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AzTrials

Non-Squamous Non-Small Cell Lung CancerPhase 3NCT01456325

A Study of Onartuzumab (MetMAb) in Combination With Tarceva (Erlotinib) in Participants With Met Diagnostic-Positive Non-Small Cell Lung Cancer Who Have Received Chemotherapy For Advanced or Metastatic Disease (MetLung)

A Phase 3 study testing Erlotinib and Onartuzumab (MetMab) in people with Non-Squamous Non-Small Cell Lung Cancer, run by Genentech, Inc. at 213 sites in 27 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This randomized, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of onartuzumab (MetMAb) in combination with Tarceva (erlotinib) in participants with incurable non-small cell lung cancer identified to be Met diagnostic-positive. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Squamous Non-Small Cell Lung Cancer
What is being tested?
Erlotinib and Onartuzumab (MetMab)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
494 participants
Where
213 sitesin 27 countries
Study dates
Jan 2012to Jan 2016
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult participants, greater than or equal to (>/=) 18 years of age
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Histologically or cytologically confirmed incurable Stage IIIb/IV NSCLC tumor
  • Met diagnostic-positive status tested by immunohistochemistry (IHC)
  • Results of endothelial growth factor receptor (EGFR)-activating mutation testing
  • Radiographic evidence of disease
  • Prior treatment with at least one platinum-based line of treatment (for stage IIIb/IV) and no more than one additional line of chemotherapy treatment; the last dose of chemotherapy must have been administered >/= 21 days prior to Day 1
  • availability of tissue sample for diagnostic testing is required

Who cannot join

  • More than 30 days of exposure to an investigational or marketed agent that can act by EGFR inhibition, or a known EGFR-related toxicity resulting in dose modifications (EGFR inhibitors including but not limited to gefitinib, erlotinib and cetuximab)
  • Brain metastases or spinal cord compression not definitively treated with surgery and/or radiation, or previously treated central nervous system (CNS) metastases or spinal cord compression without evidence of stable disease for >/= 14 days
  • History of another malignancy in the previous 3 years, unless cured by surgery alone and continuously disease free for at least 3 years; participants with prior history of non-invasive cancers are eligible
  • Inadequate hematological, biochemical or organ function
  • Significant history of cardiac disease
  • Serious active infection at time of randomization or other serious underlying medical conditions that would impair the ability of the participant to receive protocol treatment
Show all 10Show fewer
  • Any inflammatory changes of the surface of the eye
  • Clinically significant gastro-intestinal disease, including uncontrolled inflammatory gastro-intestinal diseases
  • Pregnant or lactating women
  • Positive for human immunodefinciency (HIV) infection

Trial locations and contacts

213 sites in 27 countries.

