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Phase 2b Randomized Controlled Study of Tecemotide (L-BLP25) for Immunotherapy of NSCLC (Non-Small Cell Lung Cancer)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00157209
Recruitment Status : Completed
First Posted : September 12, 2005
Results First Posted : November 18, 2015
Last Update Posted : November 18, 2015
Sponsor:
Information provided by (Responsible Party):
Merck KGaA, Darmstadt, Germany

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Interventions Biological: Tecemotide (L-BLP25)
Drug: Single low dose cyclophosphamide
Other: Best Supportive Care (BSC)
Enrollment 171
Recruitment Details First/Last participant (informed consent): 08 August 2000/02 December 2002. Clinical data cut-off: 15 March 2006. Participants randomized at 17 centers in Canada and United Kingdom.
Pre-assignment Details A total of 437 participants were screened for eligibility and 171 participants were randomized.
Arm/Group Title Tecemotide (L-BLP25) Plus Best Supportive Care (BSC) Best Supportive Care (BSC) Alone
Hide Arm/Group Description A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment. After receiving cyclophosphamide, participants received 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 with 1000 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until discontinuation from study due to ECOG status of 4, participation in alternate trial, serious adverse event, or reasons that preclude assessment of clinical status in the opinion of investigator, and incase of unavailability of study vaccine. The Best Supportive Care (BSC) was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease. The BSC was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
Period Title: Overall Study
Started 88 83
Completed 78 83
Not Completed 10 0
Reason Not Completed
Ongoing at data cut-off             10             0
Arm/Group Title Tecemotide (L-BLP25) Plus Best Supportive Care (BSC) Best Supportive Care (BSC) Alone Total
Hide Arm/Group Description A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment. After receiving cyclophosphamide, participants received 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 with 1000 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until discontinuation from study due to ECOG status of 4, participation in alternate trial, serious adverse event, or reasons that preclude assessment of clinical status in the opinion of investigator, and incase of unavailability of study vaccine. The Best Supportive Care (BSC) was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease. The BSC was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease. Total of all reporting groups
Overall Number of Baseline Participants 88 83 171
Hide Baseline Analysis Population Description
Baseline analysis population included all randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 88 participants 83 participants 171 participants
60.4  (10.0) 58.7  (11.3) 59.6  (10.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 88 participants 83 participants 171 participants
Female
36
  40.9%
40
  48.2%
76
  44.4%
Male
52
  59.1%
43
  51.8%
95
  55.6%
1.Primary Outcome
Title Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death, and TEAEs With Cancer and Leukemia Group B (CALGB) Toxicity Grade 3 or 4
Hide Description An adverse event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. A serious AE was an AE that results in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with TEAEs, serious TEAEs, TEAEs leading to death, and TEAEs with CALGB toxicity Grade 3 or 4 were reported.
Time Frame From the first dose of study drug administration until 30 days after the last dose of study drug administration or assessed until cut-off date (15 March 2006)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants randomized in the study.
Arm/Group Title Tecemotide (L-BLP25) Plus Best Supportive Care (BSC) Best Supportive Care (BSC) Alone
Hide Arm/Group Description:
A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment. After receiving cyclophosphamide, participants received 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 with 1000 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until discontinuation from study due to ECOG status of 4, participation in alternate trial, serious adverse event, or reasons that preclude assessment of clinical status in the opinion of investigator, and incase of unavailability of study vaccine. The Best Supportive Care (BSC) was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
The BSC was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
Overall Number of Participants Analyzed 88 83
Measure Type: Number
Unit of Measure: participants
TEAEs 88 80
Serious TEAEs 29 34
TEAEs leading to death 13 20
TEAEs with CALGB toxicity Grade 3 or 4 42 42
2.Primary Outcome
Title Overall Survival Time
Hide Description Time from randomization to death or last day known to be alive. Participants without event were censored at the last date known to be alive or at the clinical cut-off date (15 March 2006), whichever was earlier.
