Randomized Study of Maintenance Therapy With MGN1703 in Patients With SCLC

NCT02200081 | Completed Phase 2 DMC

• 1 other identifier: MGN1703-C03
• Study Type: interventional
• Target: 103
• Locations: 4 countries
• Sites: 4

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.

Conditions

Small Cell Lung Cancer

Keywords

Extensive disease; After first line therapy; Immuno therapy

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

  The primary efficacy endpoint is the OS which is defined as the time interval starting with the randomization and lasting until death (=event) or until the date of last information available from the patient.

  24 months

Secondary Outcomes (1)

• OS1

  24 months

Other Outcomes (1)

• Progression-free survival (PFS) PFS from the start of the first cycle of induction therapy (PFS1) ass

  24 months

Study Arms (2)

MGN1703

EXPERIMENTAL

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

Drug: MGN1703

Standard of care

OTHER

Continous first line therapy

Other: Standard of care

Interventions

MGN1703 DRUG

Also known as: dSLIM

MGN1703

Standard of care OTHER

Usual Standard of Care according to local investigators practise, e.g. Treatment break continous treatment and other

Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Mologen AG: lead

Study Sites (4)

Medizinische Universitaet Innsbruck

Innsbruck, 6020, Austria

Location

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Location

Thoraxklinik Heidelberg gGmbH

Heidelberg, Baden-Wurttemberg, 69126, Germany

Location

Hospital Universitario Fundación Jiménez Díaz

Madrid, 28040, Spain

Location

Related Publications (1)

• 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.

  PMID: 30137193 RESULT

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

MGN1703; Standard of Care

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Veerle Surmont, MD

  University Hospital Ghent, Belgium 9000

  PRINCIPAL INVESTIGATOR

• Georg Pall, MD

  Medizinische Universität Innsbruck, Innere Medizin, Hämatologie und Onkologie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2014
• First Posted: July 25, 2014
• Study Start: March 1, 2014
• Primary Completion: November 1, 2016
• Study Completion: October 5, 2017
• Last Updated: November 15, 2018

Record last verified: 2018-11

Locations

AU (1); DE (1); BE (1); ES (1)