AzTrials
AzTrials

Non-Squamous Non-Small Cell Lung CancerPhase 3NCT01351415

A Study of Bevacizumab in Combination With Standard of Care Treatment in Participants With Advanced Non-squamous Non-small Cell Lung Cancer (NSCLC)

A Phase 3 study testing Bevacizumab, Docetaxel and Erlotinib in people with Non-Squamous Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 179 sites in 18 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 open-label, randomized, multicenter study will evaluate the efficacy and safety of bevacizumab (Avastin) in combination with standard of care (SOC) treatment in participants with advanced non-squamous NSCLC. 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?
Bevacizumab, Docetaxel and Erlotinib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
485 participants
Where
179 sitesin 18 countries
Study dates
25 Jun 2011to 25 Jun 2016
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 non-squamous NSCLC
  • Documented progression of disease (locally recurrent or metastatic) per investigator assessment following first-line treatment with 4-6 cycles of Bevacizumab plus a platinum doublet-containing chemotherapy regimen and a minimum of 2 cycles of Bevacizumab (monotherapy) maintenance treatment prior to first progression of disease
  • No treatment interruption of Bevacizumab treatment greater than 2 consecutive cycles (42 days) between the start of first-line treatment to start of Cycle 1 of second line treatment
  • Randomization within 4 weeks of progression of disease
  • At least one unidimensionally measurable lesion meeting RECIST v1.1 criteria
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Participants with adequate hematological, liver, and renal function
  • Female participants must not be pregnant or breast-feeding. Female participants of childbearing potential and fertile male participants must agree to use a highly effective contraceptive during the trial and for a period of at least 6 months following the last administration of trial drug(s)

Who cannot join

  • Mixed, non-small cell and small cell tumors or mixed adenosquamous carcinomas with a predominant squamous component
  • Epidermal growth factor receptor (EGFR)-mutation-positive disease according to local laboratory testing
  • History of hemoptysis greater than or equal to (>/=) grade 2 within 3 months of randomization
  • History or evidence of inherited bleeding diathesis or coagulopathy with a risk of bleeding and active gastrointestinal bleeding
  • Major cardiac disease
  • Treatment with any other investigational agent within 28 days prior to randomization
  • Known hypersensitivity to bevacizumab or any of its excipients, or any SOC drugs foreseen
  • Malignancy other than NSCLC within 5 years prior to randomization and evidence of any other disease that contraindicates the use of an investigational or SOC drug

Trial locations and contacts

179 sites in 18 countries.

179 sites in 18 countries

United States68 sites

  • McFarland Clinic

    Ames, Iowa, 50010

  • Ann Arbor Hematology Oncology

    Ann Arbor, Michigan, 48106

  • Anne Arundel Health System Research Instit-Annapolis Oncology Ctr

    Annapolis, Maryland, 21401

  • Fox Valley Hema and Onc SC

    Appleton, Wisconsin, 54915

  • Emory Univ Winship Cancer Inst

    Atlanta, Georgia, 30322

  • Hematology/Oncology Clinic, LLP

    Baton Rouge, Louisiana, 70809

  • St. Lukes Hospital and Health Network

    Bethlehem, Pennsylvania, 18015

  • Lynn Cancer Institute - West

    Boca Raton, Florida, 33428

  • Tufts Medical Center; Neely Cancer Center

    Boston, Massachusetts, 02111

  • East Valley Hematology ; Oncology Medical Group

    Burbank, California, 91505

  • Aultman Hospital

    Canton, Ohio, 44710

  • Mid Ohio Onc Hematology Inc

    Columbus, Ohio, 43219

  • Bay Area Hospital

    Coos Bay, Oregon, 97420

  • Unv of TX SW Med Cntr; Hematology/Onc

    Dallas, Texas, 75390-9015

  • Dayton Clinical Oncology Prog

    Dayton, Ohio, 45420

  • Henry Ford Hospital; Hematology Oncology

    Detroit, Michigan, 48202

  • Hematology & Oncology Assoc; North Eastern Pennsylvania

    Dunmore, Pennsylvania, 18512

  • Alexian Brothers Neurosci Inst

    Elk Grove Village, Illinois, 60007

  • California Cancer Associates for Research & Excellence, Inc.

    Encinitas, California, 92008

  • Oncology-Evanston Nthwest Healthcare Kellogg Cancer Care Ctr

    Evanston, Illinois, 60201

  • West Clinic

    Germantown, Tennessee, 38138

  • Palo Verde Hema/Onc

    Glendale, Arizona, 85304

  • Arizona Center for Cancer Care

    Glendale, Arizona, 85306

  • Cancer & Hematology Center of West Michigan

    Grand Rapids, Michigan, 49546

  • Carolina Oncology Specialists, PA - Hickory

    Hickory, North Carolina, 28602

  • St. Francis Medical Group

    Indianapolis, Indiana, 46237

  • Baptist - MD Anderson Cancer Center

    Jacksonville, Florida, 32207

  • Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy)

    Jacksonville, Florida, 32256

  • Joliet Oncology Hematology Associates, Ltd.

    Joliet, Illinois, 60435

  • Clopton Clinic

    Jonesboro, Arkansas, 72401

  • University of Tennessee Medical Center Cancer Institute

    Knoxville, Tennessee, 37920

  • Gundersen Lutheran

    La Crosse, Wisconsin, 54601

  • Scripps Clinic; Hematology & Oncology

    La Jolla, California, 92037-1027

  • Louisiana Oncology Associates

    Lafayette, Louisiana, 70508

  • St. Mary Medical Center

    Langhorne, Pennsylvania, 19047

  • University of Kentucky Medical Center

    Lexington, Kentucky, 40536

  • Jewish Cancer Care

    Louisville, Kentucky, 40245

  • UNI OF WISCONSIN SCHOOL OF MEDICINE; GI Oncology Research Group, Paul P Carbone Cancer Center

    Madison, Wisconsin, 53792

  • Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Signal Point Clinical; Research Center, LLC

