Status:
COMPLETED
Randomized Study of Maintenance Therapy With MGN1703 in Patients With SCLC
Lead Sponsor:
Mologen AG
Conditions:
Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 lea...
Eligibility Criteria
Inclusion
- 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).
Exclusion
Key Trial Info
Start Date :
March 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 5 2017
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT02200081
Start Date
March 1 2014
End Date
October 5 2017
Last Update
November 15 2018
Active Locations (4)
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1
Medizinische Universitaet Innsbruck
Innsbruck, Austria, 6020
2
Universitair Ziekenhuis Gent
Ghent, Belgium, 9000
3
Thoraxklinik Heidelberg gGmbH
Heidelberg, Baden-Wurttemberg, Germany, 69126
4
Hospital Universitario Fundación Jiménez Díaz
Madrid, Spain, 28040