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A Trial for the Treatment of Advanced Large-Cell Neuroendocrine Cancer of the Lung

ConditionLarge Cell Neuroendocrine Carcinoma of the Lung
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTechnische Universität Dresden

About this trial

This phase II clinical trial evaluates the efficacy, safety and tolerability of Obrixtamig in addition to standard of care chemotherapy (Platinum/Etoposide) in LCNEC.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient has provided written informed consent and is able to consent

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%

Patients with locally advanced or metastatic disease without curative treatment options

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.

Disqualifiers

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.)

Known leptomeningeal disease

Any prior systemic treatment for metastatic disease, except for one cycle of SoC as described under inclusion criteria

Previous treatment with obrixtamig or any anti-DLL3 compound including T-cell engagers and antibody-drug conjugates

Trial design

Design model

Single group

Treatments tested in this trial

  • Obrixtamig

    Drug

    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.

Treatment groups

75 Participants
are divided into 1 treatment group
Group A: Obrixtamig/Platinum/EtoposideExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

Objective Response Rate (ORR)

defined as PR or CR according to RECIST v1.1 as assessed by local investigator

Time frame
app. 69 months
2

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
3

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
4

Disease Control Rate (DCR)

defined as combination of CR, PR and SD according to RECIST v1.1

Time frame
app. 69 months

Other outcomes

1

PFS, OS, DOR and ORR in central pathology confirmed cases of LCNEC

Time frame
app. 69 months
2

PFS, OS, DOR and ORR in defined LCNEC molecular subtypes

(type I, type II - NSCLC and SCLC like) and depending on DLL3 expression to identify potential correlation between responses in molecular subtypes and DLL3 expression levels (high vs. low)

Time frame
appr. 69 months
3

Quality of Life assessment

Changes from baseline in EORTC-QLQ-C30 as well as QLQ-LC13 global and LC specific health/QoL score.

Time frame
appr. 69 months
4

further exploratory end points

For other exploratory end points respective biomaterials will be banked within the trial but analyses will be contingent on specimen availability. These analyses will include but are not limited to: * Changes in cellular and humoral immune effectors in peripheral blood and their correlation with response * Mutational landscape of LCNEC in comparison to SCLC as well as squamous and adenocarcinoma of the lung * Dynamics of circulating tumor DNA levels (changes from baseline) * Mechanisms of therapy resistance (changes of immune invasion and mutational landscape in tumor re-biopsy upon progression) * Expression of DLL3 in pre- and post-treatment samples including analyses in BI-designated central lab * Composition of the tumor microenvironment using multiplex immunofluorescence

Time frame
appr. 69 months

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Technische Universität Dresden

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: