.9M
NCATS NIH HHS UL1 TR001863NCI NIH HHS U10 CA180798NCI NIH HHS U10 CA180819NCI NIH HHS U10 CA180820NCI NIH HHS U10 CA180821NCI NIH HHS U10 CA180826NCI NIH HHS U10 CA180858NCI NIH HHS U10 CA180868NCI NIH HHS U10 CA180888NCI NIH HHS UG1 CA189821NCI NIH HHS UG1 CA189822NCI NIH HHS UG1 CA189830NCI NIH HHS UG1 CA189858NCI NIH HHS UG1 CA189861NCI NIH HHS UG1 CA189971NCI NIH HHS UG1 CA189972NCI NIH HHS UG1 CA233329NCI NIH HHS UG1 CA233340
6 · The paper itself

Abstract

backgroundS1400D is a biomarker-driven therapeutic substudy of Lung-MAP evaluating the fibroblast growth factor (FGF) receptor (FGFR) inhibitor AZD4547 in patients with FGF pathway-activated squamous cell. This is the first phase II trial to evaluate AZD4547 as a targeted approach in patients with previously treated FGFR-altered squamous cell NSCLC and is the first demonstration of successful implementation and conduct of a national umbrella protocol in this disease setting.

methodsEligible patients had tumoral FGFR alteration or mutation and had progressive disease after at least one line of platinum-based systemic therapy. Patients received AZD4547 80 mg twice daily orally. Primary endpoint was response by Response Evaluation Criteria in Solid Tumors version 1.1; secondary endpoints included progression-free survival, overall survival, and duration of response (DoR).

resultsNinety-two patients were assigned to S1400D, 43 were enrolled, and 27 AZD4547-treated patients were evaluable. Evaluable patients were predominantly white (n = 24, 89%), median age 66 years (range, 49-88 years old), and female (n = 7, 26%). FGFR alterations included FGFR1 amplification (n = 23; 85%), FGFR3 amplification (n = 2; 7%), FGFR3 S249C (n = 2; 7%), and FGFR3 fusion (n = 1; 4%). Treatment with ADZ4547 was well tolerated; grade 3 adverse events occurred in six patients, and one patient had grade 4 sepsis. Of 27 response-evaluable patients, 1 patient with FGFR3 S249C had unconfirmed partial response with a DoR of 1.5 months and 1 patient with FGFR1 amplification had a confirmed partial response with a DoR of 2.9 months (7%, 95% confidence interval [CI]: 0%-17%). Median progression-free survival and overall survival for the AZD4547-treated cohort were 2.7 months (95% CI: 1.4- 4.5 months) and 7.5 months (95% CI: 3.7-9.3 months).

conclusionsAZD4547 had an acceptable safety profile but minimal activity in this predominantly FGFR1/FGFR3-amplified cohort. Evaluation of other targeted agents in Lung-MAP is ongoing.

Indexed as

Salvage TherapyAgedAged, 80 and overAntineoplastic AgentsBenzamidesBiomarkers, TumorCarcinoma, Non-Small-Cell LungCarcinoma, Squamous CellFemaleFollow-Up StudiesGene AmplificationHumansLung NeoplasmsMaleMiddle AgedNeoplasm StagingAntineoplastic AgentsAZD4547BenzamidesBiomarkers, TumorFGFR1 protein, humanFGFR3 protein, humanPiperazinesPyrazolesReceptor, Fibroblast Growth Factor, Type 1Receptor, Fibroblast Growth Factor, Type 3FGFR inhibitorLUNG-MAPSWOG1400

Identifiers

PMID31195180
PMCPMC6901020
OpenAlexW2952562570

What OpenQuestion holds

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Registered trials

None linked

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.