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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Standard of care | Other | Continous first line therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MGN1703 | Drug |
|
| |
| Standard of care |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| OS1 | The secondary efficacy endpoint OS1 is defined as the time interval starting at the first cycle of induction therapy and lasting until death (=event) or until the date of last information available from the patient. OS1 will be estimated by Kaplan-Meier estimates. The comparison between the treatment groups will be performed using the log-rank test with a significance level of α = 2.5% for the 1-sided test. The OS1 will be presented as Kaplan-Meier figures also. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) PFS from the start of the first cycle of induction therapy (PFS1) ass | Progression-free survival is the time after randomization to either disease progression (PD), measured using RECIST 1.1 and irRC criteria and confirmed via centralized review or death | 24 months |
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| Name | Affiliation | Role |
|---|---|---|
| Veerle Surmont, MD | University Hospital Ghent, Belgium 9000 | Principal Investigator |
| Georg Pall, MD | Medizinische Universität Innsbruck, Innere Medizin, Hämatologie und Onkologie | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medizinische Universitaet Innsbruck | Innsbruck | 6020 | Austria | |||
| Universitair Ziekenhuis Gent |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30137193 | Result | 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. |
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| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| C000597235 | MGN1703 |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Other |
Usual Standard of Care according to local investigators practise, e.g. Treatment break continous treatment and other |
|
| 24 months |
| Ghent |
| 9000 |
| Belgium |
| Thoraxklinik Heidelberg gGmbH | Heidelberg | Baden-Wurttemberg | 69126 | Germany |
| Hospital Universitario Fundación Jiménez Díaz | Madrid | 28040 | Spain |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |