Trial document
This study has been imported from ClinicalTrials.gov without additional data checks.
DRKS00003815
Trial Description
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.
Trial Acronym
START
URL of the Trial
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Brief Summary in Lay Language
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.
Brief Summary in Scientific Language
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)
Organizational Data
- DRKS00003815
- 2012/05/02
- 2006/12/07
- no
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Secondary IDs
- NCT00409188 (ClinicalTrials.gov)
- EMR 63325-001 (EMD Serono)
Health Condition or Problem studied
- Non-small Cell Lung Cancer
- C34 - Malignant neoplasm of bronchus and lung
Interventions/Observational Groups
- Biological: Tecemotide (L-BLP25)
- Biological: Placebo
Characteristics
- Interventional
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- Randomized controlled trial
- Blinded
- patient/subject, caregiver, investigator/therapist, assessor
- Placebo
- Treatment
- Parallel
- III
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Primary Outcome
- 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)
Secondary Outcome
- 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)
- Time To Progression (TTP) as determined by the investigator; time frame: Interim analysis at 353 + 529 events (deaths); Final analysis at 705 events (deaths)
- One-, two- and three-year survival; time frame: Analyzed at 1, 2, & 3 years post treatment onset
- Safety; time frame: Assessed throughout, from first patient in until last patient out
Countries of Recruitment
- 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, Province of China
- United Kingdom
Locations of Recruitment
Recruitment
- Planned
- 2007/01/31
- 1514
- Multicenter trial
- International
Inclusion Criteria
- Both, male and female
- 18 Years
- no maximum age
Additional 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 ECOG performance status of 0-1.
- A Platlet count > 140 x 10(9)/L; 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
Addresses
-
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- EMD Serono
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- Medical Oncology Princess Margaret Hospital, 610 University Avenue, 5-104, Toronto, ON M5G 2M9A, Canada
- Frances Shepherd, MD, FRCPC
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- Medical Oncology Princess Margaret Hospital, 610 University Avenue, 5-104, Toronto, ON M5G 2M9A, Canada
- Frances Shepherd, MD, FRCPC
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Sources of Monetary or Material Support
-
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- Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status
- Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents
- 12
- 2013/10/30