This trial is active, not recruiting.

Condition small cell lung cancer
Treatments mgn1703, standard of care
Phase phase 2
Target TLR9
Sponsor Mologen AG
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

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
MGN1703, solution in Dulbecco's Phosphate-Buffered Saline (DPBS), 2 mL of 60 mg/4 mL (15 mg/mL), administered SC at 2 application sites twice weekly
mgn1703 dSLIM
Continous first line therapy
standard of care
Usual Standard of Care according to local investigators practise, e.g. Treatment break continous treatment and other

Primary Outcomes

Overall survival (OS)
time frame: 24 months

Secondary Outcomes

time frame: 24 months

Eligibility Criteria

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).

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Mologen AG.