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

This study has been completed.
Sponsor:
Collaborator:
Merck KGaA
Information provided by (Responsible Party):
EMD Serono
ClinicalTrials.gov Identifier:
NCT00409188
First received: December 7, 2006
Last updated: August 12, 2014
Last verified: August 2014
  Purpose

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 patients 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)
Biological: 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:
  • To compare survival duration of all randomized subjects by treatment arm [ Time Frame: Interim analysis at 353 + 529 events (deaths); Final analysis at 705 events (deaths) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare all randomized subjects by treatment arm for: Time To Symptom Progression (TTSP) as measured by the Lung Cancer Symptom Scale (LCSS) [ Time Frame: Interim analysis at 353 + 529 events (deaths); Final analysis at 705 events (deaths) ] [ Designated as safety issue: No ]
  • Time To Progression (TTP) as determined by the investigator [ Time Frame: Interim analysis at 353 + 529 events (deaths); Final analysis at 705 events (deaths) ] [ Designated as safety issue: No ]
  • One-, two- and three-year survival [ Time Frame: Analyzed at 1, 2, & 3 years post treatment onset ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: Assessed throughout, from first patient in until last patient out ] [ Designated as safety issue: Yes ]

Enrollment: 1513
Study Start Date: January 2007
Study Completion Date: August 2014
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Following randomization, subjects in the investigational arm will receive, within 3 days of their treatment assignment, a single intravenous (I.V.) infusion of 300 mg/m2 (to a maximum of 600 mg) cyclophosphamide three days before the first Tecemotide (L-BLP25) vaccination. Subjects will then receive eight consecutive weekly subcutaneous vaccinations with Tecemotide (L-BLP25) (primary treatment phase) followed by vaccinations with Tecemotide (L-BLP25) at 6-week intervals, commencing at week 13 (maintenance treatment phase). Subjects will be discontinued from the study treatment upon documented disease progression (to be assessed according to Response Evaluation Criteria in Solid Tumors [RECIST])
Biological: Tecemotide (L-BLP25)

A single infusion (IV) of 300mg/m² (to a max.600mg) of Cyclophosphamide will be given three days before first L-BLP25 vaccination.

Subjects will then receive eight consecutive weekly subcutaneous vaccinations with 806µg of Tecemotide (L-BLP25) at weeks 0; 1; 2; 3; 4; 5; 6 and 7 followed by maintenance vaccinations (806µg of Tecemotide (L-BLP25) at 6-week intervals, commencing at week 13, until disease progression is documented.

Placebo Comparator: 2
Following randomization, subjects in the placebo arm will receive, within 3 days of their treatment assignment, 0.9 percent (%) sodium chloride (saline) instead of cyclophosphamide and placebo instead of L-BLP25.
Biological: 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 a 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 as well as a modulation of cellular and soluble components of the immune response in patients 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 patients

All inclusion criteria specified in the START clinical trial protocol except for hemoglobin ≥ 100g/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 (80mL whole blood each)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically documented unresectable stage III NSCLC.
  • Documented stable disease or objective response, according to 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 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)/L; white blood cells (WBC) > 2.5 x 10(9)/L and hemoglobin > 90 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
  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 ClinicalTrials.gov identifier: NCT00409188

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Locations
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
Cedars-Sinai Outpatient Cancer Center at the Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California, United States, 90048
Norris Cancer Hospital
Los Angeles, California, United States, 90033
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
United States, Maryland
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
University of Maryland, Marlene and Steward Greenbaum Cancer Center
Baltimore, Maryland, United States
United States, Massachusetts
Lahey Clinic
Burlington, Massachusetts, United States
United States, Michigan
Oncology Care Associates
Saint Joseph, Michigan, United States, 49085
United States, Minnesota
University of Minnesota Physicians, Masonic Cancer Center
Minneapolis, Minnesota, United States
United States, Missouri
Saint Louis University Cance Center
Saint Louis, Missouri, United States
United States, Montana
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
United States, New York
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
Carolinas Hematology-Oncology
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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Southwestern Regional Medical Center
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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Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Univ. of Pennsylvania Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19104
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The Jones Clinic, PC
Germantown, Tennessee, United States, 38138
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Center for Oncology Research
Dallas, Texas, United States, 75230
John Peter Smith Center for Cancer Care
Fort Worth, Texas, United States, 76104
The Center for Cancer and Blood Disorders
Fort Worth, Texas, United States, 76104
Cancer Therapy & Research Center, Institute for Drug Development
San Antonio, Texas, United States, 78229
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Fairfax, Virginia, United States, 22031
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Wheeling Hospital
Wheeling, West Virginia, United States, 26003
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Bahia Blanca, Buenos Aires, Argentina
Paliar
Capital, Buenos Aires, 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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Ciudad Autonoma de Buenos Aires, Argentina
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Santa Casa de Misericordia De Sao Paulo
Sao Paulo, Brazil
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Tom Baker Cancer Center
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Morelia, Michoacan, Mexico
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Chihuahua, Mexico
Instituto Nacional de Cancerologia (INCAN)
Mexico City, Mexico
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Amsterdam, Noord-Holland, Netherlands
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Zabrze, Poland
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Coimbra, Portugal
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Lisboa, Portugal
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Genova
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Saint Petersburg, Russian Federation
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Voronezh, Russian Federation
Singapore
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Singapore, Singapore
Slovakia
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Bratislava, Slovakia
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Kosice, Slovakia
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Nitra, Slovakia
Spain
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Mataro, Barcelona, Spain
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Barakaldo, Bilbao, Spain
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Donostia-San Sebastian, Guipuzcoa, Spain
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A Coruna, Spain
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Alicante, Spain
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Barcelona, Spain
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Burgos, Spain
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Girona, Spain
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Jaen, Spain
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Lugo, Spain
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Madrid, Spain
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Malaga, Spain
Sweden
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Gävle, Sweden
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Göteborg, Sweden
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Lund, Sweden
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Stockholm, Sweden
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Umea, Sweden
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Uppsala, Sweden
Switzerland
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Basel, Switzerland
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Geneve, Switzerland
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Genève, Switzerland
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Winterthur, Switzerland
Taiwan
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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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Cornwall, United Kingdom
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Edinburgh, United Kingdom
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Glasgow, United Kingdom
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Guildford, 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
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Surrey, United Kingdom
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Torquay, United Kingdom
Research Site
Wirral, United Kingdom
Sponsors and Collaborators
EMD Serono
Merck KGaA
Investigators
Principal Investigator: Frances Shepherd, MD, FRCPC Medical Oncology Princess Margaret Hospital, 610 University Avenue, 5-104, Toronto, ON M5G 2M9A, Canada
  More Information

Additional Information:
No publications provided by EMD Serono

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: EMD Serono
ClinicalTrials.gov Identifier: NCT00409188     History of Changes
Other Study ID Numbers: EMR 63325-001
Study First Received: December 7, 2006
Last Updated: August 12, 2014
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;
unresectable;
vaccine; Tecemotide; L-BLP25;
Cyclophosphamide;
placebo controlled;
randomized;
double blind;
immunotherapy;

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Cyclophosphamide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists

ClinicalTrials.gov processed this record on October 01, 2014