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Non-small Cell Lung CancerPhase 3STARTNCT00409188

Cancer Vaccine Study for Unresectable Stage III Non-small Cell Lung Cancer (START)

A Phase 3 study testing Tecemotide (L-BLP25) and Single low dose cyclophosphamide in people with Non-small Cell Lung Cancer, run by EMD Serono at 290 sites in 33 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

The purpose of this study is to determine whether the cancer vaccine tecemotide (L-BLP25) in addition to best supportive care is effective in prolonging the lives of subjects with unresectable stage III non-small cell lung cancer, compared to best supportive care alone. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
Tecemotide (L-BLP25) and Single low dose cyclophosphamide
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,513 participants
Where
290 sitesin 33 countries
Study dates
Jan 2007to Apr 2015
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 documented unresectable stage III non-small cell lung cancer (NSCLC)
  • Documented stable disease or objective response, according to Response Evaluation Criteria in Solid Tumors (RECIST), after primary chemoradiotherapy (either sequential or concomitant) for unresectable stage III disease, within 4 weeks (28 days) prior to randomization
  • Receipt of concomitant or sequential chemoradiotherapy, consisting of a minimum of two cycles of platinum-based chemotherapy and a minimum radiation dose of >=50 Gray (Gy). Subjects must have completed the primary thoracic chemo-radiotherapy at least four weeks (28 days) and no later than 12 weeks (84 days) prior to randomization. Subjects who received prophylactic brain irradiation as part of primary chemo-radiotherapy are eligible
  • Geographically accessible for ongoing follow-up, and committed to comply with the designated visits
  • An Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  • A platelet count > 140 x 10^9/Liter; white blood cells (WBC) > 2.5 x 10^9/Liter and hemoglobin > 90 gram per liter (g/L)

Who cannot join

  • Pre-Therapies:
  • Undergone lung cancer specific therapy (including surgery) other than primary chemo-radiotherapy
  • Receipt of immunotherapy (e.g. interferons, tumor necrosis factor [TNF], interleukins, or biological response modifiers [granulocyte macrophage colony stimulating factor {GM-CSF}, granulocyte colony stimulating factor {G-CSF}, macrophage-colony stimulating factor {M-CSF}], monoclonal antibodies) within 4 weeks (28 days) prior to randomization
  • Receipt of investigational systemic drugs (including off-label use of approved products) within 4 weeks (28 days) prior to randomization
  • Disease Status:
  • Metastatic disease
Show all 22Show fewer
  • Malignant pleural effusion at initial diagnosis and/or at study entry
  • Past or current history of neoplasm other than lung carcinoma, except for curatively treated non-melanoma skin cancer, in situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least 5 years
  • Autoimmune disease
  • A recognized immunodeficiency disease including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia; subjects who have hereditary or congenital immunodeficiencies
  • Any preexisting medical condition requiring chronic steroid or immunosuppressive therapy (steroids for the treatment of radiation pneumonitis are allowed)
  • Known Hepatitis B and/or C
  • Physiological Functions:
  • Clinically significant hepatic dysfunction
  • Clinically significant renal dysfunction
  • Clinically significant cardiac disease
  • Splenectomy
  • Infectious process that in the opinion of the investigator could compromise the subject's ability to mount an immune response
  • Standard Safety:
  • Pregnant or breast-feeding women, women of childbearing potential, unless using effective contraception as determined by the investigator
  • Known drug abuse/alcohol abuse
  • Legal incapacity or limited legal capacity

Trial locations and contacts

290 sites in 33 countries.

