Evidence map›Paper›PMID 33221175›Full record

Trial reportClinical lung cancer2021

A Phase II Study of Telisotuzumab Vedotin in Patients With c-MET-positive Stage IV or Recurrent Squamous Cell Lung Cancer (LUNG-MAP Sub-study S1400K, NCT03574753).

Saiama N Waqar, Mary W Redman, Susanne M Arnold, Fred R Hirsch, Philip C Mack, Lawrence H Schwartz, David R Gandara, Thomas E Stinchcombe, Natasha B Leighl, Suresh S Ramalingam 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 46 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
46citing papers in PubMed, 3 pooled it
5.1field-weighted citation impact, top 3% 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

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

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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 14 institutions in 2 countries.

Saiama N WaqarWashington University School of Medicine, St. Louis, MO. Electronic address: saiamawaqar@wustl.edu.
Mary W RedmanSWOG Statistical Center, Seattle, WA; Fred Hutchinson Cancer Research Center, Seattle, WA.
Susanne M ArnoldUniversity of Kentucky Markey Cancer Center, Lexington, KY.
Fred R HirschUniversity of Colorado Cancer Center, Denver, CO (previous affiliation); Mt. Sinai School of Medicine, New York, NY (current affiliation).
Philip C MackUniversity of California Davis Comprehensive Cancer Center, Sacramento, CA (previous affiliation); Mt. Sinai School of Medicine, New York, NY (current affiliation).
Lawrence H SchwartzColumbia University, New York, NY.
David R GandaraUniversity of California Davis Comprehensive Cancer Center, Sacramento, CA.
Thomas E StinchcombeDuke Cancer Institute, Durham, NC.
Natasha B LeighlPrincess Margaret Hospital, Toronto, Ontario, Canada.
Suresh S RamalingamEmory University, Atlanta, GA.
Saloni H TannaGeorgia NCORP/Oncology Specialists of Northeast Georgia, Gainesville, VA.
Ryan S RaddinSoutheast COR NCORP/Bon Secours St. Francis Medical Center Cancer Institute, Midlothian, VA.
Katherine MinichielloSWOG Statistical Center, Seattle, WA; Fred Hutchinson Cancer Research Center, Seattle, WA.
Jeffrey D BradleyEmory University, Atlanta, GA.
Karen KellyUniversity of California Davis Comprehensive Cancer Center, Sacramento, CA.
Roy S HerbstYale School of Medicine, New Haven, CT.
Vassiliki A PapadimitrakopoulouThe University of Texas MD Anderson Cancer Center, Houston, TX (at time of study).
Emory University · USFred Hutch Cancer Center · USUC Davis Comprehensive Cancer CenterColumbia University · USDuke Medical Center · USOncology Specialists · USPrincess Margaret Cancer Centre · CASt. Francis Medical Center · USThe University of Texas MD Anderson Cancer Center · USUniversity of California Davis Medical Center · USUniversity of Colorado Cancer Center · USUniversity of Kentucky · USWashington University in St. Louis · USYale University · 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 · 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
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
Georgia NCI Community Oncology Research Program (NCORP)UG1CA189997 · NCI · NORTHSIDE HOSPITAL ATLANTA · PI Guilherme Cantuaria, Leonard R. Henry · 2014 to 2026
$20.9M
The Hawaii NCORPUG1CA189804 · NCI · UNIVERSITY OF HAWAII AT MANOA · PI Jared Acoba, Jeffrey Lee Berenberg · 2014 to 2026
$15.7M
NCATS NIH HHS UL1 TR001863NCI NIH HHS P30 CA093373NCI NIH HHS U10 CA180819NCI NIH HHS U10 CA180820NCI NIH HHS U10 CA180821NCI NIH HHS U10 CA180828NCI NIH HHS U10 CA180868NCI NIH HHS U10 CA180888NCI NIH HHS UG1 CA189804NCI NIH HHS UG1 CA189808NCI NIH HHS UG1 CA189830NCI NIH HHS UG1 CA189858NCI NIH HHS UG1 CA189873NCI NIH HHS UG1 CA189952NCI NIH HHS UG1 CA189958NCI NIH HHS UG1 CA189971NCI NIH HHS UG1 CA189997NCI NIH HHS UG1 CA233339NCI NIH HHS UG1 CA233340NCI NIH HHS UG1 CA239767NCI NIH HHS UM1 CA186704
6 · The paper itself

Abstract

introductionLung-MAP S1400K was designed to evaluate the response to telisotuzumab vedotin, an antibody-drug conjugate targeting c-MET, in patients with c-MET-positive squamous cell carcinoma (SCC). PATIENTS AND

methodsPatients with previously treated SCC with c-MET-positive tumors (H score ≥ 150, Ventana SP44 assay) were enrolled into 2 cohorts: Cohort 1 (immune checkpoint inhibitor-naive) and Cohort 2 (immune checkpoint inhibitor refractory). Telisotuzumab vedotin 2.7 mg/kg was administered intravenously every 3 weeks until disease progression or unacceptable toxicity. Response assessments were performed every 6 weeks. The primary endpoint was response by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Secondary endpoints included progression-free survival, overall survival, response within cohort, duration of response, and toxicities. Interim analysis was planned after 20 evaluable patients, with ≥ 3 responses needed to continue enrollment.

resultsForty-nine patients (14% of screened patients) were assigned to S1400K, 28 patients enrolled (15 in Cohort 1 and 13 in Cohort 2), and 23 were eligible. S1400K closed on December 21, 2018 owing to lack of efficacy. Two responses (response rate of 9%; 95% confidence interval, 0%-20%) were reported in cohort 1 (1 complete and 1 unconfirmed partial response), whereas 10 patients had stable disease, with a disease control rate of 52%. The median overall and progression-free survival was 5.6 and 2.4 months, respectively. There were 3 grade 5 events (2 pneumonitis, in Cohort 2, and 1 bronchopulmonary hemorrhage, in Cohort 1).

conclusionTelisotuzumab vedotin failed to meet the pre-specified response needed to justify continuing enrollment to S1400K. Pneumonitis was an unanticipated toxicity observed in patients with SCC.

Indexed as

AgedAged, 80 and overAntibodies, MonoclonalAntineoplastic AgentsCarcinoma, Non-Small-Cell LungCarcinoma, Squamous CellCohort StudiesFemaleHumansLung NeoplasmsMaleMiddle AgedNeoplasm Recurrence, LocalNeoplasm StagingPneumoniaProgression-Free SurvivalAntibodies, MonoclonalAntineoplastic AgentsProto-Oncogene Proteins c-mettelisotuzumab vedotinAntibody-drug conjugatec-METLung-MAPSquamous cell carcinomaTelisotuzumab vedotin

Identifiers

PMID33221175
PMCPMC8044254
OpenAlexW3093030175

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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.