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

October 19, 2015 updated by: EMD Serono

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

1513

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Ciudad Autonoma de Buenos Aires, 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
      • Cordoba, Argentina
        • Clinica Universitaria Reina Fabiola
      • Tandil, Argentina
        • Research Site
    • Buenos Aires
      • Bahia Blanca, Buenos Aires, Argentina
        • Hospital Italiano Regional del Sur
      • Capital, Buenos Aires, Buenos Aires, Argentina
        • Paliar
      • San Martin, Buenos Aires, Argentina
        • Corporacion Medica General San Martin
    • Santa Fe
      • Rosario, Santa Fe, Argentina
        • Centro Oncologico de Roario
  • Australia
      • 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
    • Western Australia
      • Nedlands, Western Australia, Australia
        • Research Site
  • Austria
      • Inssbruck, Austria
        • Research Site
      • Salzburg, Austria
        • Research Site
      • Wein, Venna, Austria
        • Research Site
      • Wels, Austria
        • Research Site
      • Wien, Austria
        • Research Site
    • Styria
      • Graz, Styria, Austria
        • Research Site
    • Upper Austria
      • Linz, Upper Austria, Austria
        • Research Site
  • Belgium
      • Brasschaat, Belgium
        • Research Site
      • Brussels, Belgium
        • Research Site
      • Haine-Saint Paul, Belgium
        • Research Site
      • Leuven, Belgium
        • Research Site
      • Liege, Belgium
        • Research Site
      • Mechelen, Belgium
        • Research Site
  • Brazil
      • Ondina-Salvdor, Brazil
        • Research Site
      • Rio de Janeriro, Brazil
        • Instituto Nacional Do Câncer - Inca
      • Sao Paulo, Brazil
        • Instituto do Cancer Arnaldo Vieira de Caralho-Onco-pneumonia
      • Sao Paulo, Brazil
        • Santa Casa de Misericordia de Sao Paulo
    • Bahia
      • Salvador, Bahia, Brazil
        • Nugieo de Oncologia da Bahia
    • De ao Paulo
      • São Paulo, De ao Paulo, Brazil
        • Hospital das Clinicas da Faculdade de Medinina de Univeridade
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil
        • Hospital Lifecenter
    • Rio Grande Do Sol
      • Porto Alegre, Rio Grande Do Sol, Brazil
        • Hospital Nossa Senhora da Conceicao, Centro de Pesquisas Medicas e Ensaios Clinicos
    • Rio Grande Do Sul
      • Ijuí, Rio Grande Do Sul, Brazil
        • Associacao Hospital de Caridade Ijui
      • Porto Alegre, 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 Algre, Rio Grande Do Sul, Brazil
        • Research Site
    • Sao Paulo
      • Campinas, Sao Paulo, Brazil
        • Centro de Oncologia de Campinas - OCC
      • Jau, Sao Paulo, Brazil
        • Fundacao Hospital Amaral Carvalho
      • Sorocaba, Sao Paulo, Brazil
        • Instituto de Oncologia de Sorocaba
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • Tom Baker Cancer Center
      • Edmonton, Alberta, Canada
        • Cross Cancer Institue
    • British Columbia
      • Surrey, British Columbia, Canada
        • Frazer Valley Cancer Center
      • Vancouver, British Columbia, Canada
        • British Columbia Cancer Agency
      • Victoria, British Columbia, Canada
        • Vancouver Island Cancer Center
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • Cancer Care Manitoba
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • Capital District Health Authority
      • Sydney, Nova Scotia, Canada
        • Cape Breton Districk Health Authority Cancer Care
    • Ontario
      • Hamilton, Ontario, Canada
        • Juravinski Cancer Center
      • Saint Catharines, Ontario, Canada
        • Niagara Health System
      • Thunder Bay, Ontario, Canada
        • Thunder Bay Regional Health Science Center Northwestern Ontario Regional Center
      • Toronto, Ontario, Canada
        • Mount Sinai Hospital
      • Toronto, Ontario, Canada
        • Princess Margaret Hospital
      • Windsor, Ontario, Canada
        • Windsor Regional Cancer Center
    • Quebec
      • Montreal, Quebec, Canada
        • Jewish General Hospital
      • Montreal, Quebec, Canada
        • Hopital Notre Dame