290 sites in 33 countries

United States49 sites

  • Pacific Cancer Medical Center

    Anaheim, California, 92801

  • Sinai Hospital of Baltimore

    Baltimore, Maryland, 21215

  • University of Maryland, Marlene and Steward Greenbaum Cancer Center

    Baltimore, Maryland

  • Deaconess Billings Clinic

    Billings, Montana, 59101

  • Pasco Hernando Oncology Associates P.A

    Brooksville, Florida, 34613

  • Lahey Clinic

    Burlington, Massachusetts

  • Gabrail Cancer Center

    Canton, Ohio, 44718

  • Southern Illinois Hematology/Oncology

    Centralia, Illinois, 62801

  • Univ. of North Carolina at Chapel Hill, Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

  • Carolinas Hematology-Oncology

    Charlotte, North Carolina, 28203

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University Hospitals of Cleveland

    Cleveland, Ohio, 44106

  • Center for Oncology Research

    Dallas, Texas, 75230

  • University of Colorado Cancer Center

    Denver, Colorado, 80045

  • Fairfax-Northern Virginia Hematology Oncology, PC

    Fairfax, Virginia, 22031

  • Saint Edward Mercy Medical Center

    Fort Smith, Arkansas, 72901

  • John Peter Smith Center for Cancer Care

    Fort Worth, Texas, 76104

  • The Center for Cancer and Blood Disorders

    Fort Worth, Texas, 76104

  • The Jones Clinic, PC

    Germantown, Tennessee, 38138

  • Glendale Adventist Medical Center

    Glendale, California, 91206

  • Big Sky Oncology, Sletten Cancer Institute

    Great Falls, Montana, 59405

  • Nebraska Cancer Care, LLC

    Hastings, Nebraska, 68901

  • Kentucky Cancer Center

    Hazard, Kentucky, 41701

  • Leonard J. Chabert Medical Center

    Houma, Louisiana

  • Joliet Oncology-Hematology Associates, Ltd.

    Joliet, Illinois, 60435

  • Southeast Nebraska Cancer Center

    Lincoln, Nebraska, 68510

  • Norris Cancer Hospital

    Los Angeles, California, 90033

  • Cedars-Sinai Outpatient Cancer Center at the Samuel Oschin Comprehensive Cancer Institute

    Los Angeles, California, 90048

  • Hematology and Oncology Specialists, LLC

    Metarie, Louisiana, 70006

  • University of Miami, Sylvester Comprehensive Cancer Center

    Miami, Florida

  • Signal Point Clinical Research Center, LLC

    Middletown, Ohio, 45042

  • University of Minnesota Physicians, Masonic Cancer Center

    Minneapolis, Minnesota

  • Clinical Trials and Research Associates, Inc.

    Montebello, California, 90640

  • Pasco Hernando Oncology Associates, PA

    New Port Richey, Florida, 34652

  • St. Vincents Comprehensive Cancer Center

    New York, New York, 10011

  • Hematology Oncology Associates of Rockland

    Nyack, New York, 10960

  • Florida Hospital Memorial System

    Ormond Beach, Florida, 32174

  • Univ. of Pennsylvania Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Desert Hematology Oncology Medical Group, Inc

    Rancho Mirage, California

  • Oncology Care Associates

    Saint Joseph, Michigan, 49085

  • Cancer Therapy & Research Center, Institute for Drug Development

    San Antonio, Texas, 78229

  • Saint Louis University Cance Center

    St Louis, Missouri

  • Stockton Hematology Oncology Medical Group, Inc.

    Stockton, California, 95204

  • Southwestern Regional Medical Center

    Tulsa, Oklahoma, 74133

  • Southwestern Regional Medical Center

    Tulsa, Oklahoma

  • Wheeling Hospital

    Wheeling, West Virginia, 26003

  • Hanover Medical Specialts PA

    Wilmington, North Carolina, 28401

Other trials in United States

Germany24 sites

  • Research Site

    Berlin

  • Research Site

    Cologne

  • Research Site

    Coswig

  • Research Site

    Essen, North Rhine-Westphalia

  • Research Site

    Essen

  • Research Site

    Frankfurt am Main

  • Research Site

    Freiburg im Breisgau

  • Research Site

    Gauting

  • Research Site

    Großhansdorf

  • Research Site

    Hamburg

  • Reseach Site

    Heidelberg

  • Research Site

    Hemer, North Rhine-Westphalia

  • Research Site

    Homburg, Saarland

  • Research Site

    Kassel

  • Research Site

    Kiel

  • Research Site

    Leipzig

  • Research Site

    Magdeburg

  • Research Site

    Mainz, Rhineland-Palatinate

  • Research Site

    Mainz

  • Research Site

    Minden

  • Research Site

    München

  • Research Site

    Mutzschen

  • Research Site

    Oldenburg

  • Research Site

    Rostock

Other trials in Germany

Canada17 sites

  • Tom Baker Cancer Center

    Calgary, Alberta

  • Cross Cancer Institue

    Edmonton, Alberta

  • Capital District Health Authority

    Halifax, Nova Scotia

  • Juravinski Cancer Center

    Hamilton, Ontario

  • Hopital Notre Dame

    Montreal, Quebec

  • Jewish General Hospital

    Montreal, Quebec

  • Niagara Health System

    Saint Catharines, Ontario

  • Hopital Laval

    Sainte-Foy, Quebec

  • Frazer Valley Cancer Center

    Surrey, British Columbia

  • Cape Breton Districk Health Authority Cancer Care

    Sydney, Nova Scotia

  • Thunder Bay Regional Health Science Center Northwestern Ontario Regional Center

    Thunder Bay, Ontario

  • Mount Sinai Hospital

    Toronto, Ontario

  • Princess Margaret Hospital

    Toronto, Ontario

  • British Columbia Cancer Agency

    Vancouver, British Columbia

  • Vancouver Island Cancer Center

    Victoria, British Columbia

  • Windsor Regional Cancer Center

    Windsor, Ontario

  • Cancer Care Manitoba

    Winnipeg, Manitoba

Other trials in Canada

Italy17 sites

  • Research Site

    Avelino

  • Research Site

    Bologna

  • Research Site

    Candiolo, Torino

  • Research Site

    Carpi

  • Research Site

    Chieti

  • Research Site

    Forlì

  • Research Site

    Genova, Genova

  • Research Site

    Meldola

  • Research Site

    Milan

  • Research Site

    Naples

  • Research Site

    Orbassano-Torino

  • Research Site

    Palermo, Palermo

  • Research Site

    Parma

  • Research Site

    Rome

  • Research Site

    Rozzano-Milano

  • Research Site

    Sassari

  • Research Site

    Trento

Other trials in Italy

Brazil15 sites

  • Hospital LifeCenter

    Belo Horizonte, Minas Gerais

  • Centro de Oncologia de Campinas - OCC

    Campinas, São Paulo

  • Associacao Hospital de Caridade Ijui

    Ijuí, Rio Grande do Sul

  • Fundacao Hospital Amaral Carvalho

    Jaú, São Paulo

  • Research Site

    Ondina-Salvdor

  • Hospital Nossa Senhora da Conceicao, Centro de Pesquisas Medicas e Ensaios Clinicos

