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NCT Number: NCT07561645

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

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

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Key information

Conditions

Large Cell Neuroendocrine Carcinoma of the Lung Adenocarcinoma Carcinoma Carcinoma, Neuroendocrine Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(main criteria)

  • 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

Exclusion criteria

(main criteria)

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Overall Survival (OS)

    Time frame: 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 outcomes

  1. Objective Response Rate (ORR)

    Time frame: app. 69 months

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

  2. Progression-Free Survival (PFS)

    Time frame: 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

  3. Duration Of Response (DOR)

    Time frame: 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

  4. Disease Control Rate (DCR)

    Time frame: app. 69 months

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

  5. immune Objective Response Rate (iORR)

    Time frame: app. 69 months

    immune ORR (iORR) defined as iPR or iCR according to iRECIST

  6. immune Progression Free Survival (iPFS)

    Time frame: 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

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

    Time frame: appr. 69 months

    (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)

  3. Quality of Life assessment

    Time frame: appr. 69 months

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

  4. further exploratory end points

    Time frame: appr. 69 months

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Felix Carl Saalfeld, Dr. med.

CONTACT

[email protected]

Martin Wermke, Prof. Dr. med.

CONTACT

[email protected]

+49 351 7566

Sponsors and collaborators

Lead sponsor

Technische Universität Dresden

Other

Registry information

Official study title

A Phase II, Single-arm Trial on the Addition of the DLL3xCD3 Bispecific T-cell Engager Obrixtamig (BI 764532) to Standard-of-care Platinum-based First-line Treatment of Advanced Large-cell Neuroendocrine Carcinoma of the Lung

Acronym: ALPINE 2

Important dates

Study start
2026
Primary completion
2032
Study completion
2032
First posted
May 1, 2026
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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