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Cancer Vaccine Study for Stage III, Unresectable, Non-small Cell Lung Cancer (NSCLC) in the Asian Population (INSPIRE)

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: NCT01015443
Recruitment Status : Terminated (The study is terminated prematurely as the sponsor decided to discontinue program with Tecemotide in NSCLC.)
First Posted : November 18, 2009
Results First Posted : August 2, 2016
Last Update Posted : October 26, 2016
Sponsor:
Information provided by (Responsible Party):
Merck KGaA, Darmstadt, Germany

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Non-Small Cell Lung Cancer
Interventions Biological: Tecemotide
Drug: Single low dose cyclophosphamide
Drug: Placebo
Other: Saline
Other: Best Supportive Care (BSC)
Enrollment 285
Recruitment Details First/last subject (informed consent): 03 Dec 2009/10-Sep-2014. Data cut-off date: June 2015; Subjects were randomized at 45 centers in 5 countries worldwide.
Pre-assignment Details A total of 350 subjects were screened for eligibility and 285 subjects were enrolled and randomized.
Arm/Group Title Tecemotide (L-BLP25)+Cyclophosphamide+Best Supportive Care Saline + Placebo + BSC
Hide Arm/Group Description A single intravenous (IV) infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of low dose cyclophosphamide was given 3 days prior to first tecemotide (L-BLP25) vaccination. After receiving single low dose cyclophosphamide, subjects received 8 consecutive weekly (Week 1, 2, 3, 4, 5, 6, 7, and 8 primary treatment phase) subcutaneous tecemotide (L-BLP25) vaccinations at a dose of 918 microgram (mcg) and then at 6-Week interval, beginning at Week 14 (maintenance phase) until disease progression (PD) is documented or the subject discontinued for any other reason. The best supportive care (BSC) was provided as per the investigator's discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support. A single IV infusion of 0.9 percent (%) sodium chloride (saline) was administered 3 days prior to first placebo vaccination. After receiving saline solution, subjects received 8 consecutive weekly subcutaneous vaccinations with placebo at Week 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance treatment at 6-Week intervals, beginning at Week 14, until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator's discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
Period Title: Overall Study
Started 191 94
Treated 191 93
Completed 191 94
Not Completed 0 0
Arm/Group Title Tecemotide (L-BLP25)+Cyclophosphamide+BSC Saline + Placebo + BSC Total
Hide Arm/Group Description A single IV infusion of 300 mg/m^2 (to a maximum 600 mg) of low dose cyclophosphamide was given 3 days prior to first tecemotide (L-BLP25) vaccination. After receiving single low dose cyclophosphamide, subjects received 8 consecutive weekly (Week 1, 2, 3, 4, 5, 6, 7, and 8 primary treatment phase) subcutaneous tecemotide (L-BLP25) vaccinations at a dose of 918 mcg and then at 6-Week interval, beginning at Week 14 (maintenance phase) until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator's discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support. A single IV infusion of 0.9% sodium chloride (saline) was administered 3 days prior to first placebo vaccination. After receiving saline solution, subjects received 8 consecutive weekly subcutaneous vaccinations with placebo at Week 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance treatment at 6-Week intervals, beginning at Week 14, until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator's discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support. Total of all reporting groups
Overall Number of Baseline Participants 191 94 285
Hide Baseline Analysis Population Description
Intention to treat (ITT) subjects included all the subjects randomized into the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 191 participants 94 participants 285 participants
56.5  (8.93) 59.3  (9.08) 57.4  (9.06)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 191 participants 94 participants 285 participants
Female
31
  16.2%
18
  19.1%
49
  17.2%
Male
160
  83.8%
76
  80.9%
236
  82.8%
1.Primary Outcome
Title Overall Survival (OS) Time
Hide Description OS time was measured as the time (in months) between the date of randomization and the date of death. For subjects alive or lost to follow-up at time of analysis, the time between the date of randomization and the date on which the subject was last known alive was calculated and used as a censored observation in the analysis.
Time Frame From the date of randomization until death, assessed up to 5.6 years
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) analysis set was based on the intention-to-treat (ITT) analysis set (ITT analysis set included all the subjects randomized into the study), but included only subjects with concurrent primary chemo-radiotherapy and prospectively excluded the 5 subjects who were randomized prior to the clinical hold.
Arm/Group Title Tecemotide (L-BLP25)+Cyclophosphamide+BSC Saline + Placebo + BSC
Hide Arm/Group Description:
A single IV infusion of 300 mg/m^2 (to a maximum 600 mg) of low dose cyclophosphamide was given 3 days prior to first tecemotide (L-BLP25) vaccination. After receiving single low dose cyclophosphamide, subjects received 8 consecutive weekly (Week 1, 2, 3, 4, 5, 6, 7, and 8 primary treatment phase) subcutaneous tecemotide (L-BLP25) vaccinations at a dose of 918 mcg and then at 6-Week interval, beginning at Week 14 (maintenance phase) until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator's discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
A single IV infusion of 0.9% sodium chloride (saline) was administered 3 days prior to first placebo vaccination. After receiving saline solution, subjects received 8 consecutive weekly subcutaneous vaccinations with placebo at Week 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance treatment at 6-Week intervals, beginning at Week 14, until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator's discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
Overall Number of Participants Analyzed 135 68
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(28.7 to NA)
NA [1] 
(23.7 to NA)
[1]
Fewer subjects were randomized than planned and analysis was performed earlier than planned due to termination of the tecemotide (L-BLP25) program which resulted in few events. Hence, median and upper limit of confidence interval were not estimable.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tecemotide (L-BLP25)+Cyclophosphamide+BSC, Saline + Placebo + BSC
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.921
Comments [Not Specified]
Method Adjusted log rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.032
Confidence Interval (2-Sided) 95%
0.552 to 1.931
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Time to Symptom Progression (TTSP)
Hide Description TTSP was measured from randomization to symptomatic progression by lung cancer symptom scale (LCSS) used to measure symptom changes relevant to quality of life (QoL).It consisted of 9 items focused on cancer symptoms (loss of appetite, fatigue, cough, shortness of breath, blood in sputum, pain, symptoms of cancer, illness affecting normal activity, QoL).For each symptom score distance from left boundary to point where subject has marked line was measured in millimeters (mm).Total scale length was 100 mm. Symptomatic progression was defined as increase/worsening of average symptomatic burden index (ASBI) (mean of 6 major lung cancer specific symptom scores);Worsening defined as 10% increase of scale breadth from baseline. Score 0 indicate no/minimum symptoms;100 indicates maximum level of symptoms. Subjects without symptomatic progression/lost to follow-up at time of analysis: time from date of randomization to date of last LCSS assessment was calculated & used as censored observation.
Time Frame From the date of randomization to the date of symptomatic progression, assessed up to 5.6 years
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT analysis set was based on the ITT analysis set (ITT analysis set included all the subjects randomized into the study), but included only subjects with concurrent primary chemo-radiotherapy and prospectively excluded the 5 subjects who were randomized prior to the clinical hold.
Arm/Group Title Tecemotide (L-BLP25)+Cyclophosphamide+BSC Saline + Placebo + BSC
Hide Arm/Group Description:
A single IV infusion of 300 mg/m^2 (to a maximum 600 mg) of low dose cyclophosphamide was given 3 days prior to first tecemotide (L-BLP25) vaccination. After receiving single low dose cyclophosphamide, subjects received 8 consecutive weekly (Week 1, 2, 3, 4, 5, 6, 7, and 8 primary treatment phase) subcutaneous tecemotide (L-BLP25) vaccinations at a dose of 918 mcg and then at 6-Week interval, beginning at Week 14 (maintenance phase) until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator's discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
A single IV infusion of 0.9% sodium chloride (saline) was administered 3 days prior to first placebo vaccination. After receiving saline solution, subjects received 8 consecutive weekly subcutaneous vaccinations with placebo at Week 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance treatment at 6-Week intervals, beginning at Week 14, until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator's discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
Overall Number of Participants Analyzed 135 68
Median (95% Confidence Interval)
Unit of Measure: Months
19.3 [1] 
(16.7 to NA)
24.2 [1] 
(10.8 to NA)
[1]
Fewer subjects were randomized than planned and analysis was performed earlier than planned due to termination of the tecemotide (L-BLP25) program which resulted in few events. Hence, upper limit of confidence interval was not estimable.