      • Sainte-Foy, Quebec, Canada
        • Hôpital Laval
  • China
      • Beijing, China
        • Research Site
      • Guangzhou, China
        • Research Site
      • Shanghai, China
        • Research Site
  • Czech Republic
      • Hradec Králové, Czech Republic
        • Research Site
      • Ostrava-Poruba, Czech Republic
        • Research Site
      • Prague, Czech Republic
        • Research Site
      • Praha, Czech Republic
        • Research Site
      • Praha 2, Czech Republic
        • Research Site
      • Usti nad Labem, Czech Republic
        • Research Site
  • Denmark
      • Herlev, Denmark
        • Research Site
      • Odense C, Denmark
        • Research Site
  • France
      • Beuvry, France
        • Research Site
      • Brest, France
        • Research Site
      • Caen, France
        • Research Site
      • Chauny, France
        • Research Site
      • Marseille, France
        • Research Site
      • Marseille Cedex, 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
    • Franche-Comte
      • Besancon, Franche-Comte, France
        • Research Site
    • Rhone-Alpes
      • Pierre-Benite Cedex, Rhone-Alpes, France
        • Research Site
  • Germany
      • 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
        • Research Site
      • Heidelberg, Germany
        • Reseach 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
    • Nordrhein-Westfalen
      • Essen, Nordrhein-Westfalen, Germany
        • Research Site
      • Hemer, Nordrhein-Westfalen, Germany
        • Research Site
    • Rheinland-Pfalz
      • Mainz, Rheinland-Pfalz, Germany
        • Research Site
    • Saar
      • Homburg, Saar, Germany
        • Research Site
  • Greece
      • Athens, Greece
        • Research Site
      • Chidari, Athens, Greece
        • Research Site
      • Heraklion, Greece
        • Research Site
    • Athens
      • Maroussi, Athens, Greece
        • Research Site
    • Attica
      • Athens, Attica, Greece
        • Research Site
    • Nea Efkarpia
      • Thessaloniki, Nea Efkarpia, Greece
        • Research Site
  • Hong Kong
      • Hong Kong, Hong Kong
        • Research Site
    • New Territories
      • Shatin, New Territories, Hong Kong
        • Research Site
  • Hungary
      • Budapest, Hungary
        • Research Site
      • Mátraháza, Hungary
        • Research Site
      • Nyíregyháza, Hungary
        • Research Site
      • Tatabayana, Hungary
        • Research Site
  • India
      • Chennai, India
        • Research Site
      • Hyderabad, India
        • Research Site
      • Mumbai, India
        • Research Site
      • New Delhi, India
        • Research Site
      • Vellore, India
        • Research Site
  • Ireland
      • Dublin, Ireland
        • Research Site
  • Israel
      • 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
    • Tel Avir
      • Tel Hashomer, Tel Avir, Israel
        • Research Site
  • Italy
      • 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
        • Research Site
    • Torino
      • Candiolo, Torino, Italy
        • Research Site
  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Research Site
    • Gyeonggi-Do
      • Seoul, Gyeonggi-Do, Korea, Republic of
        • Research Site
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, Korea, Republic of
        • Research Site
  • Mexico
      • Chihuahua, Mexico
        • Centro Oncologico de Chihuahua
      • Mexico City, Mexico
        • Instituto Nacional de Cancerología (INCan)
    • Michoacan
      • Morelia, Michoacan, Mexico
        • Consultorio del
  • Netherlands
      • Amsterdam, Netherlands
        • Research Site
      • Eindhoven, Netherlands
        • Research Site
      • Hoofdrop, Netherlands
        • Research Site
      • Tilburg, Netherlands
        • Research Site
      • Zwolle, Netherlands
        • Research Site
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands
        • Research Site
  • Poland
      • Bialystok, Poland
        • Research Site
      • Bydgoszcz, Poland
        • Research Site
      • Bytom, Poland
        • Research Site
      • Gdynia, Poland
        • Research Site
      • Kraków, Poland
        • Research Site
      • Lodz, Poland
        • Genova
      • Olsztyn, Poland
