Evidence map›Paper›PMID 31302234›Full record

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

SWOG S1400C (NCT02154490)-A Phase II Study of Palbociclib for Previously Treated Cell Cycle Gene Alteration-Positive Patients with Stage IV Squamous Cell Lung Cancer (Lung-MAP Substudy).

Martin J Edelman, Mary W Redman, Kathy S Albain, Eric C McGary, Noman M Rafique, Daniel Petro, Saiama N Waqar, Katherine Minichiello, Jieling Miao, Vassiliki A Papadimitrakopoulou and 3 more

Open access · bronzeAbstract readClinical Trial, Phase IIRandomized Controlled TrialAdaptive Clinical Trial
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 50 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
50citing papers in PubMed, 3 pooled it
8.5field-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

50 citing papers in PubMed, 3 syntheses or guidelines pooled it, 77 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Review
  9. Article
  10. Article
  11. Article
  12. Review
  13. Article
  14. 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
  15. Article
  16. Targeting KRASDrugs · 2024
    Review
  17. Article
  18. Novel Approach to Accelerate Lung Cancer Research: Lung-MAP and the Potential of Public-Private Partnerships.Clinical cancer research : an official journal of the American Association for Cancer Research · 2024
    Article
  19. Review
  20. Targeting NFE2L2/KEAP1 Mutations in Advanced NSCLC With the TORC1/2 Inhibitor TAK-228.Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer · 2023
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 10 institutions in 1 country.

Martin J EdelmanFox Chase Cancer Center, Philadelphia, Pennsylvania. Electronic address: Martin.edelman@fccc.edu.
Mary W RedmanSWOG Statistics and Data Management Center at Fred Hutchinson Cancer Reseach Center, Seattle, Washington.
Kathy S AlbainLoyola University Chicago Stritch School of Medicine, Maywood, Illinois.
Eric C McGaryKaiser Permanente National Community Oncology Research Program/Kaiser Permanente Medical Group, Los Angeles, California.
Noman M RafiqueMercy Medical Center Tri-County Hematology/Oncology Association, Canton, Ohio.
Daniel PetroUniversity of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania.
Saiama N WaqarWashington University School of Medicine, St. Louis, Missouri.
Katherine MinichielloSWOG Statistics and Data Management Center at Fred Hutchinson Cancer Reseach Center, Seattle, Washington.
Jieling MiaoSWOG Statistics and Data Management Center at Fred Hutchinson Cancer Reseach Center, Seattle, Washington.
Vassiliki A PapadimitrakopoulouThoracic/Head and Neck Medical Oncology, University of Texas M. D. Anderson Cancer Center, Houston, Texas.
Karen KellyUniversity of California Davis Cancer Center, Sacramento, California.
David R GandaraUniversity of California Davis Cancer Center, Sacramento, California.
Roy S HerbstMedical Oncology, Yale Cancer Center, New Haven, Connecticut.
Fred Hutch Cancer Center · USUniversity of California, Davis · USFox Chase Cancer Center · USKaiser Permanente · USLoyola University Chicago · USMercy Medical Center · USThe University of Texas MD Anderson Cancer Center · USUPMC Hillman Cancer Center · USWashington University in St. Louis · 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
WORD PROCESSING CENTER--COREP30CA006927 · NCI · RESEARCH INST OF FOX CHASE CAN CTR · PI Margaret von Mehren · 1985 to 2026
$138.8M
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
Staff InvestigatorsP30CA093373 · NCI · UNIVERSITY OF CALIFORNIA DAVIS · PI Laura Marcu · 2002 to 2026
$84.9M
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
Ozark Health Ventures, LLC dba Cancer Research for the Ozarks (CRO)UG1CA189822 · NCI · OZARK HEALTH VENTURES, LLC · PI Jay W Carlson · 2014 to 2026
$14.2M
Essentia Health Community Cancer Research Program NCORPUG1CA189812 · NCI · ESSENTIA INSTITUTE OF RURAL HEALTH · PI Bret E.B. Friday · 2014 to 2026
$12.5M
NCATS NIH HHS UL1 TR001863NCI NIH HHS P30 CA006927NCI NIH HHS P30 CA093373NCI NIH HHS U10 CA011083NCI NIH HHS U10 CA046282NCI NIH HHS U10 CA046368NCI NIH HHS U10 CA180801NCI NIH HHS U10 CA180818NCI NIH HHS U10 CA180819NCI NIH HHS U10 CA180820NCI NIH HHS U10 CA180821NCI NIH HHS U10 CA180826NCI NIH HHS U10 CA180828NCI NIH HHS U10 CA180834NCI NIH HHS U10 CA180846NCI NIH HHS U10 CA180868NCI NIH HHS U10 CA180888NCI NIH HHS UG1 CA189809NCI NIH HHS UG1 CA189812NCI NIH HHS UG1 CA189821NCI NIH HHS UG1 CA189822NCI NIH HHS UG1 CA189830NCI NIH HHS UG1 CA189872NCI NIH HHS UG1 CA189873NCI NIH HHS UG1 CA189954NCI NIH HHS UG1 CA190002NCI NIH HHS UG1 CA233340NCI NIH HHS UM1 CA186704
6 · The paper itself

