Evidence map›Paper›PMID 34429332›Full record

Trial reportJournal for immunotherapy of cancer2021

Phase II study of durvalumab plus tremelimumab as therapy for patients with previously treated anti-PD-1/PD-L1 resistant stage IV squamous cell lung cancer (Lung-MAP substudy S1400F, NCT03373760).

Natasha B Leighl, Mary W Redman, Naiyer Rizvi, Fred R Hirsch, Philip C Mack, Lawrence H Schwartz, James L Wade, William J Irvin, Sreekanth C Reddy, Jeffrey Crawford and 9 more

Open access · goldAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Journal for immunotherapy of cancer, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 2 pooled it
3.3field-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.

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

32 citing papers in PubMed, 2 syntheses or guidelines pooled it, 47 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Review
  6. Review
  7. Article
  8. Review
  9. Review
  10. Review
  11. Review
  12. Review
  13. Review
  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. Observational
  16. Article
  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. Article
  20. 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

19 authors at 13 institutions in 2 countries.

Natasha B Leighl *Division of Medical Oncology/Hematology, Princess Margaret Hospital Cancer Centre, Toronto, Ontario, Canada natasha.leighl@uhn.ca.ORCID 0000-0002-3249-4602
Mary W Redman *Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.
Naiyer Rizvi *Thoracic Oncology, Columbia University Irving Medical Center, New York, New York, USA.
Fred R HirschCenter for Thoracic Oncology, Tisch Cancer Institute and Icahn School of Medicine Mount Sinai, New York, New York, USA.
Philip C MackCenter for Thoracic Oncology, Tisch Cancer Institute and Icahn School of Medicine Mount Sinai, New York, New York, USA.
Lawrence H SchwartzDepartment of Radiology, NewYork-Presbyterian/Columbia University Medical Center, New York, New York, USA.
James L WadeMedical Oncology, Heartland NCORP, Decatur, Illinois, USA.
William J IrvinHematology Oncology, Bon Secours Cancer Institute, Richmond, Virginia, USA.
Sreekanth C ReddyMedical Oncology/Hematology, Atlanta Cancer Care Centers, Atlanta, Georgia, USA.
Jeffrey CrawfordMedical Oncology, Duke University Medical Center, Durham, North Carolina, USA.
Jeffrey D BradleyDepartment of Radiation Oncology, Washington University in St Louis School of Medicine, St Louis, Missouri, USA.
Thomas E StinchcombeMedical Oncology, Duke University Medical Center, Durham, North Carolina, USA.
Suresh S RamalingamDepartment of Hematology and Medical Oncology, Winship Cancer Institute of Emory University, Atlanta, Georgia, USA.
Jieling MiaoClinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.
Katherine MinichielloClinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.
Roy S HerbstMedical Oncology, Yale Cancer Center | Yale School of Medicine | Smilow Cancer Hospital at Yale New Haven, New Haven, Connecticut, USA.
Vassiliki A PapadimitrakopoulouDepartment of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Karen KellyDivison of Hematology and Oncology, Department of Medicine, University of California Davis Comprehensive Cancer Center, Sacramento, California, USA.ORCID 0000-0002-2235-6636
David R GandaraDivision of Hematology/Oncology, Department of Medicine, UC Davis Comprehensive Cancer Center, Sacramento, California, USA.ORCID 0000-0003-1784-048X
Fred Hutch Cancer Center · USColumbia University Irving Medical Center · USDuke Medical Center · USTisch Hospital · USEmory University · USHeartland Cancer Research · USPrincess Margaret Cancer Centre · CAThe University of Texas MD Anderson Cancer Center · USUC Davis Comprehensive Cancer CenterUniversity of California Davis Medical Center · USVirginia Cancer Institute · 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
Women's Cancer Research ProgramP30CA014236 · NCI · DUKE UNIVERSITY · PI JOHN N. NORTON · 1985 to 2026
$174.8M
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 Michael L. LeBlanc · 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 Gina M Dayton · 2002 to 2026
$84.9M
NCIC Clinical Trials Group - Canadian Collaborating Clinical Trials NetworkU10CA180863 · NCI · QUEEN'S UNIVERSITY AT KINGSTON · PI Janet Ellen Dancey · 2014 to 2026
$40.4M
UCDCCC NCTN UG1 PROGRAMUG1CA233340 · NCI · UNIVERSITY OF CALIFORNIA AT DAVIS · PI GANDARA, DAVID R, VALICENTI, RICHARD · 2019 to 2025
$3.7M
NCATS NIH HHS UL1 TR001863NCI NIH HHS P30 CA014236NCI NIH HHS P30 CA093373NCI NIH HHS U10 CA180819NCI NIH HHS U10 CA180820NCI NIH HHS U10 CA180821NCI NIH HHS U10 CA180863NCI NIH HHS U10 CA180868NCI NIH HHS U10 CA180888NCI NIH HHS UG1 CA233340
6 · The paper itself

Abstract

introductionS1400F is a non-match substudy of Lung Cancer Master Protocol (Lung-MAP) evaluating the immunotherapy combination of durvalumab and tremelimumab to overcome resistance to anti-programmed death ligand 1 (PD-(L)1) therapy in patients with advanced squamous lung carcinoma (sq non-small-cell lung cancer (NSCLC)).

methodsPatients with previously treated sqNSCLC with disease progression after anti-PD-(L)1 monotherapy, who did not qualify for any active molecularly targeted Lung-MAP substudies, were eligible. Patients received tremelimumab 75 mg plus durvalumab 1500 mg once every 28 days for four cycles then durvalumab alone every 28 days until disease progression. The primary endpoint was the objective response rate (RECIST V.1.1). Primary and acquired resistance cohorts, defined as disease progression within 24 weeks versus ≥24 weeks of starting prior anti-PD-(L)1 therapy, were analyzed separately and an interim analysis for futility was planned after 20 patients in each cohort were evaluable for response.

resultsA total of 58 eligible patients received drug, 28 with primary resistance and 30 with acquired resistance to anti-PD-(L)1 monotherapy. Grade ≥3 adverse events at least possibly related to treatment were seen in 20 (34%) patients. The response rate in the primary resistance cohort was 7% (95% CI 0% to 17%), with one complete and one partial response. No responses were seen in the acquired resistance cohort. In the primary and resistance cohorts the median progression-free survival was 2.0 months (95% CI 1.6 to 3.0) and 2.1 months (95% CI 1.6 to 3.2), respectively, and overall survival was 7.7 months (95% CI 4.0 to 12.0) and 7.6 months (95% CI 5.3 to 10.2), respectively.

conclusionDurvalumab plus tremelimumab had minimal activity in patients with advanced sqNSCLC progressing on prior anti-PD-1 therapy.

Indexed as

AgedAged, 80 and overAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Squamous CellFemaleHumansImmune Checkpoint InhibitorsImmunotherapyLung NeoplasmsMaleMiddle AgedNeoplasm StagingAntibodies, MonoclonalAntibodies, Monoclonal, HumanizeddurvalumabImmune Checkpoint InhibitorstremelimumabcombinationCTLA-4 antigendrug therapyimmunotherapylung neoplasms

Identifiers

PMID34429332
PMCPMC8386207
OpenAlexW3195751328

What OpenQuestion holds

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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.