Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00409188




Registration number
NCT00409188
Ethics application status
Date submitted
7/12/2006
Date registered
8/12/2006
Date last updated
20/11/2015

Titles & IDs
Public title
Cancer Vaccine Study for Unresectable Stage III Non-small Cell Lung Cancer (START)
Scientific 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.
Secondary ID [1] 0 0
EMR 63325-001
Universal Trial Number (UTN)
Trial acronym
START
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Tecemotide (L-BLP25)
Treatment: Drugs - Single low dose cyclophosphamide
Treatment: Drugs - Placebo

Experimental: Tecemotide (L-BLP25) -

Placebo comparator: Placebo -


Treatment: Other: 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.

Treatment: Drugs: 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.

Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
Up to 66 months
Secondary outcome [1] 0 0
Time To Symptom Progression (TTSP) as Measured by the Lung Cancer Symptom Scale (LCSS)
Timepoint [1] 0 0
Up to 66 months
Secondary outcome [2] 0 0
Time To Progression (TTP)
Timepoint [2] 0 0
Up to 66 months
Secondary outcome [3] 0 0
One-, Two- and Three-year Survival Rate
Timepoint [3] 0 0
Years 1, 2, and 3
Secondary outcome [4] 0 0
Number of Participants With Treatment Emergent Adverse Events and Injection Site Reactions
Timepoint [4] 0 0
From first dose up to 42 days after the last dose of the trial treatment

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2015
Sample size
Target
Accrual to date
Final
1513
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Research Site - Nedlands
Recruitment hospital [2] 0 0
Research Site - Bankstown, NSW
Recruitment hospital [3] 0 0
Research Site - Camperdown
Recruitment hospital [4] 0 0
Research Site - Heidelberg
Recruitment hospital [5] 0 0
Research Site - Kingswood
Recruitment hospital [6] 0 0
Research Site - Saint Leonards
Recruitment hospital [7] 0 0
Research Site - Woolloongabba
Recruitment postcode(s) [1] 0 0
- Nedlands
Recruitment postcode(s) [2] 0 0
- Bankstown, NSW
Recruitment postcode(s) [3] 0 0
- Camperdown
Recruitment postcode(s) [4] 0 0
- Heidelberg
Recruitment postcode(s) [5] 0 0
- Kingswood
Recruitment postcode(s) [6] 0 0
- Saint Leonards
Recruitment postcode(s) [7] 0 0
- Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Kentucky
Country [7] 0 0
United States of America
State/province [7] 0 0
Louisiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Minnesota
Country [12] 0 0
United States of America
State/province [12] 0 0
Missouri
Country [13] 0 0
United States of America
State/province [13] 0 0
Montana
Country [14] 0 0
United States of America
State/province [14] 0 0
Nebraska
Country [15] 0 0
United States of America
State/province [15] 0 0
New York
Country [16] 0 0
United States of America
State/province [16] 0 0
North Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Ohio
Country [18] 0 0
United States of America
State/province [18] 0 0
Oklahoma
Country [19] 0 0
United States of America
State/province [19] 0 0
Oregon
Country [20] 0 0
United States of America
State/province [20] 0 0
Pennsylvania
Country [21] 0 0
United States of America
State/province [21] 0 0
Tennessee
Country [22] 0 0
United States of America
State/province [22] 0 0
Texas
Country [23] 0 0
United States of America
State/province [23] 0 0
Virginia
Country [24] 0 0
United States of America
State/province [24] 0 0
West Virginia
Country [25] 0 0
Argentina
State/province [25] 0 0
Buenos Aires
Country [26] 0 0
Argentina
State/province [26] 0 0
Santa Fe
Country [27] 0 0
Argentina
State/province [27] 0 0
Ciudad Autonoma de Buenos Aires
Country [28] 0 0
Argentina
State/province [28] 0 0
Cordoba
Country [29] 0 0
Argentina
State/province [29] 0 0
Tandil
Country [30] 0 0
Austria
State/province [30] 0 0
Styria
Country [31] 0 0
Austria
State/province [31] 0 0
Upper Austria
Country [32] 0 0
Austria
State/province [32] 0 0
Inssbruck
Country [33] 0 0
Austria
State/province [33] 0 0
Salzburg
Country [34] 0 0
Austria
State/province [34] 0 0
Wein, Venna
Country [35] 0 0
Austria
State/province [35] 0 0
Wels
Country [36] 0 0
Austria
State/province [36] 0 0
Wien
Country [37] 0 0
Belgium
State/province [37] 0 0
Brasschaat
Country [38] 0 0
Belgium
State/province [38] 0 0
Brussels
Country [39] 0 0
Belgium
State/province [39] 0 0
Haine-Saint Paul
Country [40] 0 0
Belgium
State/province [40] 0 0
Leuven
Country [41] 0 0
Belgium
State/province [41] 0 0
Liege
Country [42] 0 0
Belgium
State/province [42] 0 0
Mechelen
Country [43] 0 0
Brazil
State/province [43] 0 0
Bahia
Country [44] 0 0
Brazil
State/province [44] 0 0
De ao Paulo
Country [45] 0 0
Brazil
State/province [45] 0 0
Minas Gerais
Country [46] 0 0
Brazil
State/province [46] 0 0
Rio Grande Do Sol
Country [47] 0 0
Brazil
State/province [47] 0 0
Rio Grande Do Sul
Country [48] 0 0
Brazil
State/province [48] 0 0
Sao Paulo
Country [49] 0 0
Brazil
State/province [49] 0 0
Ondina-Salvdor
Country [50] 0 0
Brazil
State/province [50] 0 0
Rio de Janeriro
Country [51] 0 0
Canada
State/province [51] 0 0
Alberta
Country [52] 0 0
Canada
State/province [52] 0 0
British Columbia
Country [53] 0 0
Canada
State/province [53] 0 0
Manitoba
Country [54] 0 0
Canada
State/province [54] 0 0
Nova Scotia
Country [55] 0 0
Canada
State/province [55] 0 0
Ontario
Country [56] 0 0
Canada
State/province [56] 0 0
Quebec
Country [57] 0 0
China
State/province [57] 0 0
Beijing
Country [58] 0 0
China
State/province [58] 0 0
Guangzhou
Country [59] 0 0
China
State/province [59] 0 0
Shanghai
Country [60] 0 0
Czech Republic
State/province [60] 0 0
Hradec Králové
Country [61] 0 0
Czech Republic
State/province [61] 0 0
Ostrava-Poruba
Country [62] 0 0
Czech Republic
State/province [62] 0 0
Prague
Country [63] 0 0
Czech Republic
State/province [63] 0 0
Praha 2
Country [64] 0 0
Czech Republic
State/province [64] 0 0
Praha
Country [65] 0 0
Czech Republic
State/province [65] 0 0
Usti nad Labem
Country [66] 0 0
Denmark
State/province [66] 0 0
Herlev
Country [67] 0 0
Denmark
State/province [67] 0 0
Odense C
Country [68] 0 0
France
State/province [68] 0 0
Franche-Comte
Country [69] 0 0
France
State/province [69] 0 0
Rhone-Alpes
Country [70] 0 0
France
State/province [70] 0 0
Beuvry
Country [71] 0 0
France
State/province [71] 0 0
Brest
Country [72] 0 0
France
State/province [72] 0 0
Caen
Country [73] 0 0
France
State/province [73] 0 0
Chauny
Country [74] 0 0
France
State/province [74] 0 0
Marseille Cedex
Country [75] 0 0
France
State/province [75] 0 0
Marseille
Country [76] 0 0
France
State/province [76] 0 0
Nancy
Country [77] 0 0
France
State/province [77] 0 0
Nantes-Saint Herblain
Country [78] 0 0
France
State/province [78] 0 0
Paris Cedex 15
Country [79] 0 0
France
State/province [79] 0 0
Perpignan
Country [80] 0 0
France
State/province [80] 0 0
Poitiers Cedex
Country [81] 0 0
France
State/province [81] 0 0
Strasbourg Cedex
Country [82] 0 0
Germany
State/province [82] 0 0
Nordrhein-Westfalen
Country [83] 0 0
Germany
State/province [83] 0 0
Rheinland-Pfalz
Country [84] 0 0
Germany
State/province [84] 0 0
Saar
Country [85] 0 0
Germany
State/province [85] 0 0
Berlin
Country [86] 0 0
Germany
State/province [86] 0 0
Coswig
Country [87] 0 0
Germany
State/province [87] 0 0
Essen
Country [88] 0 0
Germany
State/province [88] 0 0
Frankfurt am Main
Country [89] 0 0
Germany
State/province [89] 0 0
Freiburg
Country [90] 0 0
Germany
State/province [90] 0 0
Gauting
Country [91] 0 0
Germany
State/province [91] 0 0
Großhansdorf
Country [92] 0 0
Germany
State/province [92] 0 0
Hamburg
Country [93] 0 0
Germany
State/province [93] 0 0
Heidelberg
Country [94] 0 0
Germany
State/province [94] 0 0
Kassel
Country [95] 0 0
Germany
State/province [95] 0 0
Kiel
Country [96] 0 0
Germany
State/province [96] 0 0
Koln
Country [97] 0 0
Germany
State/province [97] 0 0
Leipzig
Country [98] 0 0
Germany
State/province [98] 0 0
Magdeburg
Country [99] 0 0
Germany
State/province [99] 0 0
Mainz
Country [100] 0 0
Germany
State/province [100] 0 0
Minden
Country [101] 0 0
Germany
State/province [101] 0 0
Muchen
Country [102] 0 0
Germany
State/province [102] 0 0
München
Country [103] 0 0
Germany
State/province [103] 0 0
Oldenburg
Country [104] 0 0
Germany
State/province [104] 0 0
Rostock
Country [105] 0 0
Greece
State/province [105] 0 0
Athens
Country [106] 0 0
Greece
State/province [106] 0 0
Attica
Country [107] 0 0
Greece
State/province [107] 0 0
Nea Efkarpia
Country [108] 0 0
Greece
State/province [108] 0 0
Chidari, Athens
Country [109] 0 0
Greece
State/province [109] 0 0
Heraklion
Country [110] 0 0
Hong Kong
State/province [110] 0 0
New Territories
Country [111] 0 0
Hong Kong
State/province [111] 0 0
Hong Kong
Country [112] 0 0
Hungary
State/province [112] 0 0
Budapest
Country [113] 0 0
Hungary
State/province [113] 0 0
Mátraháza
Country [114] 0 0
Hungary
State/province [114] 0 0
Nyíregyháza
Country [115] 0 0
Hungary
State/province [115] 0 0
Tatabayana
Country [116] 0 0
India
State/province [116] 0 0
Chennai
Country [117] 0 0
India
State/province [117] 0 0
Hyderabad
Country [118] 0 0
India
State/province [118] 0 0
Mumbai
Country [119] 0 0
India
State/province [119] 0 0
New Delhi
Country [120] 0 0
India
State/province [120] 0 0
Vellore
Country [121] 0 0
Ireland
State/province [121] 0 0
Dublin
Country [122] 0 0
Israel
State/province [122] 0 0
Tel Avir
Country [123] 0 0
Israel
State/province [123] 0 0
Beer Sheva
Country [124] 0 0
Israel
State/province [124] 0 0
Haifa
Country [125] 0 0
Israel
State/province [125] 0 0
Jerusalem
Country [126] 0 0
Israel
State/province [126] 0 0
Kfar Saba
Country [127] 0 0
Israel
State/province [127] 0 0
Petach Tikva
Country [128] 0 0
Israel
State/province [128] 0 0
Tel Aviv
Country [129] 0 0
Israel
State/province [129] 0 0
Zerifin
Country [130] 0 0
Italy
State/province [130] 0 0
Torino
Country [131] 0 0
Italy
State/province [131] 0 0
Avelino
Country [132] 0 0
Italy
State/province [132] 0 0
Bologna
Country [133] 0 0
Italy
State/province [133] 0 0
Carpi
Country [134] 0 0
Italy
State/province [134] 0 0
Chieti
Country [135] 0 0
Italy
State/province [135] 0 0
Forli
Country [136] 0 0
Italy
State/province [136] 0 0
Genova
Country [137] 0 0
Italy
State/province [137] 0 0
Meldola
Country [138] 0 0
Italy
State/province [138] 0 0
Milano
Country [139] 0 0
Italy
State/province [139] 0 0
Napoli
Country [140] 0 0
Italy
State/province [140] 0 0
Orbassano-Torino
Country [141] 0 0
Italy
State/province [141] 0 0
Palermo
Country [142] 0 0
Italy
State/province [142] 0 0
Parma
Country [143] 0 0
Italy
State/province [143] 0 0
Rome
Country [144] 0 0
Italy
State/province [144] 0 0
Rozzano-Milano
Country [145] 0 0
Italy
State/province [145] 0 0
Sassari
Country [146] 0 0
Italy
State/province [146] 0 0
Trento
Country [147] 0 0
Korea, Republic of
State/province [147] 0 0
Gyeonggi-do
Country [148] 0 0
Korea, Republic of
State/province [148] 0 0
Gyeonggi-Do
Country [149] 0 0
Korea, Republic of
State/province [149] 0 0
Seoul
Country [150] 0 0
Mexico
State/province [150] 0 0
Michoacan
Country [151] 0 0
Mexico
State/province [151] 0 0
Chihuahua
Country [152] 0 0
Mexico
State/province [152] 0 0
Mexico City
Country [153] 0 0
Netherlands
State/province [153] 0 0
Noord-Holland
Country [154] 0 0
Netherlands
State/province [154] 0 0
Amsterdam
Country [155] 0 0
Netherlands
State/province [155] 0 0
Eindhoven
Country [156] 0 0
Netherlands
State/province [156] 0 0
Hoofdrop
Country [157] 0 0
Netherlands
State/province [157] 0 0
Tilburg
Country [158] 0 0
Netherlands
State/province [158] 0 0
Zwolle
Country [159] 0 0
Poland
State/province [159] 0 0
Mazowieckie
Country [160] 0 0
Poland
State/province [160] 0 0
Bialystok
Country [161] 0 0
Poland
State/province [161] 0 0
Bydgoszcz
Country [162] 0 0
Poland
State/province [162] 0 0
Bytom
Country [163] 0 0
Poland
State/province [163] 0 0
Gdynia
Country [164] 0 0
Poland
State/province [164] 0 0
Kraków
Country [165] 0 0
Poland
State/province [165] 0 0
Lodz
Country [166] 0 0
Poland
State/province [166] 0 0
Olsztyn
Country [167] 0 0
Poland
State/province [167] 0 0
Otwock
Country [168] 0 0
Poland
State/province [168] 0 0
Poznan
Country [169] 0 0
Poland
State/province [169] 0 0
Torun
Country [170] 0 0
Poland
State/province [170] 0 0
Warsaw
Country [171] 0 0
Poland
State/province [171] 0 0
Warszawa
Country [172] 0 0
Poland
State/province [172] 0 0
Wroclaw
Country [173] 0 0
Poland
State/province [173] 0 0
Zabrze
Country [174] 0 0
Portugal
State/province [174] 0 0
Coimbra
Country [175] 0 0
Portugal
State/province [175] 0 0
Lisboa
Country [176] 0 0
Portugal
State/province [176] 0 0
Porto
Country [177] 0 0
Portugal
State/province [177] 0 0
Santa Maria de Feira
Country [178] 0 0
Romania
State/province [178] 0 0
Bucharest
Country [179] 0 0
Romania
State/province [179] 0 0
Bucuresti
Country [180] 0 0
Romania
State/province [180] 0 0
Cluj-Napoca
Country [181] 0 0
Romania
State/province [181] 0 0
Iasi
Country [182] 0 0
Romania
State/province [182] 0 0
Sibiu
Country [183] 0 0
Romania
State/province [183] 0 0
Suceava
Country [184] 0 0
Romania
State/province [184] 0 0
Timisoara
Country [185] 0 0
Russian Federation
State/province [185] 0 0
Tatarstan
Country [186] 0 0
Russian Federation
State/province [186] 0 0
Yaroslavlr
Country [187] 0 0
Russian Federation
State/province [187] 0 0
Barnaul
Country [188] 0 0
Russian Federation
State/province [188] 0 0
Chelaybinsk
Country [189] 0 0
Russian Federation
State/province [189] 0 0
Ivanovo
Country [190] 0 0
Russian Federation
State/province [190] 0 0
Kazan
Country [191] 0 0
Russian Federation
State/province [191] 0 0
Moscow
Country [192] 0 0
Russian Federation
State/province [192] 0 0
Obninsk
Country [193] 0 0
Russian Federation
State/province [193] 0 0
Saint Petersburg
Country [194] 0 0
Russian Federation
State/province [194] 0 0
Tomsk
Country [195] 0 0
Russian Federation
State/province [195] 0 0
Voronezh
Country [196] 0 0
Singapore
State/province [196] 0 0
Singapore
Country [197] 0 0
Slovakia
State/province [197] 0 0
Bratislava
Country [198] 0 0
Slovakia
State/province [198] 0 0
Kosice
Country [199] 0 0
Slovakia
State/province [199] 0 0
Nitra
Country [200] 0 0
Spain
State/province [200] 0 0
Barcelona
Country [201] 0 0
Spain
State/province [201] 0 0
Bilbao
Country [202] 0 0
Spain
State/province [202] 0 0
Guipuzcoa
Country [203] 0 0
Spain
State/province [203] 0 0
A Coruna
Country [204] 0 0
Spain
State/province [204] 0 0
Alicante
Country [205] 0 0
Spain
State/province [205] 0 0
Burgos
Country [206] 0 0
Spain
State/province [206] 0 0
Girona
Country [207] 0 0
Spain
State/province [207] 0 0
Jaen
Country [208] 0 0
Spain
State/province [208] 0 0
Lugo
Country [209] 0 0
Spain
State/province [209] 0 0
Madrid
Country [210] 0 0
Spain
State/province [210] 0 0
Malaga
Country [211] 0 0
Sweden
State/province [211] 0 0
Gävle
Country [212] 0 0
Sweden
State/province [212] 0 0
Göteborg
Country [213] 0 0
Sweden
State/province [213] 0 0
Lund
Country [214] 0 0
Sweden
State/province [214] 0 0
Stockholm
Country [215] 0 0
Sweden
State/province [215] 0 0
Umea
Country [216] 0 0
Sweden
State/province [216] 0 0
Uppsala
Country [217] 0 0
Switzerland
State/province [217] 0 0
Basel
Country [218] 0 0
Switzerland
State/province [218] 0 0
Geneve
Country [219] 0 0
Switzerland
State/province [219] 0 0
Genève
Country [220] 0 0
Switzerland
State/province [220] 0 0
Winterthur
Country [221] 0 0
Taiwan
State/province [221] 0 0
Kaohsiung
Country [222] 0 0
Taiwan
State/province [222] 0 0
Taichung
Country [223] 0 0
Taiwan
State/province [223] 0 0
Tainan
Country [224] 0 0
Taiwan
State/province [224] 0 0
Taipei
Country [225] 0 0
Taiwan
State/province [225] 0 0
Tao-Yuan
Country [226] 0 0
United Kingdom
State/province [226] 0 0
Cornwall
Country [227] 0 0
United Kingdom
State/province [227] 0 0
Edinburgh
Country [228] 0 0
United Kingdom
State/province [228] 0 0
Glasgow
Country [229] 0 0
United Kingdom
State/province [229] 0 0
Guildford
Country [230] 0 0
United Kingdom
State/province [230] 0 0
Inverness
Country [231] 0 0
United Kingdom
State/province [231] 0 0
Leeds
Country [232] 0 0
United Kingdom
State/province [232] 0 0
Leicester
Country [233] 0 0
United Kingdom
State/province [233] 0 0
London
Country [234] 0 0
United Kingdom
State/province [234] 0 0
Manchester
Country [235] 0 0
United Kingdom
State/province [235] 0 0
Southampton
Country [236] 0 0
United Kingdom
State/province [236] 0 0
Surrey
Country [237] 0 0
United Kingdom
State/province [237] 0 0
Torquay
Country [238] 0 0
United Kingdom
State/province [238] 0 0
Wirral

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
EMD Serono
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Merck KGaA, Darmstadt, Germany
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00409188
Trial related presentations / publications
Butts C, Socinski MA, Mitchell P, Thatcher N, Havel L, Krzakowski M, Nawrocki S, Ciuleanu TE, Bosquée L, Trigo JM, Spira A, Tremblay L, Nyman J, Ramlau R, Helwig C, Falk MH, Shepherd FA. START: A phase III study of L-BLP25 cancer immunotherapy for unresectable stage III non-small cell lung cancer. American Society of Clinical Oncology - 49th Annual Meeting. 2013; Abstr No. 7500.
Shepherd FA, Socinski MA, Mitchell P, Thatcher N, Havel L, Krzakowski M, Nawrocki S, Helwig C, Schroeder A, Butts C. Updated analysis and secondary endpoints with L-BLP25 in unresectable stage III non-small cell lung cancer in the phase III START study. European Society for Medical Oncology 38th Congress - ECCO 17, ESMO 38, ESTRO 32. 2013. Abstr No. 3419.
Mitchell P, Butts C, Socinski M, Thatcher N, Wichardt-Johansson G, Ellis P, Gladkov O, Pereira J, Eberhardt W, Horwood K, Szczesna A, Helwig C, Schröder A, Shepherd F. Tecemotide (L-BLP25) in unresectable stage III non-small cell lung cancer in the phase III START study: Further endpoint and exploratory biomarker results. World Conference on Lung Cancer - 15th. 2013; Abstr. No. 2779.
Thatcher N, Shepherd FA, Mitchell P, Socinski MA, Paredes A, Lambrechts M, Thomas M, Kollmeier J, Zemanová M, Sadjadian P, Peylan-Ramu N, Helwig C, Schröder A, Butts C. Geographic differences in the combined-modality treatment of stage III unresectable non-small cell lung cancer: Results from a global phase III trial of tecemotide (L-BLP25). World Conference on Lung Cancer - 15th. 2013; Abstr. No. 2712.
Socinski M, Butts C, Mitchell P, Thatcher N, Scagliotti G, Robinet G, Martin C, Zukin M, Ragulin Y, Bonomi P, Yang CH, Regnault A, Helwig C, de Nigris E, Shepherd F. Exploration of patient health status as measured by the generic preference-based questionnaire EQ-5D alongside the START trial of tecemotide in non-small cell lung cancer. World Conference on Lung Cancer - 15th. 2013; Abstr. No. 2744.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Medical Responsible
Address 0 0
EMD Serono Inc., an affiliate of Merck KGaA, Darmstadt, Germany
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00409188