Abstract

objectiveLung-MAP (SWOG S1400) is a master platform trial assessing targeted therapies in squamous NSCLC. The objective of study C (S1400C) was to evaluate the response rate to palbociclib, a cyclin-dependent kinase 4 and cyclin-dependent kinase 6 inhibitor, in patients with cell cycle gene abnormalities.

methodsPatients with squamous NSCLC, a performance status of 0 to 2, and normal organ function who had progressed after at least one prior platinum-based chemotherapy with cyclin-dependent kinase 4 gene (CDK4) or cyclin D1 gene (CCND1), cyclin D2 gene (CCND2), or cyclin D3 gene (CCND3) amplifications on tumor specimens were eligible. The study was originally designed as a phase II/III trial comparing palbociclib with docetaxel, but it was modified to a single-arm phase II trial with the primary end point of response when immunotherapy was approved. If two or fewer responses were seen in the first 20 patients, then the study would cease enrollment.

resultsA total of 88 patients (9% of patients screened) were assigned to S1400C, and 53 patients enrolled (including 17 to receive docetaxel). One patient who had been registered to receive docetaxel was re-registered to receive palbociclib after progression while taking docetaxel. The frequencies of cell cycle gene alterations in the eligible patients taking palbociclib (n = 32) were as follows: CCND1, 81% (n = 26); CCND2, 9% (n = 3); CCND3, 6% (n = 2); and CDK4, 3% (n = 1). In all, 32 eligible patients received palbociclib. There were two partial responses (response rate 6% [95% confidence interval (CI): 0%-15%]), both with CCND1 amplification. Twelve patients had stable disease (38% [95% CI: 21%-54%]). The median progression-free survival was 1.7 months (95% CI: 1.6-2.9 months) and the median overall survival was 7.1 months (95% CI: 4.2-12.5).

conclusionPalbociclib as monotherapy failed to demonstrate the prespecified criteria for advancement to phase III testing.

Indexed as

MutationSalvage TherapyAgedAged, 80 and overAntineoplastic AgentsBiomarkers, TumorBone NeoplasmsCarcinoma, Non-Small-Cell LungCarcinoma, Squamous CellCell Cycle ProteinsFemaleFollow-Up StudiesGene AmplificationHumansLung NeoplasmsMaleAntineoplastic AgentsBiomarkers, TumorCell Cycle ProteinspalbociclibPiperazinesPyridinesCell cycle gene alterationCyclin-dependent kinaseLung cancerMaster protocolSquamous NSCLCTargeted therapy

Identifiers

PMID31302234
PMCPMC6764876
OpenAlexW2957919816

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.