Safety Study of Tecemotide (L-BLP25) in Non-Small Cell Lung Cancer (NSCLC) Subjects With Unresectable Stage III Disease
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|ClinicalTrials.gov Identifier: NCT00157196|
Recruitment Status : Completed
First Posted : September 12, 2005
Results First Posted : August 18, 2015
Last Update Posted : August 18, 2015
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Non-Small-Cell Lung Lung Neoplasms||Biological: Tecemotide (L-BLP25) Drug: Single low dose cyclophosphamide Other: Best standard of care (BSC)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multi-center, Non-randomized, Open Label Safety Study of BLP25 Liposome Vaccine (L-BLP25) in Non-Small Cell Lung Cancer (NSCLC) Patients With Unresectable Stage III Disease|
|Study Start Date :||April 2005|
|Actual Primary Completion Date :||September 2007|
|Actual Study Completion Date :||April 2012|
|Experimental: Tecemotide(L-BLP25)+Cyclophosphomide+best standard of care||
Biological: Tecemotide (L-BLP25)
After receiving single low-dose cyclophosphamide, subjects will receive 8 consecutive weekly subcutaneous vaccinations with 1000 microgram (mcg) of tecemotide (L-BLP25) at weeks 0, 1, 2, 3, 4, 5, 6 and 7 followed by maintenance vaccinations (1000 mcg of tecemotide [L-BLP25]) at 6-week intervals, commencing at Week 13, until disease progression is documented.
Drug: 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 administered 3 days prior to tecemotide (L-BLP25), the first vaccine treatment.
Other: Best standard of care (BSC)
The BSC will be provided at the investigator's discretion, and may include but not be limited to psychosocial support, nutritional support and other supportive therapies.
- Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs With CALGB-ECTC Grade 3 or 4, TEAEs Leading to Discontinuation, TEAEs Leading to Death, and Injection Site Reactions (ISRs) [ Time Frame: Up to data cut-off date (17 September 2007) ]TEAEs occurred between the first dose of study drug and up to 42 days after the last dose that were absent before treatment or that worsened relative to pretreatment state. A serious TEAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs with Cancer and Leukemia Group B Extended Clinical Toxicity Criteria (CALGB-ECTC) Grade 3 or 4 were also reported.
- Survival Time [ Time Frame: Up to data cut-off date (17 September 2007) ]Survival time was to be measured from study entry (date of cyclophosphamide administration) to date of death. For subjects alive or lost to follow-up at time of analysis, the time between date of cyclophosphamide administration and date on which the subject was last known alive was to be calculated and used as a censored observation in the analysis.
- Progression Free Survival (PFS) Time [ Time Frame: Up to data cut-off date (17 September 2007) ]PFS was defined as duration from first administration of trial treatment until progressive disease [PD] (radiological or clinical, if radiological progression is not available) or death due to any cause. Participants without event were censored on the date of last tumor assessment. Clinical assessments were performed 4 weekly in primary treatment and 6 weekly in maintenance treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00157196
|Study Director:||Medical Responsible||Merck KGaA|