    Middletown, Ohio, 45042

  • USA Mitchell Cancer Institute

    Mobile, Alabama, 36688

  • The Hospital of Central CT

    New Britain, Connecticut, 06050

  • Oncology Hematology Associates of Southwest Indiana

    Newburgh, Indiana, 47630

  • Cancer Care & Hematology; Specialists of Chicagoland

    Niles, Illinois, 60714

  • Eastern Ct Hema/Onco Assoc; Dept of Oncology

    Norwich, Connecticut, 06360

  • Memorial Hospital of Rhode Island

    Pawtucket, Rhode Island, 02860

  • University of Pennsylvania; Radiation Oncology

    Philadelphia, Pennsylvania, 19104

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140

  • Delta Hematology/ Oncology Associates

    Portsmouth, Virginia, 23704

  • Kootenai Cancer Center

    Post Falls, Idaho, 83854

  • W. Suburban Ctr for Cncer Care

    River Forest, Illinois, 60305

  • Blue Ridge Cancer Care - Roanoke

    Roanoke, Virginia, 24014

  • Cancer Care Centers of Brevard

    Rockledge, Florida, 32955

  • Sutter Cancer Center

    Sacramento, California, 95816

  • St Joseph Oncology

    Saint Joseph, Missouri, 64507

  • Metro-Minnesota CCOP

    Saint Louis Park, Minnesota, 55416

  • Coastal Integrative Cancer Care

    San Luis Obispo, California, 93401

  • Summit Cancer Care PC

    Savannah, Georgia, 31405

  • New England Cancer Specialists

    Scarborough, Maine, 04074

  • Medical Oncology Associates

    Spokane, Washington, 99208

  • Heartland CCOP/Missouri Baptist Medical Center

    St Louis, Missouri, 63131

  • Stony Brook Univ Cancer Ctr; Medical Oncology Clinic

    Stony Brook, New York, 11794-9447

  • Toledo Hospital; CCOP Toledo

    Toledo, Ohio, 43617

  • Innovative Clinical Research Institute

    Whittier, California, 90603

  • Cancer Center of Kansas

    Wichita, Kansas, 67214-3728

  • Lankenau Hospital

    Wynnewood, Pennsylvania, 19096

  • York Hospital

    York Village, Maine, 03909

Other trials in United States

France19 sites

  • Poly Parc Rambot La Provencale; Chimiotherapie Ambulatoire

    Aix-en-Provence, 13617

  • Centre Francois Baclesse; Oncologie

    Caen, 14076

  • Centre Hospitalier Intercommunal; Service de Pneumologie

    Créteil, 94010

  • Hopital Nord Ouest;Unite 2c

    Gleizé, 69400

  • Centre Oscar Lambret

    Lille, 59020

  • Hopital Calmette; Pneumologie

    Lille, 59037

  • Hopital Louis Pradel; Cardiologie B

    Lyon, 69394

  • Hôpital Saint Joseph; Oncologie Medicale

    Marseille, 13285

  • Hopital Nord; Service d'Oncologie Multidisciplinaire et Innovation Thérapeutique

    Marseille, 13915

  • Centre Antoine Lacassagne

    Nice, 06189

  • Ch Lyon Sud; Chir Onc Gyne Sct Jules Courmont

    Pierre-Bénite, 69310

  • CH Rene Dubos; Oncologie

    Pontoise, 95300

  • Ico Rene Gauducheau; Oncologie

    Saint-Herblain, 44805

  • Institut de Cancérologie de Loire

    Saint-Priest-en-Jarez, 42271

  • Centre Paul Strauss; Oncologie Medicale

    Strasbourg, 67065

  • Hia Sainte Anne; Pneumologie

    Toulon, 83041

  • Hopital Sainte Musse; Pneumologie

    Toulon, 83056

  • Clinique Pasteur; Pneumologie

    Toulouse, 31076

  • Chi De La Haute Saone De Vesoul; Pneumologie

    Vesoul, 70014

Other trials in France

Germany15 sites

  • Zentralklinik Bad Berka GmbH; Pneumologie

    Bad Berka, 99437

  • Praxis Dr. med. David Borquez

    Bergisch Gladbach, 51465

  • Klinikum Esslingen; Klinik für Kardiologie, Angiologie und Pneumologie

    Esslingen am Neckar, 73730

  • Krankenhaus Nordwest; Klinik f. Onkologie und Hämatologie

    Frankfurt, 60488

  • SRH Wald-Klinikum Gera; Klinik für Hautkrankheiten und Allergologie

    Gera, 07548

  • LungenClinic Großhansdorf

    Großhansdorf, 22927

  • Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin I

    Halle, 06120

  • Universitaetsklinikum des Saarlandes; Innere Medizin V

    Homburg/Saar, 66421

  • Fachklinik für Lungenerkrankungen

    Immenhausen, 34376

  • St. Vincentius Kliniken Karlsruhe; Abteilung Hämatologie / Onkologie

    Karlsruhe, 76137

  • Robert-Koch-Klinik; Pneumologie

    Leipzig, 04207

  • Praxis Christian Geßner

    Leipzig, 04357

  • Johannes-Wesling-Klinikum Minden; Onkologische Ambulanz / Tagesklinik

    Minden, 32429

  • Ludwig-Maximilians Uni Klinik Innenstadt; Medizinische Klinik

    München, 80336

  • Pius-Hospital; Klinik fuer Haematologie und Onkologie

    Oldenburg, 26121

Other trials in Germany

Japan14 sites

  • Aichi Cancer Center Hospital; Respiratory Medicine

    Aichi, 464-8681

  • National Cancer Center Hospital East; Thoracic Oncology

    Chiba, 277-8577

  • National Hospital Organization Shikoku Cancer Center; Thoracic Oncology

    Ehime, 791-0280

  • National Hospital Organization Kyushu Cancer Center, Thoracic Oncology

    Fukuoka, 811-1395

  • Hyogo Cancer Center; Thoracic Oncology

    Hyōgo, 673-8553

  • Kanagawa Cardiovascular and Respiratory Center; Respiratory Medicine

    Kanagawa, 236-0051

  • Yokohama Municipal Citizen'S Hospital; Respiratory

    Kanagawa, 240-8555

  • Miyagi Cancer Center; Respiratory Medicine

    Miyagi, 981-1293

  • Okayama University Hospital; Respiratory and Allergy Medicine

    Okayama, 700-8558

  • OSAKA CITY GENERAL HOSPITAL;Medical Oncology

    Osaka, 534-0021

  • Osaka International Cancer Institute; Thoracic Oncology

    Osaka, 541-8567

  • Shizuoka Cancer Center; Thoracic Oncology

    Shizuoka, 411-8777

  • National Cancer Center Hospital; Thoracic Medical Oncology

    Tokyo, 104-0045

  • The Cancer Institute Hospital of JFCR, Respiratory Medicine

    Tokyo, 135-8550

Other trials in Japan

Brazil10 sites

  • Sociedade beneficente de senhoras Hospital Sirio Libanes

    Brasília, Federal District, 70200-730

  • Centro de Estudos e Pesquisas Oncologicas - CESPO

    Brasília, Federal District, 70390-150

  • Centro de Pesquisa Clínica- Instituto do Câncer do Ceará- ICC

    Fortaleza, Ceará, 60125-120

  • Hospital de Caridade de Ijui; Oncologia

    Ijuí, Rio Grande do Sul, 98700-000

  • Clinica de Neoplasias Litoral

    Itajaí, Santa Catarina, 88301-220

  • Clinicas Oncologicas Integradas - COI

    Rio de Janeiro, Rio de Janeiro, 22793-080

  • Nucleo de Oncologia da Bahia - NOB

    Salvador, Bahia, Estado de Bahia, 40170-380

  • Hospital A. C. Camargo; Oncologia

    São Paulo, São Paulo, 01509-010

  • Hospital Sao Jose

    São Paulo, São Paulo, CEP 01321-001

  • Instituto de Câncer de Brasília

    Taguatinga, Federal District, 72110-980

Other trials in Brazil

Austria8 sites

  • LKH Hohenems; Abteilung für Pulmologie

    Hohenems, 6845

  • Tiroler Landeskrankenanstalten Ges.M.B.H.; Innere Medizin Abt. Für Hämatologie & Onkologie

    Innsbruck, 6020

  • Lkh Natters; Abt. Für Atemwegs- & Lungenkrankheiten

    Natters, 6161

  • A.Ö. LKH; Abt. für Lungenkrankheiten

    Steyr, 4400

  • Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie

    Vienna, 1090

  • Krankenhaus Der Stadt Wien Lainz; V. Medizinische Abt.

    Vienna, 1130

  • SMZ - Baumgartner Hohe, Pavilion Leopold; 1.Interne Lungenabteilung, Onkologische Tagesklinik

    Vienna, 1140

  • Klinikum Wels-Grieskirchen; Lungenabt.

