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

This study has been terminated.
(The study is terminated prematurely as the sponsor decided to discontinue program with Tecemotide in NSCLC.)
Sponsor:
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01015443
First received: October 1, 2009
Last updated: September 16, 2016
Last verified: September 2016
Results First Received: June 17, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, 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)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 350 subjects were screened for eligibility and 285 subjects were enrolled and randomized.

Reporting Groups
  Description
Tecemotide (L-BLP25)+Cyclophosphamide+Best Supportive Care 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.
Saline + Placebo + BSC 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.

Participant Flow:   Overall Study
    Tecemotide (L-BLP25)+Cyclophosphamide+Best Supportive Care   Saline + Placebo + BSC
STARTED   191   94 
Treated   191   93 
COMPLETED   191   94 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to treat (ITT) subjects included all the subjects randomized into the study.

Reporting Groups
  Description
Tecemotide (L-BLP25)+Cyclophosphamide+BSC 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.
Saline + Placebo + BSC 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 Total of all reporting groups

Baseline Measures
   Tecemotide (L-BLP25)+Cyclophosphamide+BSC   Saline + Placebo + BSC   Total 
Overall Participants Analyzed 
[Units: Participants]
 191   94   285 
Age 
[Units: Years]
Mean (Standard Deviation)
 56.5  (8.93)   59.3  (9.08)   57.4  (9.06) 
Gender 
[Units: Subjects]
     
Female   31   18   49 
Male   160   76   236 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Overall Survival (OS) Time   [ Time Frame: From the date of randomization until death, assessed up to 5.6 years ]

2.  Secondary:   Time to Symptom Progression (TTSP)   [ Time Frame: From the date of randomization to the date of symptomatic progression, assessed up to 5.6 years ]

3.  Secondary:   Time to Progression (TTP)   [ Time Frame: From the date of randomization to the date of radiological confirmation of PD, assessed up to 5.6 years ]

4.  Secondary:   Progression Free Survival (PFS)   [ Time Frame: From the date of randomization to PD, assessed up to 5.6 years ]

5.  Secondary:   Time to Treatment Failure (TTF)   [ Time Frame: From the date of randomization to the date of first missed treatment, assessed up to 5.6 years ]

6.  Secondary:   Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death   [ 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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The study is terminated prematurely as the sponsor decided to discontinue program with Tecemotide in NSCLC.


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Merck KGaA Communication Center
Organization: Merck KGaA
phone: +49-6151-72-5200
e-mail: service@merckgroup.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01015443     History of Changes
Other Study ID Numbers: EMR63325-012
Study First Received: October 1, 2009
Results First Received: June 17, 2016
Last Updated: September 16, 2016