Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objective is to document the safety of tecemotide (L-BLP25) phase III formulation in non-small cell lung cancer (NSCLC) subjects with unresectable Stage III disease. This population includes Stage IIIA NSCLC subjects, a population not studied in former clinical studies with this vaccine. The secondary objective is to document the survival of subjects treated.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tecemotide(L-BLP25)+Cyclophosphomide+best standard of care | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tecemotide (L-BLP25) | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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. | Up to data cut-off date (17 September 2007) |
| Measure | Description | Time Frame |
|---|---|---|
| Survival Time | 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. | Up to data cut-off date (17 September 2007) |
Not provided
Inclusion Criteria:
Histologically documented unresectable stage III NSCLC. Mediastinal (N2) involvement must be confirmed by biopsy
Stable disease or clinical response after primary therapy of chemo-radiation treatment for unresectable stage III disease
Primary therapy should be a minimum of 2 cycles of Platinum-based first-line chemotherapy, given concurrent with thoracic radiation. The combined modality should consist of either:
A minimum radiation dose of greater than or equal to (>=) 6,000 centigray (cGy) should be administered. Subjects must have completed the primary therapy at least 4 weeks and no later than 6 months prior to study entry
Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to (<=) 1
Ability to understand and willingness to sign a written informed consent
Other protocol defined inclusion criteria could apply
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Merck KGaA, Darmstadt, Germany | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21071331 | Result | Butts C, Murray RN, Smith CJ, Ellis PM, Jasas K, Maksymiuk A, Goss G, Ely G, Beier F, Soulieres D. A multicenter open-label study to assess the safety of a new formulation of BLP25 liposome vaccine in patients with unresectable stage III non-small-cell lung cancer. Clin Lung Cancer. 2010 Nov 1;11(6):391-5. doi: 10.3816/CLC.2010.n.101. |
Not provided
Not provided
Enrolled: 22 participants.
First/last participant (informed consent): April 2005/September 2005. Last participant completed: April 2012; Clinical data cut-off: 17 September 2007. The study was conducted at 8 centers in Canada.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Tecemotide (L-BLP25)+Cyclophosphamide+Best Standard of Care | A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was administered 3 days prior to tecemotide (L-BLP25) first vaccine treatment followed by weekly subcutaneous vaccinations of 1000 microgram (mcg) of tecemotide (L-BLP25) at Week 0, 1, 2, 3, 4, 5, 6, and 7 in the primary treatment phase. Maintenance dose of 1000 mcg of tecemotide (L-BLP25) was administered subcutaneously in the deltoid or triceps region of the upper arms, and the left and right anterolateral aspects of the abdomen at a 6-week intervals, starting at Week 13, until disease progression was documented. The best standard of care (BSC) was provided at the investigator's discretion, and included psychosocial support, nutritional support and other supportive therapies as required. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Single low dose cyclophosphamide | Drug | 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. |
|
| Best standard of care (BSC) | Other | 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. |
|
| Progression Free Survival (PFS) Time | 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. | Up to data cut-off date (17 September 2007) |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The intention-to-treat (ITT) analysis set included all the enrolled participants who received at least 1 dose of trial treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Tecemotide (L-BLP25)+Cyclophosphamide+Best Standard of Care | A single intravenous infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was administered 3 days prior to tecemotide (L-BLP25) first vaccine treatment followed by weekly subcutaneous vaccinations of 1000 mcg of tecemotide (L-BLP25) at Week 0, 1, 2, 3, 4, 5, 6, and 7 in the primary treatment phase. Maintenance dose of 1000 mcg of tecemotide (L-BLP25) was administered subcutaneously in the deltoid or triceps region of the upper arms, and the left and right anterolateral aspects of the abdomen at a 6-week intervals, starting at Week 13, until disease progression was documented. The BSC was provided at the investigator's discretion, and included psychosocial support, nutritional support and other supportive therapies as required. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | 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. | Safety analysis set included all the enrolled participants who received at least one dose of the trial treatment. | Posted | Number | participants | Up to data cut-off date (17 September 2007) |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Survival Time | 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. | Safety analysis set included all the enrolled participants who received at least one dose of the trial treatment. | Posted | Median | 95% Confidence Interval | months | Up to data cut-off date (17 September 2007) |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) Time | 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. | Safety analysis set included all the enrolled participants who received at least one dose of the trial treatment. | Posted | Median | 95% Confidence Interval | months | Up to data cut-off date (17 September 2007) |
|
Time from first dose of cyclophosphamide until 42 days following the last vaccination of tecemotide (L-BLP25) or until the data cut-off date (17 September 2007)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tecemotide (L-BLP25)+Cyclophosphamide+Best Standard of Care | A single intravenous infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was administered 3 days prior to tecemotide (L-BLP25) first vaccine treatment followed by weekly subcutaneous vaccinations of 1000 mcg of tecemotide (L-BLP25) at Week 0, 1, 2, 3, 4, 5, 6, and 7 in the primary treatment phase. Maintenance dose of 1000 mcg of tecemotide (L-BLP25) was administered subcutaneously in the deltoid or triceps region of the upper arms, and the left and right anterolateral aspects of the abdomen at a 6-week intervals, starting at Week 13, until disease progression was documented. The BSC was provided at the investigator's discretion, and included psychosocial support, nutritional support and other supportive therapies as required. | 4 | 22 | 22 | 22 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary artery insufficiency | Cardiac disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 10.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tachycardia | Cardiac disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Early satiety | General disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Injection site bruising | General disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Radiation fibrosis - lung | Injury, poisoning and procedural complications | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Radiation pneumonitis | Injury, poisoning and procedural complications | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Weight increased | Investigations | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Sinus headache | Nervous system disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 10.1 | Non-systematic Assessment |
|
The study as a whole will be published prior to any individual investigator publications. It is required that copies of all papers, abstracts, articles, etc. that contain study data are to be forward to the Sponsor for review 30 days prior to submission for publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Merck KGaA Communication Center | Merck Serono, a division of Merck KGaA | +49-6151-72-5200 | service@merckgroup.com |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| D002277 | Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| C518273 | L-BLP25 |
| D012847 | Single Person |
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D017533 | Marital Status |
| D005191 | Family Characteristics |
| D003710 | Demography |
| D011154 | Population Characteristics |
| D012959 | Socioeconomic Factors |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| TEAEs leading to death |
|
| ISRs |
|
| Participants |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|