Time Frame Time from randomization to death or last day known to be alive, reported between day of first participant randomized that is, 08 August 2000, up to cut-off (15 March 2006)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all randomized participants.
Arm/Group Title Tecemotide (L-BLP25) Plus Best Supportive Care (BSC) Best Supportive Care (BSC) Alone
Hide Arm/Group Description:
A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment. After receiving cyclophosphamide, participants received 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 with 1000 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until discontinuation from study due to ECOG status of 4, participation in alternate trial, serious adverse event, or reasons that preclude assessment of clinical status in the opinion of investigator, and incase of unavailability of study vaccine. The Best Supportive Care (BSC) was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
The BSC was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
Overall Number of Participants Analyzed 88 83
Median (95% Confidence Interval)
Unit of Measure: months
17.2
(12.9 to 24.2)
13.0
(11.2 to 16.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tecemotide (L-BLP25) Plus Best Supportive Care (BSC), Best Supportive Care (BSC) Alone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.045
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.745
Confidence Interval (2-Sided) 95%
0.533 to 1.042
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Functional Assessment of Cancer Therapy (FACT-L) Questionnaire Score
Hide Description Functional Assessment of Cancer Therapy - Lung cancer (FACT-L) is a valid instrument used to measure quality of life (QoL) in participants with cancer consisting of the 27-item FACT-General (G) and 9-item lung cancer subscale (LCS). FACT-G is organized into subscales: physical well-being (PWB)-7 items; social/family well-being (SWB)-7 items; emotional well-being (EWB)-6 items; functional well-being (FWB)-7 items. Each item uses a 5 point rating scale (0="not at all" and 4=equals "very much"). FACT-L total score=4 subscales + LCS and ranges from 0 to 144. Higher scores indicate better QOL.
Time Frame At baseline, Week 4, Week 8 and then at 12 Week intervals beginning at week 19 until withdrawal/discontinuation from the study.
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all the participants with a baseline and at least one post-baseline complete FACT-L questionnaire. "n" signifies number of participants evaluable at each timepoint for this outcome measure, for each reporting group, respectively.
Arm/Group Title Tecemotide (L-BLP25) Plus Best Supportive Care (BSC) Best Supportive Care (BSC) Alone
Hide Arm/Group Description:
A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment. After receiving cyclophosphamide, participants received 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 with 1000 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until discontinuation from study due to ECOG status of 4, participation in alternate trial, serious adverse event, or reasons that preclude assessment of clinical status in the opinion of investigator, and incase of unavailability of study vaccine. The Best Supportive Care (BSC) was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
The BSC was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
Overall Number of Participants Analyzed 88 78
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline (n=88, 78) 109.3  (14.8) 106.4  (15.6)
Week 4 (n=86, 75) 109.4  (15.9) 104.1  (17.0)
Week 8 (n=84, 73) 108.1  (16.1) 101.6  (17.5)
Week 19 (n=54, 55) 108.2  (14.9) 100.1  (20.6)
Week 31(n=34, 36) 110.1  (14.7) 103.5  (19.6)
Week 43 (n=31, 20) 110.3  (17.4) 111.6  (12.8)
4.Secondary Outcome
Title Number of Participants With Positive T-cell Proliferation
Hide Description T-cell proliferation assays were performed and the number of participants with positive mucinous glycoprotein 1 (MUC1) specific T-cell proliferative response were reported.
Time Frame Time from randomization until cut-off date (15 March 2006)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all randomized participants. "N" signifies total number of participants who were evaluable for this measure. T-cell measure was done only on arm A where subjects received tecemotide for induction of t-cell response. Therefore arm B BSC did not have any samples taken for this assessment.
