Large Cell Neuroendocrine Carcinoma of the LungPhase 2ALPINE 2NCT07561645
A Trial for the Treatment of Advanced Large-Cell Neuroendocrine Cancer of the Lung
A Phase 2 study testing Obrixtamig in people with Large Cell Neuroendocrine Carcinoma of the Lung, run by Technische Universität Dresden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Large Cell Neuroendocrine Carcinoma of the Lung
- What is being tested?
- Obrixtamig
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Apr 2032
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Felix Carl Saalfeld, Dr. med. contact
About this study
Official 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
This phase II clinical trial evaluates the efficacy, safety and tolerability of Obrixtamig in addition to standard of care chemotherapy (Platinum/Etoposide) in LCNEC.
- Being tested
- Obrixtamig
- Keywords
- lung cancer, LCNEC, lung carcinoma, neuroendocrine carcinoma
- Medical subject headings
- Lung Neoplasms, Carcinoma, Neuroendocrine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Obrixtamig/Platinum/Etoposide | Experimental | Obrixtamig/Platinum/Etoposide. Platinum will be carboplatin. Receives: Drug: Obrixtamig |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: app. 69 months
Secondary outcomes (6)
Objective Response Rate (ORR)
defined as PR or CR according to RECIST v1.1 as assessed by local investigator
Measured: 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
Measured: 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
Measured: app. 69 months
Disease Control Rate (DCR)
defined as combination of CR, PR and SD according to RECIST v1.1
Measured: app. 69 months
immune Objective Response Rate (iORR)
immune ORR (iORR) defined as iPR or iCR according to iRECIST
Measured: 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
Measured: appr. 69 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study startSep 2026 (estimated)
- Primary completionApr 2032 (estimated)
- Study completionApr 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Large Cell Neuroendocrine Carcinoma of the LungStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Wermke, Prof. Dr. med., Principal investigator, Technische Universität Dresden, Medizinische Fakultät
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07561645
- Sponsor's protocol ID
- TUD-ALPIN2-089
- Other IDs
- 2025-524345-28-00, 2025
- Acronym
- ALPINE 2
- Status last verified
- Aug 2026
- First submitted
- 15 Apr 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07561645
- Acronym / sponsor ID
- ALPINE 2 / TUD-ALPIN2-089
- Keywords
- lung cancer, LCNEC, lung carcinoma, neuroendocrine carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Apr 2032 (estimated)
- Study completion
- Apr 2032 (estimated)
- First posted
- 1 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obrixtamig/Platinum/Etoposide | Experimental | Drug: ObrixtamigObrixtamig/Platinum/Etoposide. Platinum will be carboplatin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObrixtamigObrixtamig (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. | Drug | Obrixtamig/Platinum/Etoposide |
Primary outcome
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.
6 secondary outcomes
Objective Response Rate (ORR)
Time frame: app. 69 months
Progression-Free Survival (PFS)
Time frame: app. 69 months
Duration Of Response (DOR)
Time frame: app. 69 months
Disease Control Rate (DCR)
Time frame: app. 69 months
immune Objective Response Rate (iORR)
Time frame: app. 69 months
immune Progression Free Survival (iPFS)
Time frame: appr. 69 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Felix Carl Saalfeld, Dr. med. contact
Martin Wermke, Prof. Dr. med. principal investigator
Technische Universität Dresden, Medizinische Fakultät
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Obrixtamig in people with Large Cell Neuroendocrine Carcinoma of the Lung, run by Technische Universität Dresden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martin Wermke, Prof. Dr. med. (+49 351 7566, martin.wermke@ukdd.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: app. 69 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.