        • Research Site
      • Otwock, Poland
        • Research Site
      • Poznan, Poland
        • Research Site
      • Torun, Poland
        • Research Site
      • Warsaw, Poland
        • Research Site
      • Warszawa, Poland
        • Genova
      • Wroclaw, Poland
        • Research Site
      • Zabrze, Poland
        • Research Site
    • Mazowieckie
      • Warszawa, Mazowieckie, Poland
        • Research Site
  • Portugal
      • Coimbra, Portugal
        • Genova
      • Lisboa, Portugal
        • Genova
      • Porto, Portugal
        • Genova
      • Santa Maria de Feira, Portugal
        • Genova
  • Romania
      • 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
        • Research Site
  • Russian Federation
      • Barnaul, Russian Federation
        • Research Site
      • Chelaybinsk, Russian Federation
        • Genova
      • 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
    • Tatarstan
      • Kazan, Tatarstan, Russian Federation
        • Reseaerch Site
    • Yaroslavlr
      • Yaroslavl, Yaroslavlr, Russian Federation
        • Research Site
  • Singapore
      • Singapore, Singapore
        • Research Site
  • Slovakia
      • Bratislava, Slovakia
        • Research Site
      • Kosice, Slovakia
        • Research Site
      • Nitra, Slovakia
        • Research Site
  • Spain
      • 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
    • Barcelona
      • Mataro, Barcelona, Spain
        • Research Site
    • Bilbao
      • Barakaldo, Bilbao, Spain
        • Research Site
    • Guipuzcoa
      • Donostia-San Sebastian, Guipuzcoa, Spain
        • Research Site
  • Sweden
      • Gävle, Sweden
        • Research Site
      • Göteborg, Sweden
        • Research Site
      • Lund, Sweden
        • Research Site
      • Stockholm, Sweden
        • Research Site
      • Umea, Sweden
        • Research Site
      • Uppsala, Sweden
        • Research Site
  • Switzerland
      • Basel, Switzerland
        • Research Site
      • Geneve, Switzerland
        • Research Site
      • Genève, Switzerland
        • Research Site
      • Winterthur, Switzerland
        • Research Site
  • Taiwan
      • Kaohsiung, Taiwan
        • Research Site
      • Taichung, Taiwan
        • Research Site
      • Tainan, Taiwan
        • Research Site
      • Taipei, Taiwan
        • Research Site
      • Tao-Yuan, Taiwan
        • Research Site
  • United Kingdom
      • 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
        • Research Site
  • United States
    • Arkansas
      • Fort Smith, Arkansas, United States, 72901
        • Saint Edward Mercy Medical Center
    • California
      • Anaheim, California, United States, 92801
        • Pacific Cancer Medical Center
      • Glendale, California, United States, 91206
        • Glendale Adventist Medical Center
      • Los Angeles, California, United States, 90033
        • Norris Cancer Hospital
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Outpatient Cancer Center at the Samuel Oschin Comprehensive Cancer Institute
      • Montebello, California, United States, 90640
        • Clinical Trials and Research Associates, Inc.
      • Rancho Mirage, California, United States
        • Desert Hematology Oncology Medical Group, Inc
      • Stockton, California, United States, 95204
        • Stockton Hematology Oncology Medical Group, Inc.
    • Colorado
      • Denver, Colorado, United States, 80045
        • University of Colorado Cancer Center
    • Florida
      • Brooksville, Florida, United States, 34613
        • Pasco Hernando Oncology Associates P.A
      • Miami, Florida, United States
        • University of Miami, Sylvester Comprehensive Cancer Center
      • New Port Richey, Florida, United States, 34652
        • Pasco Hernando Oncology Associates, PA
      • Ormond Beach, Florida, United States, 32174
        • Florida Hospital Memorial System
    • Illinois
      • Centralia, Illinois, United States, 62801
        • Southern Illinois Hematology/Oncology
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Joliet, Illinois, United States, 60435
        • Joliet Oncology-Hematology Associates, Ltd.
    • Kentucky
      • Hazard, Kentucky, United States, 41701
        • Kentucky Cancer Center
    • Louisiana
      • Houma, Louisiana, United States
        • Leonard J. Chabert Medical Center
      • Metarie, Louisiana, United States, 70006
        • Hematology And Oncology Specialists, Llc
    • Maryland
      • Baltimore, Maryland, United States, 21215
        • Sinai Hospital of Baltimore
      • Baltimore, Maryland, United States
        • University of Maryland, Marlene and Steward Greenbaum Cancer Center
    • Massachusetts
      • Burlington, Massachusetts, United States
        • Lahey Clinic
    • Michigan
      • Saint Joseph, Michigan, United States, 49085
        • Oncology Care Associates
    • Minnesota
      • Minneapolis, Minnesota, United States
        • University of Minnesota Physicians, Masonic Cancer Center
    • Missouri
      • Saint Louis, Missouri, United States
        • Saint Louis University Cance Center
    • Montana
      • Billings, Montana, United States, 59101
        • Deaconess Billings Clinic
      • Great Falls, Montana, United States, 59405
        • Big Sky Oncology, Sletten Cancer Institute
    • Nebraska
      • Hastings, Nebraska, United States, 68901
        • Nebraska Cancer Care, LLC
      • Lincoln, Nebraska, United States, 68510
        • Southeast Nebraska Cancer Center
    • New York
      • New York, New York, United States, 10011
        • St. Vincents Comprehensive Cancer Center
      • Nyack, New York, United States, 10960
        • Hematology Oncology Associates of Rockland
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Univ. of North Carolina at Chapel Hill, Lineberger Comprehensive Cancer Center
      • Charlotte, North Carolina, United States, 28203
        • Carolinas Hematology-Oncology
      • Wilmington, North Carolina, United States, 28401
        • Hanover Medical Specialts PA
    • Ohio
      • Canton, Ohio, United States, 44718
        • Gabrail Cancer Center
      • Cleveland, Ohio, United States, 44106
        • University Hospitals of Cleveland
      • Middletown, Ohio, United States, 45042
        • Signal Point Clinical Research Center, LLC
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74133
        • Southwestern Regional Medical Center
      • Tulsa, Oklahoma, United States
        • Southwestern Regional Medical Center
    • Oregon
      • Portland, Oregon, United States, 97213
        • Providence Portland Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center
      • Philadelphia, Pennsylvania, United States, 19104
        • Univ. of Pennsylvania Abramson Cancer Center
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • The Jones Clinic, PC
    • Texas
      • Dallas, Texas, United States, 75230
        • Center for Oncology Research
      • Fort Worth, Texas, United States, 76104
        • The Center for Cancer and Blood Disorders
      • Fort Worth, Texas, United States, 76104
        • John Peter Smith Center for Cancer Care
      • San Antonio, Texas, United States, 78229
        • Cancer Therapy & Research Center, Institute for Drug Development
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Fairfax-Northern Virginia Hematology Oncology, PC
    • West Virginia
      • Wheeling, West Virginia, United States, 26003
        • Wheeling Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 66 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 66 months
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.
Up to 66 months
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.
Years 1, 2, and 3
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.
From first dose up to 42 days after the last dose of the trial treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EMD Serono

Collaborators

Merck KGaA, Darmstadt, Germany

Investigators

  • Study Director: Medical Responsible, EMD Serono Inc., an affiliate of Merck KGaA, Darmstadt, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

December 7, 2006

First Submitted That Met QC Criteria

December 7, 2006

First Posted (Estimate)

December 8, 2006

Study Record Updates

Last Update Posted (Estimate)

November 20, 2015

Last Update Submitted That Met QC Criteria

October 19, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMR 63325-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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