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This is a prospective open label, controlled, randomized study to test the safety and efficacy of active specific immunotherapy with tecemotide (L-BLP25) for the treatment of subjects with Stage IIIB or Stage IV non-small cell lung cancer (NSCLC). To be eligible, subjects entering the trial will have to demonstrate either stable disease or a clinical response after first-line treatment (chemotherapy alone, or chemotherapy and radiotherapy) and have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2. Following a 3 week washout period, subjects will be stratified by disease status (either Stage IIIB locoregional disease or Stage IIIB with malignant pleural effusion and Stage IV), and randomized to either best supportive care (BSC) plus tecemotide (L-BLP25) treatment or BSC alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tecemotide (L-BLP25) plus Best Supportive Care (BSC) | Experimental |
| |
| Best Supportive Care (BSC) Alone | Active Comparator |
|
| 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 discontinuation from the 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 the investigator, and in case of unavailability of study vaccine. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | 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) |
| Overall Survival Time | 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 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Assessment of Cancer Therapy (FACT-L) Questionnaire Score | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Merck KGaA, Darmstadt, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Please Contact the Merck KGaA Communication Center | Darmstadt | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16170175 | Result | Butts C, Murray N, Maksymiuk A, Goss G, Marshall E, Soulieres D, Cormier Y, Ellis P, Price A, Sawhney R, Davis M, Mansi J, Smith C, Vergidis D, Ellis P, MacNeil M, Palmer M. Randomized phase IIB trial of BLP25 liposome vaccine in stage IIIB and IV non-small-cell lung cancer. J Clin Oncol. 2005 Sep 20;23(27):6674-81. doi: 10.1200/JCO.2005.13.011. | |
| 21744082 |
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A total of 437 participants were screened for eligibility and 171 participants were randomized.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tecemotide (L-BLP25) Plus Best Supportive Care (BSC) | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| 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 given 3 days before the first vaccine treatment. |
|
| Best Supportive Care (BSC) | Other | The BSC will be provided at the investigator's discretion, and may include palliative radiation, psychosocial support, analgesics and nutritional support. Second-line chemotherapy is permitted when indicated for treatment of progressive disease. |
|
| At baseline, Week 4, Week 8 and then at 12 Week intervals beginning at week 19 until withdrawal/discontinuation from the study. |
| Number of Participants With Positive T-cell Proliferation | 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 from randomization until cut-off date (15 March 2006) |
| Number of Participants With Elevated CA27-29 Antigen Levels | 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. | Study entry, Week 8 |
| Butts C, Maksymiuk A, Goss G, Soulieres D, Marshall E, Cormier Y, Ellis PM, Price A, Sawhney R, Beier F, Falk M, Murray N. Updated survival analysis in patients with stage IIIB or IV non-small-cell lung cancer receiving BLP25 liposome vaccine (L-BLP25): phase IIB randomized, multicenter, open-label trial. J Cancer Res Clin Oncol. 2011 Sep;137(9):1337-42. doi: 10.1007/s00432-011-1003-3. Epub 2011 Jul 9. |
| Result | 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. |
| Result | 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. |
| FG001 | Best Supportive Care (BSC) Alone | 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. |
| COMPLETED |
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| NOT COMPLETED |
|
|
Baseline analysis population included all randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Tecemotide (L-BLP25) Plus Best Supportive Care (BSC) | 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. |
| BG001 | Best Supportive Care (BSC) Alone | 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. |
| BG002 | Total | Total of all reporting groups |
| 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 Leading to Death, and TEAEs With Cancer and Leukemia Group B (CALGB) Toxicity Grade 3 or 4 | 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. | Analysis population included all participants randomized in the study. | Posted | Number | participants | 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) |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Overall Survival Time | 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. | Analysis population included all randomized participants. | Posted | Median | 95% Confidence Interval | months | 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) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Functional Assessment of Cancer Therapy (FACT-L) Questionnaire Score | 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. | 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. | Posted | Mean | Standard Deviation | Units on a scale | At baseline, Week 4, Week 8 and then at 12 Week intervals beginning at week 19 until withdrawal/discontinuation from the study. |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Positive T-cell Proliferation | T-cell proliferation assays were performed and the number of participants with positive mucinous glycoprotein 1 (MUC1) specific T-cell proliferative response were reported. | 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. | Posted | Number | participants | Time from randomization until cut-off date (15 March 2006) |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Elevated CA27-29 Antigen Levels | 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. | Analysis population included all randomized participants. "n" signifies number of participants evaluable at each timepoint for this outcome measure, for each reporting group, respectively. | Posted | Number | participants | Study entry, Week 8 |
|
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)
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.