213 sites in 27 countries

United States56 sites

  • Study site

    Ann Arbor, Michigan, 48106

  • Study site

    Annapolis, Maryland, 21401

  • Study site

    Baltimore, Maryland, 21201

  • Study site

    Baltimore, Maryland, 21231

  • Study site

    Baltimore, Maryland, 21237

  • Study site

    Bettendorf, Iowa, 52722

  • Study site

    Boca Raton, Florida, 33486

  • Study site

    Boston, Massachusetts, 02114

  • Study site

    Boston, Massachusetts, 02115

  • Study site

    Bristol, Virginia, 24201

  • Study site

    Canton, Ohio, 44718

  • Study site

    Chandler, Arizona, 85224

  • Study site

    Chapel Hill, North Carolina, 27514

  • Study site

    Charleston, South Carolina, 29403

  • Study site

    Chattanooga, Tennessee, 37404

  • Study site

    Chicago, Illinois, 60637

  • Study site

    Clearwater, Florida, 33761

  • Study site

    Cleveland, Ohio, 44106

  • Study site

    Columbia, South Carolina, 29210

  • Study site

    Columbus, Ohio, 43210

  • Study site

    Columbus, Ohio, 43219

  • Study site

    Dallas, Texas, 75390

  • Study site

    Duluth, Minnesota, 55805

  • Study site

    Farmington, New Mexico, 87401

  • Study site

    Fort Myers, Florida, 33901

  • Study site

    Fort Worth, Texas, 76104

  • Study site

    Hayward, California, 94545

  • Study site

    Houston, Texas, 77030

  • Study site

    Jacksonville, Florida, 32207

  • Study site

    Jacksonville, Florida, 32256

  • Study site

    Knoxville, Tennessee, 37909

  • Study site

    Louisville, Kentucky, 40207

  • Study site

    Modesto, California, 95355

  • Study site

    Nashville, Tennessee, 37203

  • Study site

    Oakland, California, 94611

  • Study site

    Omaha, Nebraska, 68114

  • Study site

    Orange, California, 92868

  • Study site

    Philadelphia, Pennsylvania, 19104

  • Study site

    Pittsburgh, Pennsylvania, 15232

  • Study site

    Reno, Nevada, 89502

  • Study site

    Roanoke, Virginia, 24014

  • Study site

    Roseville, California, 95661

  • Study site

    Sacramento, California, 95817

  • Study site

    Sacramento, California, 95825

  • Study site

    San Diego, California, 92108

  • Study site

    San Francisco, California, 94115

  • Study site

    San Jose, California, 95119

  • Study site

    Santa Clara, California, 95051

  • Study site

    Sioux City, Iowa, 51101

  • Study site

    South San Francisco, California, 94080

  • Study site

    Springfield, Massachusetts, 01107

  • Study site

    St Louis, Missouri, 63110

  • Study site

    Syracuse, New York, 13210

  • Study site

    Urbana, Illinois, 61801

  • Study site

    Vallejo, California, 94589

  • Study site

    Walnut Creek, California, 94596

Other trials in United States

Japan25 sites

  • Study site

    Aichi, 464-8681

  • Study site

    Chiba, 277-8577

  • Study site

    Ehime, 791-0280

  • Study site

    Fukuoka, 811-1395

  • Study site

    Fukuoka, 812-8582

  • Study site

    Hyōgo, 650-0047

  • Study site

    Hyōgo, 673-8553

  • Study site

    Kanagawa, 236-0051

  • Study site

    Kyoto, 606-8507

  • Study site

    Miyagi, 980-8574

  • Study site

    Miyagi, 981-1293

  • Study site

    Okayama, 700-8558

  • Study site

    Okayama, 710-8602

  • Study site

    Osaka, 534-0021

  • Study site

    Osaka, 537-8511

  • Study site

    Osaka, 589-8511

  • Study site

    Osaka, 591-8555

  • Study site

    Saitama, 362-0806

  • Study site

    Shizuoka, 411-8777

  • Study site

    Tokyo, 104-0045

  • Study site

    Tokyo, 113-8677

  • Study site

    Tokyo, 135-8550

  • Study site

    Tokyo, 160-0023

  • Study site

    Tokyo, 173-8605

  • Study site

    Yamaguchi, 755-0241

Other trials in Japan

Germany12 sites

  • Study site

    Bad Berka, 99437

  • Study site

    Berlin, 14165

  • Study site

    Großhansdorf, 22927

  • Study site

    Hamburg, 21075

  • Study site

    Heidelberg, 69126

  • Study site

    Karlsruhe, 76137

  • Study site

    Mainz, 55131

  • Study site

    München, 80336

  • Study site

    Oldenburg, 26121

  • Study site

    Regensburg, 93053

  • Study site

    Ulm, 89081

  • Study site

    Villingen-Schwenningen, 78052

Other trials in Germany

France11 sites

  • Study site

    Besançon, 25030

  • Study site

    Caen, 14076

  • Study site

    Grenoble, 38 043

  • Study site

    Limoges, 87042

  • Study site

    Marseille, 13915

  • Study site

    Montpellier, 34295

  • Study site

    Paris, 75970

  • Study site

    Poitiers, 86021

  • Study site

    Saint-Herblain, 44805

  • Study site

    Suresnes, 92151

  • Study site

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Spain11 sites

  • Study site

    Barcelona, Barcelona, 08035

  • Study site

    Barcelona, Barcelona, 08036

  • Study site

    Barcelona, Barcelona, 08041

  • Study site

    Barcelona, Barcelona, 08916

  • Study site

    Madrid, Madrid, 28007

  • Study site

    Madrid, Madrid, 28034

  • Study site

    Madrid, Madrid, 28050

  • Study site

    Madrid, Madrid, 28222

  • Study site

    Sabadell, Barcelona, 08208

  • Study site

    Seville, Sevilla, 41013

  • Study site

    Valencia, Valencia, 41014

Other trials in Spain

Italy9 sites

  • Study site

    Ancona, The Marches, 60121

  • Study site

    Aviano, Friuli Venezia Giulia, 33081

  • Study site

    Genoa, Liguria, 16132

  • Study site

    Lido di Camaiore, Tuscany, 55043

  • Study site

    Milan, Lombardy, 20141

  • Study site

    Monza, Lombardy, 20900

  • Study site

    Orbassano, Piedmont, 10043

  • Study site

    Perugia, Umbria, 06123

  • Study site

    Rozzano, Lombardy, 20089

Other trials in Italy

Israel8 sites

  • Study site

    Beersheba, 8410101

  • Study site

    Haifa, 4959381

  • Study site

    Jerusalem, 91120-01

  • Study site

    Jerusalem, 9372212

  • Study site

    Kfar Saba, 4428164

  • Study site

    Petah Tikva, 49100

  • Study site

    Ramat Gan, 5262100

  • Study site

    Rehovot, 76100

Other trials in Israel

Russia7 sites

  • Study site

    Ivanovo, 153040

  • Study site

    Krasnodar, 350040

  • Study site

    Omsk, 644013

  • Study site

    Saint Petersburg, 189646

  • Study site

    Saint Petersburg, 197022

  • Study site

    Saint Petersburg, 197101

  • Study site

    Tomsk, 634050

Other trials in Russia

Brazil6 sites

  • Study site

    Jaú, São Paulo, 17210-080

  • Study site

    Lajeado, Rio Grande do Sul, 95900-000

  • Study site

    Novo Hamburgo, Rio Grande do Sul, 93510-250

  • Study site

    Salvador/BA, Estado de Bahia, 41820-021

  • Study site

    São Paulo, São Paulo, 08270-070

  • Study site

    Sorocaba, São Paulo, 18030-005

Other trials in Brazil

Canada6 sites

  • Study site

    Montreal, Quebec, H3A 1A1

  • Study site

    Montreal, Quebec, J4B 5Z7

  • Study site

    Saint John, New Brunswick, E2L 4L2

  • Study site

    Sault Ste. Marie, Ontario, P6A 2C4

  • Study site

    Toronto, Ontario, M4N 3M5

  • Study site

    Toronto, Ontario, M5G 2M9

Other trials in Canada

United Kingdom6 sites

  • Study site

    Belfast, BT9 7AB

  • Study site

    Grimsby, DN33 2BA

  • Study site

    Leicester, LE1 5WW

  • Study site

    London, SE1 9RT

  • Study site

    London, SW10 9NH

  • Study site

    Manchester, M2O 4BX

Other trials in United Kingdom

Australia5 sites

  • Study site

    Adelaide, South Australia, 5041

  • Study site

    Camperdown, New South Wales, 2050