3.Secondary Outcome
Title Time to Progression (TTP)
Hide Description Time from randomization to radiological confirmation of disease progression (PD) as determined by the investigator. PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions from nadir, or the appearance of one or more new lesions as per RECIST version 1.0. For subjects without radiological confirmed PD who discontinued or died due to PD, the date of trial treatment discontinuation was used as event date. Subjects who missed 2 consecutive scheduled doses without evaluable assessment for the related visits and who were lost to follow-up thereafter were considered as having PD, TTP was calculated from the date of randomization to the date of their first missed treatment. Subjects without PD at time of analysis are censored at either date of last vaccination or death or discontinuation of treatment or lost to follow-up.
Time Frame From the date of randomization to the date of radiological confirmation of PD, assessed up to 5.6 years
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT analysis set was based on the ITT analysis set (ITT analysis set included all the subjects randomized into the study), but included only subjects with concurrent primary chemo-radiotherapy and prospectively excluded the 5 subjects who were randomized prior to the clinical hold.
Arm/Group Title Tecemotide (L-BLP25)+Cyclophosphamide+BSC Saline + Placebo + BSC
Hide Arm/Group Description:
A single IV infusion of 300 mg/m^2 (to a maximum 600 mg) of low dose cyclophosphamide was given 3 days prior to first tecemotide (L-BLP25) vaccination. After receiving single low dose cyclophosphamide, subjects received 8 consecutive weekly (Week 1, 2, 3, 4, 5, 6, 7, and 8 primary treatment phase) subcutaneous tecemotide (L-BLP25) vaccinations at a dose of 918 mcg and then at 6-Week interval, beginning at Week 14 (maintenance phase) until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator's discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
A single IV infusion of 0.9% sodium chloride (saline) was administered 3 days prior to first placebo vaccination. After receiving saline solution, subjects received 8 consecutive weekly subcutaneous vaccinations with placebo at Week 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance treatment at 6-Week intervals, beginning at Week 14, until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator's discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
Overall Number of Participants Analyzed 135 68
Median (95% Confidence Interval)
Unit of Measure: Months
6.4
(5.5 to 8.6)
7.5
(5.9 to 15.2)
4.Secondary Outcome
Title Progression Free Survival (PFS)
Hide Description Time from randomization to objective disease progression (PD) as determined by the investigator or death. PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions from nadir, or the appearance of one or more new lesions as per RECIST version 1.0. Subjects who missed 2 consecutive scheduled doses without evaluable assessment for the related visits and who were lost to follow-up thereafter were considered as having PD, and the PFS was calculated from the date of randomization to the date of their first missed treatment. PFS time for subjects without an event was censored as of the date of last performed imaging.
Time Frame From the date of randomization to PD, assessed up to 5.6 years
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT analysis set was based on the ITT analysis set (ITT analysis set included all the subjects randomized into the study), but included only subjects with concurrent primary chemo-radiotherapy and prospectively excluded the 5 subjects who were randomized prior to the clinical hold.
Arm/Group Title Tecemotide (L-BLP25)+Cyclophosphamide+BSC Saline + Placebo + BSC
Hide Arm/Group Description:
A single IV infusion of 300 mg/m^2 (to a maximum 600 mg) of low dose cyclophosphamide was given 3 days prior to first tecemotide (L-BLP25) vaccination. After receiving single low dose cyclophosphamide, subjects received 8 consecutive weekly (Week 1, 2, 3, 4, 5, 6, 7, and 8 primary treatment phase) subcutaneous tecemotide (L-BLP25) vaccinations at a dose of 918 mcg and then at 6-Week interval, beginning at Week 14 (maintenance phase) until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator's discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
A single IV infusion of 0.9% sodium chloride (saline) was administered 3 days prior to first placebo vaccination. After receiving saline solution, subjects received 8 consecutive weekly subcutaneous vaccinations with placebo at Week 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance treatment at 6-Week intervals, beginning at Week 14, until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator's discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
Overall Number of Participants Analyzed 135 68
Median (95% Confidence Interval)
Unit of Measure: Months
7.0
(5.5 to 8.7)
8.7
(5.9 to 15.2)
5.Secondary Outcome
Title Time to Treatment Failure (TTF)
Hide Description TTF was time from randomization to discontinuation of trial treatment for any reason as reported by the investigator. For subjects still receiving treatment at the time of analysis, the time between the date of randomization and the last date of treatment will be used as a censored observation in the analysis. Subjects who missed 2 consecutive scheduled doses without evaluable assessment for the related visits and who were lost to follow-up thereafter were considered treatment failure and the TTF was calculated from the date of randomization to the date of their first missed treatment.
Time Frame From the date of randomization to the date of first missed treatment, assessed up to 5.6 years
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT analysis set was based on the ITT analysis set (ITT analysis set included all the subjects randomized into the study), but included only subjects with concurrent primary chemo-radiotherapy and prospectively excluded the 5 subjects who were randomized prior to the clinical hold.
Arm/Group Title Tecemotide (L-BLP25)+Cyclophosphamide+BSC Saline + Placebo + BSC
Hide Arm/Group Description:
A single IV infusion of 300 mg/m^2 (to a maximum 600 mg) of low dose cyclophosphamide was given 3 days prior to first tecemotide (L-BLP25) vaccination. After receiving single low dose cyclophosphamide, subjects received 8 consecutive weekly (Week 1, 2, 3, 4, 5, 6, 7, and 8 primary treatment phase) subcutaneous tecemotide (L-BLP25) vaccinations at a dose of 918 mcg and then at 6-Week interval, beginning at Week 14 (maintenance phase) until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator's discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
A single IV infusion of 0.9% sodium chloride (saline) was administered 3 days prior to first placebo vaccination. After receiving saline solution, subjects received 8 consecutive weekly subcutaneous vaccinations with placebo at Week 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance treatment at 6-Week intervals, beginning at Week 14, until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator's discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
Overall Number of Participants Analyzed 135 68
Median (95% Confidence Interval)
Unit of Measure: Months
4.6
(4.5 to 6.0)
4.6
(3.3 to 5.9)
6.Secondary Outcome
Title Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death
Hide Description An Adverse Event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A Serious Adverse Event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs were defined as the AEs that occur between first dose of study drug administration and 42 days after the last dose of study drug administration that were absent before treatment or that worsened relative to pretreatment state. Number of subjects with TEAE leading to death and permanent discontinuation of any trial treatment were presented.
Time Frame From the first dose of study drug administration until 42 days after the last dose of study drug administration, assessed up to 5.6 years
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all subjects who received at least one dose of trial treatment.
Arm/Group Title Tecemotide (L-BLP25)+Cyclophosphamide+BSC Saline + Placebo + BSC
Hide Arm/Group Description:
A single IV infusion of 300 mg/m^2 (to a maximum 600 mg) of low dose cyclophosphamide was given 3 days prior to first tecemotide (L-BLP25) vaccination. After receiving single low dose cyclophosphamide, subjects received 8 consecutive weekly (Week 1, 2, 3, 4, 5, 6, 7, and 8 primary treatment phase) subcutaneous tecemotide (L-BLP25) vaccinations at a dose of 918 mcg and then at 6-Week interval, beginning at Week 14 (maintenance phase) until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator's discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
A single IV infusion of 0.9% sodium chloride (saline) was administered 3 days prior to first placebo vaccination. After receiving saline solution, subjects received 8 consecutive weekly subcutaneous vaccinations with placebo at Week 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance treatment at 6-Week intervals, beginning at Week 14, until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator's discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
Overall Number of Participants Analyzed 191 93
Measure Type: Number
Unit of Measure: Subjects
TEAEs 156 73
Serious TEAE 34 21
TEAEs leading to discontinuation 22 11
TEAEs leading to death 4 2
Time Frame From the first dose of study drug administration until 42 days after the last dose of study drug administration, assessed up to 5.6 years
Adverse Event Reporting Description Safety analysis set included all subjects who received at least one dose of trial treatment.
