Evidence map›Paper›PMID 35658002›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2022

Phase II Randomized Study of Ramucirumab and Pembrolizumab Versus Standard of Care in Advanced Non-Small-Cell Lung Cancer Previously Treated With Immunotherapy-Lung-MAP S1800A.

Karen L Reckamp, Mary W Redman, Konstantin H Dragnev, Katherine Minichiello, Liza C Villaruz, Bryan Faller, Tareq Al Baghdadi, Susan Hines, Leah Everhart, Louise Highleyman and 8 more

Erratum issued Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT07330596 (A Randomized Controlled Study Comparing the Efficacy of QL1706 Combined With Chemotherapy in the Treatment of Immune-mediated Non-small Cell Lung Cancer), which is not on this map. Cited by 138 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
138citing papers in PubMed, 6 pooled it
24.6field-weighted citation impact, top 1% 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.

NCT07330596 phase2recruitingnot on this mapstarted 2025, after this paper: background citation

A Randomized Controlled Study Comparing the Efficacy of QL1706 Combined With Chemotherapy in the Treatment of Immune-mediated Non-small Cell Lung Cancer

TypeinterventionalSponsorAnhui Provincial Cancer HospitalRan2025 to 2028Enrolled96ConditionsNSCLC (Advanced Non-small Cell Lung Cancer)ArmsQL1706 combined with Chemotherapy, Chemotherapy
3 · Its place in the literature

Who cites it

138 citing papers in PubMed, 6 syntheses or guidelines pooled it, 231 citations in OpenAlex.

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78 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors at 14 institutions in 1 country.

Karen L ReckampCedars-Sinai Medical Center, Los Angeles, CA.ORCID 0000-0002-9213-0325
Mary W RedmanSWOG Statistics and Data Management Center, Fred Hutchinson Cancer Research Center, Seattle, WA.ORCID 0000-0003-2294-9674
Konstantin H DragnevDartmouth-Hitchcock Norris Cotton Cancer Center, Alliance for Clinical Trials in Oncology, Lebanon, NH.
Katherine MinichielloSWOG Statistics and Data Management Center, Fred Hutchinson Cancer Research Center, Seattle, WA.
Liza C VillaruzUPMC Hillman Cancer Center, Pittsburgh, PA.
Bryan FallerIHA Hematology Oncology Consultants, CRC NCORP, Ann Arbor, MI.
Tareq Al BaghdadiIHA Hematology Oncology Consultants, CRC NCORP, Ann Arbor, MI.
Susan HinesNovant Health Cancer Institute, Southeast Clinical Oncology Research Consortium NCORP, Mount Airy, NC.
Leah EverhartSWOG Statistics and Data Management Center, Cancer Research and Biostatistics, Seattle, WA.
Louise HighleymanSWOG Statistics and Data Management Center, Cancer Research and Biostatistics, Seattle, WA.ORCID 0000-0002-3430-5334
Vassiliki PapadimitrakopoulouPfizer, Inc, New York, NY.
Joel W Neal
Saiama N Waqar
Jyoti D Patel
Jhanelle E Gray
David R GandaraUC Davis Comprehensive Cancer Center, Sacramento, CA.ORCID 0000-0003-1784-048X
Karen KellyUC Davis Comprehensive Cancer Center, Sacramento, CA.ORCID 0000-0002-2235-6636
Roy S HerbstYale Comprehensive Cancer Center, New Haven, CT.ORCID 0000-0003-2535-5847
Cancer Research And Biostatistics · USFred Hutch Cancer Center · USHematology Oncology Consultants · USUC Davis Comprehensive Cancer CenterAlliance for Clinical Trials in Oncology · USCedars-Sinai Medical Center · USMoffitt Cancer Center · USNorthwestern University · USNovant Health · USPfizer (United States) · USStanford University · USUPMC Hillman Cancer Center · USWashington University in St. Louis · USYale Cancer Center · US

Funding

Member Site CoreU10CA180821 · NCI · BRIGHAM AND WOMEN'S HOSPITAL · PI Evanthia Galanis · 2014 to 2026
$177.3M
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
UCDCCC NCTN UG1 PROGRAMUG1CA233340 · NCI · UNIVERSITY OF CALIFORNIA AT DAVIS · PI GANDARA, DAVID R, VALICENTI, RICHARD · 2019 to 2025
$3.7M
NCI National Clinical Trials Network - Network Lead Academic Participating Site (UG1)UG1CA233323 · NCI · DARTMOUTH-HITCHCOCK CLINIC · PI Konstantin H. Dragnev · 2019 to 2026
$2.5M
NCATS NIH HHS UL1 TR001863NCI NIH HHS P30 CA093373NCI NIH HHS U10 CA180819NCI NIH HHS U10 CA180821NCI NIH HHS U10 CA180888NCI NIH HHS UG1 CA189830NCI NIH HHS UG1 CA189858NCI NIH HHS UG1 CA189971NCI NIH HHS UG1 CA233323NCI NIH HHS UG1 CA233340
6 · The paper itself

Abstract

purposeResistance to immune checkpoint inhibition (ICI) in advanced non-small-cell lung cancer (NSCLC) represents a major unmet need. Combining ICI with vascular endothelial growth factor (VEGF)/VEGF receptor inhibition has yielded promising results in multiple tumor types.

methodsIn this randomized phase II Lung-MAP nonmatch substudy (S1800A), patients ineligible for a biomarker-matched substudy with NSCLC previously treated with ICI and platinum-based chemotherapy and progressive disease at least 84 days after initiation of ICI were randomly assigned to receive ramucirumab plus pembrolizumab (RP) or investigator's choice standard of care (SOC: docetaxel/ramucirumab, docetaxel, gemcitabine, and pemetrexed). With a goal of 130 eligible patients, the primary objective was to compare overall survival (OS) using a one-sided 10% level using the better of a standard log-rank (SLR) and weighted log-rank (WLR; G[rho = 0, gamma = 1]) test. Secondary end points included objective response, duration of response, investigator-assessed progression-free survival, and toxicity.

resultsOf 166 patients enrolled, 136 were eligible (69 RP; 67 SOC). OS was significantly improved with RP (hazard ratio [80% CI]: 0.69 [0.51 to 0.92]; SLR one-sided

conclusionThis randomized phase II trial demonstrated significantly improved OS with RP compared with SOC in patients with advanced NSCLC previously treated with ICI and chemotherapy. The safety was consistent with known toxicities of both drugs. These data warrant further evaluation.

Indexed as

Carcinoma, Non-Small-Cell LungLung NeoplasmsAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsDocetaxelHumansImmunotherapyLungRamucirumabStandard of CareVascular Endothelial Growth Factor AAntibodies, Monoclonal, HumanizedDocetaxelpembrolizumabRamucirumabVascular Endothelial Growth Factor A

Identifiers

PMID35658002
PMCPMC9287284
OpenAlexW4281721227

What OpenQuestion holds

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LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

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.