  • Study site

    Chermside, Queensland, 4032

  • Study site

    Parkville, Victoria, 3050

  • Study site

    Waratah, New South Wales, 2298

Other trials in Australia

Belgium5 sites

  • Study site

    Brussels, 1200

  • Study site

    Ghent, 9000

  • Study site

    Gilly (Charleroi), 6000

  • Study site

    Liège, 4000

  • Study site

    Namur, 5000

Other trials in Belgium

Poland5 sites

  • Study site

    Gdansk, 80-952

  • Study site

    Krakow, 31-531

  • Study site

    Lodz, 93-509

  • Study site

    Olsztyn, 10-357

  • Study site

    Poznan

Other trials in Poland

Ukraine5 sites

  • Study site

    Cherkassy, 18009

  • Study site

    Chernivtsi, 58013

  • Study site

    Dnipropetrovsk, 49102

  • Study site

    Sumy, 40005

  • Study site

    Zaporizhzhya, 69040

Other trials in Ukraine

Croatia4 sites

  • Study site

    Čakovec, 40000

  • Study site

    Dubrovnik, 20000

  • Study site

    Pula, 52100

  • Study site

    Zagreb, 10000

Other trials in Croatia

South Korea4 sites

  • Study site

    Gyeonggi-do, 443-380

  • Study site

    Seoul, 05505

  • Study site

    Seoul, 06591

  • Study site

    Seoul, 120-752

Other trials in South Korea

Argentina3 sites

  • Study site

    La Plata, B1900BAJ

  • Study site

    Quilmes, 1878

  • Study site

    Santa Fe, S3000FFU

Other trials in Argentina

Chile3 sites

  • Study site

    Santiago, 0

  • Study site

    Santiago, Providencia

  • Study site

    Temuco, 4810469

Other trials in Chile

Hungary3 sites

  • Study site

    Edelény, 3780

  • Study site

    Miskolc, 3529

  • Study site

    Szombathely, 9700

Other trials in Hungary

Netherlands3 sites

  • Study site

    Amsterdam, 1081 HV

  • Study site

    Groningen, 9700 RB

  • Study site

    Maastricht, 6229 HX

Other trials in Netherlands

Peru3 sites

  • Study site

    Lima, L27

  • Study site

    Lima, Lima 1

  • Study site

    Lima, Lima 27

Other trials in Peru

Serbia3 sites

  • Study site

    Belgrade, 11000

  • Study site

    Belgrade, 11080

  • Study site

    Kragujevac, 34000

Other trials in Serbia

South Africa3 sites

  • Study site

    Bloemfontein, 9301

  • Study site

    Johannesburg, 2193

  • Study site

    Sandton, 2196

Other trials in South Africa

Taiwan3 sites

  • Study site

    Changhua, 500

  • Study site

    Kaohsiung City, 813

  • Study site

    Taipei, 100

Other trials in Taiwan

Hong Kong2 sites

  • Study site

    Pokfulam

  • Study site

    Shatin

Other trials in Hong Kong

Ireland2 sites

  • Study site

    Cork

  • Study site

    Dublin, 8

Other trials in Ireland

About this study

Official title: A Randomized, Phase III, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Onartuzumab (Metmab) in Combination With Tarceva (Erlotinib) in Patients With Met Diagnostic-Positive Non-Small Cell Lung Cancer Who Have Received Standard Chemotherapy for Advanced/Metastatic Disease

This randomized, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of onartuzumab (MetMAb) in combination with Tarceva (erlotinib) in participants with incurable non-small cell lung cancer identified to be Met diagnostic-positive. Participants will be randomized to receive either onartuzumab (MetMAb) or placebo in combination with erlotinib. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

Being tested
Erlotinib, Onartuzumab (MetMab), Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ErlotinibDrug

    Also called Tarceva

    Participants will receive erlotinib 150 mg tablet orally once daily from Day 1, Cycle 1.

  • Onartuzumab (MetMab)Drug

    Also called RO5490258

    Participants will receive onartuzumab 15 mg/kg IV infusion on Day 1 of every 3-week cycle.

