This phase II clinical trial evaluates the efficacy, safety and tolerability of Obrixtamig in addition to standard of care chemotherapy (Platinum/Etoposide) in LCNEC.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
75
Obrixtamig (IMP) will be added to Platinum/Etoposide (Standard-of-Care). Three cycles of combined immunochemotherapy 3qw will be followed by maintenance with obrixtamig monotherapy until progression.
Overall Survival (OS)
To assess the efficacy of Obrixtamig in addition to standard of care chemotherapy (Platinum/Etoposide) in LCNEC as measured by overall survival.
Time frame: app. 69 months
Objective Response Rate (ORR)
defined as PR or CR according to RECIST v1.1 as assessed by local investigator
Time frame: app. 69 months
Progression-Free Survival (PFS)
defined as time from first application of obrixtamig to progression according to RECIST v1.1, or to start of any other anticancer treatment, or death from any cause whichever occurs first
Time frame: app. 69 months
Duration Of Response (DOR)
defined as time from first documented PR or CR according to RECIST v1.1 to time of disease progression according to RECIST v1.1 or death from any cause, whichever occurs first
Time frame: app. 69 months
Disease Control Rate (DCR)
defined as combination of CR, PR and SD according to RECIST v1.1
Time frame: app. 69 months
immune Objective Response Rate (iORR)
immune ORR (iORR) defined as iPR or iCR according to iRECIST
Time frame: app. 69 months
immune Progression Free Survival (iPFS)
defined as time from first application of obrixtamig to progression according to iRECIST, clinical progression with change of treatment or death from any cause, whichever occurs first
Time frame: appr. 69 months
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