Arm/Group Title Tecemotide (L-BLP25) Plus Best Supportive Care (BSC) Best Supportive Care (BSC) Alone
Hide Arm/Group Description:
A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment. After receiving cyclophosphamide, participants received 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 with 1000 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until discontinuation from study due to ECOG status of 4, participation in alternate trial, serious adverse event, or reasons that preclude assessment of clinical status in the opinion of investigator, and incase of unavailability of study vaccine. The Best Supportive Care (BSC) was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
The BSC was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
Overall Number of Participants Analyzed 78 0
Measure Type: Number
Unit of Measure: participants
16
5.Secondary Outcome
Title Number of Participants With Elevated CA27-29 Antigen Levels
Hide Description CA 27-29 is a blood test used to monitor certain types of cancer. CA 27-29 is the name of an antigen, which is a substance that stimulates your body's defense system. CA27-29 antigen levels were determined on all participants and assessed the disease burden of participants at study entry, evaluated early recurrence, presence of residual disease, continued remission or poor prognosis.
Time Frame Study entry, Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all randomized participants. "n" signifies number of participants evaluable at each timepoint for this outcome measure, for each reporting group, respectively.
Arm/Group Title Tecemotide (L-BLP25) Plus Best Supportive Care (BSC) Best Supportive Care (BSC) Alone
Hide Arm/Group Description:
A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment. After receiving cyclophosphamide, participants received 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 with 1000 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until discontinuation from study due to ECOG status of 4, participation in alternate trial, serious adverse event, or reasons that preclude assessment of clinical status in the opinion of investigator, and incase of unavailability of study vaccine. The Best Supportive Care (BSC) was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
The BSC was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
Overall Number of Participants Analyzed 88 83
Measure Type: Number
Unit of Measure: participants
Study entry (n=84, 82) 21 21
Week 8 (n=82, 71) 20 18
Time Frame From the first dose of study drug administration until 30 days after the last dose of study drug administration or assessed until cut-off date (15 March 2006)
Adverse Event Reporting Description A serious adverse event 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.
 
Arm/Group Title Tecemotide (L-BLP25) Plus Best Supportive Care (BSC) Best Supportive Care (BSC) Alone
Hide Arm/Group Description A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment. After receiving cyclophosphamide, participants received 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 with 1000 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until discontinuation from study due to ECOG status of 4, participation in alternate trial, serious adverse event, or reasons that preclude assessment of clinical status in the opinion of investigator, and incase of unavailability of study vaccine. The Best Supportive Care (BSC) was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease. The BSC was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
All-Cause Mortality
Tecemotide (L-BLP25) Plus Best Supportive Care (BSC) Best Supportive Care (BSC) Alone
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Tecemotide (L-BLP25) Plus Best Supportive Care (BSC) Best Supportive Care (BSC) Alone
Affected / at Risk (%) Affected / at Risk (%)
Total   29/88 (32.95%)   34/83 (40.96%) 
Blood and lymphatic system disorders     
Febrile neutropenia * 1  0/88 (0.00%)  2/83 (2.41%) 
Neutropenia * 1  0/88 (0.00%)  2/83 (2.41%) 
Cardiac disorders     
Atrial fibrillation * 1  0/88 (0.00%)  4/83 (4.82%) 
Cardiac arrest * 1  1/88 (1.14%)  1/83 (1.20%) 
Myocardial infarction * 1  0/88 (0.00%)  2/83 (2.41%) 
Angina unstable * 1  0/88 (0.00%)  1/83 (1.20%) 
Cardiac tamponade * 1  1/88 (1.14%)  0/83 (0.00%) 
Pericardial effusion * 1  0/88 (0.00%)  1/83 (1.20%) 
Gastrointestinal disorders     
Gastrointestinal haemorrhage NOS * 1  0/88 (0.00%)  2/83 (2.41%) 
Abdominal pain NOS * 1  1/88 (1.14%)  0/83 (0.00%) 
Intestinal perforation NOS * 1  1/88 (1.14%)  0/83 (0.00%) 
Melaena * 1  0/88 (0.00%)  1/83 (1.20%) 
General disorders     
Weakness * 1  0/88 (0.00%)  1/83 (1.20%) 
Hepatobiliary disorders     
Bile duct stone * 1  1/88 (1.14%)  0/83 (0.00%) 
Infections and infestations     
Pneumonia NOS * 1  2/88 (2.27%)  3/83 (3.61%) 
Lower respiratory tract infection NOS * 1  1/88 (1.14%)  1/83 (1.20%) 
Bronchopneumonia NOS * 1  0/88 (0.00%)  1/83 (1.20%) 
Empyema NOS * 1  1/88 (1.14%)  0/83 (0.00%) 
Sepsis NOS * 1  1/88 (1.14%)  0/83 (0.00%) 
Septic shock * 1  0/88 (0.00%)  1/83 (1.20%) 
Injury, poisoning and procedural complications     
Collapse of lung * 1  0/88 (0.00%)  1/83 (1.20%) 
Fractured pelvis NOS * 1  1/88 (1.14%)  0/83 (0.00%) 
Radiation injury NOS * 1  0/88 (0.00%)  1/83 (1.20%) 
Metabolism and nutrition disorders     
Diabetic ketoacidosis * 1  0/88 (0.00%)  1/83 (1.20%) 
Hyperglycaemia NOS * 1  0/88 (0.00%)  1/83 (1.20%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  1/88 (1.14%)  0/83 (0.00%) 
Back pain * 1  0/88 (0.00%)  1/83 (1.20%) 
Bone pain * 1  1/88 (1.14%)  0/83 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Malignant neoplasm progression * 1  6/88 (6.82%)  6/83 (7.23%) 
Metastases to brain * 1  3/88 (3.41%)  3/83 (3.61%) 
Malignant pleural effusion * 1  0/88 (0.00%)  3/83 (3.61%) 
Metastases to bone * 1  1/88 (1.14%)  1/83 (1.20%) 
Metastases to spine * 1  2/88 (2.27%)  0/83 (0.00%) 
Breast cancer in situ * 1  1/88 (1.14%)  0/83 (0.00%) 
Lung cancer stage unspecified (excl metastatic tumours to lung) * 1  0/88 (0.00%)  1/83 (1.20%) 
Lung squamous cell carcinoma stage IV * 1  0/88 (0.00%)  1/83 (1.20%) 
Metastatic neoplasm NOS, primary site unknown * 1  1/88 (1.14%)  0/83 (0.00%) 
Non-small cell lung cancer NOS * 1  0/88 (0.00%)  1/83 (1.20%) 
Second primary malignancy * 1  1/88 (1.14%)  0/83 (0.00%) 
Nervous system disorders     
Cerebrovascular accident * 1  0/88 (0.00%)  1/83 (1.20%) 
