Randomized Study of Maintenance Therapy With MGN1703 in Patients With SCLC

Small Cell Lung Cancer Clinical Trial

— IMPULSE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02200081
• Other study ID #: MGN1703-C03
• Status: Completed
• Phase: Phase 2
• Start date: March 2014
• Est. completion date: October 5, 2017

Study information

• Verified date: November 2018
• Source: Mologen AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: October 5, 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

Drug:
• MGN1703

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

Locations

Country	Name	City	State
Austria	Medizinische Universitaet Innsbruck	Innsbruck
Belgium	Universitair Ziekenhuis Gent	Gent
Germany	Thoraxklinik Heidelberg gGmbH	Heidelberg	Baden Württemberg
Spain	Hospital Universitario Fundación Jiménez Díaz	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Mologen AG

Countries where clinical trial is conducted

Austria,  Belgium,  Germany,  Spain, 

References & Publications (1)

Thomas M, Ponce-Aix S, Navarro A, Riera-Knorrenschild J, Schmidt M, Wiegert E, Kapp K, Wittig B, Mauri C, Dómine Gómez M, Kollmeier J, Sadjadian P, Fröhling KP, Huber RM, Wolf M; IMPULSE study team . Immunotherapeutic maintenance treatment with toll-like — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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 a = 2.5% for the 1-sided test. The OS1 will be presented as Kaplan-Meier figures also.	24 months