Large Cell Neuroendocrine Carcinoma of the Lung
Conditions
Keywords
lung cancer, LCNEC, lung carcinoma, neuroendocrine carcinoma
Brief summary
This phase II clinical trial evaluates the efficacy, safety and tolerability of Obrixtamig in addition to standard of care chemotherapy (Platinum/Etoposide) in LCNEC.
Interventions
DRUGObrixtamig
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.
Sponsors
Technische Universität Dresden
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
(main criteria) 1. Patient has provided written informed consent and is able to consent 2. Patients with pulmonary large-cell neuroendocrine carcinoma (LCNEC) defined by local histology and immunohistochemistry; patients with mixed histology are eligible if LCNEC is the predominant histology, i.e. ≥50% 3. Patients with locally advanced or metastatic disease without curative treatment options 4. All patients must have received one, but not more than one, cycle of platinum/etoposide chemotherapy with or without immune checkpoint inhibitor (standard-of-care; SoC). Other than that, patients must be previously untreated with systemic therapy. 5. Measurable disease according to RECIST v1.11
Exclusion criteria
(main criteria) 1. Symptomatic brain metastases (Patients with asymptomatic brain metastases are allowed provided they are clinically stable, receiving no or a stable dose of anticonvulsants without steroid treatment for at least 3 weeks.) 2. Known leptomeningeal disease 3. Any prior systemic treatment for metastatic disease, except for one cycle of SoC as described under inclusion criteria 4. Previous treatment with obrixtamig or any anti-DLL3 compound including T-cell engagers and antibody-drug conjugates
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | app. 69 months | To assess the efficacy of Obrixtamig in addition to standard of care chemotherapy (Platinum/Etoposide) in LCNEC as measured by overall survival. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | app. 69 months | defined as PR or CR according to RECIST v1.1 as assessed by local investigator |
| Progression-Free Survival (PFS) | app. 69 months | 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 |
| Duration Of Response (DOR) | app. 69 months | 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 |
| Disease Control Rate (DCR) | app. 69 months | defined as combination of CR, PR and SD according to RECIST v1.1 |
| immune Objective Response Rate (iORR) | app. 69 months | immune ORR (iORR) defined as iPR or iCR according to iRECIST |
| immune Progression Free Survival (iPFS) | appr. 69 months | 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 |
Contacts
CONTACTMartin Wermke, Prof. Dr. med.
CONTACTFelix Carl Saalfeld, Dr. med.
PRINCIPAL_INVESTIGATORMartin Wermke, Prof. Dr. med.
Technische Universität Dresden, Medizinische Fakultät
Outcome results
None listed