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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 : January 5, 2018
Sponsor:
Information provided by (Responsible Party):
Mologen AG

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 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 4, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

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




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



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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).

Information from the National Library of Medicine

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


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

Responsible Party: Mologen AG
ClinicalTrials.gov Identifier: NCT02200081     History of Changes
Other Study ID Numbers: MGN1703-C03
First Posted: July 25, 2014    Key Record Dates
Last Update Posted: January 5, 2018
Last Verified: January 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