Convulsions NOS * 1  0/88 (0.00%)  1/83 (1.20%) 
Intracranial haemorrhage NOS * 1  0/88 (0.00%)  1/83 (1.20%) 
Renal and urinary disorders     
Renal failure NOS * 1  0/88 (0.00%)  1/83 (1.20%) 
Respiratory, thoracic and mediastinal disorders     
Pleural effusion * 1  1/88 (1.14%)  3/83 (3.61%) 
Pulmonary embolism * 1  1/88 (1.14%)  3/83 (3.61%) 
Dyspnoea NOS * 1  1/88 (1.14%)  2/83 (2.41%) 
Dyspnoea exacerbated * 1  1/88 (1.14%)  2/83 (2.41%) 
Pneumothorax NOS * 1  1/88 (1.14%)  1/83 (1.20%) 
Bronchial obstruction * 1  0/88 (0.00%)  1/83 (1.20%) 
Pneumonitis NOS * 1  1/88 (1.14%)  0/83 (0.00%) 
Pulmonary haemorrhage * 1  1/88 (1.14%)  0/83 (0.00%) 
Vascular disorders     
Aortic dissection * 1  1/88 (1.14%)  0/83 (0.00%) 
Deep venous thrombosis NOS * 1  1/88 (1.14%)  0/83 (0.00%) 
Superior vena caval obstruction * 1  1/88 (1.14%)  0/83 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 5.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tecemotide (L-BLP25) Plus Best Supportive Care (BSC) Best Supportive Care (BSC) Alone
Affected / at Risk (%) Affected / at Risk (%)
Total   88/88 (100.00%)   80/83 (96.39%) 
Blood and lymphatic system disorders     
Anaemia NOS * 1  5/88 (5.68%)  6/83 (7.23%) 
Cardiac disorders     
Tachycardia NOS * 1  2/88 (2.27%)  5/83 (6.02%) 
Gastrointestinal disorders     
Abdominal pain NOS * 1  9/88 (10.23%)  8/83 (9.64%) 
Abdominal pain upper * 1  7/88 (7.95%)  3/83 (3.61%) 
Constipation * 1  15/88 (17.05%)  17/83 (20.48%) 
Diarrhoea NOS * 1  13/88 (14.77%)  8/83 (9.64%) 
Dyspepsia * 1  11/88 (12.50%)  9/83 (10.84%) 
Dysphagia * 1  6/88 (6.82%)  5/83 (6.02%) 
Nausea * 1  44/88 (50.00%)  31/83 (37.35%) 
Vomiting NOS * 1  18/88 (20.45%)  17/83 (20.48%) 
General disorders     
Chest discomfort * 1  7/88 (7.95%)  3/83 (3.61%) 
Chest pain * 1  26/88 (29.55%)  13/83 (15.66%) 
Chest tightness * 1  8/88 (9.09%)  2/83 (2.41%) 
Fatigue * 1  39/88 (44.32%)  32/83 (38.55%) 
Fatigue aggravated * 1  6/88 (6.82%)  8/83 (9.64%) 
Influenza like illness * 1  10/88 (11.36%)  3/83 (3.61%) 
Injection site bruising * 1  19/88 (21.59%)  0/83 (0.00%) 
Injection site erythema * 1  22/88 (25.00%)  0/83 (0.00%) 
Injection site pain * 1  21/88 (23.86%)  0/83 (0.00%) 
Injection site swelling * 1  7/88 (7.95%)  0/83 (0.00%) 
Lethargy * 1  5/88 (5.68%)  4/83 (4.82%) 
Nodule * 1  14/88 (15.91%)  0/83 (0.00%) 
Oedema peripheral * 1  8/88 (9.09%)  7/83 (8.43%) 
Pyrexia * 1  13/88 (14.77%)  10/83 (12.05%) 
Rigors * 1  7/88 (7.95%)  4/83 (4.82%) 
Weakness * 1  10/88 (11.36%)  12/83 (14.46%) 
Infections and infestations     
Bronchitis NOS * 1  6/88 (6.82%)  2/83 (2.41%) 
Herpes simplex * 1  6/88 (6.82%)  1/83 (1.20%) 
Influenza * 1  6/88 (6.82%)  0/83 (0.00%) 
Lower respiratory tract infection NOS * 1  4/88 (4.55%)  10/83 (12.05%) 
Nasopharyngitis * 1  19/88 (21.59%)  13/83 (15.66%) 
Oral candidiasis * 1  1/88 (1.14%)  6/83 (7.23%) 
Pneumonia NOS * 1  5/88 (5.68%)  3/83 (3.61%) 
Upper respiratory tract infection NOS * 1  11/88 (12.50%)  6/83 (7.23%) 
Investigations     
Weight decreased * 1  11/88 (12.50%)  11/83 (13.25%) 
Metabolism and nutrition disorders     
Anorexia * 1  30/88 (34.09%)  25/83 (30.12%) 
Appetite decreased NOS * 1  4/88 (4.55%)  7/83 (8.43%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  22/88 (25.00%)  20/83 (24.10%) 