    Porto Alegre, Rio Grande Do Sol

  • Hospital de Clinicas de Porto Alegre, Dept. de Endocrinologia

    Porto Alegre, Rio Grande do Sul

  • Hospital Sao Lucas-Pucrs

    Porto Alegre, Rio Grande do Sul

  • Research Site

    Porto Algre, Rio Grande do Sul

  • Instituto Nacional do Cancer - INCA

    Rio de Janeriro

  • Nugieo de Oncologia da Bahia

    Salvador, Estado de Bahia

  • Hospital das Clinicas da Faculdade de Medinina de Univeridade

    São Paulo, De Ao Paulo

  • Instituto do Cancer Arnaldo Vieira de Caralho-Onco-pneumonia

    São Paulo, São Paulo

  • Santa Casa de Misericordia De Sao Paulo

    São Paulo, São Paulo

  • Instituto de Oncologia de Sorocaba

    Sorocaba, São Paulo

Other trials in Brazil

Poland15 sites

  • Research Site

    Bialystok

  • Research Site

    Bydgoszcz

  • Research Site

    Bytom

  • Research Site

    Gdynia

  • Research Site

    Krakow

  • Genova

    Lodz

  • Research Site

    Olsztyn

  • Research Site

    Otwock

  • Research Site

    Poznan

  • Research Site

    Torun

  • Research Site

    Warsaw, Masovian Voivodeship

  • Genova

    Warsaw

  • Research Site

    Warsaw

  • Research Site

    Wroclaw

  • Research Site

    Zabrze

Other trials in Poland

France13 sites

  • Research Site

    Besançon, Franche-Comte

  • Research Site

    Beuvry

  • Research Site

    Brest

  • Research Site

    Caen

  • Research Site

    Chauny

  • Research Site

    Marseille

  • Research Site

    Nancy

  • Research Site

    Nantes-Saint Herblain

  • Research Site

    Paris

  • Research Site

    Perpignan

  • Research Site

    Pierre-Bénite, Auvergne-Rhône-Alpes

  • Research Site

    Poitiers

  • Research Site

    Strasbourg

Other trials in France

United Kingdom13 sites

  • Research Site

    Cornwall

  • Research Site

    Edinburgh

  • Research Site

    Glasgow

  • Research Site

    Guildford

  • Research Site

    Inverness

  • Research Site

    Leeds

  • Research Site

    Leicester

  • Research Site

    London

  • Research Site

    Manchester

  • Research Site

    Metropolitan Borough of Wirral

  • Research Site

    Southampton

  • Research Site

    Surrey

  • Research Site

    Torquay

Other trials in United Kingdom

Spain12 sites

  • Research Site

    A Coruña

  • Research Site

    Alicante

  • Research Site

    Barakaldo, Bilbao

  • Research Site

    Barcelona

  • Research Site

    Burgos

  • Research Site

    Donostia / San Sebastian, Guipuzcoa

  • Research Site

    Girona

  • Research Site

    Jaén, Jaen

  • Research Site

    Lugo

  • Research Site

    Madrid

  • Research Site

    Málaga

  • Research Site

    Mataró, Barcelona

Other trials in Spain

Russia11 sites

  • Research Site

    Barnaul

  • Genova

    Chelaybinsk

  • Research Site

    Ivanovo

  • Reseaerch Site

    Kazan', Tatarstan Republic

  • Research Site

    Kazan'

  • Research Site

    Moscow

  • Research Site

    Obninsk

  • Research Site

    Saint Petersburg

  • Research Site

    Tomsk

  • Research Site

    Voronezh

  • Research Site

    Yaroslavl, Yaroslavlr

Other trials in Russia

Argentina9 sites

  • Hospital Italiano Regional del Sur

    Bahía Blanca, Buenos Aires

  • Centro de Educacion Medica e Investigaciones Clinicas "Norberto Quirno" (CEMIC)

    Buenos Aires

  • Instituto Especializado Alexander Fleming

    Buenos Aires

  • Sociedad Intaliana de Beneficencia en Buenos Aires, Hospital Italiano

    Buenos Aires

  • Paliar

    Capital, Buenos Aires, Buenos Aires

  • Clinica Universitaria Reina Fabiola

    Córdoba

  • Centro Oncologico de Roario

    Rosario, Santa Fe Province

  • Corporacion Medica General San Martin

    San Martín, Buenos Aires

  • Research Site

    Tandil

Other trials in Argentina

Israel8 sites

  • Research Site

    Beersheba

  • Research Site

    Haifa

  • Research Site

    Jerusalem

  • Research Site

    Kfar Saba

  • Research Site

    Petah Tikva

  • Research Site

    Tel Aviv

  • Research Site

    Tel HaShomer, Tel Avir

  • Research Site

    Tsrifin

Other trials in Israel

Australia7 sites

  • Research Site

    Bankstown, NSW

  • Research Site

    Camperdown

  • Research Site

    Heidelberg

  • Research Site

    Kingswood

  • Research Site

    Nedlands, Western Australia

  • Research Site

    Saint Leonards

  • Research Site

    Woolloongabba

Other trials in Australia

Austria7 sites

  • Research Site

    Graz, Styria

  • Research Site

    Inssbruck

  • Research Site

    Linz, Upper Austria

  • Research Site

    Salzburg

  • Research Site

    Vienna

  • Research Site

    Wein, Venna

  • Research Site

    Wels

Other trials in Austria

Belgium6 sites

  • Research Site

    Brasschaat

  • Research Site

    Brussels

  • Research Site

    Haine-Saint-Paul

  • Research Site

    Leuven

  • Research Site

    Liège

  • Research Site

    Mechelen

Other trials in Belgium

Greece6 sites

  • Research Site

    Athens, Attica

  • Research Site

    Athens

  • Research Site

    Chidari, Athens

  • Research Site

    Heraklion

  • Research Site

    Marousi, Athens

  • Research Site

    Thessaloniki, Nea Efkarpia

Other trials in Greece

Netherlands6 sites

  • Research Site

    Amsterdam, North Holland

  • Research Site

    Amsterdam

  • Research Site

    Eindhoven

  • Research Site

    Hoofdrop

  • Research Site

    Tilburg

  • Research Site

    Zwolle

Other trials in Netherlands

Romania6 sites

  • Research Site

    Bucharest

  • Research Site

    Cluj-Napoca

  • Research Site

    Iași

  • Research Site

    Sibiu

  • Research Site

    Suceava

  • Research Site

    Timișoara

Other trials in Romania

Sweden6 sites

  • Research Site

    Gävle

  • Research Site

    Gothenburg

  • Research Site

    Lund

  • Research Site

    Stockholm

  • Research Site

    Umeå

  • Research Site

    Uppsala

Other trials in Sweden

India5 sites

  • Research Site

    Chennai

  • Research Site

    Hyderabad

  • Research Site

    Mumbai

  • Research Site

    New Delhi

  • Research Site

    Vellore

Other trials in India

Taiwan5 sites

  • Research Site

    Kaohsiung City

  • Research Site

    Taichung

  • Research Site

    Tainan

  • Research Site

    Taipei

  • Research Site

    Taoyuan

Other trials in Taiwan

Czechia4 sites

  • Research Site

    Hradec Králové

  • Research Site

    Ostrava-Poruba

  • Research Site

    Prague

  • Research Site

    Ústí nad Labem

Other trials in Czechia

Hungary4 sites

  • Research Site

    Budapest

  • Research Site

    Mátraháza

  • Research Site

    Nyíregyháza

  • Research Site

    Tatabayana

Other trials in Hungary

Portugal4 sites

  • Genova

    Coimbra

  • Genova

    Lisbon

  • Genova

    Porto

  • Genova

    Santa Maria de Feira

Other trials in Portugal

China3 sites

  • Research Site

    Beijing

  • Research Site

    Guangzhou

  • Research Site

    Shanghai

Other trials in China

Mexico3 sites

  • Centro Oncologico de Chihuahua

    Chihuahua City, Chihuahua

  • Instituto Nacional de Cancerologia (INCAN)

    Mexico City

  • Consultorio del

    Morelia, Michoacán

Other trials in Mexico

Slovakia3 sites

  • Research Site

    Bratislava

  • Research Site

    Košice

  • Research Site

    Nitra

Other trials in Slovakia

South Korea3 sites

  • Research Site

    Goyang-si, Gyeonggi-do

  • Research Site

    Seoul, Gyeonggi-do

  • Research Site

    Seoul

Other trials in South Korea

Switzerland3 sites

  • Research Site

    Basel

  • Research Site

    Geneva

  • Research Site

    Winterthur

Other trials in Switzerland

Denmark2 sites

  • Research Site

    Herlev

  • Research Site

    Odense C

Other trials in Denmark

Hong Kong2 sites

  • Research Site

    Hong Kong

  • Research Site

    Shatin, New Territories

Other trials in Hong Kong

Ireland1 site

  • Research Site

    Dublin

Other trials in Ireland

Singapore1 site

  • Research Site

    Singapore

Other trials in Singapore

About this study

Official title: A Multi-center Phase III Randomized, Double-blind Placebo-controlled Study of the Cancer Vaccine Stimuvax® (L-BLP25 or BLP25 Liposome Vaccine) in Non-small Cell Lung Cancer (NSCLC) Subjects With Unresectable Stage III Disease.

