Overview

Randomized Study of Maintenance Therapy With MGN1703 in Patients With SCLC

Status:
Completed
Trial end date:
2017-10-05
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Mologen AG
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).