Back to resultsRandomized Study of Maintenance Therapy With MGN1703 in Patients With SCLC (IMPULSE)
Primary Purpose
Small Cell Lung Cancer
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
MGN1703
Standard of care
Sponsored by
About this trial
This is an interventional treatment trial for Small Cell Lung Cancer focused on measuring Extensive disease, After first line therapy, Immuno therapy
Eligibility Criteria
- 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).
Sites / Locations
- Medizinische Universitaet Innsbruck
- Universitair Ziekenhuis Gent
- Thoraxklinik Heidelberg gGmbH
- Hospital Universitario Fundación Jiménez Díaz
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
MGN1703
Standard of care
Arm Description
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
Continous first line therapy
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02200081
Brief Title
Randomized Study of Maintenance Therapy With MGN1703 in Patients With SCLC
Acronym
IMPULSE
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
March 2014 (Actual)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
October 5, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mologen AG
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Cancer
Keywords
Extensive disease, After first line therapy, Immuno therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
103 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MGN1703
Arm Type
Experimental
Arm Description
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
Arm Title
Standard of care
Arm Type
Other
Arm Description
Continous first line therapy
Intervention Type
Drug
Intervention Name(s)
MGN1703
Other Intervention Name(s)
dSLIM
Intervention Type
Other
Intervention Name(s)
Standard of care
Intervention Description
Usual Standard of Care according to local investigators practise, e.g. Treatment break continous treatment and other
Primary Outcome Measure Information:
Title
Overall survival (OS)
Description
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
Secondary Outcome Measure Information:
Title
OS1
Description
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
Other Pre-specified Outcome Measures:
Title
Progression-free survival (PFS) PFS from the start of the first cycle of induction therapy (PFS1) ass
Description
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
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Veerle Surmont, MD
Organizational Affiliation
University Hospital Ghent, Belgium 9000
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Georg Pall, MD
Organizational Affiliation
Medizinische Universität Innsbruck, Innere Medizin, Hämatologie und Onkologie
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medizinische Universitaet Innsbruck
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Universitair Ziekenhuis Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Thoraxklinik Heidelberg gGmbH
City
Heidelberg
State/Province
Baden Württemberg
ZIP/Postal Code
69126
Country
Germany
Facility Name
Hospital Universitario Fundación Jiménez Díaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
30137193
Citation
Thomas M, Ponce-Aix S, Navarro A, Riera-Knorrenschild J, Schmidt M, Wiegert E, Kapp K, Wittig B, Mauri C, Domine Gomez M, Kollmeier J, Sadjadian P, Frohling KP, Huber RM, Wolf M; IMPULSE study team. Immunotherapeutic maintenance treatment with toll-like receptor 9 agonist lefitolimod in patients with extensive-stage small-cell lung cancer: results from the exploratory, controlled, randomized, international phase II IMPULSE study. Ann Oncol. 2018 Oct 1;29(10):2076-2084. doi: 10.1093/annonc/mdy326.
Results Reference
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Randomized Study of Maintenance Therapy With MGN1703 in Patients With SCLC
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