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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00409188
Recruitment Status : Completed
First Posted : December 8, 2006
Results First Posted : November 20, 2015
Last Update Posted : November 20, 2015
Merck KGaA
Information provided by (Responsible Party):
EMD Serono

Brief 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.

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

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Biological: Tecemotide (L-BLP25) Drug: Single low dose cyclophosphamide Drug: Placebo Phase 3

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)

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1513 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.
Study Start Date : January 2007
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Tecemotide (L-BLP25) Biological: Tecemotide (L-BLP25)
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.

Drug: Single low dose cyclophosphamide
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.

Placebo Comparator: Placebo Drug: Placebo
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.

Primary Outcome Measures :
  1. Overall Survival [ Time Frame: Up to 66 months ]
    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.

Secondary Outcome Measures :
  1. Time To Symptom Progression (TTSP) as Measured by the Lung Cancer Symptom Scale (LCSS) [ Time Frame: Up to 66 months ]
    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.

  2. Time To Progression (TTP) [ Time Frame: Up to 66 months ]
    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.

  3. One-, Two- and Three-year Survival Rate [ Time Frame: Years 1, 2, and 3 ]
    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.

  4. Number of Participants With Treatment Emergent Adverse Events and Injection Site Reactions [ Time Frame: From first dose up to 42 days after the last dose of the trial treatment ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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)

Exclusion Criteria:


  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00409188

  Hide Study Locations
United States, Arkansas
Saint Edward Mercy Medical Center
Fort Smith, Arkansas, United States, 72901
United States, California
Pacific Cancer Medical Center
Anaheim, California, United States, 92801
Glendale Adventist Medical Center
Glendale, California, United States, 91206
Norris Cancer Hospital
Los Angeles, California, United States, 90033
Cedars-Sinai Outpatient Cancer Center at the Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California, United States, 90048
Clinical Trials and Research Associates, Inc.
Montebello, California, United States, 90640
Desert Hematology Oncology Medical Group, Inc
Rancho Mirage, California, United States
Stockton Hematology Oncology Medical Group, Inc.
Stockton, California, United States, 95204
United States, Colorado
University of Colorado Cancer Center
Denver, Colorado, United States, 80045
United States, Florida
Pasco Hernando Oncology Associates P.A
Brooksville, Florida, United States, 34613
University of Miami, Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Pasco Hernando Oncology Associates, PA
New Port Richey, Florida, United States, 34652
Florida Hospital Memorial System
Ormond Beach, Florida, United States, 32174
United States, Illinois
Southern Illinois Hematology/Oncology
Centralia, Illinois, United States, 62801
Rush University Medical Center
Chicago, Illinois, United States, 60612
Joliet Oncology-Hematology Associates, Ltd.
Joliet, Illinois, United States, 60435
United States, Kentucky
Kentucky Cancer Center
Hazard, Kentucky, United States, 41701
United States, Louisiana
Leonard J. Chabert Medical Center
Houma, Louisiana, United States
Hematology and Oncology Specialists, LLC
Metarie, Louisiana, United States, 70006
United States, Maryland
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
University of Maryland, Marlene and Steward Greenbaum Cancer Center
Baltimore, Maryland, United States
United States, Massachusetts
Lahey Clinic
Burlington, Massachusetts, United States
United States, Michigan
Oncology Care Associates
Saint Joseph, Michigan, United States, 49085
United States, Minnesota
University of Minnesota Physicians, Masonic Cancer Center
Minneapolis, Minnesota, United States
United States, Missouri
Saint Louis University Cance Center
Saint Louis, Missouri, United States
United States, Montana
Deaconess Billings Clinic
Billings, Montana, United States, 59101
Big Sky Oncology, Sletten Cancer Institute
Great Falls, Montana, United States, 59405
United States, Nebraska
Nebraska Cancer Care, LLC
Hastings, Nebraska, United States, 68901
Southeast Nebraska Cancer Center
Lincoln, Nebraska, United States, 68510
United States, New York
St. Vincents Comprehensive Cancer Center
New York, New York, United States, 10011
Hematology Oncology Associates of Rockland
Nyack, New York, United States, 10960
United States, North Carolina
Univ. of North Carolina at Chapel Hill, Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599
Carolinas Hematology-Oncology
Charlotte, North Carolina, United States, 28203
Hanover Medical Specialts PA
Wilmington, North Carolina, United States, 28401
United States, Ohio
Gabrail Cancer Center
Canton, Ohio, United States, 44718
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
Signal Point Clinical Research Center, LLC
Middletown, Ohio, United States, 45042
United States, Oklahoma
Southwestern Regional Medical Center
Tulsa, Oklahoma, United States, 74133
Southwestern Regional Medical Center
Tulsa, Oklahoma, United States
United States, Oregon
Providence Portland Medical Center
Portland, Oregon, United States, 97213
United States, Pennsylvania
Univ. of Pennsylvania Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19104
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
United States, Tennessee
The Jones Clinic, PC
Germantown, Tennessee, United States, 38138
United States, Texas
Center for Oncology Research
Dallas, Texas, United States, 75230
John Peter Smith Center for Cancer Care
Fort Worth, Texas, United States, 76104
The Center for Cancer and Blood Disorders
Fort Worth, Texas, United States, 76104
Cancer Therapy & Research Center, Institute for Drug Development
San Antonio, Texas, United States, 78229
United States, Virginia
Fairfax-Northern Virginia Hematology Oncology, PC
Fairfax, Virginia, United States, 22031
United States, West Virginia
Wheeling Hospital
Wheeling, West Virginia, United States, 26003
Hospital Italiano Regional del Sur
Bahia Blanca, Buenos Aires, Argentina
Capital, Buenos Aires, Buenos Aires, Argentina
Corporacion Medica General San Martin
San Martin, Buenos Aires, Argentina
Centro Oncologico de Roario
Rosario, Santa Fe, Argentina
Centro de Educacion Medica e Investigaciones Clinicas "Norberto Quirno" (CEMIC)
Ciudad Autonoma de Buenos Aires, Argentina
Instituto Especializado Alexander Fleming
Ciudad Autonoma de Buenos Aires, Argentina
Sociedad Intaliana de Beneficencia en Buenos Aires, Hospital Italiano
Ciudad Autonoma de Buenos Aires, Argentina
Clinica Universitaria Reina Fabiola
Cordoba, Argentina
Research Site
Tandil, Argentina
Australia, Western Australia
Research Site
