Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00003815

Trial Description

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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.

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Trial Acronym

START

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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.

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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)

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Organizational Data

  •   DRKS00003815
  •   2012/05/02
  •   2006/12/07
  •   no
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Secondary IDs

  •   NCT00409188  (ClinicalTrials.gov)
  •   EMR 63325-001  (EMD Serono)
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Health Condition or Problem studied

  •   Non-small Cell Lung Cancer
  •   C34 -  Malignant neoplasm of bronchus and lung
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Interventions/Observational Groups

  •   Biological: Tecemotide (L-BLP25)
  •   Biological: Placebo
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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)

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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

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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
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Locations of Recruitment

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Recruitment

  •   Planned
  •   2007/01/31
  •   1514
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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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.

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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

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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

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   12
  •   2013/10/30
* This entry means the parameter is not applicable or has not been set.