IMPULSE: Randomized Study of Maintenance Therapy With MGN1703 in Patients With SCLC

Sponsor

Mologen AG (Industry)

Overall Status

Completed

CT.gov ID

NCT02200081

Collaborator

(none)

103

Enrollment

Locations

Arms

43.2

Actual Duration (Months)

25.8

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Small Cell Lung Cancer	Drug: MGN1703 Other: Standard of care	Phase 2

Study Design

Study Type:

Interventional

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 :

Mar 1, 2014

Actual Primary Completion Date :

Nov 1, 2016

Actual Study Completion Date :

Oct 5, 2017

Arms and Interventions

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	Drug: MGN1703 Other Names: dSLIM
Other: Standard of care Continous first line therapy	Other: Standard of care Usual Standard of Care according to local investigators practise, e.g. Treatment break continous treatment and other

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

Drug: MGN1703

Other Names:

dSLIM

Other: Standard of care

Continous first line therapy

Other: Standard of care

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

Outcome Measures

Primary Outcome Measures

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

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.

Other Outcome Measures

Progression-free survival (PFS) PFS from the start of the first cycle of induction therapy (PFS1) ass [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medizinische Universitaet Innsbruck	Innsbruck		Austria	6020
2	Universitair Ziekenhuis Gent	Gent		Belgium	9000
3	Thoraxklinik Heidelberg gGmbH	Heidelberg	Baden Württemberg	Germany	69126
4	Hospital Universitario Fundación Jiménez Díaz	Madrid		Spain	28040

Sponsors and Collaborators

Mologen AG

Investigators

Principal Investigator: Veerle Surmont, MD, University Hospital Ghent, Belgium 9000
Principal Investigator: Georg Pall, MD, Medizinische Universität Innsbruck, Innere Medizin, Hämatologie und Onkologie