Evaluation of efficacy and safety of MGN1703 administered twice weekly subcutaneously (SC) as maintenance treatment in patients with extensive disease small cell lung cancer (SCLC) who achieved at least a partial response (PR) following platinum-based first-line therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
103
Usual Standard of Care according to local investigators practise, e.g. Treatment break continous treatment and other
Medizinische Universitaet Innsbruck
Innsbruck, Austria
Universitair Ziekenhuis Gent
Ghent, Belgium
Thoraxklinik Heidelberg gGmbH
Heidelberg, Baden-Wurttemberg, Germany
Hospital Universitario Fundación Jiménez Díaz
Madrid, Spain
Overall survival (OS)
The primary efficacy endpoint is the OS which is defined as the time interval starting with the randomization and lasting until death (=event) or until the date of last information available from the patient.
Time frame: 24 months
OS1
The secondary efficacy endpoint OS1 is defined as the time interval starting at the first cycle of induction therapy and lasting until death (=event) or until the date of last information available from the patient. OS1 will be estimated by Kaplan-Meier estimates. The comparison between the treatment groups will be performed using the log-rank test with a significance level of α = 2.5% for the 1-sided test. The OS1 will be presented as Kaplan-Meier figures also.
Time frame: 24 months
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