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| 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) Plus Best Supportive Care (BSC) | 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. | 29 | 88 | 88 | 88 | ||
| EG001 | Best Supportive Care (BSC) Alone | 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. | 34 | 83 | 80 | 83 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Metastases to brain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Malignant pleural effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Metastases to spine | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Breast cancer in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Lung cancer stage unspecified (excl metastatic tumours to lung) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Lung squamous cell carcinoma stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Metastatic neoplasm NOS, primary site unknown | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Non-small cell lung cancer NOS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Second primary malignancy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Dyspnoea NOS | Respiratory, thoracic and mediastinal disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Dyspnoea exacerbated | Respiratory, thoracic and mediastinal disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Pneumothorax NOS | Respiratory, thoracic and mediastinal disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Bronchial obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Pneumonitis NOS | Respiratory, thoracic and mediastinal disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Pneumonia NOS | Infections and infestations | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Lower respiratory tract infection NOS | Infections and infestations | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Bronchopneumonia NOS | Infections and infestations | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Empyema NOS | Infections and infestations | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Sepsis NOS | Infections and infestations | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage NOS | Gastrointestinal disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Abdominal pain NOS | Gastrointestinal disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Intestinal perforation NOS | Gastrointestinal disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Collapse of lung | Injury, poisoning and procedural complications | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Fractured pelvis NOS | Injury, poisoning and procedural complications | MedDRA Version 5.0 | Non-systematic Assessment |
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| Radiation injury NOS | Injury, poisoning and procedural complications | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 5.0 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 5.0 | Non-systematic Assessment |
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| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA Version 5.0 | Non-systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA Version 5.0 | Non-systematic Assessment |
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| Convulsions NOS | Nervous system disorders | MedDRA Version 5.0 | Non-systematic Assessment |
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| Intracranial haemorrhage NOS | Nervous system disorders | MedDRA Version 5.0 | Non-systematic Assessment |
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| Aortic dissection | Vascular disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Deep venous thrombosis NOS | Vascular disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Superior vena caval obstruction | Vascular disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Weakness | General disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Hyperglycaemia NOS | Metabolism and nutrition disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Renal failure NOS | Renal and urinary disorders | MedDRA Version 5.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia NOS | Blood and lymphatic system disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Tachycardia NOS | Cardiac disorders | MedDRA Version 5.0 | Non-systematic Assessment |
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| Abdominal pain NOS | Gastrointestinal disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version 5.0 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Diarrhoea NOS | Gastrointestinal disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Vomiting NOS | Gastrointestinal disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Chest tightness | General disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Fatigue aggravated | General disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Injection site bruising | General disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Lethargy | General disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Nodule | General disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Rigors | General disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Weakness | General disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Bronchitis NOS | Infections and infestations | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Lower respiratory tract infection NOS | Infections and infestations | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Pneumonia NOS | Infections and infestations | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection NOS | Infections and infestations | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Appetite decreased NOS | Metabolism and nutrition disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Chest wall pain | Musculoskeletal and connective tissue disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Muscle cramps | Musculoskeletal and connective tissue disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Pain in limb | Musculoskeletal and connective tissue disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Shoulder blade pain | Musculoskeletal and connective tissue disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Headache NOS | Nervous system disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Cough aggravated | Respiratory, thoracic and mediastinal disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Dyspnoea NOS | Respiratory, thoracic and mediastinal disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Dyspnoea exacerbated | Respiratory, thoracic and mediastinal disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Hoarseness | Respiratory, thoracic and mediastinal disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Pharyngitis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Rash NOS | Skin and subcutaneous tissue disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Sweating increased | Skin and subcutaneous tissue disorders | MedDRA Version 5.0 | Non-systematic Assessment |
| |
| Hypotension NOS | Vascular disorders | MedDRA Version 5.0 | Non-systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Merck KGaA Communication Center | Merck Serono, a division of Merck KGaA | +49-6151-72-5200 | service@merckgroup.com |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
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
| Male |
|
| TEAEs leading to death |
|
| TEAEs with CALGB toxicity Grade 3 or 4 |
|
| Best Supportive Care (BSC) Alone |
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. |
|
|
|
| OG001 | Best Supportive Care (BSC) Alone | 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. |
|
|
| OG001 | Best Supportive Care (BSC) Alone | 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. |
|
|
| OG001 | Best Supportive Care (BSC) Alone | 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. |
|
|