Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2025-12-25 @ 2:05 AM
NCT ID:
NCT01423760
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01423760
Study Brief:
Protocol Section:
NCT01423760