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

• ClinicalTrials.gov Identifier: NCT02200081
• Recruitment Status: Completed
• First Posted: July 25, 2014
• Last Update Posted: November 15, 2018
• Sponsor: Mologen AG
• Information provided by (Responsible Party): Mologen AG

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 (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

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 Name: dSLIM
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 :

1. 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.

Secondary Outcome Measures :

1. 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.

Other Outcome Measures:

1. 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

Eligibility Criteria

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

Criteria

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).

Contacts and Locations

Locations

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

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

More Information

Publications of Results:

Thomas M, Ponce-Aix S, Navarro A, Riera-Knorrenschild J, Schmidt M, Wiegert E, Kapp K, Wittig B, Mauri C, Dómine Gómez M, Kollmeier J, Sadjadian P, Fröhling 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.

• Responsible Party: Mologen AG
• ClinicalTrials.gov Identifier: NCT02200081
• Other Study ID Numbers: MGN1703-C03
• First Posted: July 25, 2014
• Last Update Posted: November 15, 2018
• Last Verified: November 2018

Keywords provided by Mologen AG:

Extensive disease; After first line therapy; Immuno therapy

Additional relevant MeSH terms:

Lung Neoplasms; Small Cell Lung Carcinoma; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms