Evidence map›Paper›PMID 33583720›Full record

Trial reportClinical lung cancer2021

Phase 2 Study of Talazoparib in Patients With Homologous Recombination Repair-Deficient Squamous Cell Lung Cancer: Lung-MAP Substudy S1400G.

Taofeek K Owonikoko, Mary W Redman, Lauren A Byers, Fred R Hirsch, Philip C Mack, Lawrence H Schwartz, Jeffrey D Bradley, Thomas E Stinchcombe, Natasha B Leighl, Tareq Al Baghdadi and 7 more

Open access · greenAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Clinical lung cancer, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 2 pooled it
2.1field-weighted citation impact, top 10% 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

18 citing papers in PubMed, 2 syntheses or guidelines pooled it, 30 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Article
  5. Article
  6. Review
  7. Article
  8. Review
  9. 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
  10. Review
  11. 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
  12. Article
  13. Article
  14. Targeting Replication Stress and Chemotherapy Resistance with a Combination of Sacituzumab Govitecan and Berzosertib: A Phase I Clinical Trial.Clinical cancer research : an official journal of the American Association for Cancer Research · 2023
    Article
  15. Review
  16. Review
  17. Article
  18. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors at 13 institutions in 2 countries.

Taofeek K OwonikokoWinship Cancer Institute, Emory University, Atlanta, GA. Electronic address: towonik@emory.edu.
Mary W RedmanSWOG Statistical Center, Seattle, WA; Fred Hutchinson Cancer Research Center, Seattle, WA.
Lauren A ByersThe University of Texas MD, Anderson Cancer Center, Houston, TX.
Fred R HirschMt Sinai Hospital, New York, NY.
Philip C MackUC Davis Comprehensive Cancer Center, Sacramento, CA.
Lawrence H SchwartzColumbia University Medical Center, New York, NY.
Jeffrey D BradleyWashington University School of Medicine in St Louis, St Louis, MO.
Thomas E StinchcombeDuke Cancer Institute, Durham, NC.
Natasha B LeighlPrincess Margaret Cancer Centre, Toronto, Canada.
Tareq Al BaghdadiSt Joseph Mercy Hospital/Michigan CRC NCORP, Ann Arbor, MI.
Primo LaraUC Davis Comprehensive Cancer Center, Sacramento, CA.
Jieling MiaoSWOG Statistical Center, Seattle, WA; Fred Hutchinson Cancer Research Center, Seattle, WA.
Karen KellyUC Davis Comprehensive Cancer Center, Sacramento, CA.
Suresh S RamalingamWinship Cancer Institute, Emory University, Atlanta, GA.
Roy S HerbstYale University, New Haven, CT.
Vassiliki PapadimitrakopoulouDepartment of Thoracic and Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.
David R GandaraUC Davis Comprehensive Cancer Center, Sacramento, CA.
University of California, Davis · USEmory University · USThe University of Texas MD Anderson Cancer Center · USCancer Research And Biostatistics · USColumbia University Irving Medical Center · USDuke Cancer InstituteFred Hutch Cancer Center · USMount Sinai Hospital · USPrincess Margaret Cancer Centre · CATrinity Health Ann Arbor Hospital · USUC Davis Comprehensive Cancer CenterWashington University in St. Louis · USYale University · US

Funding

NRG Oncology Network Group Operations Center - GY9 BIQSFP Reports/BudgetsU10CA180868 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI Quynh-Thu Xuan Le, ROBERT S. MANNEL · 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 · 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
Staff InvestigatorsP30CA093373 · NCI · UNIVERSITY OF CALIFORNIA DAVIS · PI Gina M Dayton · 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
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
Gulf South Minority/Underserved Clinical Trials Network (Gulf South M/U CTN)UG1CA189854 · NCI · LSU HEALTH SCIENCES CENTER · PI AUGUSTO C. OCHOA · 2014 to 2026
$27.1M
Georgia NCI Community Oncology Research Program (NCORP)UG1CA189997 · NCI · NORTHSIDE HOSPITAL ATLANTA · PI Guilherme Cantuaria, Leonard R. Henry · 2014 to 2026
$20.9M
NCORP of the Carolinas (Greenville Health System NCORP)UG1CA189972 · NCI · PRISMA HEALTH - UPSTATE · PI Ki Young Chung · 2014 to 2026
$17.9M
NCI NIH HHS P30 CA093373NCI NIH HHS U10 CA180798NCI NIH HHS U10 CA180819NCI NIH HHS U10 CA180820NCI NIH HHS U10 CA180821NCI NIH HHS U10 CA180826NCI NIH HHS U10 CA180828NCI NIH HHS U10 CA180835NCI NIH HHS U10 CA180846NCI NIH HHS U10 CA180868NCI NIH HHS U10 CA180888NCI NIH HHS UG1 CA189808NCI NIH HHS UG1 CA189809NCI NIH HHS UG1 CA189812NCI NIH HHS UG1 CA189821NCI NIH HHS UG1 CA189854NCI NIH HHS UG1 CA189858NCI NIH HHS UG1 CA189971NCI NIH HHS UG1 CA189972NCI NIH HHS UG1 CA189997NCI NIH HHS UG1 CA233230NCI NIH HHS UG1 CA233340
6 · The paper itself

Abstract

purposeThis signal finding study (S1400G) was designed to evaluate the efficacy of talazoparib in advanced stage squamous cell lung cancer harboring homologous recombination repair deficiency. PATIENTS AND

methodsThe full eligible population (FEP) had tumors with a deleterious mutation in any of the study-defined homologous recombination repair genes and without prior exposure to a PARP inhibitor. The primary analysis population (PAP) is a subset of FEP with alteration in ATM, ATR, BRCA1, BRCA2, or PALB2. Treatment consisted of talazoparib 1 mg daily continuously in 21-day cycles. A 2-stage design with exact 93% power and 1-sided 0.07 type I error required enrollment of 40 patients in the PAP in order to rule out an overall response rate (ORR) of 15% or less if the true ORR is ≥ 35%.

resultsThe study enrolled 47 patients in the FEP, of whom 24 were in the PAP. The median age for the FEP was 66.7 years; 83% were male and 85% white. ORR in the PAP was 4% (95% confidence interval [CI], 0, 21) with disease control rate of 54% (95% CI, 33, 74). Median progression-free survival and overall survival were 2.4 months (95% CI, 1.5-2.8) and 5.2 months (95% CI, 4.0-10), respectively. In the FEP, ORR was 11% (95% CI, 3.6, 23), the disease control rate was 51% (95% CI, 36, 66), and the median duration of response was 1.8 months (95% CI, 1.3, 4.2). Median progression-free and overall survival were 2.5 months and 5.7 months, respectively.

conclusionsS1400G failed to show sufficient level of efficacy for single agent talazoparib in a biomarker defined subset of squamous lung cancer with homologous recombination repair deficiency.

Indexed as

AdultAgedAged, 80 and overCarcinoma, Non-Small-Cell LungCarcinoma, Squamous CellFemaleHumansLung NeoplasmsMaleMiddle AgedNeoplasm StagingPhthalazinesPoly(ADP-ribose) Polymerase InhibitorsProgression-Free SurvivalRecombinational DNA RepairSurvival RatePhthalazinesPoly(ADP-ribose) Polymerase InhibitorstalazoparibBiomarkerNon–small-cell lung cancerPARPPost-frontlineTargeted therapyTrial

Identifiers

PMID33583720
PMCPMC8637652
OpenAlexW3120580407

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Registered trials

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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.