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Completed

NCT Number: NCT02200081

Randomized Study of Maintenance Therapy With MGN1703 in Patients With SCLC

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Medizinische Universitaet Innsbruck, Innsbruck, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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).

Treatment and study plan

MGN1703

Drug

Other names: dSLIM

Standard of care

Other

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

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Mologen AG

Industry

Registry information

Official study 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

Acronym: IMPULSE

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Jul 25, 2014
Registry last updated
Nov 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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