Back pain * 1  26/88 (29.55%)  14/83 (16.87%) 
Bone pain * 1  6/88 (6.82%)  5/83 (6.02%) 
Chest wall pain * 1  9/88 (10.23%)  7/83 (8.43%) 
Muscle cramps * 1  9/88 (10.23%)  1/83 (1.20%) 
Musculoskeletal discomfort * 1  8/88 (9.09%)  7/83 (8.43%) 
Myalgia * 1  18/88 (20.45%)  7/83 (8.43%) 
Neck pain * 1  5/88 (5.68%)  10/83 (12.05%) 
Pain in limb * 1  9/88 (10.23%)  7/83 (8.43%) 
Shoulder blade pain * 1  5/88 (5.68%)  1/83 (1.20%) 
Nervous system disorders     
Dizziness * 1  15/88 (17.05%)  9/83 (10.84%) 
Dysgeusia * 1  6/88 (6.82%)  2/83 (2.41%) 
Headache NOS * 1  21/88 (23.86%)  21/83 (25.30%) 
Hypoaesthesia * 1  12/88 (13.64%)  13/83 (15.66%) 
Paraesthesia * 1  6/88 (6.82%)  5/83 (6.02%) 
Psychiatric disorders     
Anxiety * 1  5/88 (5.68%)  8/83 (9.64%) 
Depression * 1  2/88 (2.27%)  5/83 (6.02%) 
Insomnia * 1  14/88 (15.91%)  11/83 (13.25%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  41/88 (46.59%)  24/83 (28.92%) 
Cough aggravated * 1  6/88 (6.82%)  5/83 (6.02%) 
Dyspnoea NOS * 1  26/88 (29.55%)  26/83 (31.33%) 
Dyspnoea exacerbated * 1  7/88 (7.95%)  7/83 (8.43%) 
Dyspnoea exertional * 1  12/88 (13.64%)  7/83 (8.43%) 
Epistaxis * 1  5/88 (5.68%)  2/83 (2.41%) 
Haemoptysis * 1  17/88 (19.32%)  12/83 (14.46%) 
Hoarseness * 1  7/88 (7.95%)  7/83 (8.43%) 
Nasal congestion * 1  9/88 (10.23%)  4/83 (4.82%) 
Pharyngitis * 1  18/88 (20.45%)  5/83 (6.02%) 
Productive cough * 1  12/88 (13.64%)  9/83 (10.84%) 
Rhinorrhoea * 1  5/88 (5.68%)  3/83 (3.61%) 
Skin and subcutaneous tissue disorders     
Alopecia * 1  5/88 (5.68%)  14/83 (16.87%) 
Rash NOS * 1  13/88 (14.77%)  4/83 (4.82%) 
Sweating increased * 1  10/88 (11.36%)  3/83 (3.61%) 
Vascular disorders     
Hypotension NOS * 1  3/88 (3.41%)  5/83 (6.02%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 5.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
By signing this protocol, the investigator affirms to the Sponsor that information furnished by the Sponsor will be maintained in confidence, and such information will be divulged to the IRB/IEC under an appropriate understanding of confidentiality with such a committee. 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Merck KGaA Communication Center
Organization: Merck Serono, a division of Merck KGaA
Phone: +49-6151-72-5200
EMail: service@merckgroup.com
Publications of Results:
Butts C, Maksymiuk A, Goss G, et al. A multi-centre phase IIB randomized controlled study of BLP25 liposome vaccine (L-BLP25 or Stimuvax) for active specific immunotherapy of non-small cell lung cancer (NSCLC): updated survival analysis. J Thoracic Oncol. 2007 Aug; 2(8), Suppl 4, S332-3.
Butts C, Anderson H, Maksymiuk A, et al. Long-term safety of BLP25 liposome vaccine (L-BLP25) in patients (pts) with stage IIIB/IV non-small cell lung cancer (NSCLC). J Clin Onc 2009; 27(15S): abstract 3055.
Layout table for additonal information
Responsible Party: Merck KGaA, Darmstadt, Germany
ClinicalTrials.gov Identifier: NCT00157209    
Other Study ID Numbers: B25-LG-304 / EMR 63325-005
First Submitted: September 8, 2005
First Posted: September 12, 2005
Results First Submitted: July 23, 2015
Results First Posted: November 18, 2015
Last Update Posted: November 18, 2015