Evidence map›Paper›PMID 32954593›Full record

Trial reportCancer science2020

Ramucirumab or placebo plus erlotinib in EGFR-mutated, metastatic non-small-cell lung cancer: East Asian subset of RELAY.

Makoto Nishio, Takashi Seto, Martin Reck, Edward B Garon, Chao-Hua Chiu, Kiyotaka Yoh, Fumio Imamura, Keunchil Park, Jin-Yuan Shih, Carla Visseren-Grul and 6 more

Erratum issuedOpen access · goldAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Cancer science, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 18 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 3 pooled it
2.0field-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, 3 syntheses or guidelines pooled it, 39 citations in OpenAlex.

  1. Guideline
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  18. Correction.Cancer science · 2021
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors at 13 institutions in 7 countries.

Makoto NishioThe Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan.ORCID https://orcid.org/0000-0003-4969-4165
Takashi SetoNational Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.
Martin ReckLungenClinic, Airway Research Center North, German Center for Lung Research, Grosshansdorf, Germany.
Edward B GaronDavid Geffen School of Medicine at UCLA/TRIO-US Network, Los Angeles, CA, USA.
Chao-Hua ChiuTaipei Veterans General Hospital, Taipei, Taiwan.
Kiyotaka YohNational Cancer Center Hospital East, Kashiwa, Japan.
Fumio ImamuraOsaka International Cancer Institute, Osaka, Japan.
Keunchil ParkSamsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Jin-Yuan ShihNational Taiwan University Hospital, Taipei, Taiwan.ORCID https://orcid.org/0000-0002-2854-5067
Carla Visseren-GrulEli Lilly and Company, Utrecht, The Netherlands.
Bente Frimodt-MollerEli Lilly and Company, Copenhagen, Denmark.
Annamaria ZimmermannEli Lilly and Company, Indianapolis, IN, USA.
Gosuke HommaEli Lilly Japan KK, Kobe, Japan.
Sotaro EnatsuEli Lilly Japan KK, Kobe, Japan.
Kazuhiko NakagawaKindai University Faculty of Medicine, Osaka, Japan.
RELAY Study Investigators
Eli Lilly (Japan) · JPEli Lilly (United States) · USEli Lilly (Netherlands) · NLGerman Center for Lung Research · DEKindai University · JPNational Cancer Center Hospital East · JPNational Hospital Organization Kyushu Cancer Center · JPNational Taiwan University Hospital · TWOsaka International Cancer Institute · JPSamsung Medical Center · KRTaipei Veterans General Hospital · TWThe Cancer Institute Hospital · JPUniversity of California, Los Angeles · US

Funding

Eli Lilly and Company
6 · The paper itself

Abstract

In the global phase III RELAY study, ramucirumab plus erlotinib (RAM + ERL) demonstrated superior progression-free survival (PFS) to placebo plus erlotinib (PL + ERL) in untreated patients with epidermal growth factor receptor (EGFR) mutation-positive metastatic non-small-cell lung cancer (NSCLC) (hazard ratio (HR) [95% CI]: 0.59 [0.46-0.76]). This prespecified analysis assessed RAM + ERL efficacy and safety in the RELAY subset enrolled in East Asia (Japan, Taiwan, South Korea, Hong Kong). Randomized (1:1) patients received oral ERL (150 mg/d) plus intravenous RAM (10 mg/kg) or PL Q2W. Primary endpoint was PFS (investigator-assessed). Key secondary endpoints included objective response rate (ORR), disease control rate (DCR), duration of response (DoR), overall survival (OS), and safety. Exploratory endpoints included biomarker analyses and time to second progression (PFS2). Median PFS was 19.4 vs 12.5 mo for RAM + ERL (n = 166) vs PL + ERL (n = 170) (HR: 0.636 [0.485-0.833]; P = .0009). The 1-y PFS rate was 72.4% vs 52.2%, respectively. PFS benefit was consistent in most subgroups, including by EGFR mutation (Ex19del, Ex21.L858R). ORR and DCR were similar in both arms, but median DoR was longer with RAM + ERL. OS and PFS2 were immature at data cut-off (censoring rates, 81.2%-84.3% and 64.1%-70.5%, respectively). Grade ≥ 3 treatment-emergent adverse events were more frequent with RAM + ERL (70.7%) than PL + ERL (49.4%). Adverse events leading to treatment discontinuation were similar in both arms (RAM + ERL, 13.3%; PL + ERL, 12.9%), as were post-progression EGFR T790M mutation rates (43%; 50%). With superior PFS over PL + ERL and safety consistent with the overall RELAY population, RAM + ERL is a viable treatment option for EGFR-mutated metastatic NSCLC in East Asia.

Indexed as

Genes, erbB-1Administration, OralAdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBrain NeoplasmsCarcinoma, Non-Small-Cell LungErlotinib HydrochlorideFemaleHong KongHumansInjections, IntravenousJapanLung NeoplasmsAntibodies, Monoclonal, HumanizedErlotinib HydrochloridePlacebosRamucirumabEast Asiaepidermal growth factor receptorerlotinib hydrochloridenon-small-cell lung cancerramucirumab

Identifiers

PMID32954593
PMCPMC7734014
OpenAlexW3087151336

What OpenQuestion holds

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LicenceCC BY-NC
Read underepoch 390

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.