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

Non-small Cell Lung Cancer Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00409188
• Other study ID #: EMR 63325-001
• Status: Completed
• Phase: Phase 3
• First received: December 7, 2006
• Last updated: October 19, 2015
• Start date: January 2007
• Est. completion date: April 2015

Study information

• Verified date: October 2015
• Source: EMD Serono
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationEuropean Union: European Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1513
• Est. completion date: April 2015
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Biological:
• Tecemotide (L-BLP25)
After receiving cyclophosphamide, participants will receive 8 consecutive weekly subcutaneous vaccinations with 806 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 806 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until disease progression is documented.

Drug:
• Single low dose cyclophosphamide
A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide will be given 3 days before first tecemotide (L-BLP25) vaccination.
• Placebo
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.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
EMD Serono	Merck KGaA

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  China,  Czech Republic,  Denmark,  France,  Germany,  Greece,  Hong Kong,  Hungary,  India,  Ireland,  Israel,  Italy,  Korea, Republic of,  Mexico,  Netherlands,  Poland,  Portugal,  Romania,  Russian Federation,  Singapore,  Slovakia,  Spain,  Sweden,  Switzerland,  Taiwan,  United Kingdom, 

References & Publications (7)

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.

Butts C, Socinski MA, Mitchell PL, Thatcher N, Havel L, Krzakowski M, Nawrocki S, Ciuleanu TE, Bosquée L, Trigo JM, Spira A, Tremblay L, Nyman J, Ramlau R, Wickart-Johansson G, Ellis P, Gladkov O, Pereira JR, Eberhardt WE, Helwig C, Schröder A, Shepherd F — View 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.2072-1439.2014.0 — View 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.

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.

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.

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival	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	No
Secondary	Time To Symptom Progression (TTSP) as Measured by the Lung Cancer Symptom Scale (LCSS)	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	No
Secondary	Time To Progression (TTP)	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	No
Secondary	One-, Two- and Three-year Survival Rate	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	No
Secondary	Number of Participants With Treatment Emergent Adverse Events and Injection Site Reactions	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	Yes