Randomized Study of Maintenance Therapy With MGN1703 in Patients With SCLC (IMPULSE)

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

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.

Study Overview

• Status: Completed
• Conditions: Small Cell Lung Cancer
• Intervention / Treatment: Drug: MGN1703; Other: Standard of care

• Study Type: Interventional
• Enrollment (Actual): 103
• Phase: Phase 2

Contacts and Locations

Study Locations

• Austria
  • Innsbruck, Austria, 6020
    • Medizinische Universitaet Innsbruck
• Belgium
  • Gent, Belgium, 9000
    • Universitair Ziekenhuis Gent
• Germany
  • Baden Württemberg
    • Heidelberg, Baden Württemberg, Germany, 69126
      • Thoraxklinik Heidelberg gGmbH
• Spain
  • Madrid, Spain, 28040
    • Hospital Universitario Fundacion Jimenez Diaz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

1. Male and female patients with extensive disease SCLC ≥ 18 years of age receiving first line treatment;
2. Histology of SCLC or mixed histology of SCLC if SCLC histology is at least 80%;
3. Completion of 4 cycles of first-line therapy with a platinum-based regimen and no other prior chemotherapy;
4. 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;
5. Brain metastases are allowed only after cranial irradiation, if not requiring continuous treatment with steroids or anticonvulsants;
6. ECOG performance status 0 or 1;
7. 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;
8. 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;
9. Patients with reproductive potential agree to use effective contraceptive measures throughout the study;
10. Negative pregnancy test in women of childbearing potential;
11. Signed informed consent form (ICF).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival (PFS) PFS from the start of the first cycle of induction therapy (PFS1) ass	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	24 months

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2014
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): October 5, 2017

Study Registration Dates

• First Submitted: January 9, 2014
• First Submitted That Met QC Criteria: July 23, 2014
• First Posted (Estimate): July 25, 2014

Study Record Updates

• Last Update Posted (Actual): November 15, 2018
• Last Update Submitted That Met QC Criteria: November 13, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Extensive disease; Immuno therapy; After first line therapy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma
• Other Study ID Numbers: MGN1703-C03