Randomized Study of Maintenance Therapy With MGN1703 in Patients With SCLC (IMPULSE)
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ClinicalTrials.gov Identifier: NCT02200081 |
Recruitment Status :
Completed
First Posted : July 25, 2014
Last Update Posted : November 15, 2018
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Condition or disease | Intervention/treatment | Phase |
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Small Cell Lung Cancer | Drug: MGN1703 Other: Standard of care | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 103 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Randomized Clinical Study of Maintenance Therapy With Immunomodulator MGN1703 in Patients With Extensive Disease Small Cell Lung Cancer After Platinum-Based First-Line Therapy |
Actual Study Start Date : | March 2014 |
Actual Primary Completion Date : | November 2016 |
Actual Study Completion Date : | October 5, 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: 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
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Drug: MGN1703
Other Name: dSLIM |
Standard of care
Continous first line therapy
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Other: Standard of care
Usual Standard of Care according to local investigators practise, e.g. Treatment break continous treatment and other |
- Overall survival (OS) [ Time Frame: 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.
- OS1 [ Time Frame: 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.
- Progression-free survival (PFS) PFS from the start of the first cycle of induction therapy (PFS1) ass [ Time Frame: 24 months ]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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
- 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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02200081
Austria | |
Medizinische Universitaet Innsbruck | |
Innsbruck, Austria, 6020 | |
Belgium | |
Universitair Ziekenhuis Gent | |
Gent, Belgium, 9000 | |
Germany | |
Thoraxklinik Heidelberg gGmbH | |
Heidelberg, Baden Württemberg, Germany, 69126 | |
Spain | |
Hospital Universitario Fundación Jiménez Díaz | |
Madrid, Spain, 28040 |
Principal Investigator: | Veerle Surmont, MD | University Hospital Ghent, Belgium 9000 | |
Principal Investigator: | Georg Pall, MD | Medizinische Universität Innsbruck, Innere Medizin, Hämatologie und Onkologie |
Responsible Party: | Mologen AG |
ClinicalTrials.gov Identifier: | NCT02200081 |
Other Study ID Numbers: |
MGN1703-C03 |
First Posted: | July 25, 2014 Key Record Dates |
Last Update Posted: | November 15, 2018 |
Last Verified: | November 2018 |
Extensive disease After first line therapy Immuno therapy |
Lung Neoplasms Small Cell Lung Carcinoma Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |