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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

MGN1703

Usual Standard of Care according to local investigators practise, e.g. Treatment break continous treatment and other

Standard of care

Veerle Surmont, MD

Georg Pall, MD

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.

Randomized Study of Maintenance Therapy With MGN1703 in Patients With SCLC

Randomized Clinical Study of Maintenance Therapy With Immunomodulator MGN1703 in Patients With Extensive Disease Small Cell Lung Cancer After Platinum-Based First-Line Therapy

Progression-free survival is the time after randomization to either disease progression (PD), measured using RECIST 1.1 and irRC criteria and confirmed via centralized review or death

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.

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.

Mologen AG

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Randomized Study of Maintenance Therapy With MGN1703 in Patients With SCLC	NCT02200081	Small Cell Lung...	MGN1703 Standard of car...	18 Years -	Mologen AG
Randomized Study of Maintenance Therapy With MGN1703 in Patients With SCLC	NCT02200081	Small Cell Lung...	MGN1703 Standard of car...	18 Years -	Mologen AG

Spots Global Cancer Trial Database for after first line therapy