Evidence map›Paper›PMID 27937096›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2017

Results From the Phase III Randomized Trial of Onartuzumab Plus Erlotinib Versus Erlotinib in Previously Treated Stage IIIB or IV Non-Small-Cell Lung Cancer: METLung.

David R Spigel, Martin J Edelman, Kenneth O'Byrne, Luis Paz-Ares, Simonetta Mocci, See Phan, David S Shames, Dustin Smith, Wei Yu, Virginia E Paton and 1 more

Abstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 208 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
208citing papers in PubMed, 3 pooled it
32.3field-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.

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

208 citing papers in PubMed, 3 syntheses or guidelines pooled it, 321 citations in OpenAlex.

  1. 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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148 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 1 institution in 1 country.

David R SpigelDavid R. Spigel, Sarah Cannon Research Institute, Nashville, TN; Martin J. Edelman, University of Maryland Greenebaum Cancer Center, Baltimore, MD; Kenneth O'Byrne, Queensland University of Technology, Brisbane, Queensland, Australia; Luis Paz-Ares, Hospital Universitario Doce de Octubre and Centro Nacional de Investigaciones Oncológicas, Madrid, Spain; Simonetta Mocci, See Phan, David S. Shames, Dustin Smith, Wei Yu, and Virginia E. Paton, Genentech, South San Francisco, CA; and Tony Mok, Chinese University of Hong Kong, Hong Kong, Special Administrative Region, People's Republic of China.
Martin J EdelmanDavid R. Spigel, Sarah Cannon Research Institute, Nashville, TN; Martin J. Edelman, University of Maryland Greenebaum Cancer Center, Baltimore, MD; Kenneth O'Byrne, Queensland University of Technology, Brisbane, Queensland, Australia; Luis Paz-Ares, Hospital Universitario Doce de Octubre and Centro Nacional de Investigaciones Oncológicas, Madrid, Spain; Simonetta Mocci, See Phan, David S. Shames, Dustin Smith, Wei Yu, and Virginia E. Paton, Genentech, South San Francisco, CA; and Tony Mok, Chinese University of Hong Kong, Hong Kong, Special Administrative Region, People's Republic of China.
Kenneth O'ByrneDavid R. Spigel, Sarah Cannon Research Institute, Nashville, TN; Martin J. Edelman, University of Maryland Greenebaum Cancer Center, Baltimore, MD; Kenneth O'Byrne, Queensland University of Technology, Brisbane, Queensland, Australia; Luis Paz-Ares, Hospital Universitario Doce de Octubre and Centro Nacional de Investigaciones Oncológicas, Madrid, Spain; Simonetta Mocci, See Phan, David S. Shames, Dustin Smith, Wei Yu, and Virginia E. Paton, Genentech, South San Francisco, CA; and Tony Mok, Chinese University of Hong Kong, Hong Kong, Special Administrative Region, People's Republic of China.
Luis Paz-AresDavid R. Spigel, Sarah Cannon Research Institute, Nashville, TN; Martin J. Edelman, University of Maryland Greenebaum Cancer Center, Baltimore, MD; Kenneth O'Byrne, Queensland University of Technology, Brisbane, Queensland, Australia; Luis Paz-Ares, Hospital Universitario Doce de Octubre and Centro Nacional de Investigaciones Oncológicas, Madrid, Spain; Simonetta Mocci, See Phan, David S. Shames, Dustin Smith, Wei Yu, and Virginia E. Paton, Genentech, South San Francisco, CA; and Tony Mok, Chinese University of Hong Kong, Hong Kong, Special Administrative Region, People's Republic of China.
Simonetta MocciDavid R. Spigel, Sarah Cannon Research Institute, Nashville, TN; Martin J. Edelman, University of Maryland Greenebaum Cancer Center, Baltimore, MD; Kenneth O'Byrne, Queensland University of Technology, Brisbane, Queensland, Australia; Luis Paz-Ares, Hospital Universitario Doce de Octubre and Centro Nacional de Investigaciones Oncológicas, Madrid, Spain; Simonetta Mocci, See Phan, David S. Shames, Dustin Smith, Wei Yu, and Virginia E. Paton, Genentech, South San Francisco, CA; and Tony Mok, Chinese University of Hong Kong, Hong Kong, Special Administrative Region, People's Republic of China.
See PhanDavid R. Spigel, Sarah Cannon Research Institute, Nashville, TN; Martin J. Edelman, University of Maryland Greenebaum Cancer Center, Baltimore, MD; Kenneth O'Byrne, Queensland University of Technology, Brisbane, Queensland, Australia; Luis Paz-Ares, Hospital Universitario Doce de Octubre and Centro Nacional de Investigaciones Oncológicas, Madrid, Spain; Simonetta Mocci, See Phan, David S. Shames, Dustin Smith, Wei Yu, and Virginia E. Paton, Genentech, South San Francisco, CA; and Tony Mok, Chinese University of Hong Kong, Hong Kong, Special Administrative Region, People's Republic of China.
David S ShamesDavid R. Spigel, Sarah Cannon Research Institute, Nashville, TN; Martin J. Edelman, University of Maryland Greenebaum Cancer Center, Baltimore, MD; Kenneth O'Byrne, Queensland University of Technology, Brisbane, Queensland, Australia; Luis Paz-Ares, Hospital Universitario Doce de Octubre and Centro Nacional de Investigaciones Oncológicas, Madrid, Spain; Simonetta Mocci, See Phan, David S. Shames, Dustin Smith, Wei Yu, and Virginia E. Paton, Genentech, South San Francisco, CA; and Tony Mok, Chinese University of Hong Kong, Hong Kong, Special Administrative Region, People's Republic of China.