The purpose of this study is to determine whether the cancer vaccine tecemotide (L-BLP25) in addition to best supportive care is effective in prolonging the lives of subjects with unresectable stage III non-small cell lung cancer, compared to best supportive care alone.

A local ancillary (sub) study in European centers will evaluate the immune response in peripheral blood after tecemotide (L-BLP25) or placebo vaccination.

Read the detailed description

Ancillary Trial: An exploratory investigation of immune response in peripheral blood after tecemotide (L-BLP25) or placebo vaccination.

The ancillary study is a sub-study within START. This is an exploratory investigation of the immune response in peripheral blood after tecemotide (L-BLP25) or placebo vaccination. The main objective is to evaluate whether administration of single-shot, low-dose cyclophosphamide followed by tecemotide (L-BLP25) vaccinations induces specific immune response in peripheral blood to BLP25 (the mucinous glycoprotein 1 [MUC1] antigen) as well as a modulation of cellular and soluble components of the immune response in subjects with unresectable stage III NSCLC.

Twenty-five of the European START sites will participate in the ancillary study.

Sample size: up to 60 to 80 subjects

All inclusion criteria specified in the START clinical trial protocol except for hemoglobin >= 100 gram/Liter (g/L)

All exclusion criteria are the same as specified in the START clinical trial protocol

Schedule of events: Blood samples will be taken at baseline, visit week 4, 8 13 and 25 (80 milliliter (mL) whole blood each)

Being tested
Tecemotide (L-BLP25), Single low dose cyclophosphamide, Placebo
Keywords
Non-Small Cell Lung Carcinoma;, stage III;, unresectable;, vaccine; Tecemotide; L-BLP25;, Cyclophosphamide;, placebo controlled;, randomized;, double blind;, immunotherapy;
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.

  • Tecemotide (L-BLP25)Biological

    After receiving cyclophosphamide, participants will receive 8 consecutive weekly subcutaneous vaccinations with 806 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 806 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until disease progression is documented.

  • Single low dose cyclophosphamideDrug

    A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide will be given 3 days before first tecemotide (L-BLP25) vaccination.

  • PlaceboDrug

    A single infusion (IV) of 0.9% Saline solution instead of cyclophosphamide but in the same calculated dose will be given three days before first placebo vaccination. Subjects will then receive eight consecutive weekly subcutaneous vaccinations with placebo at weeks 0; 1; 2; 3; 4; 5; 6 and 7 followed by maintenance placebo vaccinations at 6-week intervals, commencing at week 13, until disease progression is documented.

Study groups in NCT00409188
Study groupRoleWhat they receive
Tecemotide (L-BLP25)ExperimentalNot described
Receives: Biological: Tecemotide (L-BLP25); Drug: Single low dose cyclophosphamide
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

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

  1. Overall Survival

    Overall survival time was defined as the time from randomization to death. Participants without events were censored at the last date they were known to be alive or the clinical cut-off date, whatever was earlier.

    Measured: Up to 66 months

Secondary outcomes (4)

  1. Time To Symptom Progression (TTSP) as Measured by the Lung Cancer Symptom Scale (LCSS)

    Time to symptom progression (TTSP) was measured by LCSS. Symptomatic progression was defined as an increase (worsening) of the Average Symptomatic Burden Index (ASBI that is, the mean of the six major lung cancer specific symptom scores of the LCSS patient scale - ranging from 0 to 100 where higher score indicates worst outcome). Worsening was defined as a 10% increase in the scale breadth from the baseline score. TTSP is defined as the time from randomization to worsening in ASBI. Participants without event are censored at the date of the last LCSS assessment.

    Measured: Up to 66 months

  2. Time To Progression (TTP)

    Time from randomization to disease progression. Disease progression was defined based on Response Evaluation Criteria in Solid Tumors Version 1.0 [RECIST v1.0]) as at least a 20% increase in the sum of the longest diameter of target lesions from nadir, or the appearance of one or more new lesions.

    Measured: Up to 66 months

  3. One-, Two- and Three-year Survival Rate

    The percentages of participants who were alive at 1, 2, and 3 years were calculated as a cumulative percentage by Kaplan-Meier survival analysis approach.

