Randomized Study of Maintenance Therapy With MGN1703 in Patients With SCLC
This trial is active, not recruiting.
|Condition||small cell lung cancer|
|Treatments||mgn1703, standard of care|
|Start date||March 2014|
|End date||March 2017|
|Trial size||100 participants|
|Trial identifier||NCT02200081, MGN1703-C03|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Innsbruck, Austria||Medizinische Universitaet Innsbruck||no longer recruiting|
|Gent, Belgium||Universitair Ziekenhuis Gent||no longer recruiting|
|Heidelberg, Germany||Thoraxklinik Heidelberg gGmbH||no longer recruiting|
|Madrid, Spain||Hospital Universitario Fundación Jiménez Díaz||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Overall survival (OS)
time frame: 24 months
time frame: 24 months
Male or female participants at least 18 years old.
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).
|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|
|Principal investigator||Veerle Surmont, MD|
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