Collect Long-term Data on Subjects Following Participation in Previous EMD 531444 (L-BLP25 or BLP25 Liposome Vaccine) Clinical Trials
This is an open-label, common follow-up trial. Subjects who were enrolled in a Merck KGaA, EMD Serono or Merck Serono Japan sponsored trial with Tecemotide (L-BLP25) can be enrolled in this follow-up trial to continue their maintenance treatment with Tecemotide (L-BLP25). Subjects will be transferred once all feeder trial objectives have been met. Subjects who received Tecemotide (L-BLP25) in a feeder trial will continue Tecemotide (L-BLP25) treatment in this follow-up trial and have safety assessments performed as well as be observed for progressive disease and survival in 6- month intervals. Subjects who had not received Tecemotide (L-BLP25) in feeder trials, or discontinued treatment will only be observed for progressive disease and survival in 6-month intervals and will not be provided treatment with Tecemotide (L-BLP25).
Non-Small Cell Lung Cancer
Other: No intervention
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-label Trial to Collect Long-term Data on Subjects Following Participation in Previous EMD 531444 (L-BLP25 or BLP25 Liposome Vaccine) Clinical Trials|
- Long Term Safety - number of patients experiencing any adverse event [ Time Frame: Time from first dose up to 30 days after last dose of study treatment with L-BLP25 reported between day of first patient enrolled ] [ Designated as safety issue: Yes ]Listing of adverse event rate in patients receiving L-BLP25 only.
- Long Term Efficacy: Overall Survival (OS) [ Time Frame: Time from enrollment to death or last day known to be alive, reported between day of first patient enrolled (Dec 2011) until anticipated trial end (Dec 2019) (up to 8 years) ] [ Designated as safety issue: No ]Comparison of time of enrollment to death between L-BLP25 treatment and no treatment . Patients without an event will be censored at the last date known to be alive or at the anticipated trial end date, whichever is later.
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||May 2015|
|Estimated Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
|Experimental: Tecemotide (L-BLP25) (plus active treatment if applicable)||
Arm 1 is the treatment arm. Subjects who receive Tecemotide (L-BLP25) in a feeder trial will continue to be treated with Tecemotide (L-BLP25) and have safety assessments performed until the discontinuation criteria in the respective feeder trial protocol are met.
Other Name: L-BLP25
Other: No intervention
Observation arm for survival of all subjects who do not receive anymore or have never received Tecemotide (L-BLP25)
Please refer to this study by its ClinicalTrials.gov identifier: NCT01423760
|United States, Massachusetts|
|US Medical Information|
|Rockland, Massachusetts, United States|
|Merck KGaA Communication Center|