Cancer Vaccine Study for Unresectable Stage III Non-small Cell Lung Cancer (START)
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- Registration Number
- NCT00409188
- Lead Sponsor
- EMD Serono
- 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.
- 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)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1513
- 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)
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Tecemotide (L-BLP25) Tecemotide (L-BLP25) - Tecemotide (L-BLP25) Single low dose cyclophosphamide -
- Primary Outcome Measures
Name Time Method Overall Survival Up to 66 months 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
Name Time Method Time To Symptom Progression (TTSP) as Measured by the Lung Cancer Symptom Scale (LCSS) Up to 66 months 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) Up to 66 months 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 Years 1, 2, and 3 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 From first dose up to 42 days after the last dose of the trial treatment 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.
Trial Locations
- Locations (93)
Deaconess Billings Clinic
🇺🇸Billings, Montana, United States
University of Maryland, Marlene and Steward Greenbaum Cancer Center
🇺🇸Baltimore, Maryland, United States
Cedars-Sinai Outpatient Cancer Center at the Samuel Oschin Comprehensive Cancer Institute
🇺🇸Los Angeles, California, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Sinai Hospital of Baltimore
🇺🇸Baltimore, Maryland, United States
Univ. of Pennsylvania Abramson Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
Southern Illinois Hematology/Oncology
🇺🇸Centralia, Illinois, United States
Norris Cancer Hospital
🇺🇸Los Angeles, California, United States
Desert Hematology Oncology Medical Group, Inc
🇺🇸Rancho Mirage, California, United States
Big Sky Oncology, Sletten Cancer Institute
🇺🇸Great Falls, Montana, United States
Carolinas Hematology-Oncology
🇺🇸Charlotte, North Carolina, United States
St. Vincents Comprehensive Cancer Center
🇺🇸New York, New York, United States
Fairfax-Northern Virginia Hematology Oncology, PC
🇺🇸Fairfax, Virginia, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Centro Oncologico de Roario
🇦🇷Rosario, Santa Fe, Argentina
Research Site
🇬🇧Wirral, United Kingdom
Clinica Universitaria Reina Fabiola
🇦🇷Cordoba, Argentina
Center for Oncology Research
🇺🇸Dallas, Texas, United States
Frazer Valley Cancer Center
🇨🇦Surrey, British Columbia, Canada
Hospital Nossa Senhora da Conceicao, Centro de Pesquisas Medicas e Ensaios Clinicos
🇧🇷Porto Alegre, Rio Grande Do Sol, Brazil
The Center for Cancer and Blood Disorders
🇺🇸Fort Worth, Texas, United States
Niagara Health System
🇨🇦Saint Catharines, Ontario, Canada
Capital District Health Authority
🇨🇦Halifax, Nova Scotia, Canada
Wheeling Hospital
🇺🇸Wheeling, West Virginia, United States
Paliar
🇦🇷Capital, Buenos Aires, Buenos Aires, Argentina
Cancer Care Manitoba
🇨🇦Winnipeg, Manitoba, Canada
Instituto Especializado Alexander Fleming
🇦🇷Ciudad Autonoma de Buenos Aires, Argentina
Fundacao Hospital Amaral Carvalho
🇧🇷Jau, Sao Paulo, Brazil
Mount Sinai Hospital
🇨🇦Toronto, Ontario, Canada
Cross Cancer Institue
🇨🇦Edmonton, Alberta, Canada
Consultorio del
🇲🇽Morelia, Michoacan, Mexico
Centro Oncologico de Chihuahua
🇲🇽Chihuahua, Mexico
Vancouver Island Cancer Center
🇨🇦Victoria, British Columbia, Canada
Juravinski Cancer Center
🇨🇦Hamilton, Ontario, Canada
Cape Breton Districk Health Authority Cancer Care
🇨🇦Sydney, Nova Scotia, Canada
Nugieo de Oncologia da Bahia
🇧🇷Salvador, Bahia, Brazil
Hospital Sao Lucas-Pucrs
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Associacao Hospital de Caridade Ijui
🇧🇷IjuÃ, Rio Grande Do Sul, Brazil
Hospital LifeCenter
🇧🇷Belo Horizonte, Minas Gerais, Brazil
Glendale Adventist Medical Center
🇺🇸Glendale, California, United States
Hopital Laval
🇨🇦Sainte-Foy, Quebec, Canada
Hospital das Clinicas da Faculdade de Medinina de Univeridade
🇧🇷São Paulo, De ao Paulo, Brazil
Instituto de Oncologia de Sorocaba
🇧🇷Sorocaba, Sao Paulo, Brazil
Instituto Nacional do Cancer - INCA
🇧🇷Rio de Janeriro, Brazil
Instituto do Cancer Arnaldo Vieira de Caralho-Onco-pneumonia
🇧🇷Sao Paulo, Brazil
Santa Casa de Misericordia De Sao Paulo
🇧🇷Sao Paulo, Brazil
Pasco Hernando Oncology Associates P.A
🇺🇸Brooksville, Florida, United States
Joliet Oncology-Hematology Associates, Ltd.
🇺🇸Joliet, Illinois, United States
Hematology and Oncology Specialists, LLC
🇺🇸Metarie, Louisiana, United States
Southeast Nebraska Cancer Center
🇺🇸Lincoln, Nebraska, United States
Gabrail Cancer Center
🇺🇸Canton, Ohio, United States
Hanover Medical Specialts PA
🇺🇸Wilmington, North Carolina, United States
Southwestern Regional Medical Center
🇺🇸Tulsa, Oklahoma, United States
Signal Point Clinical Research Center, LLC
🇺🇸Middletown, Ohio, United States
University Hospitals of Cleveland
🇺🇸Cleveland, Ohio, United States
John Peter Smith Center for Cancer Care
🇺🇸Fort Worth, Texas, United States
Corporacion Medica General San Martin
🇦🇷San Martin, Buenos Aires, Argentina
Hospital Italiano Regional del Sur
🇦🇷Bahia Blanca, Buenos Aires, Argentina
Centro de Educacion Medica e Investigaciones Clinicas "Norberto Quirno" (CEMIC)
🇦🇷Ciudad Autonoma de Buenos Aires, Argentina
Sociedad Intaliana de Beneficencia en Buenos Aires, Hospital Italiano
🇦🇷Ciudad Autonoma de Buenos Aires, Argentina
Hospital de Clinicas de Porto Alegre, Dept. de Endocrinologia
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Centro de Oncologia de Campinas - OCC
🇧🇷Campinas, Sao Paulo, Brazil
Tom Baker Cancer Center
🇨🇦Calgary, Alberta, Canada
Hopital Notre Dame
🇨🇦Montreal, Quebec, Canada
British Columbia Cancer Agency
🇨🇦Vancouver, British Columbia, Canada
Windsor Regional Cancer Center
🇨🇦Windsor, Ontario, Canada
Jewish General Hospital
🇨🇦Montreal, Quebec, Canada
Instituto Nacional de Cancerologia (INCAN)
🇲🇽Mexico City, Mexico
Genova
🇷🇺Chelaybinsk, Russian Federation
Reseaerch Site
🇷🇺Kazan, Tatarstan, Russian Federation
Nebraska Cancer Care, LLC
🇺🇸Hastings, Nebraska, United States
Reseach Site
🇩🇪Heidelberg, Germany
Saint Edward Mercy Medical Center
🇺🇸Fort Smith, Arkansas, United States
Clinical Trials and Research Associates, Inc.
🇺🇸Montebello, California, United States
Pasco Hernando Oncology Associates, PA
🇺🇸New Port Richey, Florida, United States
Pacific Cancer Medical Center
🇺🇸Anaheim, California, United States
Florida Hospital Memorial System
🇺🇸Ormond Beach, Florida, United States
Stockton Hematology Oncology Medical Group, Inc.
🇺🇸Stockton, California, United States
Leonard J. Chabert Medical Center
🇺🇸Houma, Louisiana, United States
Lahey Clinic
🇺🇸Burlington, Massachusetts, United States
Kentucky Cancer Center
🇺🇸Hazard, Kentucky, United States
Saint Louis University Cance Center
🇺🇸Saint Louis, Missouri, United States
Hematology Oncology Associates of Rockland
🇺🇸Nyack, New York, United States
The Jones Clinic, PC
🇺🇸Germantown, Tennessee, United States
University of Miami, Sylvester Comprehensive Cancer Center
🇺🇸Miami, Florida, United States
University of Colorado Cancer Center
🇺🇸Denver, Colorado, United States
University of Minnesota Physicians, Masonic Cancer Center
🇺🇸Minneapolis, Minnesota, United States
Univ. of North Carolina at Chapel Hill, Lineberger Comprehensive Cancer Center
🇺🇸Chapel Hill, North Carolina, United States
Providence Portland Medical Center
🇺🇸Portland, Oregon, United States
Cancer Therapy & Research Center, Institute for Drug Development
🇺🇸San Antonio, Texas, United States
Oncology Care Associates
🇺🇸Saint Joseph, Michigan, United States
Thunder Bay Regional Health Science Center Northwestern Ontario Regional Center
🇨🇦Thunder Bay, Ontario, Canada