Dustin SmithDavid R. Spigel, Sarah Cannon Research Institute, Nashville, TN; Martin J. Edelman, University of Maryland Greenebaum Cancer Center, Baltimore, MD; Kenneth O'Byrne, Queensland University of Technology, Brisbane, Queensland, Australia; Luis Paz-Ares, Hospital Universitario Doce de Octubre and Centro Nacional de Investigaciones Oncológicas, Madrid, Spain; Simonetta Mocci, See Phan, David S. Shames, Dustin Smith, Wei Yu, and Virginia E. Paton, Genentech, South San Francisco, CA; and Tony Mok, Chinese University of Hong Kong, Hong Kong, Special Administrative Region, People's Republic of China.
Wei YuDavid R. Spigel, Sarah Cannon Research Institute, Nashville, TN; Martin J. Edelman, University of Maryland Greenebaum Cancer Center, Baltimore, MD; Kenneth O'Byrne, Queensland University of Technology, Brisbane, Queensland, Australia; Luis Paz-Ares, Hospital Universitario Doce de Octubre and Centro Nacional de Investigaciones Oncológicas, Madrid, Spain; Simonetta Mocci, See Phan, David S. Shames, Dustin Smith, Wei Yu, and Virginia E. Paton, Genentech, South San Francisco, CA; and Tony Mok, Chinese University of Hong Kong, Hong Kong, Special Administrative Region, People's Republic of China.
Virginia E PatonDavid R. Spigel, Sarah Cannon Research Institute, Nashville, TN; Martin J. Edelman, University of Maryland Greenebaum Cancer Center, Baltimore, MD; Kenneth O'Byrne, Queensland University of Technology, Brisbane, Queensland, Australia; Luis Paz-Ares, Hospital Universitario Doce de Octubre and Centro Nacional de Investigaciones Oncológicas, Madrid, Spain; Simonetta Mocci, See Phan, David S. Shames, Dustin Smith, Wei Yu, and Virginia E. Paton, Genentech, South San Francisco, CA; and Tony Mok, Chinese University of Hong Kong, Hong Kong, Special Administrative Region, People's Republic of China.
Tony MokDavid R. Spigel, Sarah Cannon Research Institute, Nashville, TN; Martin J. Edelman, University of Maryland Greenebaum Cancer Center, Baltimore, MD; Kenneth O'Byrne, Queensland University of Technology, Brisbane, Queensland, Australia; Luis Paz-Ares, Hospital Universitario Doce de Octubre and Centro Nacional de Investigaciones Oncológicas, Madrid, Spain; Simonetta Mocci, See Phan, David S. Shames, Dustin Smith, Wei Yu, and Virginia E. Paton, Genentech, South San Francisco, CA; and Tony Mok, Chinese University of Hong Kong, Hong Kong, Special Administrative Region, People's Republic of China.
Sarah Cannon · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Purpose The phase III OAM4971g study (METLung) examined the efficacy and safety of onartuzumab plus erlotinib in patients with locally advanced or metastatic non-small-cell lung cancer selected by MET immunohistochemistry whose disease had progressed after treatment with a platinum-based chemotherapy regimen. Patients and Methods Patients were randomly assigned at a one-to-one ratio to receive onartuzumab (15 mg/kg intravenously on day 1 of each 21-day cycle) plus daily oral erlotinib 150 mg or intravenous placebo plus daily oral erlotinib 150 mg. The primary end point was overall survival (OS) in the intent-to-treat population. Secondary end points included median progression-free survival, overall response rate, biomarker analysis, and safety. Results A total of 499 patients were enrolled (onartuzumab, n = 250; placebo, n = 249). Median OS was 6.8 versus 9.1 months for onartuzumab versus placebo (stratified hazard ratio [HR], 1.27; 95% CI, 0.98 to 1.65; P = .067), with a greater number of deaths in the onartuzumab arm (130 [52%] v 114 [46%]). Median progression-free survival was 2.7 versus 2.6 months (stratified HR, 0.99; 95% CI, 0.81 to 1.20; P = .92), and overall response rate was 8.4% and 9.6% for onartuzumab versus placebo, respectively. Exploratory analyses using MET fluorescence in situ hybridization status and gene expression showed no benefit for onartuzumab; patients with EGFR mutations showed a trend toward shorter OS with onartuzumab treatment (HR, 4.68; 95% CI, 0.97 to 22.63). Grade 3 to 5 adverse events were reported by 56.0% and 51.2% of patients, with serious AEs in 33.9% and 30.7%, for experimental versus control arms, respectively. Conclusion Onartuzumab plus erlotinib did not improve clinical outcomes, with shorter OS in the onartuzumab arm, compared with erlotinib in patients with MET-positive non-small-cell lung cancer.

Indexed as

Administration, IntravenousAdministration, OralAdultAgedAged, 80 and overAntibodies, MonoclonalAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Non-Small-Cell LungDisease-Free SurvivalDrug Administration ScheduleErlotinib HydrochlorideFemaleHumansKaplan-Meier EstimateLung NeoplasmsMaleAntibodies, MonoclonalErlotinib HydrochlorideonartuzumabProtein Kinase Inhibitors

Identifiers

PMID27937096
OpenAlexW2562169753

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.