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| Name | Class |
|---|---|
| Merck Serono Co., Ltd., Japan | INDUSTRY |
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This is a phase I/II study in Japan to evaluate the safety of EMD531444 and its effects on survival time in patients with stage III unresectable non-small cell lung cancer.
Phase I part is designed to evaluate the safety of EMD531444 930 microgram (mcg) dose to be used in phase II. Phase II part is designed to be conducted as randomized, double blind, placebo controlled study to compare overall survival time in all randomized subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tecemotide (L-BLP25) + Cyclophosphamide | Experimental | Active |
|
| Placebo + Saline | Placebo Comparator | Control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tecemotide (L-BLP25) | Biological | After receiving a single low-dose cyclophosphamide, participants will receive weekly subcutaneous vaccinations with tecemotide (L-BLP25) (930 microgram [mcg]) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) will be administered every 6 weeks until progressive disease (PD). |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) Time | OS time was defined as the time from randomization to death. Participants without event were censored at the last date known to be alive or at the clinical cut-off date (01 May 2014), whichever was earlier. | Time from randomization to death or last day known to be alive reported between day of first subject randomized in Step 2 (i.e. 03 Feb 2010), until clinical cut-off date (i.e. 01 May 2014). |
| Measure | Description | Time Frame |
|---|---|---|
| Time To Progression (TTP) - Investigator Read | TTP was defined as the time from date of randomization to date of radiological diagnosis of PD (based on Response Evaluation Criteria in Solid Tumors [RECIST] v1.0). In the event that radiological confirmation could not be obtained but participant was withdrawn from trial treatment or died due to disease progression, TTP was measured from date of randomization to the date of discontinuation of trial treatment. Participants without event who died from causes other than disease progression were censored at date of death. Participants without event who were lost to follow-up were censored at the date of lost to follow-up, except if they missed 2 consecutive scheduled doses, in which case they were considered as having disease progression at time of first missed administration. Participants without event with ongoing treatment at time of analysis, or who had stopped treatment for reasons other than PD, were censored on the date of last treatment administration. |
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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 |
|---|---|---|---|
| 34870327 | Derived | Zhu J, Yuan Y, Wan X, Yin D, Li R, Chen W, Suo C, Song H. Immunotherapy (excluding checkpoint inhibitors) for stage I to III non-small cell lung cancer treated with surgery or radiotherapy with curative intent. Cochrane Database Syst Rev. 2021 Dec 6;12(12):CD011300. doi: 10.1002/14651858.CD011300.pub3. |
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Enrolled: 197 screened for eligibility; 25 excluded (mainly due to non-fulfillment of inclusion or exclusion criteria) and 172 subjects randomized.
First/last subject (informed consent, Step 2 [randomized part]): 03 Feb 2010/15 Feb 2012. Clinical data cut-off: 01 May 2014. Study completion date: 15 June 2015
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| ID | Title | Description |
|---|---|---|
| FG000 | Tecemotide (L-BLP25) + Cyclophosphamide | Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (930 microgram [mcg]) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) were administered every 6 weeks until progressive disease (PD) was documented. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Single low dose cyclophosphamide | Drug | A single intravenous (IV) infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg/m^2) of cyclophosphamide will be administered 3 days prior to tecemotide (L-BLP25), the first vaccine treatment. |
|
| Placebo | Biological | After receiving single dose of saline, participants will receive weekly subcutaneous vaccinations with placebo that matches with tecemotide (L-BLP25) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo will be administered every 6 weeks until PD. |
|
| Saline | Other | A single dose of saline (sodium chloride, 9 grams per liter [g/L]) will be administered intravenously, 3 days prior to the start of placebo. |
|
| Time from randomization to PD, reported between day of first subject randomized in Step 2 (i.e. 03 Feb 2010), until clinical cut-off date (i.e. 01 May 2014). |
| Progression Free Survival (PFS) Time - Investigator Read | PFS time was defined as the duration from randomization to either first observation of objective PD (based on RECIST v1.0) or occurrence of death due to any cause. Participants without event still on treatment at time of analysis, or who stopped treatment for reasons other than PD or PD without radiological confirmed progression, were censored at the last imaging date. Participants without event who were lost to follow-up were censored at the date of lost to follow-up, except if they missed 2 consecutive scheduled doses, in which case they were considered as having disease progression at time of first missed administration. | Time from randomization to disease progression, death or last tumor assessment, reported between day of first subject randomized in Step 2 (i.e. 03 Feb 2010), until clinical cut-off date (i.e. 01 May 2014). |
| Time to Treatment Failure (TTF) | TTF was defined as the duration from date of randomization to the date of discontinuation of any trial treatment (cyclophosphamide or saline, tecemotide [L-BLP25] or placebo vaccine) for any reason as reported by the Investigator. Participants who had missed 2 consecutive scheduled doses and were subsequently lost to follow-up were considered as treatment failures with event date as date of first missed administration. Participants without event still on treatment at time of analysis were censored on the date of last treatment administration. | Time from randomization to discontinuation of trial treatment, reported between day of first subject randomized in Step 2 (i.e. 03 Feb 2010), until clinical cut-off date (i.e. 01 May 2014). |
| FG001 | Placebo + Saline | Single dose of saline (sodium chloride, 9 grams per liter [g/L]) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with placebo doses matched to tecemotide (L-BLP25) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until PD was documented. |
| COMPLETED |
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| NOT COMPLETED |
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Intention to Treat (ITT) analysis set included all subjects randomly allocated to a treatment (tecemotide [L-BLP25] or placebo)
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| ID | Title | Description |
|---|---|---|
| BG000 | Tecemotide (L-BLP25) + Cyclophosphamide | Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) were administered every 6 weeks until PD was documented. |
| BG001 | Placebo + Saline | Single dose of saline (sodium chloride, 9 grams per liter [g/L]) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with placebo doses matched to tecemotide (L-BLP25) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until PD was documented. |
| 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 | Overall Survival (OS) Time | OS time was defined as the time from randomization to death. Participants without event were censored at the last date known to be alive or at the clinical cut-off date (01 May 2014), whichever was earlier. | ITT analysis set included all subjects randomly allocated to a treatment (tecemotide [L-BLP25] or placebo). | Posted | Median | 95% Confidence Interval | Months | Time from randomization to death or last day known to be alive reported between day of first subject randomized in Step 2 (i.e. 03 Feb 2010), until clinical cut-off date (i.e. 01 May 2014). |
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| Secondary | Time To Progression (TTP) - Investigator Read | TTP was defined as the time from date of randomization to date of radiological diagnosis of PD (based on Response Evaluation Criteria in Solid Tumors [RECIST] v1.0). In the event that radiological confirmation could not be obtained but participant was withdrawn from trial treatment or died due to disease progression, TTP was measured from date of randomization to the date of discontinuation of trial treatment. Participants without event who died from causes other than disease progression were censored at date of death. Participants without event who were lost to follow-up were censored at the date of lost to follow-up, except if they missed 2 consecutive scheduled doses, in which case they were considered as having disease progression at time of first missed administration. Participants without event with ongoing treatment at time of analysis, or who had stopped treatment for reasons other than PD, were censored on the date of last treatment administration. | ITT Analysis Set included all subjects randomly allocated to a treatment (tecemotide [L-BLP25] or placebo). | Posted | Median | 95% Confidence Interval | Months | Time from randomization to PD, reported between day of first subject randomized in Step 2 (i.e. 03 Feb 2010), until clinical cut-off date (i.e. 01 May 2014). |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) Time - Investigator Read | PFS time was defined as the duration from randomization to either first observation of objective PD (based on RECIST v1.0) or occurrence of death due to any cause. Participants without event still on treatment at time of analysis, or who stopped treatment for reasons other than PD or PD without radiological confirmed progression, were censored at the last imaging date. Participants without event who were lost to follow-up were censored at the date of lost to follow-up, except if they missed 2 consecutive scheduled doses, in which case they were considered as having disease progression at time of first missed administration. | ITT analysis set included all subjects randomly allocated to a treatment (tecemotide [L-BLP25] or placebo). | Posted | Median | 95% Confidence Interval | Months | Time from randomization to disease progression, death or last tumor assessment, reported between day of first subject randomized in Step 2 (i.e. 03 Feb 2010), until clinical cut-off date (i.e. 01 May 2014). |
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| Secondary | Time to Treatment Failure (TTF) | TTF was defined as the duration from date of randomization to the date of discontinuation of any trial treatment (cyclophosphamide or saline, tecemotide [L-BLP25] or placebo vaccine) for any reason as reported by the Investigator. Participants who had missed 2 consecutive scheduled doses and were subsequently lost to follow-up were considered as treatment failures with event date as date of first missed administration. Participants without event still on treatment at time of analysis were censored on the date of last treatment administration. | ITT analysis set included all subjects randomly allocated to a treatment (tecemotide [L-BLP25] or placebo). | Posted | Median | 95% Confidence Interval | Months | Time from randomization to discontinuation of trial treatment, reported between day of first subject randomized in Step 2 (i.e. 03 Feb 2010), until clinical cut-off date (i.e. 01 May 2014). |
|
Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014).
