Clinical trial NCT02200081: Randomized Study of Maintenance Therapy With MGN1703 in Patients With SCLC
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Small Cell Lung Cancer
Keywords: Extensive disease
After first line therapy
Immuno therapy
Lead sponsor: Mologen AG
Sponsor class: INDUSTRY
First posted: 2014-07-25
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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).

Primary outcomes:
measure: Overall survival (OS)
timeFrame: 24 months
Secondary outcomes:
measure: OS1
timeFrame: 24 months
Other outcomes:
measure: Progression-free survival (PFS) PFS from the start of the first cycle of induction therapy (PFS1) ass
timeFrame: 24 months
Locations:
city: Innsbruck
country: Austria
facility: Medizinische Universitaet Innsbruck
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Heidelberg
country: Germany
facility: Thoraxklinik Heidelberg gGmbH
state: Baden Württemberg
city: Madrid
country: Spain
facility: Hospital Universitario Fundación Jiménez Díaz
Study officials:
affiliation: University Hospital Ghent, Belgium 9000
name: Veerle Surmont, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medizinische Universität Innsbruck, Innere Medizin, Hämatologie und Onkologie
name: Georg Pall, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thomas M, Ponce-Aix S, Navarro A, Riera-Knorrenschild J, Schmidt M, Wiegert E, Kapp K, Wittig B, Mauri C, Domine Gomez M, Kollmeier J, Sadjadian P, Frohling 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.