Evidence map›Paper›PMID 30429032›Full record

Trial reportLung cancer (Amsterdam, Netherlands)2018

Pembrolizumab and platinum-based chemotherapy as first-line therapy for advanced non-small-cell lung cancer: Phase 1 cohorts from the KEYNOTE-021 study.

Shirish M Gadgeel, James P Stevenson, Corey J Langer, Leena Gandhi, Hossein Borghaei, Amita Patnaik, Liza C Villaruz, Matthew Gubens, Ralph Hauke, James Chih-Hsin Yang and 5 more

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Lung cancer (Amsterdam, Netherlands), 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02039674 (A Phase I/II Study of MK-3475), which is not on this map. Cited by 53 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
53citing papers in PubMed, 11 pooled it
4.2field-weighted citation impact, top 4% 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.

NCT02039674 phase1 / phase2completednot on this map

A Phase I/II Study of MK-3475 (SCH900475) in Combination With Chemotherapy or Immunotherapy in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Carcinoma

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2014 to 2021Enrolled267ConditionsNon-small Cell Lung CarcinomaArmsPembrolizumab, Paclitaxel, Carboplatin, Bevacizumab, Pemetrexed
3 · Its place in the literature

Who cites it

53 citing papers in PubMed, 11 syntheses or guidelines pooled it, 80 citations in OpenAlex.

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  6. Update on recent key publications in lung oncology: picking up speed.European respiratory review : an official journal of the European Respiratory Society · 2021
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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

15 authors at 13 institutions in 2 countries.

Shirish M GadgeelKarmanos Cancer Institute/Wayne State University, Detroit, MI, USA. Electronic address: sgadgeel@med.umich.edu.
James P StevensonTaussig Cancer Institute/Cleveland Clinic, Cleveland, OH, USA.
Corey J LangerAbramson Cancer Center, University of Pennsylvania, Philadelphia, PA, USA.
Leena GandhiDana-Farber Cancer Institute, Boston, MA, USA.
Hossein BorghaeiFox Chase Cancer Center, Philadelphia, PA, USA.
Amita PatnaikSouth Texas Accelerated Research Therapeutics, San Antonio, TX, USA.
Liza C VillaruzUniversity of Pittsburgh Cancer Institute, Pittsburgh, PA, USA.
Matthew GubensUniversity of California, San Francisco, Helen Diller Family Comprehensive Cancer Center, San Francisco, CA, USA.
Ralph HaukeNebraska Cancer Specialists, Omaha, NE, USA.
James Chih-Hsin YangNational Taiwan University Hospital and National Taiwan University Cancer Center, Taipei, Taiwan.
Lecia V SequistMassachusetts General Hospital Cancer Center and Harvard Medical School, Boston, MA, USA.
Robert BachmanMerck & Co., Inc., Kenilworth, NJ, USA.
Sanatan SarafMerck & Co., Inc., Kenilworth, NJ, USA.
Harry RaftopoulosMerck & Co., Inc., Kenilworth, NJ, USA.
Vassiliki PapadimitrakopoulouThe University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Merck & Co., Inc., Rahway, NJ, USA (United States) · USCleveland Clinic · USDana-Farber Cancer Institute · USFox Chase Cancer Center · USHarvard University · USNational Taiwan University Hospital · TWNebraska Cancer Specialists · USSouth Texas Accelerated Research Therapeutics · USThe University of Texas MD Anderson Cancer Center · USUniversity of California, San Francisco · USUniversity of Pennsylvania · USUPMC Hillman Cancer Center · USWayne State University · US

Funding

Tumor Biology and Microenvironment (Program 1)P30CA022453 · NCI · WAYNE STATE UNIVERSITY · PI PAUL M STEMMER · 1985 to 2026
$68.4M
NCI NIH HHS P30 CA022453
6 · The paper itself

Abstract

objectivesPlatinum-based chemotherapy for advanced non-small-cell lung cancer (NSCLC) has modest benefit overall, but has the potential to amplify immune responses. In cohorts A-C of the multicohort phase 1/2 study KEYNOTE-021 (Clinicaltrials.gov, NCT02039674), we evaluated combinations of platinum-doublet chemotherapy with the anti-programmed death 1 monocloncal antibody pembrolizumab. MATERIALS AND

methodsPatients with previously untreated, advanced NSCLC without EGFR/ALK aberrations were randomized to pembrolizumab 2 or 10 mg/kg Q3W plus carboplatin area under the serum concentration-time curve (AUC) 6 mg/mL/min plus paclitaxel 200 mg/m

resultsOverall, 74 patients were randomized; median follow-up was 21.4, 16.4, and 17.4 months in cohorts A, B, and C, respectively. No dose-limiting toxicities occurred in any cohort at either pembrolizumab dose. Most frequent treatment-related adverse events (AEs) were alopecia, fatigue, and nausea. Treatment-related grade 3/4 AEs occurred in 40%, 42%, and 46% of patients in cohorts A, B, and C, respectively; AEs with possible immune etiology occurred in 24%, 50%, and 38% of patients, respectively. Objective response rates were 48%, 56%, and 75% in cohorts A, B, and C, respectively.

conclusionPembrolizumab in combination with carboplatin-paclitaxel and with pemetrexed-carboplatin yielded encouraging antitumor activity and toxicity consistent with known toxicities of platinum-based chemotherapy or pembrolizumab monotherapy.

Indexed as

AdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabCarboplatinCarcinoma, Non-Small-Cell LungCohort StudiesFemaleHumansLung NeoplasmsMaleMiddle AgedOrganoplatinum CompoundsPaclitaxelPemetrexedAntibodies, Monoclonal, HumanizedBevacizumabCarboplatinOrganoplatinum CompoundsPaclitaxelpembrolizumabPemetrexedAntineoplastic agentsBevacizumabCarcinomaCombinationDrug therapyNon–small-cell lungPembrolizumab

Identifiers

PMID30429032
PMCPMC6886233
OpenAlexW2888031957

What OpenQuestion holds

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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.