Safety analysis set included all subjects who were treated with tecemotide [L-BLP25] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state.
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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) + Cyclophosphamide | Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) were administered every 6 weeks until PD was documented. | 24 | 114 | 107 | 114 | ||
| EG001 | Placebo + Saline | Single dose of saline (sodium chloride, 9 grams per liter [g/L]) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with placebo doses matched to tecemotide (L-BLP25) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until PD was documented. | 12 | 57 | 53 | 57 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 17.0 | Non-systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA Version 17.0 | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA Version 17.0 | Non-systematic Assessment |
| |
| Vertigo positional | Ear and labyrinth disorders | MedDRA Version 17.0 | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA Version 17.0 | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA Version 17.0 | Non-systematic Assessment |
| |
| Macular fibrosis | Eye disorders | MedDRA Version 17.0 | Non-systematic Assessment |
| |
| Optic ischaemic neuropathy | Eye disorders | MedDRA Version 17.0 | Non-systematic Assessment |
| |
| Gingival cyst | Gastrointestinal disorders | MedDRA Version 17.0 | Non-systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA Version 17.0 | Non-systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA Version 17.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 17.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 17.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 17.0 | Non-systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA Version 17.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 17.0 | Non-systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA Version 17.0 | Non-systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA Version 17.0 | Non-systematic Assessment |
| |
| Compression fracture | Injury, poisoning and procedural complications | MedDRA Version 17.0 | Non-systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA Version 17.0 | Non-systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA Version 17.0 | Non-systematic Assessment |
| |
| Radiation pneumonitis | Injury, poisoning and procedural complications | MedDRA Version 17.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 17.0 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 17.0 | Non-systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 17.0 | Non-systematic Assessment |
| |
| Malignant pleural effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 17.0 | Non-systematic Assessment |
| |
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 17.0 | Non-systematic Assessment |
| |
| Salivary gland cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 17.0 | Non-systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA Version 17.0 | Non-systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA Version 17.0 | Non-systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA Version 17.0 | Non-systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA Version 17.0 | Non-systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA Version 17.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 17.0 | Non-systematic Assessment |
| |
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA Version 17.0 | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA Version 17.0 | Non-systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA Version 17.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cataract | Eye disorders | MedDRA Version 17.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 17.0 | Non-systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA Version 17.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 17.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 17.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA Version 17.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 17.0 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA Version 17.0 | Non-systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA Version 17.0 | Non-systematic Assessment |
| |
| Injection site nodule | General disorders | MedDRA Version 17.0 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA Version 17.0 | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA Version 17.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 17.0 | Non-systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA Version 17.0 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA Version 17.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 17.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 17.0 | Non-systematic Assessment |
| |
| Radiation pneumonitis | Injury, poisoning and procedural complications | MedDRA Version 17.0 | Non-systematic Assessment |
| |
| Weight increased | Investigations | MedDRA Version 17.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 17.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 17.0 | Non-systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA Version 17.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 17.0 | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 17.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 17.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 17.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 17.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 17.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 17.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 17.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 17.0 | Non-systematic Assessment |
|
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| 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 |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C518273 | L-BLP25 |
| D012847 | Single Person |
| D003520 | Cyclophosphamide |
| D012965 | Sodium Chloride |
| 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 |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
Not provided
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| Male |
|
| OG001 | Placebo + Saline | Single dose of saline (sodium chloride, 9 grams per liter [g/L]) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with placebo doses matched to tecemotide (L-BLP25) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until PD was documented. |
|
|
| Placebo + Saline |
Single dose of saline (sodium chloride, 9 grams per liter [g/L]) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with placebo doses matched to tecemotide (L-BLP25) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until PD was documented. |
|
|
Single dose of saline (sodium chloride, 9 grams per liter [g/L]) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with placebo doses matched to tecemotide (L-BLP25) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until PD was documented.
|
|