Randomized Study of Maintenance Therapy With MGN1703 in Patients With SCLC

Study Overview
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Brief Summary
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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.

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

Conditions
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Small Cell Lung Cancer

Intervention / Treatment
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* Drug: MGN1703
* Other: Standard of care


Participation Criteria
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Eligibility Criteria
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Male and female patients with extensive disease SCLC ≥ 18 years of age receiving first line treatment; Histology of SCLC or mixed histology of SCLC if SCLC histology is at least 80%; Completion of 4 cycles of first-line therapy with a platinum-based regimen and no other prior chemotherapy; Documented evidence of tumor response as assessed by investigators after the first 2 cycles of platinum-based chemotherapy followed by a confirmed PR or CR at the end of fourth cycle by CT or MRI scan; Brain metastases are allowed only after cranial irradiation, if not requiring continuous treatment with steroids or anticonvulsants; ECOG performance status 0 or 1; Adequate organ function with total bilirubin, lactate dehydrogenase [LDH], alkaline phosphatase [AP], gamma glutamyltransferase [GGT], albumin, creatinine, urea, electrolytes, and coagulation parameters ≤ 1.5 × upper limit of normal (ULN), and with aspartate aminotransferase [AST] and ALT ≤ 2.5 × ULN in the absence of liver metastases or ≤ 5.0 × ULN in the presence of liver metastases; Adequate hematological parameters: absolute neutrophil count ≥ 1.5 × 109/L; platelet count ≥ 100 × 109/L; leukocyte count ≥ 3.0 × 109/L; lymphocytes ≥ 1.0 × 109/L; hemoglobin ≥ 9.0 g/dL or 5.59 mmol/L; Patients with reproductive potential agree to use effective contraceptive measures throughout the study; Negative pregnancy test in women of childbearing potential; Signed informed consent form (ICF).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MGN1703<br>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 | Drug: MGN1703<br> <br> * Other names: dSLIM;|
| Other: Standard of care<br>Continous first line therapy | Other: Standard of care<br>* Usual Standard of Care according to local investigators practise, e.g. Treatment break continous treatment and other<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immuno therapy, Extensive disease, After first line therapy