Randomized Study of Maintenance Therapy With MGN1703 in Patients With SCLC
- Registration Number
- NCT02200081
- Lead Sponsor
- Mologen AG
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 103
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MGN1703 MGN1703 MGN1703, solution in Dulbecco's Phosphate-Buffered Saline (DPBS), 2 mL of 60 mg/4 mL (15 mg/mL), administered SC at 2 application sites twice weekly Standard of care Standard of care Continous first line therapy
- Primary Outcome Measures
Name Time Method Overall survival (OS) 24 months 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.
- Secondary Outcome Measures
Name Time Method OS1 24 months 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.
Trial Locations
- Locations (4)
Universitair Ziekenhuis Gent
🇧🇪Gent, Belgium
Hospital Universitario Fundación Jiménez Díaz
🇪🇸Madrid, Spain
Medizinische Universitaet Innsbruck
🇦🇹Innsbruck, Austria
Thoraxklinik Heidelberg gGmbH
🇩🇪Heidelberg, Baden Württemberg, Germany