  • PlaceboDrug

    Participants will receive onartuzumab matching placebo on Day 1 of every 3-week cycle.

Study groups in NCT01456325
Study groupRoleWhat they receive
Onartuzumab+ErlotinibExperimentalParticipants will receive onartuzumab 15 milligrams per kilogram (mg/kg) intravenous (IV) infusion on Day 1 of every cycle of 3 weeks along with erlotinib 150 mg tablet orally once daily (QD) from Day 1, Cycle 1 until there is evidence of disease progression, death, or unacceptable toxicity, whichever occurred first.
Receives: Drug: Erlotinib; Drug: Onartuzumab (MetMab)
Placebo+ErlotinibPlacebo comparatorParticipants will receive onartuzumab matching placebo on Day 1 of every cycle of 3 weeks along with erlotinib 150 mg tablet orally QD from Day 1, Cycle 1 until there is evidence of disease progression, death, or unacceptable toxicity, whichever occurred first.
Receives: Drug: Erlotinib; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival

    Measured: Randomization until death (up to approximately 18 months) (assessed at the treating physician's discretion using the local standard-of-care practice)

Secondary outcomes (5)

  1. European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) Scores

    Measured: Screening, Day 1 of Cycles 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22 (cycle length = 21 days), study drug discontinuation visit (up to approximately 18 months)

  2. Onartuzumab Serum Concentrations

    Measured: 1 hour pre-onartuzumab (Pr-O) infusion on Day 1 of Cycles 1, 2, and 4, 1 hour post-onartuzumab (Po-O) infusion on Day 1 of Cycle 1 (cycle length = 21 days and duration of infusion = 60 minutes), End of treatment (up to approximately 18 months)

  3. Percentage of Participants With Disease Progression or Death

    Measured: Randomization until disease progression or death, whichever occurred first (up to approximately 18 months) (assessed at the treating physician's discretion using the local standard-of-care practice)

  4. Progression Free Survival (PFS)

    Measured: Randomization until disease progression or death, whichever occurred first (up to approximately 18 months) (assessed at the treating physician's discretion using the local standard-of-care practice)

  5. Percentage of Participants with an Objective Response Assessed Using RECIST V 1.1

    Measured: Randomization until disease progression or death, whichever occurred first (up to approximately 18 months) (assessed at the treating physician's discretion using the local standard-of-care practice)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2011 (estimated)
  2. Study startJan 2012
  3. Primary completionJan 2016
  4. Study completionJan 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
494 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01456325
Sponsor's protocol ID
OAM4971g
Other IDs
GO27761, 2011-002224-40
Status last verified
Nov 2016
First submitted
18 Oct 2011
Last updated
2 Nov 2016
Results posted
No

Publications

  • Koeppen H, Yu W, Zha J, Pandita A, Penuel E, Rangell L, Raja R, Mohan S, Patel R, Desai R, Fu L, Do A, Parab V, Xia X, Januario T, Louie SG, Filvaroff E, Shames DS, Wistuba I, Lipkind M, Huang J, Lazarov M, Ramakrishnan V, Amler L, Phan SC, Patel P, Peterson A, Yauch RL. Biomarker analyses from a placebo-controlled phase II study evaluating erlotinib+/-onartuzumab in advanced non-small cell lung cancer: MET expression levels are predictive of patient benefit. Clin Cancer Res. 2014 Sep 1;20(17):4488-98. doi: 10.1158/1078-0432.CCR-13-1836. Epub 2014 Mar 31.

    PubMed 24687921

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Erlotinib and Onartuzumab (MetMab) in people with Non-Squamous Non-Small Cell Lung Cancer, run by Genentech, Inc. at 213 sites in 27 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 213 sites in United States, Japan, Germany, France, Spain and 22 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: Randomization until death (up to approximately 18 months) (assessed at the treating physician's discretion using the local standard-of-care practice)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01456325, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.

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