Nedlands, Western Australia, Australia
Research Site
Bankstown, NSW, Australia
Research Site
Camperdown, Australia
Research Site
Heidelberg, Australia
Research Site
Kingswood, Australia
Research Site
Saint Leonards, Australia
Research Site
Woolloongabba, Australia
Research Site
Graz, Styria, Austria
Research Site
Linz, Upper Austria, Austria
Research Site
Inssbruck, Austria
Research Site
Salzburg, Austria
Research Site
Wein, Venna, Austria
Research Site
Wels, Austria
Research Site
Wien, Austria
Research Site
Brasschaat, Belgium
Research Site
Brussels, Belgium
Research Site
Haine-Saint Paul, Belgium
Research Site
Leuven, Belgium
Research Site
Liege, Belgium
Research Site
Mechelen, Belgium
Nugieo de Oncologia da Bahia
Salvador, Bahia, Brazil
Hospital das Clinicas da Faculdade de Medinina de Univeridade
São Paulo, De ao Paulo, Brazil
Hospital LifeCenter
Belo Horizonte, Minas Gerais, Brazil
Hospital Nossa Senhora da Conceicao, Centro de Pesquisas Medicas e Ensaios Clinicos
Porto Alegre, Rio Grande Do Sol, Brazil
Associacao Hospital de Caridade Ijui
Ijuí, Rio Grande Do Sul, Brazil
Hospital de Clinicas de Porto Alegre, Dept. de Endocrinologia
Porto Alegre, Rio Grande Do Sul, Brazil
Hospital Sao Lucas-Pucrs
Porto Alegre, Rio Grande Do Sul, Brazil
Research Site
Porto Algre, Rio Grande Do Sul, Brazil
Centro de Oncologia de Campinas - OCC
Campinas, Sao Paulo, Brazil
Fundacao Hospital Amaral Carvalho
Jau, Sao Paulo, Brazil
Instituto de Oncologia de Sorocaba
Sorocaba, Sao Paulo, Brazil
Research Site
Ondina-Salvdor, Brazil
Instituto Nacional do Cancer - INCA
Rio de Janeriro, Brazil
Instituto do Cancer Arnaldo Vieira de Caralho-Onco-pneumonia
Sao Paulo, Brazil
Santa Casa de Misericordia De Sao Paulo
Sao Paulo, Brazil
Canada, Alberta
Tom Baker Cancer Center
Calgary, Alberta, Canada
Cross Cancer Institue
Edmonton, Alberta, Canada
Canada, British Columbia
Frazer Valley Cancer Center
Surrey, British Columbia, Canada
British Columbia Cancer Agency
Vancouver, British Columbia, Canada
Vancouver Island Cancer Center
Victoria, British Columbia, Canada
Canada, Manitoba
Cancer Care Manitoba
Winnipeg, Manitoba, Canada
Canada, Nova Scotia
Capital District Health Authority
Halifax, Nova Scotia, Canada
Cape Breton Districk Health Authority Cancer Care
Sydney, Nova Scotia, Canada
Canada, Ontario
Juravinski Cancer Center
Hamilton, Ontario, Canada
Niagara Health System
Saint Catharines, Ontario, Canada
Thunder Bay Regional Health Science Center Northwestern Ontario Regional Center
Thunder Bay, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Windsor Regional Cancer Center
Windsor, Ontario, Canada
Canada, Quebec
Hopital Notre Dame
Montreal, Quebec, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Hopital Laval
Sainte-Foy, Quebec, Canada
Research Site
Beijing, China
Research Site
Guangzhou, China
Research Site
Shanghai, China
Czech Republic
Research Site
Hradec Králové, Czech Republic
Research Site
Ostrava-Poruba, Czech Republic
Research Site
Prague, Czech Republic
Research Site
Praha 2, Czech Republic
Research Site
Praha, Czech Republic
Research Site
Usti nad Labem, Czech Republic
Research Site
Herlev, Denmark
Research Site
Odense C, Denmark
Research Site
Besancon, Franche-Comte, France
Research Site
Pierre-Benite Cedex, Rhone-Alpes, France
Research Site
Beuvry, France
Research Site
Brest, France
Research Site
Caen, France
Research Site
Chauny, France
Research Site
Marseille Cedex, France
Research Site
Marseille, France
Research Site
Nancy, France
Research Site
Nantes-Saint Herblain, France
Research Site
Paris Cedex 15, France
Research Site
Perpignan, France
Research Site
Poitiers Cedex, France
Research Site
Strasbourg Cedex, France
Research Site
Essen, Nordrhein-Westfalen, Germany
Research Site
Hemer, Nordrhein-Westfalen, Germany
Research Site
Mainz, Rheinland-Pfalz, Germany
Research Site
Homburg, Saar, Germany
Research Site
Berlin, Germany
Research Site
Coswig, Germany
Research Site
Essen, Germany
Research Site
Frankfurt am Main, Germany
Research Site
Freiburg, Germany
Research Site
Gauting, Germany
Research Site
Großhansdorf, Germany
Research Site
Hamburg, Germany
Reseach Site
Heidelberg, Germany
Research Site
Kassel, Germany
Research Site
Kiel, Germany
Research Site
Koln, Germany
Research Site
Leipzig, Germany
Research Site
Magdeburg, Germany
Research Site
Mainz, Germany
Research Site
Minden, Germany
Research Site
Muchen, Germany
Research Site
München, Germany
Research Site
Oldenburg, Germany
Research Site
Rostock, Germany
Research Site
Maroussi, Athens, Greece
Research Site
Athens, Attica, Greece
Research Site
Thessaloniki, Nea Efkarpia, Greece
Research Site
Athens, Greece
Research Site
Chidari, Athens, Greece
Research Site
Heraklion, Greece
Hong Kong
Research Site
Shatin, New Territories, Hong Kong
Research Site
Hong Kong, Hong Kong
Research Site
Budapest, Hungary
Research Site
Mátraháza, Hungary
Research Site
Nyíregyháza, Hungary
Research Site
Tatabayana, Hungary
Research Site
Chennai, India
Research Site
Hyderabad, India
Research Site
Mumbai, India
Research Site
New Delhi, India
Research Site
Vellore, India
Research Site
Dublin, Ireland
Research Site
Tel Hashomer, Tel Avir, Israel
Research Site
Beer Sheva, Israel
Research Site
Haifa, Israel
Research Site
Jerusalem, Israel
Research Site
Kfar Saba, Israel
Research Site
Petach Tikva, Israel
Research Site
Tel Aviv, Israel
Research Site
Zerifin, Israel
Research Site
Candiolo, Torino, Italy
Research Site
Avelino, Italy
Research Site
Bologna, Italy
Research Site
Carpi, Italy
Research Site
Chieti, Italy
Research Site
Forli, Italy
Research Site
Genova, Italy
Research Site
Meldola, Italy
Research Site
Milano, Italy
Research Site
Napoli, Italy
Research Site
Orbassano-Torino, Italy
Research Site
Palermo, Italy
Research Site
Parma, Italy
Research Site
Rome, Italy
Research Site
Rozzano-Milano, Italy
Research Site
Sassari, Italy
Research Site
Trento, Italy
Korea, Republic of
Research Site
Goyang-si, Gyeonggi-do, Korea, Republic of
Research Site
Seoul, Gyeonggi-Do, Korea, Republic of
Research Site
Seoul, Korea, Republic of
Consultorio del
Morelia, Michoacan, Mexico
Centro Oncologico de Chihuahua
Chihuahua, Mexico
Instituto Nacional de Cancerologia (INCAN)
Mexico City, Mexico
Research Site
Amsterdam, Noord-Holland, Netherlands
Research Site
Amsterdam, Netherlands
Research Site
Eindhoven, Netherlands
Research Site
Hoofdrop, Netherlands
Research Site
Tilburg, Netherlands
Research Site
Zwolle, Netherlands
Research Site
Warszawa, Mazowieckie, Poland
Research Site
Bialystok, Poland
Research Site
Bydgoszcz, Poland
Research Site
Bytom, Poland
Research Site
Gdynia, Poland
Research Site
Kraków, Poland
Lodz, Poland
Research Site
Olsztyn, Poland
Research Site
Otwock, Poland
Research Site
Poznan, Poland
Research Site
Torun, Poland
Research Site
Warsaw, Poland
Warszawa, Poland
Research Site
Wroclaw, Poland
Research Site
Zabrze, Poland
Coimbra, Portugal
Lisboa, Portugal
Porto, Portugal
Santa Maria de Feira, Portugal
Research Site
Bucharest, Romania
Research Site
Bucuresti, Romania
Research Site
Cluj-Napoca, Romania
Research Site
Iasi, Romania
Research Site
Sibiu, Romania
Research Site
Suceava, Romania
Research Site
Timisoara, Romania
Russian Federation
Reseaerch Site
Kazan, Tatarstan, Russian Federation
Research Site
Yaroslavl, Yaroslavlr, Russian Federation
Research Site
Barnaul, Russian Federation
Chelaybinsk, Russian Federation
Research Site
Ivanovo, Russian Federation
Research Site
Kazan, Russian Federation
Research Site
Moscow, Russian Federation
Research Site
Obninsk, Russian Federation
Research Site
Saint Petersburg, Russian Federation
Research Site
Tomsk, Russian Federation
Research Site
Voronezh, Russian Federation
Research Site
Singapore, Singapore
Research Site
Bratislava, Slovakia
Research Site
Kosice, Slovakia
Research Site
Nitra, Slovakia
Research Site
Mataro, Barcelona, Spain
Research Site
Barakaldo, Bilbao, Spain
Research Site
Donostia-San Sebastian, Guipuzcoa, Spain
Research Site
A Coruna, Spain
Research Site
Alicante, Spain
Research Site
Barcelona, Spain
Research Site
Burgos, Spain
Research Site
Girona, Spain
Research Site
Jaen, Spain
Research Site
Lugo, Spain
Research Site
Madrid, Spain
Research Site
Malaga, Spain
Research Site
Gävle, Sweden
Research Site
Göteborg, Sweden
Research Site
Lund, Sweden
Research Site
Stockholm, Sweden
Research Site
Umea, Sweden
Research Site
Uppsala, Sweden
Research Site
Basel, Switzerland
Research Site
Geneve, Switzerland
Research Site
Genève, Switzerland
Research Site
Winterthur, Switzerland
Research Site
Kaohsiung, Taiwan
Research Site
Taichung, Taiwan
Research Site
Tainan, Taiwan
Research Site
Taipei, Taiwan
Research Site
Tao-Yuan, Taiwan
United Kingdom
Research Site
Cornwall, United Kingdom
Research Site
Edinburgh, United Kingdom
Research Site
Glasgow, United Kingdom
Research Site
Guildford, United Kingdom
Research Site
Inverness, United Kingdom
Research Site
Leeds, United Kingdom
Research Site
Leicester, United Kingdom
Research Site
London, United Kingdom
Research Site
Manchester, United Kingdom
Research Site
Southampton, United Kingdom
Research Site
Surrey, United Kingdom
Research Site
Torquay, United Kingdom
Research Site
Wirral, United Kingdom
Sponsors and Collaborators
EMD Serono
Merck KGaA
Study Director: Medical Responsible EMD Serono Inc., an affiliate of Merck KGaA, Darmstadt, Germany

Publications of Results:
Other 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.
Socinski M, Butts C, Mitchell P, Thatcher N, Scagliotti G, Robinet G, Martin C, Zukin M, Ragulin Y, Bonomi P, Yang CH, Regnault A, Helwig C, de Nigris E, Shepherd F. Exploration of patient health status as measured by the generic preference-based questionnaire EQ-5D alongside the START trial of tecemotide in non-small cell lung cancer. World Conference on Lung Cancer - 15th. 2013; Abstr. No. 2744.

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: EMD Serono Identifier: NCT00409188     History of Changes
Other Study ID Numbers: EMR 63325-001
First Posted: December 8, 2006    Key Record Dates
Results First Posted: November 20, 2015
Last Update Posted: November 20, 2015
Last Verified: October 2015

Keywords provided by EMD Serono:
Non-Small Cell Lung Carcinoma;
stage III;
vaccine; Tecemotide; L-BLP25;
placebo controlled;
double blind;

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists