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

This study has been completed.
Merck KGaA
Information provided by (Responsible Party):
EMD Serono Identifier:
First received: December 7, 2006
Last updated: October 19, 2015
Last verified: October 2015

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.

Condition Intervention Phase
Non-small Cell Lung Cancer
Biological: Tecemotide (L-BLP25)
Drug: Single low dose cyclophosphamide
Drug: Placebo
Phase 3

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

Resource links provided by NLM:

Further study details as provided by EMD Serono:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: Up to 66 months ] [ Designated as safety issue: No ]
    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.

Secondary Outcome Measures:
  • Time To Symptom Progression (TTSP) as Measured by the Lung Cancer Symptom Scale (LCSS) [ Time Frame: Up to 66 months ] [ Designated as safety issue: No ]
    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.

  • Time To Progression (TTP) [ Time Frame: Up to 66 months ] [ Designated as safety issue: No ]
    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.

  • One-, Two- and Three-year Survival Rate [ Time Frame: Years 1, 2, and 3 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Treatment Emergent Adverse Events and Injection Site Reactions [ Time Frame: From first dose up to 42 days after the last dose of the trial treatment ] [ Designated as safety issue: Yes ]
    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.

Enrollment: 1513
Study Start Date: January 2007
Study Completion Date: April 2015
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tecemotide (L-BLP25) 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 Comparator: Placebo Drug: 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.

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)


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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:


  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00409188

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United States, Arkansas
Saint Edward Mercy Medical Center
Fort Smith, Arkansas, United States, 72901
United States, California
Pacific Cancer Medical Center
Anaheim, California, United States, 92801
Glendale Adventist Medical Center
Glendale, California, United States, 91206
Norris Cancer Hospital
Los Angeles, California, United States, 90033
Cedars-Sinai Outpatient Cancer Center at the Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California, United States, 90048
Clinical Trials and Research Associates, Inc.
Montebello, California, United States, 90640
Desert Hematology Oncology Medical Group, Inc
Rancho Mirage, California, United States
Stockton Hematology Oncology Medical Group, Inc.
Stockton, California, United States, 95204
United States, Colorado
University of Colorado Cancer Center
Denver, Colorado, United States, 80045
United States, Florida
Pasco Hernando Oncology Associates P.A
Brooksville, Florida, United States, 34613
University of Miami, Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Pasco Hernando Oncology Associates, PA
New Port Richey, Florida, United States, 34652
Florida Hospital Memorial System
Ormond Beach, Florida, United States, 32174
United States, Illinois
Southern Illinois Hematology/Oncology
Centralia, Illinois, United States, 62801
Rush University Medical Center
Chicago, Illinois, United States, 60612
Joliet Oncology-Hematology Associates, Ltd.
Joliet, Illinois, United States, 60435
United States, Kentucky
Kentucky Cancer Center
Hazard, Kentucky, United States, 41701
United States, Louisiana
Leonard J. Chabert Medical Center
Houma, Louisiana, United States
Hematology and Oncology Specialists, LLC
Metarie, Louisiana, United States, 70006
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Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
University of Maryland, Marlene and Steward Greenbaum Cancer Center
Baltimore, Maryland, United States
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Lahey Clinic
Burlington, Massachusetts, United States
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Oncology Care Associates
Saint Joseph, Michigan, United States, 49085
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University of Minnesota Physicians, Masonic Cancer Center
Minneapolis, Minnesota, United States
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Saint Louis University Cance Center
Saint Louis, Missouri, United States
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Deaconess Billings Clinic
Billings, Montana, United States, 59101
Big Sky Oncology, Sletten Cancer Institute
Great Falls, Montana, United States, 59405
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Nebraska Cancer Care, LLC
Hastings, Nebraska, United States, 68901
Southeast Nebraska Cancer Center
Lincoln, Nebraska, United States, 68510
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St. Vincents Comprehensive Cancer Center
New York, New York, United States, 10011
Hematology Oncology Associates of Rockland
Nyack, New York, United States, 10960
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Univ. of North Carolina at Chapel Hill, Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599
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Charlotte, North Carolina, United States, 28203
Hanover Medical Specialts PA
Wilmington, North Carolina, United States, 28401
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Gabrail Cancer Center
Canton, Ohio, United States, 44718
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
Signal Point Clinical Research Center, LLC
Middletown, Ohio, United States, 45042
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Tulsa, Oklahoma, United States, 74133
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Tulsa, Oklahoma, United States
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Providence Portland Medical Center
Portland, Oregon, United States, 97213
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Univ. of Pennsylvania Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19104
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Philadelphia, Pennsylvania, United States, 19111
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Germantown, Tennessee, United States, 38138
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Center for Oncology Research
Dallas, Texas, United States, 75230
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Fort Worth, Texas, United States, 76104
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Fort Worth, Texas, United States, 76104
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San Antonio, Texas, United States, 78229
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Fairfax, Virginia, United States, 22031
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Wheeling, West Virginia, United States, 26003
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Bahia Blanca, Buenos Aires, Argentina
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San Martin, Buenos Aires, Argentina
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Rosario, Santa Fe, Argentina
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Ciudad Autonoma de Buenos Aires, Argentina
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Sao Paulo, Brazil
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Chihuahua, Mexico
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Mexico City, Mexico
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Basel, Switzerland
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Winterthur, Switzerland
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Kaohsiung, Taiwan
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Taichung, Taiwan
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Tainan, Taiwan
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Taipei, Taiwan
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Tao-Yuan, Taiwan
United Kingdom
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Inverness, United Kingdom
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Leeds, United Kingdom
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Leicester, United Kingdom
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London, United Kingdom
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Manchester, United Kingdom
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Southampton, United Kingdom
Research Site
Surrey, United Kingdom
Research Site
Torquay, United Kingdom
Research Site
Wirral, United Kingdom
Sponsors and Collaborators
EMD Serono
Merck KGaA
Study Director: Medical Responsible EMD Serono Inc., an affiliate of Merck KGaA, Darmstadt, Germany
  More Information

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.

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: EMD Serono Identifier: NCT00409188     History of Changes
Other Study ID Numbers: EMR 63325-001 
Study First Received: December 7, 2006
Results First Received: July 23, 2015
Last Updated: October 19, 2015
Health Authority: United States: Food and Drug Administration
European Union: European Medicines Agency

Keywords provided by EMD Serono:
Non-Small Cell Lung Carcinoma;
stage III;
vaccine; Tecemotide; L-BLP25;
placebo controlled;
double blind;

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists processed this record on October 21, 2016