 
Arm/Group Title Tecemotide (L-BLP25)+Cyclophosphamide+BSC Saline + Placebo + BSC
Hide Arm/Group Description A single IV infusion of 300 mg/m^2 (to a maximum 600 mg) of low dose cyclophosphamide was given 3 days prior to first tecemotide (L-BLP25) vaccination. After receiving single low dose cyclophosphamide, subjects received 8 consecutive weekly (Week 1, 2, 3, 4, 5, 6, 7, and 8 primary treatment phase) subcutaneous tecemotide (L-BLP25) vaccinations at a dose of 918 mcg and then at 6-Week interval, beginning at Week 14 (maintenance phase) until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator's discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support. A single IV infusion of 0.9% sodium chloride (saline) was administered 3 days prior to first placebo vaccination. After receiving saline solution, subjects received 8 consecutive weekly subcutaneous vaccinations with placebo at Week 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance treatment at 6-Week intervals, beginning at Week 14, until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator's discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
All-Cause Mortality
Tecemotide (L-BLP25)+Cyclophosphamide+BSC Saline + Placebo + BSC
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Tecemotide (L-BLP25)+Cyclophosphamide+BSC Saline + Placebo + BSC
Affected / at Risk (%) Affected / at Risk (%)
Total   34/191 (17.80%)   21/93 (22.58%) 
Blood and lymphatic system disorders     
Anaemia * 1  1/191 (0.52%)  0/93 (0.00%) 
Thrombocytopenia * 1  1/191 (0.52%)  0/93 (0.00%) 
Cardiac disorders     
Aortic valve incompetence * 1  0/191 (0.00%)  1/93 (1.08%) 
Arrhythmia supraventricular * 1  1/191 (0.52%)  0/93 (0.00%) 
Gastrointestinal disorders     
Diarrhoea * 1  1/191 (0.52%)  0/93 (0.00%) 
Enteritis * 1  0/191 (0.00%)  1/93 (1.08%) 
Oesophageal stenosis * 1  2/191 (1.05%)  0/93 (0.00%) 
Pancreatic pseudocyst * 1  1/191 (0.52%)  0/93 (0.00%) 
Pancreatitis acute * 1  1/191 (0.52%)  0/93 (0.00%) 
Vomiting * 1  0/191 (0.00%)  1/93 (1.08%) 
General disorders     
Disease progression * 1  8/191 (4.19%)  3/93 (3.23%) 
Non-cardiac chest pain * 1  0/191 (0.00%)  1/93 (1.08%) 
Pyrexia * 1  0/191 (0.00%)  1/93 (1.08%) 
Infections and infestations     
Empyema * 1  1/191 (0.52%)  0/93 (0.00%) 
Infective exacerbation of chronic obstructive airways disease * 1  1/191 (0.52%)  0/93 (0.00%) 
Lower respiratory tract infection * 1  0/191 (0.00%)  2/93 (2.15%) 
Necrotising fasciitis * 1  0/191 (0.00%)  1/93 (1.08%) 
Pneumonia * 1  2/191 (1.05%)  3/93 (3.23%) 
Sepsis * 1  0/191 (0.00%)  1/93 (1.08%) 
Upper respiratory tract infection * 1  2/191 (1.05%)  0/93 (0.00%) 
Injury, poisoning and procedural complications     
Fibula fracture * 1  1/191 (0.52%)  0/93 (0.00%) 
Ligament sprain * 1  0/191 (0.00%)  1/93 (1.08%) 
Pulmonary radiation injury * 1  1/191 (0.52%)  0/93 (0.00%) 
Radiation pneumonitis * 1  3/191 (1.57%)  3/93 (3.23%) 
Spinal compression fracture * 1  0/191 (0.00%)  1/93 (1.08%) 
Metabolism and nutrition disorders     
Metabolic acidosis * 1  1/191 (0.52%)  0/93 (0.00%) 
Musculoskeletal and connective tissue disorders     
Myalgia * 1  1/191 (0.52%)  0/93 (0.00%) 
Rheumatoid arthritis * 1  1/191 (0.52%)  0/93 (0.00%) 
