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 L-BLP25 can be enrolled in this follow-up trial to continue their maintenance treatment with L-BLP25. Subjects will be transferred once all feeder trial objectives have been met. Subjects who received L-BLP25 in a feeder trial will continue 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 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 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
- 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:||June 2020|
|Estimated Primary Completion Date:||December 2019 (Final data collection date for primary outcome measure)|
|Experimental: L-BLP25 (plus active treatment if applicable)||
Arm 1 is the treatment arm. Subjects who receive L-BLP25 in a feeder trial will continue to be treated with L-BLP25 and have safety assessments performed until the discontinuation criteria in the respective feeder trial protocol are met.
Other: No intervention
Observation arm for survival of all subjects who do not receive anymore or have never received L-BLP25