Cancer Vaccine Study for Unresectable Stage III Non-small Cell Lung Cancer (START)
NCT ID: NCT00409188
Last Updated: 2015-11-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1513 participants
INTERVENTIONAL
2007-01-31
2015-04-30
Brief Summary
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A local ancillary (sub) study in European centers will evaluate the immune response in peripheral blood after tecemotide (L-BLP25) or placebo vaccination.
Detailed Description
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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)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Tecemotide (L-BLP25)
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.
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
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.
Interventions
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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.
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
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.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Merck KGaA, Darmstadt, Germany
INDUSTRY
EMD Serono
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Responsible
Role: STUDY_DIRECTOR
EMD Serono Inc., an affiliate of Merck KGaA, Darmstadt, Germany
Locations
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Saint Edward Mercy Medical Center
Fort Smith, Arkansas, United States
Pacific Cancer Medical Center
Anaheim, California, United States
Glendale Adventist Medical Center
Glendale, California, United States
Norris Cancer Hospital
Los Angeles, California, United States
Cedars-Sinai Outpatient Cancer Center at the Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California, United States
Clinical Trials and Research Associates, Inc.
Montebello, California, United States
Desert Hematology Oncology Medical Group, Inc
Rancho Mirage, California, United States
Stockton Hematology Oncology Medical Group, Inc.
Stockton, California, United States
University of Colorado Cancer Center
Denver, Colorado, United States
Pasco Hernando Oncology Associates P.A
Brooksville, Florida, United States
University of Miami, Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Pasco Hernando Oncology Associates, PA
New Port Richey, Florida, United States
Florida Hospital Memorial System
Ormond Beach, Florida, United States
Southern Illinois Hematology/Oncology
Centralia, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
Joliet Oncology-Hematology Associates, Ltd.
Joliet, Illinois, United States
Kentucky Cancer Center
Hazard, Kentucky, United States
Leonard J. Chabert Medical Center
Houma, Louisiana, United States
Hematology and Oncology Specialists, LLC
Metarie, Louisiana, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, United States
University of Maryland, Marlene and Steward Greenbaum Cancer Center
Baltimore, Maryland, United States
Lahey Clinic
Burlington, Massachusetts, United States
Oncology Care Associates
Saint Joseph, Michigan, United States
University of Minnesota Physicians, Masonic Cancer Center
Minneapolis, Minnesota, United States
Saint Louis University Cance Center
St Louis, Missouri, United States
Deaconess Billings Clinic
Billings, Montana, United States
Big Sky Oncology, Sletten Cancer Institute
Great Falls, Montana, United States
Nebraska Cancer Care, LLC
Hastings, Nebraska, United States
Southeast Nebraska Cancer Center
Lincoln, Nebraska, United States
St. Vincents Comprehensive Cancer Center
New York, New York, United States
Hematology Oncology Associates of Rockland
Nyack, New York, United States
Univ. of North Carolina at Chapel Hill, Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Carolinas Hematology-Oncology
Charlotte, North Carolina, United States
Hanover Medical Specialts PA
Wilmington, North Carolina, United States
Gabrail Cancer Center
Canton, Ohio, United States
University Hospitals of Cleveland
Cleveland, Ohio, United States
Signal Point Clinical Research Center, LLC
Middletown, Ohio, United States
Southwestern Regional Medical Center
Tulsa, Oklahoma, United States
Southwestern Regional Medical Center
Tulsa, Oklahoma, United States
Providence Portland Medical Center
Portland, Oregon, United States
Univ. of Pennsylvania Abramson Cancer Center
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
The Jones Clinic, PC
Germantown, Tennessee, United States
Center for Oncology Research
Dallas, Texas, United States
John Peter Smith Center for Cancer Care
Fort Worth, Texas, United States
The Center for Cancer and Blood Disorders
Fort Worth, Texas, United States
Cancer Therapy & Research Center, Institute for Drug Development
San Antonio, Texas, United States
Fairfax-Northern Virginia Hematology Oncology, PC
Fairfax, Virginia, United States
Wheeling Hospital
Wheeling, West Virginia, United States
Hospital Italiano Regional del Sur
Bahía Blanca, Buenos Aires, Argentina
Paliar
Capital, Buenos Aires, Buenos Aires, Argentina
Corporacion Medica General San Martin
San Martín, Buenos Aires, Argentina
Centro Oncologico de Roario
Rosario, Santa Fe Province, Argentina
Centro de Educacion Medica e Investigaciones Clinicas "Norberto Quirno" (CEMIC)
Buenos Aires, , Argentina
Instituto Especializado Alexander Fleming
Buenos Aires, , Argentina
Sociedad Intaliana de Beneficencia en Buenos Aires, Hospital Italiano
Buenos Aires, , Argentina
Clinica Universitaria Reina Fabiola
Córdoba, , Argentina
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Tandil, , Argentina
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Nedlands, Western Australia, Australia
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Bankstown, NSW, , Australia
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Camperdown, , Australia
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Heidelberg, , Australia
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Kingswood, , Australia
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Saint Leonards, , Australia
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Woolloongabba, , Australia
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Graz, Styria, Austria
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Linz, Upper Austria, Austria
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Inssbruck, , Austria
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Salzburg, , Austria
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Vienna, , Austria
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Wein, Venna, , Austria
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Wels, , Austria
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Brasschaat, , Belgium
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Brussels, , Belgium
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Haine-Saint-Paul, , Belgium
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Leuven, , Belgium
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Liège, , Belgium
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Mechelen, , Belgium
Hospital das Clinicas da Faculdade de Medinina de Univeridade
São Paulo, De Ao Paulo, Brazil
Nugieo de Oncologia da Bahia
Salvador, Estado de Bahia, 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
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Porto Algre, Rio Grande do Sul, Brazil
Centro de Oncologia de Campinas - OCC
Campinas, São Paulo, Brazil
Fundacao Hospital Amaral Carvalho
Jaú, São Paulo, Brazil
Instituto do Cancer Arnaldo Vieira de Caralho-Onco-pneumonia
São Paulo, São Paulo, Brazil
Santa Casa de Misericordia De Sao Paulo
São Paulo, São Paulo, Brazil
Instituto de Oncologia de Sorocaba
Sorocaba, São Paulo, Brazil
Research Site
Ondina-Salvdor, , Brazil
Instituto Nacional do Cancer - INCA
Rio de Janeriro, , Brazil
Tom Baker Cancer Center
Calgary, Alberta, Canada
Cross Cancer Institue
Edmonton, Alberta, Canada
Frazer Valley Cancer Center
Surrey, British Columbia, Canada
British Columbia Cancer Agency
Vancouver, British Columbia, Canada
Vancouver Island Cancer Center
Victoria, British Columbia, Canada
Cancer Care Manitoba
Winnipeg, Manitoba, Canada
Capital District Health Authority
Halifax, Nova Scotia, Canada
Cape Breton Districk Health Authority Cancer Care
Sydney, Nova Scotia, Canada
Juravinski Cancer Center
Hamilton, Ontario, Canada
Niagara Health System
St. 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
Hopital Notre Dame
Montreal, Quebec, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Hopital Laval
Sainte-Foy, Quebec, Canada
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Beijing, , China
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Guangzhou, , China
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Shanghai, , China
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Hradec Králové, , Czechia
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Ostrava-Poruba, , Czechia
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Prague, , Czechia
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Ústí nad Labem, , Czechia
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Herlev, , Denmark
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Odense C, , Denmark
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Pierre-Bénite, Auvergne-Rhône-Alpes, France
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Besançon, Franche-Comte, France
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Beuvry, , France
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Brest, , France
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Caen, , France
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Chauny, , France
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Marseille, , France
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Nancy, , France
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Nantes-Saint Herblain, , France
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Paris, , France
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Perpignan, , France
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Poitiers, , France
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Strasbourg, , France
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Essen, North Rhine-Westphalia, Germany
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Hemer, North Rhine-Westphalia, Germany
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Mainz, Rhineland-Palatinate, Germany
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Homburg, Saarland, Germany
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Berlin, , Germany
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Cologne, , Germany
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Coswig, , Germany
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Essen, , Germany
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Frankfurt am Main, , Germany
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Freiburg im Breisgau, , Germany
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Gauting, , Germany
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Großhansdorf, , Germany
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Hamburg, , Germany
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Heidelberg, , Germany
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Kassel, , Germany
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Kiel, , Germany
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Leipzig, , Germany
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Magdeburg, , Germany
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Mainz, , Germany
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Minden, , Germany
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Mutzschen, , Germany
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München, , Germany
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Oldenburg, , Germany
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Rostock, , Germany
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Marousi, Athens, Greece
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Athens, Attica, Greece
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Thessaloniki, Nea Efkarpia, Greece
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Athens, , Greece
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Chidari, Athens, , Greece
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Heraklion, , Greece
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Shatin, New Territories, Hong Kong
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Hong Kong, , Hong Kong
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Budapest, , Hungary
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Mátraháza, , Hungary
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Nyíregyháza, , Hungary
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Tatabayana, , Hungary
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Chennai, , India
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Hyderabad, , India
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Mumbai, , India
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New Delhi, , India
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Vellore, , India
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Dublin, , Ireland
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Tel Litwinsky, Tel Avir, Israel
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Beersheba, , Israel
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Haifa, , Israel
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Jerusalem, , Israel
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Kfar Saba, , Israel
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Petah Tikva, , Israel
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Tel Aviv, , Israel
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Ẕerifin, , Israel
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Genova, Genova, Italy
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Palermo, Palermo, Italy
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Candiolo, Torino, Italy
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Avelino, , Italy
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Bologna, , Italy
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Carpi, , Italy
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Chieti, , Italy
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Forlì, , Italy
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Meldola, , Italy
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Milan, , Italy
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Napoli, , Italy
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Orbassano-Torino, , Italy
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Parma, , Italy
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Rome, , Italy
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Rozzano-Milano, , Italy
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Sassari, , Italy
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Trento, , Italy
Centro Oncologico de Chihuahua
Chihuahua City, Chihuahua, Mexico
Consultorio del
Morelia, Michoacán, Mexico
Instituto Nacional de Cancerologia (INCAN)
Mexico City, , Mexico
Research Site
Amsterdam, North Holland, Netherlands
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Amsterdam, , Netherlands
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Eindhoven, , Netherlands
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Hoofdrop, , Netherlands
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Tilburg, , Netherlands
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Zwolle, , Netherlands
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Warsaw, Masovian Voivodeship, Poland
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Bialystok, , Poland
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Bydgoszcz, , Poland
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Bytom, , Poland
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Gdynia, , Poland
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Krakow, , Poland
Genova
Lodz, , Poland
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Olsztyn, , Poland
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Otwock, , Poland
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Poznan, , Poland
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Torun, , Poland
Genova
Warsaw, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Zabrze, , Poland
Genova
Coimbra, , Portugal
Genova
Lisbon, , Portugal
Genova
Porto, , Portugal
Genova
Santa Maria de Feira, , Portugal
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Bucharest, , Romania
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Cluj-Napoca, , Romania
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Iași, , Romania
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Sibiu, , Romania
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Suceava, , Romania
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Timișoara, , Romania
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Kazan', Tatarstan Republic, Russia
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Yaroslavl, Yaroslavlr, Russia
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Barnaul, , Russia
Genova
Chelaybinsk, , Russia
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Ivanovo, , Russia
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Kazan', , Russia
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Moscow, , Russia
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Obninsk, , Russia
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Saint Petersburg, , Russia
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Tomsk, , Russia
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Voronezh, , Russia
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Singapore, , Singapore
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Bratislava, , Slovakia
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Košice, , Slovakia
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Nitra, , Slovakia
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Goyang-si, Gyeonggi-do, South Korea
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Seoul, Gyeonggi-do, South Korea
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Seoul, , South Korea
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Mataró, Barcelona, Spain
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Barakaldo, Bilbao, Spain
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Donostia / San Sebastian, Guipuzcoa, Spain
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Jaén, Jaen, Spain
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A Coruña, , Spain
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Alicante, , Spain
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Barcelona, , Spain
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Burgos, , Spain
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Girona, , Spain
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Lugo, , Spain
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Madrid, , Spain
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Málaga, , Spain
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Gävle, , Sweden
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Gothenburg, , Sweden
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Lund, , Sweden
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Stockholm, , Sweden
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Umeå, , Sweden
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Uppsala, , Sweden
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Basel, , Switzerland
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Geneva, , Switzerland
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Winterthur, , Switzerland
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Kaohsiung City, , Taiwan
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Taichung, , Taiwan
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Tainan City, , Taiwan
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Taipei, , Taiwan
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Taoyuan District, , Taiwan
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Cornwall, , United Kingdom
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Edinburgh, , United Kingdom
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Glasgow, , United Kingdom
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Guildford, , United Kingdom
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Inverness, , United Kingdom
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Leeds, , United Kingdom
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Leicester, , United Kingdom
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London, , United Kingdom
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Manchester, , United Kingdom
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Metropolitan Borough of Wirral, , United Kingdom
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Southampton, , United Kingdom
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Surrey, , United Kingdom
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Torquay, , United Kingdom
Countries
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References
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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.
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.
DeGregorio M, Soe L, Wolf M. Tecemotide (L-BLP25) versus placebo after chemoradiotherapy for stage III non-small cell lung cancer (START): a randomized, double-blind, phase III trial. J Thorac Dis. 2014 Jun;6(6):571-3. doi: 10.3978/j.issn.2072-1439.2014.05.15. No abstract available.
Zhu J, Yuan Y, Wan X, Yin D, Li R, Chen W, Suo C, Song H. Immunotherapy (excluding checkpoint inhibitors) for stage I to III non-small cell lung cancer treated with surgery or radiotherapy with curative intent. Cochrane Database Syst Rev. 2021 Dec 6;12(12):CD011300. doi: 10.1002/14651858.CD011300.pub3.
Mitchell P, Thatcher N, Socinski MA, Wasilewska-Tesluk E, Horwood K, Szczesna A, Martin C, Ragulin Y, Zukin M, Helwig C, Falk M, Butts C, Shepherd FA. Tecemotide in unresectable stage III non-small-cell lung cancer in the phase III START study: updated overall survival and biomarker analyses. Ann Oncol. 2015 Jun;26(6):1134-1142. doi: 10.1093/annonc/mdv104. Epub 2015 Feb 26.
Other Identifiers
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EMR 63325-001
Identifier Type: -
Identifier Source: org_study_id