Sjogren's syndrome * 1  0/191 (0.00%)  1/93 (1.08%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Metastases to adrenals * 1  0/191 (0.00%)  1/93 (1.08%) 
Metastases to central nervous system * 1  2/191 (1.05%)  1/93 (1.08%) 
Metastases to lymph nodes * 1  1/191 (0.52%)  0/93 (0.00%) 
Renal and urinary disorders     
Acute kidney injury * 1  1/191 (0.52%)  0/93 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease * 1  1/191 (0.52%)  0/93 (0.00%) 
Dyspnoea * 1  2/191 (1.05%)  0/93 (0.00%) 
Epiglottic cyst * 1  1/191 (0.52%)  0/93 (0.00%) 
Haemoptysis * 1  3/191 (1.57%)  2/93 (2.15%) 
Pleural effusion * 1  1/191 (0.52%)  1/93 (1.08%) 
Pulmonary mass * 1  1/191 (0.52%)  0/93 (0.00%) 
Skin and subcutaneous tissue disorders     
Erythema multiforme * 1  0/191 (0.00%)  1/93 (1.08%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 18.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tecemotide (L-BLP25)+Cyclophosphamide+BSC Saline + Placebo + BSC
Affected / at Risk (%) Affected / at Risk (%)
Total   151/191 (79.06%)   70/93 (75.27%) 
Gastrointestinal disorders     
Abdominal pain upper * 1  6/191 (3.14%)  5/93 (5.38%) 
Constipation * 1  5/191 (2.62%)  8/93 (8.60%) 
Diarrhoea * 1  7/191 (3.66%)  5/93 (5.38%) 
General disorders     
Chest discomfort * 1  5/191 (2.62%)  6/93 (6.45%) 
Disease progression * 1  11/191 (5.76%)  3/93 (3.23%) 
Fatigue * 1  24/191 (12.57%)  13/93 (13.98%) 
Non-cardiac chest pain * 1  15/191 (7.85%)  11/93 (11.83%) 
Oedema peripheral * 1  5/191 (2.62%)  5/93 (5.38%) 
Pyrexia * 1  11/191 (5.76%)  11/93 (11.83%) 
Infections and infestations     
Upper respiratory tract infection * 1  15/191 (7.85%)  7/93 (7.53%) 
Injury, poisoning and procedural complications     
Radiation pneumonitis * 1  8/191 (4.19%)  6/93 (6.45%) 
Metabolism and nutrition disorders     
Decreased appetite * 1  20/191 (10.47%)  7/93 (7.53%) 
Hyperuricaemia * 1  1/191 (0.52%)  5/93 (5.38%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  6/191 (3.14%)  9/93 (9.68%) 
Back pain * 1  10/191 (5.24%)  9/93 (9.68%) 
Musculoskeletal pain * 1  8/191 (4.19%)  5/93 (5.38%) 
Nervous system disorders     
Dizziness * 1  16/191 (8.38%)  4/93 (4.30%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  47/191 (24.61%)  16/93 (17.20%) 
Dyspnoea * 1  18/191 (9.42%)  15/93 (16.13%) 
Haemoptysis * 1  11/191 (5.76%)  4/93 (4.30%) 
Productive cough * 1  10/191 (5.24%)  3/93 (3.23%) 
Skin and subcutaneous tissue disorders     
Rash * 1  13/191 (6.81%)  2/93 (2.15%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 18.0
The study is terminated prematurely as the sponsor decided to discontinue program with Tecemotide in NSCLC.
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.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Merck KGaA Communication Center
Organization: Merck KGaA
Phone: +49-6151-72-5200
EMail: service@merckgroup.com
Layout table for additonal information
Responsible Party: Merck KGaA, Darmstadt, Germany
ClinicalTrials.gov Identifier: NCT01015443    
Other Study ID Numbers: EMR63325-012
First Submitted: October 1, 2009
First Posted: November 18, 2009
Results First Submitted: June 17, 2016
Results First Posted: August 2, 2016
Last Update Posted: October 26, 2016