AzTrials
AzTrials

Non Squamous, Non-small-cell Lung CancerPhase 3NCT01244191

Tivantinib Plus Erlotinib Versus Placebo Plus Erlotinib for the Treatment of Non-squamous, Non-small-cell Lung Cancer

A Phase 3 study testing Tivantinib and Erlotinib in people with Non Squamous, Non-small-cell Lung Cancer, run by Daiichi Sankyo at 304 sites in 23 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

This study is to determine if the combination regimen of tivantinib with erlotinib will improve overall survival relative to erlotinib alone in subjects with locally advanced or metastatic non-squamous, non-small cell lung cancer who have received 1 or 2 prior systemic anti-cancer therapies. 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?
Tivantinib and Erlotinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,048 participants
Where
304 sitesin 23 countries
Study dates
11 Jan 2011to 15 Dec 2012
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Histologically or cytologically confirmed surgically unresectable locally advanced or metastatic (stage IIIB/IV) non-squamous non-small-cell lung cancer.
  • Measurable disease and documented disease progression following last prior therapy according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, Version 1.1.
  • Have received one or two prior lines of systemic anti-cancer therapy therapy for advanced or metastatic disease, one of which must be a platinum-doublet therapy. Patients who received only adjuvant treatment will be eligible only if disease progression occurred <6 months after completion of adjuvant therapy. Prior maintenance therapy is allowed and will be considered as the same line of therapy when continued without discontinuation after initiation of a treatment regimen.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Resolution of any toxic effects of prior therapy (including radiotherapy) according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0, Grade ≤1 (with the exception of alopecia and ≤grade 2 neuropathy). Subject must have recovered from significant surgery-related complications.
  • Demonstrate adequate bone marrow, liver, and renal functions, defined as:
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  • ALT, AST, and alkaline phosphatase ≤ 2.5 × upper limit of normal (ULN) in subjects with no liver metastasis and ≤5.0 x ULN in subjects with liver metastasis.
  • Total bilirubin ≤ 1.5 × ULN (≤ 4 × ULN total and ≤1.5 × ULN direct bilirubin is acceptable for subjects with Gilbert's syndrome).
  • ANC ≥1.5 × 10^9/L.
  • Platelet count ≥100 × 10^9/L.
  • Hemoglobin ≥9.0 g/dL (transfusion and/or growth factor support allowed).
  • Serum creatinine ≤1.5 × ULN or creatinine clearance ≥ 60 mL/min.
  • Archival and/or fresh biopsy tissue sample must be available for biomarker determination. The status of the following biomarkers will be collected in this study: EGFR and KRAS mutation status prior to randomization, and MET status post randomization
  • If of child-bearing/reproductive potential (female or male), must agree to use double-barrier contraceptive measures, oral contraception, or avoidance of intercourse during the study and for 90 days after last investigational drug dose received
  • If female and of childbearing potential, must have a negative result of a pregnancy test (serum or urine) within 72 hours prior to initiating study treatment.
  • Must have signed and dated an approved Informed Consent Form (Including HIPAA authorization, if applicable) before performance of any study-specific procedures or tests. Subjects must be fully informed about their illness and the investigational nature of the study protocol (including forseeable risks and possible side effects)

Who cannot join

  • Prior therapy with an EGFR inhibitor and/or ARQ 197 (or other known c-MET inhibitor).
  • Receipt of any systemic anti-tumor treatment for NSCLC within 3 weeks prior to randomization.
  • Receipt of palliative radiotherapy within 2 weeks or radiotherapy for curative intent of target lesions within 3 weeks prior to randomization. Lesions subjected to radiotherapy within 3 weeks prior to randomization may not be used as target lesions.
  • Major surgical procedure within 3 weeks prior to randomization.
  • History of cardiac disease:
  • Congestive heart failure defined as Class II to IV per New York Heart Association classification; active coronary artery disease; previously diagnosed symptomatic bradycardia (subjects with asymptomatic bradycardia and heart rate above 50 bpm are allowed) or other cardiac arrhythmia defined as ≥Grade 2 according to NCI CTCAE, version 4.0, or uncontrolled hypertension; myocardial infarction that occurred within 6 months prior to study entry (myocardial infarction that occurred > 6 months prior to study entry is permitted).
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  • Clinically unstable central nervous system (CNS) metastasis (to be enrolled in the study, subjects must have confirmation of stable disease by MRI or computed tomography (CT) scan within 4 weeks of randomization and have CNS metastases well controlled by steroids, anti-epileptics or other symptom-relieving medications).
  • Need to breastfeed a child during or within 12 weeks of completing the study.
  • Significant gastrointestinal disorder that, in the opinion of the investigator, could interfere with absorption of ARQ 197 and/or erlotinib (eg, Crohn's disease, small or large bowel resection, malabsorption syndrome).
  • Inability or unwillingness to swallow the complete doses of ARQ 197 or erlotinib.
  • Any known contraindication to treatment with, including hypersensitivity to, ARQ 197 or erlotinib.
  • History of malignancy other than NSCLC within the 5 years prior to randomization, with the exceptions of adequately treated intraepithelial carcinoma of the cervix uteri; prostate carcinoma with a prostate-specific antigen value <0.2 ng/mL; or basal or squamous-cell carcinoma of the skin.
  • Known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV).
  • Any other significant co-morbid condition that, in opinion of the investigator, would impair study participation or cooperation.

Trial locations and contacts

304 sites in 23 countries.

304 sites in 23 countries

United States111 sites

  • Study site

    Albuquerque, New Mexico, 87131

  • Study site

    Arlington, Virginia, 22205

  • Study site

    Atlanta, Georgia, 30341

  • Study site

    Aurora, Colorado, 80012

  • Study site

    Austell, Georgia, 30106

  • Study site

    Austin, Texas, 78705

  • Study site

    Austin, Texas, 78731

  • Study site

    Austin, Texas, 78745

  • Study site

    Austin, Texas, 78758

  • Study site

    Bartlett, Tennessee, 38138

  • Study site

    Boston, Massachusetts, 02114

  • Study site

    Boulder, Colorado, 80303

  • Study site

    Buffalo, New York, 14263

  • Study site

    Carmel, Indiana, 46032

  • Study site

    Carrollton, Georgia, 30117

  • Study site

    Cartersville, Georgia, 30121

  • Study site

    Cedar Park, Texas, 78731

  • Study site

    Chattanooga, Tennessee, 37404

  • Study site

    Chicago, Illinois, 60637

  • Study site

    Cincinnati, Ohio, 45242

  • Study site

    Cleveland, Ohio, 44195

  • Study site

    Colorado Springs, Colorado, 80907

  • Study site

    Colorado Springs, Colorado, 80909

  • Study site

    Columbia, South Carolina, 29120

  • Study site

    Dallas, Texas, 75216-9982

  • Study site

    Dallas, Texas, 75246

  • Study site

    Denver, Colorado, 80218

  • Study site

    Denver, Colorado, 80220

  • Study site

    Douglasville, Georgia, 30134

  • Study site

    Easley, South Carolina, 29640

  • Study site

    East Orange, New Jersey, 07018

  • Study site

    Eugene, Oregon, 97401

  • Study site

    Fairfax, Virginia, 22031

  • Study site

    Fishers, Indiana, 46037

  • Study site

    Fort Myers, Florida, 33916

  • Study site

    Fort Worth, Texas, 76104

  • Study site

    Fort Worth, Texas, 76132

  • Study site

    Gainesville, Virginia, 20155

  • Study site

    Germantown, Tennessee, 38138

  • Study site

    Goshen, Indiana, 46526

  • Study site

    Goshen, New York, 10924

  • Study site

    Grand Island, Nebraska, 68803

  • Study site

    Greenfield, Indiana, 46140

  • Study site

    Greenville, South Carolina, 29601

  • Study site

    Greenville, South Carolina, 29605

  • Study site

    Greenville, South Carolina, 29615

  • Study site

    Harrisburg, Pennsylvania, 17109

  • Study site

    Henderson, Nevada, 89052

  • Study site

    Henderson, Nevada, 89074

  • Study site

    Hershey, Pennsylvania, 17033-0850

  • Study site

    Indianapolis, Indiana, 46219

  • Study site

    Indianapolis, Indiana, 46227

  • Study site

    Indianapolis, Indiana, 48202

  • Study site

    Kettering, Ohio

  • Study site

    Knoxville, Tennessee, 37909

  • Study site

    Kyle, Texas, 78640

  • Study site

    Lakewood, Colorado, 80228

  • Study site

    Las Vegas, Nevada, 89128

  • Study site

    Las Vegas, Nevada, 89148

  • Study site

    Las Vegas, Nevada, 89169

  • Study site

    Latham, New York

  • Study site

    Leesburg, Virginia, 20176

  • Study site

    Lexington, Kentucky

  • Study site

    Littleton, Colorado, 80120

  • Study site

    Lone Tree, Colorado, 80124

  • Study site

    Longmont, Colorado, 80501

  • Study site

    Los Angeles, California, 90048

  • Study site

    Louisville, Kentucky

  • Study site

    Marietta, Georgia, 30060

  • Study site

    Memphis, Tennessee, 38104

  • Study site

    Miami Beach, Florida, 33012

  • Study site

    Midlothian, Virginia, 23112

  • Study site

    Minneapolis, Minnesota, 55455

  • Study site

    Nashville, Tennessee, 37203

  • Study site

    New York, New York, 10032

  • Study site

    Newark, Delaware, 19713

  • Study site

    Omaha, Nebraska, 68198

  • Study site

    Oxnard, California

  • Study site

    Parker, Colorado, 80138

  • Study site

    Pensacola, Florida, 32504

  • Study site

    Philadelphia, Pennsylvania, 19104

  • Study site

    Portland, Oregon, 97213

  • Study site

    Portland, Oregon, 97225

  • Study site

    Portland, Oregon, 97227

  • Study site

    Portland, Oregon, 97239

  • Study site

    Rancho Mirage, California, 39800

  • Study site

    Rancho Mirage, California, 92270

  • Study site

    Richmond, Virginia, 23298

  • Study site

    Round Rock, Texas, 78665

  • Study site

    Round Rock, Texas, 78681

  • Study site

    Salt Lake City, Utah, 84112

  • Study site

    San Marcos, Texas, 78666

  • Study site

    Santa Monica, California, 90404

  • Study site

    Seattle, Washington, 98104

  • Study site

    Southaven, Tennessee, 38671

  • Study site

    Spartanburg, South Carolina, 29307

  • Study site

    Springfield, Oregon, 97477

  • Study site

    St Louis, Missouri, 63110

  • Study site

    The Bronx, New York, 10467

  • Study site

    Thornton, Colorado, 80260

  • Study site

    Towson, Maryland, 21204

  • Study site

    Tualatin, Oregon, 97062

  • Study site

    Tucson, Arizona, 85704

  • Study site

    Tucson, Arizona, 85710

  • Study site

    Tucson, Arizona, 85715

  • Study site

    Tucson, Arizona, 85724-5024

  • Study site

    Vancouver, Washington, 98684

  • Study site

    Vancouver, Washington, 98686

  • Study site

    Winchester, Virginia, 22601

  • Study site

    Woodbridge, Virginia, 22191

  • Study site

    Yakima, Washington, 98902

Other trials in United States

Italy25 sites

  • Study site

    Ancona

  • Study site

    Avellino, 83100

  • Study site

    Aviano, 33081

  • Study site

    Bari, 70124

  • Study site

    Catania, 95126

  • Study site

    Cremona, 26100

  • Study site

    Cuneo, 12100

  • Study site

    Florence, 50134

  • Study site

    Livorno, 57100

  • Study site

    Milan, 20162

  • Study site

    Modena, 41124

  • Study site

    Monza, 20900

  • Study site

    Naples, 80131

  • Study site

    Novara, 28100

  • Study site

    Orbassano, 10043

  • Study site

    Padova, 35128

  • Study site

    Palermo, 90146

  • Study site

    Parma, 43126

  • Study site

    Perugia, 06132

  • Study site

    Roma, 00152

  • Study site

    Rozzano, 20089

  • Study site

    Sassari, 07100

  • Study site

    Sondalo, 23035

  • Study site

    Sora, 03039

  • Study site

    Torino

Other trials in Italy

Germany24 sites

  • Study site

    Bad Berka, 99437

  • Study site

    Berlin, 10117

  • Study site

    Berlin, 12203

  • Study site

    Cologne, 51109

  • Study site

    Erfurt

  • Study site

    Essen, 45122

  • Study site

    Esslingen am Neckar, 73730

  • Study site

    Gauting, 82131

  • Study site

    Großhansdorf, 22927

  • Study site

    Halle, 06120

  • Study site

    Hamburg, 21075

  • Study site

    Hanover, 30625

  • Study site

    Karlsruhe, 76137

  • Study site

    Kassel, 34125

  • Study site

    Leverkusen, 51375

  • Study site

    Löwenstein, 74245

  • Study site

    Mainz, 55131

  • Study site

    Mannheim, 68167

  • Study site

    München, 80336

  • Study site

    München, 81925

  • Study site

    München

  • Study site

    Porta Westfalica, 32457

  • Study site

    Rheine, 48431

  • Study site

    Villingen-Schwenningen, 78050

Other trials in Germany

Spain21 sites

  • Study site

    A Coruña, 15006

  • Study site

    A Coruña, 15009

  • Study site

    Alicante, 03010

  • Study site

    Barakaldo, Bilbao, 48903

  • Study site

    Barcelona, 08003

  • Study site

    Barcelona, 08907

  • Study site

    Madrid, 28034

  • Study site

    Madrid, 28041

  • Study site

    Madrid

  • Study site

    Málaga, 29010

  • Study site

    Manresa, 08243

  • Study site

    Oviedo, 33006

  • Study site

    Palma de Mallorca, 07010

  • Study site

    Sabadell, 08208

  • Study site

    San Cristóbal de La Laguna, 38320

  • Study site

    Santiago de Compostela, 15706

  • Study site

    Seville, 41013

  • Study site

    Seville, 41700

  • Study site

    Valencia, 46010

  • Study site

    Vigo, Pontevedra, 36204

  • Study site

    Zaragoza, 50009

Other trials in Spain

France15 sites

  • Study site

    Besançon, 25000

  • Study site

    Brest, 29609

  • Study site

    Caen, 14033

  • Study site

    Grenoble, 9

  • Study site

    Lille, 59037

  • Study site

    Marseille

  • Study site

    Paris, 75013

  • Study site

    Paris, 75230

  • Study site

    Pierre-Bénite, 69495

  • Study site

    Rennes, 35033

  • Study site

    Saint-Priest-en-Jarez

  • Study site

    Strasbourg

  • Study site

    Toulouse, 31059

  • Study site

    Tours, 37044

  • Study site

    Villejuif, 94805

Other trials in France

Russia14 sites

  • Study site

    Chelyabinsk, 454087

  • Study site

    Irkutsk, 664035

  • Study site

    Izhevsk, 426009

  • Study site

    Kursk, 305035

  • Study site

    Moscow, 115478

  • Study site

    Moscow, 125367

  • Study site

    Novosibirsk

  • Study site

    Pyatigorsk, 357502

  • Study site

    Saint Petersburg, 197022

  • Study site

    Saint Petersburg, 197758

  • Study site

    Saint Petersburg, 198255

  • Study site

    Tula, 300040

  • Study site

    Tyumen, 625041

  • Study site

    Velikiy Novgorod, 603081

Other trials in Russia

Poland12 sites

  • Study site

    Bystra, 43-360

  • Study site

    Krakow, 31302

  • Study site

    Lublin

  • Study site

    Olsztyn, 31302

  • Study site

    Opole

  • Study site

    Poznan, 60-569

  • Study site

    Poznan

  • Study site

    Prabuty, 82550

  • Study site

    Rzeszów, 35922

  • Study site

    Szczecin, 70891

  • Study site

    Torun

  • Study site

    Wałbrzych

Other trials in Poland

Brazil11 sites

  • Study site

    Ijuí

  • Study site

    Joinville, Santa Catarina, 89202050

  • Study site

    Joinville, Santa Catarina, 89202

  • Study site

    Passo Fundo, Rio Grande do Sul, 99010-080

  • Study site

    Passo Fundo, Rio Grande do Sul, 99010-260

  • Study site

    Porto Alegre, Rio Grande do Sul, 90430-090

  • Study site

    Porto Alegre

  • Study site

    Rio de Janeiro, Rio de Janeiro, 20231-050

  • Study site

    Salvador, Estado de Bahia, 41253-190

  • Study site

    São Paulo, 01224-10

  • Study site

    São Paulo

Other trials in Brazil

Canada11 sites

  • Study site

    Edmonton, Alberta, T6G 1Z2

  • Study site

    London, Ontario, N6A 4L6

  • Study site

    Montreal, Quebec, H1T 2M4

  • Study site

    Montreal, H2W 1S6

  • Study site

    Québec, G1V 4G5

  • Study site

    Surrey, British Columbia, V3V 1Z2

  • Study site

    Thunder Bay, Ontario, P7B6V4

  • Study site

    Toronto, Ontario, M5G 1X5

  • Study site

    Toronto, M5G 2M9

  • Study site

    Victoria, British Columbia, V8R lC3

  • Study site

    Winnipeg, Manitoba, RSE 0V9

Other trials in Canada

United Kingdom8 sites

  • Study site

    Aberdeen, AB25 2ZN

  • Study site

    Glasgow, G12OYN

  • Study site

    Guildford, Surrey, GU2 7XX

  • Study site

    London, NW1 2PG

  • Study site

    London, W6 9RF

  • Study site

    Manchester, M20 4BX

  • Study site

    Nottingham, NG5 1PB

  • Study site

    Sheffield, S10 2SJ

Other trials in United Kingdom

Australia7 sites

  • Study site

    Camperdown

  • Study site

    Greenslopes, Queensland, 4120

  • Study site

    Kogarah

  • Study site

    Perth

  • Study site

    St Leonards, 2065

  • Study site

    Wollongong

  • Study site

    Woodville

Other trials in Australia

Mexico6 sites

  • Study site

    Guadalajara, 44280

  • Study site

    Mexico City, Mexico City

  • Study site

    Mexico City

  • Study site

    Monterrey, Nuevo León, 64460

  • Study site

    Oaxaca City, 68000

  • Study site

    Oaxaca City, 70000

Other trials in Mexico

Argentina5 sites

  • Study site

    Buenos Aires

  • Study site

    Córdoba, X5000AA1

  • Study site

    Rosario, Santa Fe Province, S2000SDV

  • Study site

    San Miguel de Tucumán

  • Study site

    Viedma

Other trials in Argentina

Hungary5 sites

  • Study site

    Deszk, H-6772

  • Study site

    Gyula, H-5703

  • Study site

    Mátraháza, H-3233

  • Study site

    Székesfehérvár, H-8000

  • Study site

    Szolnok, H-5000

Other trials in Hungary

Peru5 sites

  • Study site

    Arequipa

  • Study site

    Lima, 27

  • Study site

    Lima, 34

  • Study site

    Lima, 41

  • Study site

    Lima

Other trials in Peru

Chile4 sites

  • Study site

    Santiago, 7500710

  • Study site

    Santiago, 7500921

  • Study site

    Santiago, 7520378

  • Study site

    Santiago, 8380455

Other trials in Chile

Czechia4 sites

  • Study site

    Ostrava, 70384

  • Study site

    Pardubice, 53203

  • Study site

    Prague, 12808

  • Study site

    Ústí nad Labem

Other trials in Czechia

Belgium3 sites

  • Study site

    Brasschaat, 2930

  • Study site

    Brussels

  • Study site

    Duffel, 2570

Other trials in Belgium

Denmark3 sites

  • Study site

    Herlev, DK-2730

  • Study site

    Næstved, 4700

  • Study site

    Odense, DK-5000

Other trials in Denmark

Netherlands3 sites

  • Study site

    Amsterdam

  • Study site

    Enschede, ER, 7513

  • Study site

    Helmond, HA, 5707

Other trials in Netherlands

Romania3 sites

  • Study site

    Cluj-Napoca, 400015

  • Study site

    Craiova, 200385

  • Study site

    Oradea, 410167

Other trials in Romania

Austria2 sites

  • Study site

    Salzburg, 5020

  • Study site

    Wels, A-4600

Other trials in Austria

Sweden2 sites

  • Study site

    Linköping, 581 85

  • Study site

    Lund

Other trials in Sweden

About this study

Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of ARQ197 Plus Erlotinib Versus Placebo Plus Erlotinib in Previously Treated Subjects With Locally Advanced or Metastatic, Non-Squamous, Non-Small-Cell Lung Cancer (NSCLC)

This study is to determine if the combination regimen of tivantinib with erlotinib will improve overall survival relative to erlotinib alone in subjects with locally advanced or metastatic non-squamous, non-small cell lung cancer who have received 1 or 2 prior systemic anti-cancer therapies.

Being tested
Tivantinib, Placebo, Erlotinib
Keywords
Non squamous, non-small-cell lung cancer, Epidermal growth factor receptor, c-Met inhibitor
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • TivantinibDrug

    Also called ARQ197

    Tivantinib 720 mg daily as 3 x 120 mg oral tablets given twice a day

  • PlaceboDrug

    Also called No drug

    Tivantinib Placebo tablets given twice a day

  • ErlotinibDrug

    Erlotinib 150 mg oral tablets, given once a day

Study groups in NCT01244191
Study groupRoleWhat they receive
Tivantinib and erlotinibExperimentalTivantinib 720 mg daily (360 mg twice a day) in combination with 150 mg of erlotinib, given once a day
Receives: Drug: Tivantinib; Drug: Erlotinib
Placebo and erlotinibActive comparatorTivantinib placebo given twice a day in combination with 150 mg of erlotinib, given once a day
Receives: Drug: Placebo; Drug: Erlotinib

What is being measured

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

  1. Overall Survival Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Locally Advanced or Metastatic, Non-Squamous, Non-Small-Cell Lung Cancer

    The overall survival (OS) was defined as the time from the date of randomization to the date of death from any cause.

    Measured: Date of randomization up to date of death, up to approximately 1 year 11 months postdose

Secondary outcomes (7)

  1. Progression-free Survival Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Locally Advanced or Metastatic, Non-Squamous, Non-Small-Cell Lung Cancer

    Progression-free Survival (PFS) was defined as the time from the date of randomization to the date of the first objective documentation of disease progression or date of death from any cause (whichever comes first). As per the Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) criteria, progression was defined as at least a 20% increase in the sum of diameters of target lesions.

    Measured: Date of randomization to disease progression or death (whichever comes first), up to 1 year 11 months postdose

  2. Overall Survival in the Epidermal Growth Factor Receptor Gene Wild-Type Subpopulation Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Non-Squamous NSCLC

    The overall survival (OS) was defined as the time from the date of randomization to the date of death from any cause.

    Measured: Date of randomization up to date of death, up to approximately 1 year 11 months postdose

  3. Progression-free Survival in the Epidermal Growth Factor Receptor (EGFR) Gene Wild-Type Subpopulation Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants Non-Squamous NSCLC

    Progression-free Survival (PFS) was defined as the time from the date of randomization to the date of the first objective documentation of disease progression or date of death from any cause (whichever comes first). As per the Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) criteria, progression was defined as at least a 20% increase in the sum of diameters of target lesions.

    Measured: Date of randomization to disease progression or death (whichever comes first), up to 1 year 11 months postdose

  4. Best Overall Tumor Response Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Locally Advanced or Metastatic, Non-Squamous, Non-Small-Cell Lung Cancer

    The best overall response was defined as the best response (in the order of confirmed complete response [CR], confirmed partial response [PR], stable disease [SD], and progressive disease [PD]) among all overall responses recorded from the start of treatment until the participant withdrew from the study. If there was no tumor assessment after the first dose of study drug, the best overall response was classified as Inevaluable. Based on RECIST v1.1, CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions.

    Measured: From baseline up to disease progression or the development of unacceptable toxicity (whichever occurs first), up to 1 year 11 months postdose

  5. Duration of Response Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Locally Advanced or Metastatic, Non-Squamous, Non-Small-Cell Lung Cancer

    Duration of response was defined for participants with confirmed CR or PR as the time from the date of the first documentation of objective response (CR or PR) to the date of the first documentation of progressive disease. Duration of SD was defined for participants whose best response was SD as the time from the randomization date to the date of the first documentation of progressive disease.

    Measured: From the date of first objective response (CR or PR) or SD to date of progressive disease, up to 1 year 11 months postdose

  6. Treatment-Emergent Adverse Events Reported in ≥5% of Participants Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Non-Squamous, Non-Small-Cell Lung Cancer

    Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration.

    Measured: Baseline up to 30 days after last dose, up to 1 year 11 months postdose

  7. Treatment-Emergent Adverse Events Related to Tivantinib/Placebo Experienced by ≥5% of Participants Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Non-Squamous NSCLC

    Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration.

    Measured: Baseline up to 30 days after last dose, up to 1 year 11 months postdose

Timeline

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

  1. First posted19 Nov 2010 (estimated)
  2. Study start11 Jan 2011
  3. Primary completion15 Dec 2012
  4. Study completion15 Dec 2012

Why it stopped: Sponsor decision due to the protocol-defined stopping boundary for futility was met based on the interim OS data.

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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
1,048 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01244191
Sponsor's protocol ID
ARQ197-A-U302
Other IDs
2010-022365-10
Status last verified
Mar 2021
First submitted
17 Nov 2010
Last updated
6 Apr 2021
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Scagliotti G, von Pawel J, Novello S, Ramlau R, Favaretto A, Barlesi F, Akerley W, Orlov S, Santoro A, Spigel D, Hirsh V, Shepherd FA, Sequist LV, Sandler A, Ross JS, Wang Q, von Roemeling R, Shuster D, Schwartz B. Phase III Multinational, Randomized, Double-Blind, Placebo-Controlled Study of Tivantinib (ARQ 197) Plus Erlotinib Versus Erlotinib Alone in Previously Treated Patients With Locally Advanced or Metastatic Nonsquamous Non-Small-Cell Lung Cancer. J Clin Oncol. 2015 Aug 20;33(24):2667-74. doi: 10.1200/JCO.2014.60.7317. Epub 2015 Jul 13.

    PubMed 26169611

  • Scagliotti GV, Novello S, Schiller JH, Hirsh V, Sequist LV, Soria JC, von Pawel J, Schwartz B, Von Roemeling R, Sandler AB. Rationale and design of MARQUEE: a phase III, randomized, double-blind study of tivantinib plus erlotinib versus placebo plus erlotinib in previously treated patients with locally advanced or metastatic, nonsquamous, non-small-cell lung cancer. Clin Lung Cancer. 2012 Sep;13(5):391-5. doi: 10.1016/j.cllc.2012.01.003. Epub 2012 Mar 21.

    PubMed 22440336

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tivantinib and Erlotinib in people with Non Squamous, Non-small-cell Lung Cancer, run by Daiichi Sankyo at 304 sites in 23 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 16 inclusion and 14 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: stopped early, as of the sponsor's last update on 6 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 304 sites in United States, Italy, Germany, Spain, France and 18 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. 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?

Yes. Results are posted in the registry (first posted 30 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Locally Advanced or Metastatic, Non-Squamous, Non-Small-Cell Lung Cancer (time frame: Date of randomization up to date of death, up to approximately 1 year 11 months postdose). 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 NCT01244191, which also lists 2 linked publications.

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 6 Apr 2021.

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