    Wels, 4600

Other trials in Austria

Spain8 sites

  • Hospital General Univ. de Alicante; Servicio de Oncologia

    Alicante, 3010

  • Hospital de Cruces; Servicio de Oncologia

    Barakaldo, Vizcaya, 48903

  • Centro Oncologico MD Anderson International Espana

    Madrid, 28033

  • Hospital Universitario Clínico San Carlos; Servicio de Oncologia

    Madrid, 28040

  • Hospital Universitario La Paz; Servicio de Oncologia

    Madrid, 28046

  • Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

    Valencia, 46010

  • Hospital Universitario Dr. Peset; Servicio de Oncologia

    Valencia, 46017

  • Hospital Universitario Miguel Servet; Servicio Oncologia

    Zaragoza, 50009

Other trials in Spain

Italy7 sites

  • Citta Ospedaliera; Divisione Oncologia Medica

    Avellino, Campania, 83100

  • IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A

    Genoa, Liguria, 16132

  • IRCCS Istituto Nazionale Tumori Fondazione Pascale; Oncologia Medica A

    Naples, Campania, 80131

  • A.O. Universitaria Pisana-Ospedale Cisanello; Dipartimento Cardio Toracico-Pneumologia Ii

    Pisa, Tuscany, 56124

  • Policlinico Universitario Campus Biomedico; Uoc Oncologia Medica

    Rome, Lazio, 00128

  • Azienda Ospedaliera San Camillo Forlanini; U.O.C. Pneumologia Ad Indirizzo Oncologico 1

    Rome, Lazio, 00152

  • Az. Osp. Di Busto P.O. Di Saronno; U.O. Di Oncologia Medica

    Saronno, Lombardy, 21047

Other trials in Italy

Argentina6 sites

  • Inst. Alexander Fleming; Oncology Dept

    Buenos Aires, C1426ANZ

  • Centro Oncologico Infinito; Oncologia

    La Pampa, 6300

  • Hospital Privado de Comunidad; Oncology

    Mar del Plata, 7600

  • Sanatorio Parque de Rosario

    Rosario, S2000DSV

  • ISIS Clinica Especializada

    Santa Fe, 03000

  • Clínica Viedma

    Viedma, Rio Negro, 8500

Other trials in Argentina

Netherlands6 sites

  • Amphia Ziekenhuis; Afdeling Longziekten

    Breda, 4818 CK

  • Catharina Ziekenhuis; Dept of Lung Diseases

    Eindhoven, 5623 EJ

  • Ziekenhuis St Jansdal; Dept of Lung Diseases

    Harderwijk, 3844 DG

  • Academisch Ziekenhuis Maastricht

    Maastricht, 6202 AZ

  • Antonius Ziekenhuis; Dept of Lung Diseases

    Nieuwegein, 3435 CM

  • Leyenburg Hospital; Pulmonology

    The Hague, 2504 LN

Other trials in Netherlands

Greece4 sites

  • Sotiria Hospital

    Athens, 11527

  • Metropolitan Hospital; 2Nd Oncology Clinic

    Piraeus, 185 47

  • General Hospital of Thessaloniki Papanikolaou; Uni Pneumonology Dept.

    Thessaloniki, 570 10

  • Diavalkaniko Hospital

    Thessaloniki, 57001

Other trials in Greece

Slovakia4 sites

  • Fnsp Fdr Banska Bystrica; Dep of Pneumology&Ftizeology

    Banská Bystrica, 975 17

  • FNsP Bratislava, Nemocnica Ruzinov

    Bratislava, 826 06

  • Vychodoslovensky onkologicky ustav

    Košice, 04001

  • Inst. of Tb & Respiratory Diseases; Dep. of Oncology

    Nitra, 949 88

Other trials in Slovakia

Lebanon3 sites

  • American University of Beirut - Medical Center

    Beirut, 11-236

  • Hotel Dieu de France; Oncology

    Beirut, 16830

  • Middle East Inst. of Health; Oncology

    Beirut

Other trials in Lebanon

Mexico3 sites

  • Centenario Hospital Miguel Hidalgo

    Aguascalientes, 20230

  • Hospital Central Sur de Alta Especialidad Petróleos Mexicanos

    Mexico City, 14140

  • Centro Médico Abc the American British Cowdray Medical Center, I.A.P. - Centro de Cáncer

    Mexico City

Other trials in Mexico

Belgium1 site

  • Clin. Europe (Ste Elisabeth)

    Brussels, 1180

Other trials in Belgium

Denmark1 site

  • Nordsjællands Hospital, Hillerød, Onkologisk Afdeling

    Hillerød, 3400

Other trials in Denmark

Oman1 site

  • College of Medicine & Sciences, Sultan Qaboos University Hospital

    Muscat, P.O Box 35

Other trials in Oman

United Arab Emirates1 site

  • Tawam Hospital; Medical Oncology Department

    Al Ain City, 15258

Other trials in United Arab Emirates

About this study

Official title: An Open-label, Randomized, Phase IIIb Trial Evaluating the Efficacy and Safety of Standard of Care +/- Continuous Bevacizumab Treatment Beyond Progression of Disease (PD) in Patients With Advanced Non-squamous Non-small Cell Lung Cancer (NSCLC) After First Line Treatment With Bevacizumab Plus a Platinum Doublet-containing Chemotherapy

This open-label, randomized, multicenter study will evaluate the efficacy and safety of bevacizumab (Avastin) in combination with standard of care (SOC) treatment in participants with advanced non-squamous NSCLC. Participants will be enrolled at documentation of progression of disease (PD) after 4-6 cycles of first-line treatment with bevacizumab plus a platinum doublet-containing therapy and a minimum of two cycles of bevacizumab maintenance treatment prior to PD. Participants will be randomly assigned to one of two treatment arms to receive either bevacizumab plus SOC treatment or SOC treatment alone.

What participants receive

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

  • BevacizumabDrug

    Also called Avastin

    Participants will receive bevacizumab 7.5 or 15 milligrams per kilogram (mg/kg) intravenously.

  • DocetaxelDrug

    Docetaxel 60 or 75 milligram per meter square (mg/m^2) on Day 1 every 21 days.

  • ErlotinibDrug

    Erlotinib 150 mg daily taken on an empty stomach at least one hour before or two hours after the ingestion of food.

  • PemetrexedDrug

    Pemetrexed 500 mg/m^2 IV over 10 minutes on Day 1 every 21 days.

Study groups in NCT01351415
Study groupRoleWhat they receive
Bevacizumab + Standard of CareExperimentalParticipants will receive bevacizumab on Day 1 of every 21-days cycle along with standard of care (Erlotinib or Docetaxel or Pemetrexed) as second line treatment, until the occurrence of an unacceptable toxicity or withdrawal of consent (whichever occurs first).
Receives: Drug: Bevacizumab; Drug: Docetaxel; Drug: Erlotinib; Drug: Pemetrexed
Standard of CareActive comparatorParticipants will receive investigator's choice of standard of care (Erlotinib or Docetaxel or Pemetrexed) according to local practice until the occurrence of an unacceptable toxicity or withdrawal of consent (whichever occurs first).
Receives: Drug: Docetaxel; Drug: Erlotinib; Drug: Pemetrexed

What is being measured

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

  1. Overall Survival (OS)

    Overall survival (OS) was defined as the time from the date of randomization at first progression of disease to the date of death, regardless of the cause of death.

    Measured: Up to data cut-off date 24 June 2016 (approximately 5 years)

Secondary outcomes (7)

  1. Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

    PFS was defined as the time from start of treatment to the first event of death or PD. Tumor response was assessed by the IRF according to RECIST v1.1. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. PFS2 is defined as the time between randomization at PD1 and the date of PD2 or death, whichever occurs first. PFS3 is defined as the time between PD2 and the date of PD3 or death, whichever occurs first.

    Measured: Up to data cut-off date 24 June 2016 (approximately 5 years)

  2. Percentage of Participants With Objective Response According to RECIST v1.1

    The objective response is defined as complete response (CR) or partial response (PR) assessed according to the RECIST v.1.1 criteria with baseline tumour assessment as the reference. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as greater than or equal to (≥) 30 percent (%) decrease in sum of longest diameter (LD) of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR.

    Measured: Up to data cut-off date 24 June 2016 (approximately 5 years)

  3. Percentage of Participants With Disease Control According to RECIST v1.1

    The disease control rate is defined as CR or PR or stable disease (SD) assessed according to the RECIST v.1.1 criteria with baseline tumour assessment as the reference. SD was defined as neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of the longest diameter since treatment started for target lesions and the persistence of 1 or more non-target lesions.

    Measured: Up to data cut-off date 24 June 2016 (approximately 5 years)

  4. Duration of Response (DoR) According to RECIST v1.1

    Duration of response is defined as the time that measurement criteria are met for objective response (CR/PR) (whichever status is recorded first) until the first date of progression or death is documented. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than < 10 mm. PR was defined as greater than or equal to ≥30 % decrease in sum of longest diameter of target lesions in reference to baseline sum longest diameter.

    Measured: Up to data cut-off date 24 June 2016 (approximately 5 years)

  5. Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events. A SAE was any experience that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant.

    Measured: Up to data cut-off date 24 June 2016 (approximately 5 years)

  6. Time to Progression (TTP) According to RECIST v1.1

    The time to progression was defined as the time from baseline until disease progression as determined by the RECIST v1.1. TTP2 is defined as the interval between the day of randomization at PD1 and PD2. TTP3 is defined as the interval between the day of PD2 and PD3. PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

    Measured: Up to data cut-off date 24 June 2016 (approximately 5 years)

  7. Percentage of Participants Who Are Alive at Month 6, 12, and 18

    Percentage of participants who were alive at Month 6, 12 and 18 were reported.

    Measured: Month 6, 12, 18

Timeline

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

  1. First posted10 May 2011 (estimated)
  2. Study start25 Jun 2011
  3. Primary completion25 Jun 2016
  4. Study completion25 Jun 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
None (open label)
Enrolment
485 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01351415
Sponsor's protocol ID
MO22097
Other IDs
2010-022645-14
Status last verified
Aug 2017
First submitted
9 May 2011
Last updated
18 Sep 2017

Publications

  • Gridelli C, de Castro Carpeno J, Dingemans AC, Griesinger F, Grossi F, Langer C, Ohe Y, Syrigos K, Thatcher N, Das-Gupta A, Truman M, Donica M, Smoljanovic V, Bennouna J. Safety and Efficacy of Bevacizumab Plus Standard-of-Care Treatment Beyond Disease Progression in Patients With Advanced Non-Small Cell Lung Cancer: The AvaALL Randomized Clinical Trial. JAMA Oncol. 2018 Dec 1;4(12):e183486. doi: 10.1001/jamaoncol.2018.3486. Epub 2018 Dec 13.

    PubMed 30177994

  • Takeda M, Yamanaka T, Seto T, Hayashi H, Azuma K, Okada M, Sugawara S, Daga H, Hirashima T, Yonesaka K, Urata Y, Murakami H, Saito H, Kubo A, Sawa T, Miyahara E, Nogami N, Nakagawa K, Nakanishi Y, Okamoto I. Bevacizumab beyond disease progression after first-line treatment with bevacizumab plus chemotherapy in advanced nonsquamous non-small cell lung cancer (West Japan Oncology Group 5910L): An open-label, randomized, phase 2 trial. Cancer. 2016 Apr 1;122(7):1050-9. doi: 10.1002/cncr.29893. Epub 2016 Feb 1.

    PubMed 26828788

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Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bevacizumab, Docetaxel and Erlotinib in people with Non-Squamous Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 179 sites in 18 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 8 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 18 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 179 sites in United States, France, Germany, Japan, Brazil and 13 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 18 Sep 2017). 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 (OS) (time frame: Up to data cut-off date 24 June 2016 (approximately 5 years)). 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 NCT01351415, which also lists 3 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 18 Sep 2017.

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