Common Safety Follow-up Trial of Tecemotide (L-BLP25)

Not Applicable

Terminated

Brief Summary: 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) were enrolled in this follow-up trial to continue their maintenance treatment with tecemotide (L-BLP25). Subjects were transferred once the feeder trial (EMR 63325-005 \[NCT00157209\], EMR 63325-006 \[NCT00157196\] and EMR 63325-008 \[NCT01094548\]) objectives were met. Subjects who received tecemotide (L-BLP25) in a feeder trial continued tecemotide (L-BLP25) treatment in this follow-up trial and have safety assessments performed as well as were observed for progressive disease (PD) and survival in 6- month intervals. Subjects who had not received tecemotide (L-BLP25) in feeder trials, or discontinued treatment were only observed for PD and survival in 6-month intervals and were not provided treatment with tecemotide (L-BLP25).

Recruitment & Eligibility

Inclusion Criteria

Signed written informed consent.
Registration and treatment in a clinical trial with tecemotide (L-BLP25) under sponsorship of Merck KGaA/EMD Serono/Merck Serono Japan (feeder trial). [Note, subjects who have been allocated to treatments not containing tecemotide (L BLP25) in the feeder trial are eligible for this trial and will be followed-up for progressive disease (PD) (if applicable) and survival.]
End of Treatment procedures have been performed in the feeder trial.
Other protocol defined inclusion criteria could apply

Exclusion Criteria

Pregnancy and lactation period; women of childbearing potential, unless using effective contraception as determined by the Investigator. Subjects whom the Investigator considers may be at risk of pregnancy will have a pregnancy test performed per institutional standard
Known hypersensitivity to any of the trial treatment ingredients (if applicable)
Legal incapacity or limited legal capacity
Any other reason that, in the opinion of the Investigator, precludes the subject from participating in the trial
Other protocol defined exclusion criteria could apply

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Tecemotide (L-BLP25)	Tecemotide	-
Observational	No intervention	-

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Adverse Events (AEs), Serious AEs, AEs Leading to Discontinuation and AEs Leading to Death	Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years	An Adverse Event (AE) is defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A Serious AE is 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, AEs leading to discontinuation and AEs leading to death.

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	From randomization to death, assessed up to 3.6 years	Overall survival time was defined as the time from randomization to death. Subjects without events were censored at the last date they were known to be alive.