Randomized Study of Maintenance Therapy With MGN1703 in Patients With SCLC (IMPULSE)

Mologen

Status and phase: Completed; Phase 2

Conditions: Small Cell Lung Cancer

Treatments: Drug: MGN1703; Other: Standard of care

Study type: Interventional

Funder types: Industry

Identifiers

NCT02200081

MGN1703-C03

Details and patient eligibility

About

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.

Enrollment: 103 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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103 participants in 2 patient groups

MGN1703

Experimental group

Description:

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

Treatment:

Drug: MGN1703

Standard of care

Other group

Description:

Continous first line therapy

Treatment:

Other: Standard of care