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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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
Other interventions - Tecemotide (L-BLP25)
Treatment: Drugs - Single low dose cyclophosphamide
Treatment: Drugs - Placebo

Experimental: Tecemotide (L-BLP25) -

Placebo Comparator: Placebo -


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

Outcomes
Primary outcome [1] 0 0
Overall Survival - 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.
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) - 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.
Timepoint [1] 0 0
Up to 66 months
Secondary outcome [2] 0 0
Time To Progression (TTP) - 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.
Timepoint [2] 0 0
Up to 66 months
Secondary outcome [3] 0 0
One-, Two- and Three-year Survival Rate - 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.
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 - 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.
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
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Research Site - Nedlands
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Research Site - Bankstown, NSW
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Research Site - Camperdown
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Research Site - Heidelberg
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Research Site - Kingswood
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Research Site - Saint Leonards
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Research Site - Woolloongabba
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- Nedlands
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- Bankstown, NSW
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- Camperdown
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- Heidelberg
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- Kingswood
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- Saint Leonards
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- Woolloongabba
Recruitment outside Australia
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Israel
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Israel
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Israel
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Israel
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Petach Tikva
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Israel
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Tel Aviv
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Israel
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Bologna
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Genova
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Meldola
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Milano
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Napoli
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Palermo
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Parma
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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
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.
Trial website
https://clinicaltrials.gov/show/NCT00409188
Trial related presentations / publications
Butts C, Socinski MA, Mitchell P, Thatcher N, Havel L, Krzakowski M, Nawrocki S, Ciuleanu TE, Bosquée L, Trigo JM, Spira A, Tremblay L, Nyman J, Ramlau R, Helwig C, Falk MH, Shepherd FA. START: A phase III study of L-BLP25 cancer immunotherapy for unresectable stage III non-small cell lung cancer. American Society of Clinical Oncology - 49th Annual Meeting. 2013; Abstr No. 7500.
Shepherd FA, Socinski MA, Mitchell P, Thatcher N, Havel L, Krzakowski M, Nawrocki S, Helwig C, Schroeder A, Butts C. Updated analysis and secondary endpoints with L-BLP25 in unresectable stage III non-small cell lung cancer in the phase III START study. European Society for Medical Oncology 38th Congress - ECCO 17, ESMO 38, ESTRO 32. 2013. Abstr No. 3419.
Mitchell P, Butts C, Socinski M, Thatcher N, Wichardt-Johansson G, Ellis P, Gladkov O, Pereira J, Eberhardt W, Horwood K, Szczesna A, Helwig C, Schröder A, Shepherd F. Tecemotide (L-BLP25) in unresectable stage III non-small cell lung cancer in the phase III START study: Further endpoint and exploratory biomarker results. World Conference on Lung Cancer - 15th. 2013; Abstr. No. 2779.
Thatcher N, Shepherd FA, Mitchell P, Socinski MA, Paredes A, Lambrechts M, Thomas M, Kollmeier J, Zemanová M, Sadjadian P, Peylan-Ramu N, Helwig C, Schröder A, Butts C. Geographic differences in the combined-modality treatment of stage III unresectable non-small cell lung cancer: Results from a global phase III trial of tecemotide (L-BLP25). World Conference on Lung Cancer - 15th. 2013; Abstr. No. 2712.
Socinski M, Butts C, Mitchell P, Thatcher N, Scagliotti G, Robinet G, Martin C, Zukin M, Ragulin Y, Bonomi P, Yang CH, Regnault A, Helwig C, de Nigris E, Shepherd F. Exploration of patient health status as measured by the generic preference-based questionnaire EQ-5D alongside the START trial of tecemotide in non-small cell lung cancer. World Conference on Lung Cancer - 15th. 2013; Abstr. No. 2744.
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

Summary results
Other publications