Trial document

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

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DRKS-ID: 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

DRKS-ID: DRKS00003815
Date of Registration in DRKS: 2012/05/02
Date of Registration in Partner Registry or other Primary Registry: 2006/12/07
Investigator Sponsored/Initiated Trial (IST/IIT): no
Ethics Approval/Approval of the Ethics Committee: [---]*
(leading) Ethics Committee No.: [---]*

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Secondary IDs

Primary Registry-ID: NCT00409188 (ClinicalTrials.gov)
Sponsor-ID: EMR 63325-001 (EMD Serono)

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Health Condition or Problem studied

Free text: Non-small Cell Lung Cancer
ICD10: C34 - Malignant neoplasm of bronchus and lung

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Interventions/Observational Groups

Arm 1: Biological: Tecemotide (L-BLP25)
Arm 2: Biological: Placebo

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Characteristics

Study Type: Interventional
Study Type Non-Interventional: [---]*
Allocation: Randomized controlled trial
Blinding: Blinded
Who is blinded: patient/subject, caregiver, investigator/therapist, assessor
Control: Placebo
Purpose: Treatment
Assignment: Parallel
Phase: III
Off-label Drug use: [---]*

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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

US: United States
AR: Argentina
AU: Australia
AT: Austria
BE: Belgium
BR: Brazil
CA: Canada
CN: China
CZ: Czech Republic
DK: Denmark
FR: France
DE: Germany
GR: Greece
HK: Hong Kong
HU: Hungary
IN: India
IE: Ireland
IL: Israel
IT: Italy
KR: Korea, Republic of
MX: Mexico
NL: Netherlands
PL: Poland
PT: Portugal
RO: Romania
RU: Russian Federation
SG: Singapore
SK: Slovakia
ES: Spain
SE: Sweden
CH: Switzerland
TW: Taiwan, Province of China
UK: United Kingdom

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Locations of Recruitment

Research Site, Essen
Research Site, Hemer
Research Site, Mainz
Research Site, Homburg
Research Site, Berlin
Research Site, Coswig
Research Site, Essen
Research Site, Frankfurt am Main
Research Site, Freiburg
Research Site, Gauting
Research Site, Großhansdorf
Research Site, Hamburg
Reseach Site, Heidelberg
Research Site, Kassel
Research Site, Kiel
Research Site, Koln
Research Site, Leipzig
Research Site, Magdeburg
Research Site, Mainz
Research Site, Minden
Research Site, Muchen
Research Site, München
Research Site, Oldenburg
Research Site, Rostock

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Recruitment

Planned/Actual: Planned
(Anticipated or Actual) Date of First Enrollment: 2007/01/31
Target Sample Size: 1514
Monocenter/Multicenter trial: Multicenter trial
National/International: International

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Inclusion Criteria

Gender: Both, male and female
Minimum Age: 18 Years
Maximum Age: 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

Primary Sponsor
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- EMD Serono
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Contact for Scientific Queries
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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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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Contact for Public Queries
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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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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Sources of Monetary or Material Support

Commercial (pharmaceutical industry, medical engineering industry, etc.)
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- Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Status

Recruitment Status: Recruiting complete, follow-up continuing
Study Closing (LPLV): [---]*

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Trial Publications, Results and other Documents

Further trial documents: For more information on the study click below

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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 .

Translation on version: 12
Last processed date by ClinicalTrials.gov: 2013/10/30

* This entry means the parameter is not applicable or has not been set.