    Measured: Years 1, 2, and 3

  4. Number of Participants With Treatment Emergent Adverse Events and Injection Site Reactions

    Treatment -emergent adverse events were defined as those with onset or worsening occurring at or after the first dosing day of study medication and up to 42 days after the last administration of any study drug or the clinical cut-off date. Injection site reactions were reported as assessed by the Investigator.

    Measured: From first dose up to 42 days after the last dose of the trial treatment

Timeline

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

  1. First posted8 Dec 2006 (estimated)
  2. Study startJan 2007
  3. Primary completionApr 2012
  4. Study completionApr 2015

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
1,513 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00409188
Sponsor's protocol ID
EMR 63325-001
Acronym
START
Status last verified
Oct 2015
First submitted
7 Dec 2006
Last updated
20 Nov 2015
Data monitoring committee
Yes

Publications

  • Butts C, Socinski MA, Mitchell P, Thatcher N, Havel L, Krzakowski M, Nawrocki S, Ciuleanu TE, Bosquée L, Trigo JM, Spira A, Tremblay L, Nyman J, Ramlau R, Helwig C, Falk MH, Shepherd FA. START: A phase III study of L-BLP25 cancer immunotherapy for unresectable stage III non-small cell lung cancer. American Society of Clinical Oncology - 49th Annual Meeting. 2013; Abstr No. 7500.

  • Shepherd FA, Socinski MA, Mitchell P, Thatcher N, Havel L, Krzakowski M, Nawrocki S, Helwig C, Schroeder A, Butts C. Updated analysis and secondary endpoints with L-BLP25 in unresectable stage III non-small cell lung cancer in the phase III START study. European Society for Medical Oncology 38th Congress - ECCO 17, ESMO 38, ESTRO 32. 2013. Abstr No. 3419.

  • Mitchell P, Butts C, Socinski M, Thatcher N, Wichardt-Johansson G, Ellis P, Gladkov O, Pereira J, Eberhardt W, Horwood K, Szczesna A, Helwig C, Schröder A, Shepherd F. Tecemotide (L-BLP25) in unresectable stage III non-small cell lung cancer in the phase III START study: Further endpoint and exploratory biomarker results. World Conference on Lung Cancer - 15th. 2013; Abstr. No. 2779.

  • Thatcher N, Shepherd FA, Mitchell P, Socinski MA, Paredes A, Lambrechts M, Thomas M, Kollmeier J, Zemanová M, Sadjadian P, Peylan-Ramu N, Helwig C, Schröder A, Butts C. Geographic differences in the combined-modality treatment of stage III unresectable non-small cell lung cancer: Results from a global phase III trial of tecemotide (L-BLP25). World Conference on Lung Cancer - 15th. 2013; Abstr. No. 2712.

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  • Butts C, Socinski MA, Mitchell PL, Thatcher N, Havel L, Krzakowski M, Nawrocki S, Ciuleanu TE, Bosquee L, Trigo JM, Spira A, Tremblay L, Nyman J, Ramlau R, Wickart-Johansson G, Ellis P, Gladkov O, Pereira JR, Eberhardt WE, Helwig C, Schroder A, Shepherd FA; START trial team. Tecemotide (L-BLP25) versus placebo after chemoradiotherapy for stage III non-small-cell lung cancer (START): a randomised, double-blind, phase 3 trial. Lancet Oncol. 2014 Jan;15(1):59-68. doi: 10.1016/S1470-2045(13)70510-2. Epub 2013 Dec 9.

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Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tecemotide (L-BLP25) and Single low dose cyclophosphamide in people with Non-small Cell Lung Cancer, run by EMD Serono at 290 sites in 33 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 6 inclusion and 22 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 20 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 290 sites in United States, Germany, Canada, Italy, Brazil and 28 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?

Yes. Results are posted in the registry (first posted 20 Nov 2015). 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 (time frame: Up to 66 months). 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 NCT00409188, which also lists 9 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 20 Nov 2015.

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