This phase II clinical trial evaluates the efficacy, safety and tolerability of Atezolizumab in addition to standard of care chemotherapy (Platinum/Etoposide) in LCNEC.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
67
Atezolizumab (IMP) will be added to Platinum/Etoposide (Standard-of-Care). Four cycles of combined immunochemotherapy 3qw will be follows by maintenance with atezolizumab monotherapy until progression.
Charité - Universitätsklinikum Berlin Centrum 12, Medizinische Klinik
Berlin, Germany
Evangelische Lungenklinik
Berlin, Germany
Overall survival
To assess the efficacy of Atezolizumab in addition to standard of care chemotherapy (Platinum/Etoposide) in LCNEC as measured by overall survival.
Time frame: appr. 72 months
Objective Response Rate (ORR)
According to RECIST v1.1 as assessed by local investigator.
Time frame: appr. 72 months
Immune Objective Response Rate (iORR)
According to iRECIST as assessed by local investigator.
Time frame: appr. 72 months
Disease Control Rate (DCR)
According to RECIST v1.1 as assessed by local investigator.
Time frame: appr. 72 months
Progression Free Survival (PFS)
Time frame: appr. 72 months
Immune Progression Free Survival (iPFS)
Time frame: appr. 72 months
Duration of Response (DoR)
Time frame: appr. 72 months
Progression Free Survival (PFS) rate at one year
Time frame: 1 year
Immune Progression Free Survival (iPFS) rate at one year
Time frame: 1 year
Overall survival at one year
Time frame: 1 year
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Klinikum der Universität zu Köln, Klinik I für Innere Medizin
Cologne, Germany
Universitätsklinikum Dresden, Medizinische Klinik 1
Dresden, Germany
Klinikum der J.W. Goethe Universität, Medizinische Klinik II
Frankfurt am Main, Germany
Asklepios Fachkliniken München-Gauting
Gauting, Germany
LungenClinic Grosshansdorf GmbH
Großhansdorf, Germany
Krankenhaus St. Elisabeth und St. Barbara Halle (Saale) GmbH
Halle, Germany
Thoraxklinik Heidelberg gGmbH, Universitätsklinikum Heidelberg
Heidelberg, Germany
Lungenklinik Hemer des Deutschen Gemeinschafts-Diakonieverbandes GmbH
Hemer, Germany
...and 5 more locations
Incidence, intensity, seriousness, relationship to Atezolizumab, and outcome of adverse events graded according to NCI CTCAE (v5.0).
Time frame: appr. 72 months