Clinical trial NCT00409188: Cancer Vaccine Study for Unresectable Stage III Non-small Cell Lung Cancer (START)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-small Cell Lung Cancer
Keywords: Non-Small Cell Lung Carcinoma;
stage III;
unresectable;
vaccine; Tecemotide; L-BLP25;
Cyclophosphamide;
placebo controlled;
randomized;
double blind;
immunotherapy;
Lead sponsor: EMD Serono
Sponsor class: INDUSTRY
Collaborators: name: Merck KGaA, Darmstadt, Germany
First posted: 2006-12-08
Enrollment: 1513
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Eligibility criteria: 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

Primary outcomes:
measure: Overall Survival
timeFrame: Up to 66 months
Secondary outcomes:
measure: Time To Symptom Progression (TTSP) as Measured by the Lung Cancer Symptom Scale (LCSS)
timeFrame: Up to 66 months
measure: Time To Progression (TTP)
timeFrame: Up to 66 months
measure: One-, Two- and Three-year Survival Rate
timeFrame: Years 1, 2, and 3
measure: Number of Participants With Treatment Emergent Adverse Events and Injection Site Reactions
timeFrame: From first dose up to 42 days after the last dose of the trial treatment
Other outcomes:
Locations:
city: Fort Smith
country: United States
facility: Saint Edward Mercy Medical Center
state: Arkansas
city: Anaheim
country: United States
facility: Pacific Cancer Medical Center
state: California
city: Glendale
country: United States
facility: Glendale Adventist Medical Center
state: California
city: Los Angeles
country: United States
facility: Norris Cancer Hospital
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Outpatient Cancer Center at the Samuel Oschin Comprehensive Cancer Institute
state: California
city: Montebello
country: United States
facility: Clinical Trials and Research Associates, Inc.
state: California
city: Rancho Mirage
country: United States
facility: Desert Hematology Oncology Medical Group, Inc
state: California
city: Stockton
country: United States
facility: Stockton Hematology Oncology Medical Group, Inc.
state: California
city: Denver
country: United States
facility: University of Colorado Cancer Center
state: Colorado
city: Brooksville
country: United States
facility: Pasco Hernando Oncology Associates P.A
state: Florida
city: Miami
country: United States
facility: University of Miami, Sylvester Comprehensive Cancer Center
state: Florida
city: New Port Richey
country: United States
facility: Pasco Hernando Oncology Associates, PA
state: Florida
city: Ormond Beach
country: United States
facility: Florida Hospital Memorial System
state: Florida
city: Centralia
country: United States
facility: Southern Illinois Hematology/Oncology
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Joliet
country: United States
facility: Joliet Oncology-Hematology Associates, Ltd.
state: Illinois
city: Hazard
country: United States
facility: Kentucky Cancer Center
state: Kentucky
city: Houma
country: United States
facility: Leonard J. Chabert Medical Center
state: Louisiana
city: Metarie
country: United States
facility: Hematology and Oncology Specialists, LLC
state: Louisiana
city: Baltimore
country: United States
facility: Sinai Hospital of Baltimore
state: Maryland
city: Baltimore
country: United States
facility: University of Maryland, Marlene and Steward Greenbaum Cancer Center
state: Maryland
city: Burlington
country: United States
facility: Lahey Clinic
state: Massachusetts
city: Saint Joseph
country: United States
facility: Oncology Care Associates
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota Physicians, Masonic Cancer Center
state: Minnesota
city: Saint Louis
country: United States
facility: Saint Louis University Cance Center
state: Missouri
city: Billings
country: United States
facility: Deaconess Billings Clinic
state: Montana
city: Great Falls
country: United States
facility: Big Sky Oncology, Sletten Cancer Institute
state: Montana
city: Hastings
country: United States
facility: Nebraska Cancer Care, LLC
state: Nebraska
city: Lincoln
country: United States
facility: Southeast Nebraska Cancer Center
state: Nebraska
city: New York
country: United States
facility: St. Vincents Comprehensive Cancer Center
state: New York
city: Nyack
country: United States
facility: Hematology Oncology Associates of Rockland
state: New York
city: Chapel Hill
country: United States
facility: Univ. of North Carolina at Chapel Hill, Lineberger Comprehensive Cancer Center
state: North Carolina
city: Charlotte
country: United States
facility: Carolinas Hematology-Oncology
state: North Carolina
city: Wilmington
country: United States
facility: Hanover Medical Specialts PA
state: North Carolina
city: Canton
country: United States
facility: Gabrail Cancer Center
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
city: Middletown
country: United States
facility: Signal Point Clinical Research Center, LLC
state: Ohio
city: Tulsa
country: United States
facility: Southwestern Regional Medical Center
state: Oklahoma
city: Tulsa
country: United States
facility: Southwestern Regional Medical Center
state: Oklahoma
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Philadelphia
country: United States
facility: Univ. of Pennsylvania Abramson Cancer Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Germantown
country: United States
facility: The Jones Clinic, PC
state: Tennessee
city: Dallas
country: United States
facility: Center for Oncology Research
state: Texas
city: Fort Worth
country: United States
facility: John Peter Smith Center for Cancer Care
state: Texas
city: Fort Worth
country: United States
facility: The Center for Cancer and Blood Disorders
state: Texas
city: San Antonio
country: United States
facility: Cancer Therapy & Research Center, Institute for Drug Development
state: Texas
city: Fairfax
country: United States
facility: Fairfax-Northern Virginia Hematology Oncology, PC
state: Virginia
city: Wheeling
country: United States
facility: Wheeling Hospital
state: West Virginia
city: Bahia Blanca
country: Argentina
facility: Hospital Italiano Regional del Sur
state: Buenos Aires
city: Capital, Buenos Aires
country: Argentina
facility: Paliar
state: Buenos Aires
city: San Martin
country: Argentina
facility: Corporacion Medica General San Martin
state: Buenos Aires
city: Rosario
country: Argentina
facility: Centro Oncologico de Roario
state: Santa Fe
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Centro de Educacion Medica e Investigaciones Clinicas "Norberto Quirno" (CEMIC)
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Instituto Especializado Alexander Fleming
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Sociedad Intaliana de Beneficencia en Buenos Aires, Hospital Italiano
city: Cordoba
country: Argentina
facility: Clinica Universitaria Reina Fabiola
city: Tandil
country: Argentina
facility: Research Site
city: Nedlands
country: Australia
facility: Research Site
state: Western Australia
city: Bankstown, NSW
country: Australia
facility: Research Site
city: Camperdown
country: Australia
facility: Research Site
city: Heidelberg
country: Australia
facility: Research Site
city: Kingswood
country: Australia
facility: Research Site
city: Saint Leonards
country: Australia
facility: Research Site
city: Woolloongabba
country: Australia
facility: Research Site
city: Graz
country: Austria
facility: Research Site
state: Styria
city: Linz
country: Austria
facility: Research Site
state: Upper Austria
city: Inssbruck
country: Austria
facility: Research Site
city: Salzburg
country: Austria
facility: Research Site
city: Wein, Venna
country: Austria
facility: Research Site
city: Wels
country: Austria
facility: Research Site
city: Wien
country: Austria
facility: Research Site
city: Brasschaat
country: Belgium
facility: Research Site
city: Brussels
country: Belgium
facility: Research Site
city: Haine-Saint Paul
country: Belgium
facility: Research Site
city: Leuven
country: Belgium
facility: Research Site
city: Liege
country: Belgium
facility: Research Site
city: Mechelen
country: Belgium
facility: Research Site
city: Salvador
country: Brazil
facility: Nugieo de Oncologia da Bahia
state: Bahia
city: São Paulo
country: Brazil
facility: Hospital das Clinicas da Faculdade de Medinina de Univeridade
state: De ao Paulo
city: Belo Horizonte
country: Brazil
facility: Hospital LifeCenter
state: Minas Gerais
city: Porto Alegre
country: Brazil
facility: Hospital Nossa Senhora da Conceicao, Centro de Pesquisas Medicas e Ensaios Clinicos
state: Rio Grande Do Sol
city: Ijuí
country: Brazil
facility: Associacao Hospital de Caridade Ijui
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre, Dept. de Endocrinologia
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Sao Lucas-Pucrs
state: Rio Grande Do Sul
city: Porto Algre
country: Brazil
facility: Research Site
state: Rio Grande Do Sul
city: Campinas
country: Brazil
facility: Centro de Oncologia de Campinas - OCC
state: Sao Paulo
city: Jau
country: Brazil
facility: Fundacao Hospital Amaral Carvalho
state: Sao Paulo
city: Sorocaba
country: Brazil
facility: Instituto de Oncologia de Sorocaba
state: Sao Paulo
city: Ondina-Salvdor
country: Brazil
facility: Research Site
city: Rio de Janeriro
country: Brazil
facility: Instituto Nacional do Cancer - INCA
city: Sao Paulo
country: Brazil
facility: Instituto do Cancer Arnaldo Vieira de Caralho-Onco-pneumonia
city: Sao Paulo
country: Brazil
facility: Santa Casa de Misericordia De Sao Paulo
city: Calgary
country: Canada
facility: Tom Baker Cancer Center
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institue
state: Alberta
city: Surrey
country: Canada
facility: Frazer Valley Cancer Center
state: British Columbia
city: Vancouver
country: Canada
facility: British Columbia Cancer Agency
state: British Columbia
city: Victoria
country: Canada
facility: Vancouver Island Cancer Center
state: British Columbia
city: Winnipeg
country: Canada
facility: Cancer Care Manitoba
state: Manitoba
city: Halifax
country: Canada
facility: Capital District Health Authority
state: Nova Scotia
city: Sydney
country: Canada
facility: Cape Breton Districk Health Authority Cancer Care
state: Nova Scotia
city: Hamilton
country: Canada
facility: Juravinski Cancer Center
state: Ontario
city: Saint Catharines
country: Canada
facility: Niagara Health System
state: Ontario
city: Thunder Bay
country: Canada
facility: Thunder Bay Regional Health Science Center Northwestern Ontario Regional Center
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Windsor
country: Canada
facility: Windsor Regional Cancer Center
state: Ontario
city: Montreal
country: Canada
facility: Hopital Notre Dame
state: Quebec
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Sainte-Foy
country: Canada
facility: Hopital Laval
state: Quebec
city: Beijing
country: China
facility: Research Site
city: Guangzhou
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Hradec Králové
country: Czech Republic
facility: Research Site
city: Ostrava-Poruba
country: Czech Republic
facility: Research Site
city: Prague
country: Czech Republic
facility: Research Site
city: Praha 2
country: Czech Republic
facility: Research Site
city: Praha
country: Czech Republic
facility: Research Site
city: Usti nad Labem
country: Czech Republic
facility: Research Site
city: Herlev
country: Denmark
facility: Research Site
city: Odense C
country: Denmark
facility: Research Site
city: Besancon
country: France
facility: Research Site
state: Franche-Comte
city: Pierre-Benite Cedex
country: France
facility: Research Site
state: Rhone-Alpes
city: Beuvry
country: France
facility: Research Site
city: Brest
country: France
facility: Research Site
city: Caen
country: France
facility: Research Site
city: Chauny
country: France
facility: Research Site
city: Marseille Cedex
country: France
facility: Research Site
city: Marseille
country: France
facility: Research Site
city: Nancy
country: France
facility: Research Site
city: Nantes-Saint Herblain
country: France
facility: Research Site
city: Paris Cedex 15
country: France
facility: Research Site
city: Perpignan
country: France
facility: Research Site
city: Poitiers Cedex
country: France
facility: Research Site
city: Strasbourg Cedex
country: France
facility: Research Site
city: Essen
country: Germany
facility: Research Site
state: Nordrhein-Westfalen
city: Hemer
country: Germany
facility: Research Site
state: Nordrhein-Westfalen
city: Mainz
country: Germany
facility: Research Site
state: Rheinland-Pfalz
city: Homburg
country: Germany
facility: Research Site
state: Saar
city: Berlin
country: Germany
facility: Research Site
city: Coswig
country: Germany
facility: Research Site
city: Essen
country: Germany
facility: Research Site
city: Frankfurt am Main
country: Germany
facility: Research Site
city: Freiburg
country: Germany
facility: Research Site
city: Gauting
country: Germany
facility: Research Site
city: Großhansdorf
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Heidelberg
country: Germany
facility: Reseach Site
city: Kassel
country: Germany
facility: Research Site
city: Kiel
country: Germany
facility: Research Site
city: Koln
country: Germany
facility: Research Site
city: Leipzig
country: Germany
facility: Research Site
city: Magdeburg
country: Germany
facility: Research Site
city: Mainz
country: Germany
facility: Research Site
city: Minden
country: Germany
facility: Research Site
city: Muchen
country: Germany
facility: Research Site
city: München
country: Germany
facility: Research Site
city: Oldenburg
country: Germany
facility: Research Site
city: Rostock
country: Germany
facility: Research Site
city: Maroussi
country: Greece
facility: Research Site
state: Athens
city: Athens
country: Greece
facility: Research Site
state: Attica
city: Thessaloniki
country: Greece
facility: Research Site
state: Nea Efkarpia
city: Athens
country: Greece
facility: Research Site
city: Chidari, Athens
country: Greece
facility: Research Site
city: Heraklion
country: Greece
facility: Research Site
city: Shatin
country: Hong Kong
facility: Research Site
state: New Territories
city: Hong Kong
country: Hong Kong
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Mátraháza
country: Hungary
facility: Research Site
city: Nyíregyháza
country: Hungary
facility: Research Site
city: Tatabayana
country: Hungary
facility: Research Site
city: Chennai
country: India
facility: Research Site
city: Hyderabad
country: India
facility: Research Site
city: Mumbai
country: India
facility: Research Site
city: New Delhi
country: India
facility: Research Site
city: Vellore
country: India
facility: Research Site
city: Dublin
country: Ireland
facility: Research Site
city: Tel Hashomer
country: Israel
facility: Research Site
state: Tel Avir
city: Beer Sheva
country: Israel
facility: Research Site
city: Haifa
country: Israel
facility: Research Site
city: Jerusalem
country: Israel
facility: Research Site
city: Kfar Saba
country: Israel
facility: Research Site
city: Petach Tikva
country: Israel
facility: Research Site
city: Tel Aviv
country: Israel
facility: Research Site
city: Zerifin
country: Israel
facility: Research Site
city: Candiolo
country: Italy
facility: Research Site
state: Torino
city: Avelino
country: Italy
facility: Research Site
city: Bologna
country: Italy
facility: Research Site
city: Carpi
country: Italy
facility: Research Site
city: Chieti
country: Italy
facility: Research Site
city: Forli
country: Italy
facility: Research Site
city: Genova
country: Italy
facility: Research Site
city: Meldola
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Napoli
country: Italy
facility: Research Site
city: Orbassano-Torino
country: Italy
facility: Research Site
city: Palermo
country: Italy
facility: Research Site
city: Parma
country: Italy
facility: Research Site
city: Rome
country: Italy
facility: Research Site
city: Rozzano-Milano
country: Italy
facility: Research Site
city: Sassari
country: Italy
facility: Research Site
city: Trento
country: Italy
facility: Research Site
city: Goyang-si
country: Korea, Republic of
facility: Research Site
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Research Site
state: Gyeonggi-Do
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Morelia
country: Mexico
facility: Consultorio del
state: Michoacan
city: Chihuahua
country: Mexico
facility: Centro Oncologico de Chihuahua
city: Mexico City
country: Mexico
facility: Instituto Nacional de Cancerologia (INCAN)
city: Amsterdam
country: Netherlands
facility: Research Site
state: Noord-Holland
city: Amsterdam
country: Netherlands
facility: Research Site
city: Eindhoven
country: Netherlands
facility: Research Site
city: Hoofdrop
country: Netherlands
facility: Research Site
city: Tilburg
country: Netherlands
facility: Research Site
city: Zwolle
country: Netherlands
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
state: Mazowieckie
city: Bialystok
country: Poland
facility: Research Site
city: Bydgoszcz
country: Poland
facility: Research Site
city: Bytom
country: Poland
facility: Research Site
city: Gdynia
country: Poland
facility: Research Site
city: Kraków
country: Poland
facility: Research Site
city: Lodz
country: Poland
facility: Genova
city: Olsztyn
country: Poland
facility: Research Site
city: Otwock
country: Poland
facility: Research Site
city: Poznan
country: Poland
facility: Research Site
city: Torun
country: Poland
facility: Research Site
city: Warsaw
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Genova
city: Wroclaw
country: Poland
facility: Research Site
city: Zabrze
country: Poland
facility: Research Site
city: Coimbra
country: Portugal
facility: Genova
city: Lisboa
country: Portugal
facility: Genova
city: Porto
country: Portugal
facility: Genova
city: Santa Maria de Feira
country: Portugal
facility: Genova
city: Bucharest
country: Romania
facility: Research Site
city: Bucuresti
country: Romania
facility: Research Site
city: Cluj-Napoca
country: Romania
facility: Research Site
city: Iasi
country: Romania
facility: Research Site
city: Sibiu
country: Romania
facility: Research Site
city: Suceava
country: Romania
facility: Research Site
city: Timisoara
country: Romania
facility: Research Site
city: Kazan
country: Russian Federation
facility: Reseaerch Site
state: Tatarstan
city: Yaroslavl
country: Russian Federation
facility: Research Site
state: Yaroslavlr
city: Barnaul
country: Russian Federation
facility: Research Site
city: Chelaybinsk
country: Russian Federation
facility: Genova
city: Ivanovo
country: Russian Federation
facility: Research Site
city: Kazan
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Obninsk
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Tomsk
country: Russian Federation
facility: Research Site
city: Voronezh
country: Russian Federation
facility: Research Site
city: Singapore
country: Singapore
facility: Research Site
city: Bratislava
country: Slovakia
facility: Research Site
city: Kosice
country: Slovakia
facility: Research Site
city: Nitra
country: Slovakia
facility: Research Site
city: Mataro
country: Spain
facility: Research Site
state: Barcelona
city: Barakaldo
country: Spain
facility: Research Site
state: Bilbao
city: Donostia-San Sebastian
country: Spain
facility: Research Site
state: Guipuzcoa
city: A Coruna
country: Spain
facility: Research Site
city: Alicante
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Burgos
country: Spain
facility: Research Site
city: Girona
country: Spain
facility: Research Site
city: Jaen
country: Spain
facility: Research Site
city: Lugo
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Malaga
country: Spain
facility: Research Site
city: Gävle
country: Sweden
facility: Research Site
city: Göteborg
country: Sweden
facility: Research Site
city: Lund
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Umea
country: Sweden
facility: Research Site
city: Uppsala
country: Sweden
facility: Research Site
city: Basel
country: Switzerland
facility: Research Site
city: Geneve
country: Switzerland
facility: Research Site
city: Genève
country: Switzerland
facility: Research Site
city: Winterthur
country: Switzerland
facility: Research Site
city: Kaohsiung
country: Taiwan
facility: Research Site
city: Taichung
country: Taiwan
facility: Research Site
city: Tainan
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Tao-Yuan
country: Taiwan
facility: Research Site
city: Cornwall
country: United Kingdom
facility: Research Site
city: Edinburgh
country: United Kingdom
facility: Research Site
city: Glasgow
country: United Kingdom
facility: Research Site
city: Guildford
country: United Kingdom
facility: Research Site
city: Inverness
country: United Kingdom
facility: Research Site
city: Leeds
country: United Kingdom
facility: Research Site
city: Leicester
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
city: Southampton
country: United Kingdom
facility: Research Site
city: Surrey
country: United Kingdom
facility: Research Site
city: Torquay
country: United Kingdom
facility: Research Site
city: Wirral
country: United Kingdom
facility: Research Site
Study officials:
affiliation: EMD Serono Inc., an affiliate of Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.