NCT07561645

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for phase_2

Timeline
70mo left

Started Jul 2026

Longer than P75 for phase_2

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 1, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2032

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2032

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

5.8 years

First QC Date

April 15, 2026

Last Update Submit

April 27, 2026

Conditions

Large Cell Neuroendocrine Carcinoma of the Lung

Keywords

lung cancerLCNEClung carcinomaneuroendocrine carcinoma

Outcome Measures

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.

    app. 69 months

Secondary Outcomes (6)

  • Objective Response Rate (ORR)

    app. 69 months

  • Progression-Free Survival (PFS)

    app. 69 months

  • Duration Of Response (DOR)

    app. 69 months

  • Disease Control Rate (DCR)

    app. 69 months

  • immune Objective Response Rate (iORR)

    app. 69 months

  • +1 more secondary outcomes

Other Outcomes (4)

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

    app. 69 months

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

    appr. 69 months

  • Quality of Life assessment

    appr. 69 months

  • +1 more other outcomes

Study Arms (1)

Obrixtamig/Platinum/Etoposide

EXPERIMENTAL

Obrixtamig/Platinum/Etoposide. Platinum will be carboplatin.

Drug: Obrixtamig

Interventions

ObrixtamigDRUG

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.

Obrixtamig/Platinum/Etoposide

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Measurable disease according to RECIST v1.11

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Neuroendocrine

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Martin Wermke, Prof. Dr. med.

    Technische Universität Dresden, Medizinische Fakultät

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Wermke, Prof. Dr. med.

CONTACT

+49 351 7566martin.wermke@ukdd.de

Felix Carl Saalfeld, Dr. med.

CONTACT

felix.saalfeld@ukdd.de

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2026

First Posted

May 1, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

April 1, 2032

Study Completion (Estimated)

April 1, 2032

Last Updated

May 1, 2026

Record last verified: 2026-04