Cancer Vaccine Study for Unresectable Stage III Non-small Cell Lung Cancer (START)
START
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.
1 other identifier
interventional
1,513
32 countries
283
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 nonsmall-cell-lung-cancer
Started Jan 2007
Longer than P75 for phase_3 nonsmall-cell-lung-cancer
283 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 7, 2006
CompletedFirst Posted
Study publicly available on registry
December 8, 2006
CompletedStudy Start
First participant enrolled
January 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedResults Posted
Study results publicly available
November 20, 2015
CompletedNovember 20, 2015
October 1, 2015
5.3 years
December 7, 2006
July 23, 2015
October 19, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (4)
Time To Symptom Progression (TTSP) as Measured by the Lung Cancer Symptom Scale (LCSS)
Up to 66 months
Time To Progression (TTP)
Up to 66 months
One-, Two- and Three-year Survival Rate
Years 1, 2, and 3
Number of Participants With Treatment Emergent Adverse Events and Injection Site Reactions
From first dose up to 42 days after the last dose of the trial treatment
Study Arms (2)
Tecemotide (L-BLP25)
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
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.
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.
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
You may qualify if:
- 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)
You may not qualify if:
- 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
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- EMD Seronolead
- Merck KGaA, Darmstadt, Germanycollaborator
Study Sites (290)
Saint Edward Mercy Medical Center
Fort Smith, Arkansas, 72901, United States
Pacific Cancer Medical Center
Anaheim, California, 92801, United States
Glendale Adventist Medical Center
Glendale, California, 91206, United States
Norris Cancer Hospital
Los Angeles, California, 90033, United States
Cedars-Sinai Outpatient Cancer Center at the Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California, 90048, United States
Clinical Trials and Research Associates, Inc.
Montebello, California, 90640, United States
Desert Hematology Oncology Medical Group, Inc
Rancho Mirage, California, United States
Stockton Hematology Oncology Medical Group, Inc.
Stockton, California, 95204, United States
University of Colorado Cancer Center
Denver, Colorado, 80045, United States
Pasco Hernando Oncology Associates P.A
Brooksville, Florida, 34613, United States
University of Miami, Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Pasco Hernando Oncology Associates, PA
New Port Richey, Florida, 34652, United States
Florida Hospital Memorial System
Ormond Beach, Florida, 32174, United States
Southern Illinois Hematology/Oncology
Centralia, Illinois, 62801, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Joliet Oncology-Hematology Associates, Ltd.
Joliet, Illinois, 60435, United States
Kentucky Cancer Center
Hazard, Kentucky, 41701, United States
Leonard J. Chabert Medical Center
Houma, Louisiana, United States
Hematology and Oncology Specialists, LLC
Metarie, Louisiana, 70006, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215, 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, 49085, 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, 59101, United States
Big Sky Oncology, Sletten Cancer Institute
Great Falls, Montana, 59405, United States
Nebraska Cancer Care, LLC
Hastings, Nebraska, 68901, United States
Southeast Nebraska Cancer Center
Lincoln, Nebraska, 68510, United States
St. Vincents Comprehensive Cancer Center
New York, New York, 10011, United States
Hematology Oncology Associates of Rockland
Nyack, New York, 10960, United States
Univ. of North Carolina at Chapel Hill, Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599, United States
Carolinas Hematology-Oncology
Charlotte, North Carolina, 28203, United States
Hanover Medical Specialts PA
Wilmington, North Carolina, 28401, United States
Gabrail Cancer Center
Canton, Ohio, 44718, United States
University Hospitals of Cleveland
Cleveland, Ohio, 44106, United States
Signal Point Clinical Research Center, LLC
Middletown, Ohio, 45042, United States
Southwestern Regional Medical Center
Tulsa, Oklahoma, 74133, United States
Southwestern Regional Medical Center
Tulsa, Oklahoma, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
Univ. of Pennsylvania Abramson Cancer Center
Philadelphia, Pennsylvania, 19104, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
The Jones Clinic, PC
Germantown, Tennessee, 38138, United States
Center for Oncology Research
Dallas, Texas, 75230, United States
John Peter Smith Center for Cancer Care
Fort Worth, Texas, 76104, United States
The Center for Cancer and Blood Disorders
Fort Worth, Texas, 76104, United States
Cancer Therapy & Research Center, Institute for Drug Development
San Antonio, Texas, 78229, United States
Fairfax-Northern Virginia Hematology Oncology, PC
Fairfax, Virginia, 22031, United States
Wheeling Hospital
Wheeling, West Virginia, 26003, 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
Research Site
Tandil, Argentina
Research Site
Nedlands, Western Australia, Australia
Research Site
Bankstown, NSW, Australia
Research Site
Camperdown, Australia
Research Site
Heidelberg, Australia
Research Site
Kingswood, Australia
Research Site
Saint Leonards, Australia
Research Site
Woolloongabba, Australia
Research Site
Graz, Styria, Austria
Research Site
Linz, Upper Austria, Austria
Research Site
Inssbruck, Austria
Research Site
Salzburg, Austria
Research Site
Vienna, Austria
Research Site
Wein, Venna, Austria
Research Site
Wels, Austria
Research Site
Brasschaat, Belgium
Research Site
Brussels, Belgium
Research Site
Haine-Saint-Paul, Belgium
Research Site
Leuven, Belgium
Research Site
Liège, Belgium
Research Site
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
Research Site
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
Saint 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
Research Site
Beijing, China
Research Site
Guangzhou, China
Research Site
Shanghai, China
Research Site
Hradec Králové, Czechia
Research Site
Ostrava-Poruba, Czechia
Research Site
Prague, Czechia
Research Site
Ústí nad Labem, Czechia
Research Site
Herlev, Denmark
Research Site
Odense C, Denmark
Research Site
Pierre-Bénite, Auvergne-Rhône-Alpes, France
Research Site
Besançon, 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
Nancy, France
Research Site
Nantes-Saint Herblain, France
Research Site
Paris, France
Research Site
Perpignan, France
Research Site
Poitiers, France
Research Site
Strasbourg, France
Research Site
Essen, North Rhine-Westphalia, Germany
Research Site
Hemer, North Rhine-Westphalia, Germany
Research Site
Mainz, Rhineland-Palatinate, Germany
Research Site
Homburg, Saarland, Germany
Research Site
Berlin, Germany
Research Site
Cologne, Germany
Research Site
Coswig, Germany
Research Site
Essen, Germany
Research Site
Frankfurt am Main, Germany
Research Site
Freiburg im Breisgau, Germany
Research Site
Gauting, Germany
Research Site
Großhansdorf, Germany
Research Site
Hamburg, Germany
Reseach Site
Heidelberg, Germany
Research Site
Kassel, Germany
Research Site
Kiel, Germany
Research Site
Leipzig, Germany
Research Site
Magdeburg, Germany
Research Site
Mainz, Germany
Research Site
Minden, Germany
Research Site
Mutzschen, Germany
Research Site
München, Germany
Research Site
Oldenburg, Germany
Research Site
Rostock, Germany
Research Site
Marousi, Athens, Greece
Research Site
Athens, Attica, Greece
Research Site
Thessaloniki, Nea Efkarpia, Greece
Research Site
Athens, Greece
Research Site
Chidari, Athens, Greece
Research Site
Heraklion, Greece
Research Site
Shatin, New Territories, Hong Kong
Research Site
Hong Kong, Hong Kong
Research Site
Budapest, Hungary
Research Site
Mátraháza, Hungary
Research Site
Nyíregyháza, Hungary
Research Site
Tatabayana, Hungary
Research Site
Chennai, India
Research Site
Hyderabad, India
Research Site
Mumbai, India
Research Site
New Delhi, India
Research Site
Vellore, India
Research Site
Dublin, Ireland
Research Site
Tel Litwinsky, Tel Avir, Israel
Research Site
Beersheba, Israel
Research Site
Haifa, Israel
Research Site
Jerusalem, Israel
Research Site
Kfar Saba, Israel
Research Site
Petah Tikva, Israel
Research Site
Tel Aviv, Israel
Research Site
Ẕerifin, Israel
Research Site
Genova, Genova, Italy
Research Site
Palermo, Palermo, Italy
Research Site
Candiolo, Torino, Italy
Research Site
Avelino, Italy
Research Site
Bologna, Italy
Research Site
Carpi, Italy
Research Site
Chieti, Italy
Research Site
Forlì, Italy
Research Site
Meldola, Italy
Research Site
Milan, Italy
Research Site
Napoli, Italy
Research Site
Orbassano-Torino, Italy
Research Site
Parma, Italy
Research Site
Rome, Italy
Research Site
Rozzano-Milano, Italy
Research Site
Sassari, Italy
Research Site
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
Research Site
Amsterdam, Netherlands
Research Site
Eindhoven, Netherlands
Research Site
Hoofdrop, Netherlands
Research Site
Tilburg, Netherlands
Research Site
Zwolle, Netherlands
Research Site
Warsaw, Masovian Voivodeship, Poland
Research Site
Bialystok, Poland
Research Site
Bydgoszcz, Poland
Research Site
Bytom, Poland
Research Site
Gdynia, Poland
Research Site
Krakow, Poland
Genova
Lodz, Poland
Research Site
Olsztyn, Poland
Research Site
Otwock, Poland
Research Site
Poznan, Poland
Research Site
Torun, Poland
Genova
Warsaw, Poland
Research Site
Warsaw, Poland
Research Site
Wroclaw, Poland
Research Site
Zabrze, Poland
Genova
Coimbra, Portugal
Genova
Lisbon, Portugal
Genova
Porto, Portugal
Genova
Santa Maria de Feira, Portugal
Research Site
Bucharest, Romania
Research Site
Cluj-Napoca, Romania
Research Site
Iași, Romania
Research Site
Sibiu, Romania
Research Site
Suceava, Romania
Research Site
Timișoara, Romania
Reseaerch Site
Kazan', Tatarstan Republic, Russia
Research Site
Yaroslavl, Yaroslavlr, Russia
Research Site
Barnaul, Russia
Genova
Chelaybinsk, Russia
Research Site
Ivanovo, Russia
Research Site
Kazan', Russia
Research Site
Moscow, Russia
Research Site
Obninsk, Russia
Research Site
Saint Petersburg, Russia
Research Site
Tomsk, Russia
Research Site
Voronezh, Russia
Research Site
Singapore, Singapore
Research Site
Bratislava, Slovakia
Research Site
Košice, Slovakia
Research Site
Nitra, Slovakia
Research Site
Goyang-si, Gyeonggi-do, South Korea
Research Site
Seoul, Gyeonggi-do, South Korea
Research Site
Seoul, South Korea
Research Site
Mataró, Barcelona, Spain
Research Site
Barakaldo, Bilbao, Spain
Research Site
Donostia / San Sebastian, Guipuzcoa, Spain
Research Site
Jaén, Jaen, Spain
Research Site
A Coruña, Spain
Research Site
Alicante, Spain
Research Site
Barcelona, Spain
Research Site
Burgos, Spain
Research Site
Girona, Spain
Research Site
Lugo, Spain
Research Site
Madrid, Spain
Research Site
Málaga, Spain
Research Site
Gävle, Sweden
Research Site
Gothenburg, Sweden
Research Site
Lund, Sweden
Research Site
Stockholm, Sweden
Research Site
Umeå, Sweden
Research Site
Uppsala, Sweden
Research Site
Basel, Switzerland
Research Site
Geneva, Switzerland
Research Site
Winterthur, Switzerland
Research Site
Kaohsiung City, Taiwan
Research Site
Taichung, Taiwan
Research Site
Tainan, Taiwan
Research Site
Taipei, Taiwan
Research Site
Taoyuan District, Taiwan
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
Metropolitan Borough of Wirral, United Kingdom
Research Site
Southampton, United Kingdom
Research Site
Surrey, United Kingdom
Research Site
Torquay, United Kingdom
Related Publications (9)
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.
BACKGROUNDShepherd 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.
BACKGROUNDMitchell 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.
BACKGROUNDThatcher 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.
BACKGROUNDSocinski 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.
BACKGROUNDButts 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.
PMID: 24331154RESULTDeGregorio 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.
PMID: 24976972RESULTZhu 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.
PMID: 34870327DERIVEDMitchell 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.
PMID: 25722382DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Merck KGaA Communication Center
- Organization
- Merck Serono, a division of Merck KGaA
Study Officials
- STUDY DIRECTOR
Medical Responsible
EMD Serono Inc., an affiliate of Merck KGaA, Darmstadt, Germany
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 7, 2006
First Posted
December 8, 2006
Study Start
January 1, 2007
Primary Completion
April 1, 2012
Study Completion
April 1, 2015
Last Updated
November 20, 2015
Results First Posted
November 20, 2015
Record last verified: 2015-10