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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00409188




Registration number
NCT00409188
Ethics application status
Date submitted
7/12/2006
Date registered
8/12/2006
Date last updated
20/11/2015

Titles & IDs
Public title
Cancer Vaccine Study for Unresectable Stage III Non-small Cell Lung Cancer (START)
Scientific 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.
Secondary ID [1] 0 0
EMR 63325-001
Universal Trial Number (UTN)
Trial acronym
START
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Tecemotide (L-BLP25)
Treatment: Drugs - Single low dose cyclophosphamide
Treatment: Drugs - Placebo

Experimental: Tecemotide (L-BLP25) -

Placebo comparator: Placebo -


Treatment: Other: Tecemotide (L-BLP25)
After receiving cyclophosphamide, participants will receive 8 consecutive weekly subcutaneous vaccinations with 806 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 806 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until disease progression is documented.

Treatment: Drugs: Single low dose cyclophosphamide
A single intravenous infusion of 300 milligram per square meter (mg/m\^2) (to a maximum 600 mg) of cyclophosphamide will be given 3 days before first tecemotide (L-BLP25) vaccination.

Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
Up to 66 months
Secondary outcome [1] 0 0
Time To Symptom Progression (TTSP) as Measured by the Lung Cancer Symptom Scale (LCSS)
Timepoint [1] 0 0
Up to 66 months
Secondary outcome [2] 0 0
Time To Progression (TTP)
Timepoint [2] 0 0
Up to 66 months
Secondary outcome [3] 0 0
One-, Two- and Three-year Survival Rate
Timepoint [3] 0 0
Years 1, 2, and 3
Secondary outcome [4] 0 0
Number of Participants With Treatment Emergent Adverse Events and Injection Site Reactions
Timepoint [4] 0 0
From first dose up to 42 days after the last dose of the trial treatment

Eligibility
Key inclusion criteria
* 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2015
Sample size
Target
Accrual to date
Final
1513
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Research Site - Nedlands
Recruitment hospital [2] 0 0
Research Site - Bankstown, NSW
Recruitment hospital [3] 0 0
Research Site - Camperdown
Recruitment hospital [4] 0 0
Research Site - Heidelberg
Recruitment hospital [5] 0 0
Research Site - Kingswood
Recruitment hospital [6] 0 0
Research Site - Saint Leonards
Recruitment hospital [7] 0 0
Research Site - Woolloongabba
Recruitment postcode(s) [1] 0 0
- Nedlands
Recruitment postcode(s) [2] 0 0
- Bankstown, NSW
Recruitment postcode(s) [3] 0 0
- Camperdown
Recruitment postcode(s) [4] 0 0
- Heidelberg
Recruitment postcode(s) [5] 0 0
- Kingswood
Recruitment postcode(s) [6] 0 0
- Saint Leonards
Recruitment postcode(s) [7] 0 0
- Woolloongabba
Recruitment outside Australia
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United States of America
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Arkansas
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California
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Prague
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Attica
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Chidari, Athens
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Nyíregyháza
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India
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Israel
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Israel
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Israel
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Tel Aviv
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Israel
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Torino
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Bologna
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Chieti
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Meldola
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Ivanovo
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Saint Petersburg
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Kosice
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State/province [206] 0 0
Girona
Country [207] 0 0
Spain
State/province [207] 0 0
Jaen
Country [208] 0 0
Spain
State/province [208] 0 0
Lugo
Country [209] 0 0
Spain
State/province [209] 0 0
Madrid
Country [210] 0 0
Spain
State/province [210] 0 0
Malaga
Country [211] 0 0
Sweden
State/province [211] 0 0
Gävle
Country [212] 0 0
Sweden
State/province [212] 0 0
Göteborg
Country [213] 0 0
Sweden
State/province [213] 0 0
Lund
Country [214] 0 0
Sweden
State/province [214] 0 0
Stockholm
Country [215] 0 0
Sweden
State/province [215] 0 0
Umea
Country [216] 0 0
Sweden
State/province [216] 0 0
Uppsala
Country [217] 0 0
Switzerland
State/province [217] 0 0
Basel
Country [218] 0 0
Switzerland
State/province [218] 0 0
Geneve
Country [219] 0 0
Switzerland
State/province [219] 0 0
Genève
Country [220] 0 0
Switzerland
State/province [220] 0 0
Winterthur
Country [221] 0 0
Taiwan
State/province [221] 0 0
Kaohsiung
Country [222] 0 0
Taiwan
State/province [222] 0 0
Taichung
Country [223] 0 0
Taiwan
State/province [223] 0 0
Tainan
Country [224] 0 0
Taiwan
State/province [224] 0 0
Taipei
Country [225] 0 0
Taiwan
State/province [225] 0 0
Tao-Yuan
Country [226] 0 0
United Kingdom
State/province [226] 0 0
Cornwall
Country [227] 0 0
United Kingdom
State/province [227] 0 0
Edinburgh
Country [228] 0 0
United Kingdom
State/province [228] 0 0
Glasgow
Country [229] 0 0
United Kingdom
State/province [229] 0 0
Guildford
Country [230] 0 0
United Kingdom
State/province [230] 0 0
Inverness
Country [231] 0 0
United Kingdom
State/province [231] 0 0
Leeds
Country [232] 0 0
United Kingdom
State/province [232] 0 0
Leicester
Country [233] 0 0
United Kingdom
State/province [233] 0 0
London
Country [234] 0 0
United Kingdom
State/province [234] 0 0
Manchester
Country [235] 0 0
United Kingdom
State/province [235] 0 0
Southampton
Country [236] 0 0
United Kingdom
State/province [236] 0 0
Surrey
Country [237] 0 0
United Kingdom
State/province [237] 0 0
Torquay
Country [238] 0 0
United Kingdom
State/province [238] 0 0
Wirral

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
EMD Serono
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Merck KGaA, Darmstadt, Germany
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Responsible
Address 0 0
EMD Serono Inc., an affiliate of Merck KGaA, Darmstadt, Germany
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents


Results are available at https://clinicaltrials.gov/study/NCT00409188