Recruiting
Phase 3

Obrixtamig & Standard Treatment

Sponsor:

Boehringer Ingelheim

Code:

NCT07472517

Conditions

Small Cell Lung Cancer (SCLC)

Extensive-stage Small Cell Lung Cancer (ES-SCLC)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

obrixtamig

atezolizumab

carboplatin

etoposide

Study Details

Brief summary:

This study is open to adults with advanced small cell lung cancer (SCLC). The purpose of this study is to find out if a study medicine called obrixtamig plus standard treatment (atezolizumab, carboplatin, and etoposide) improves survival when compared to standard treatment alone. Obrixtamig is an antibody-like molecule that may help the immune system fight cancer. Another purpose of the study is to test a medical device being developed to measure levels of the tumour marker DLL3.

Participants are put into 2 groups randomly, which means by chance. One group receives obrixtamig and standard treatment. The other group receives standard treatment without obrixtamig. All treatments are given as infusions into a vein.

Participants are in the study for up to 3 years. During this time, they visit the study site regularly. Participants in the group receiving obrixtamig stay overnight at the study site following the first 2 obrixtamig treatments. At the visits, doctors check the size of the tumour(s). The results are compared between the 2 groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.

Conditions

Small Cell Lung Cancer (SCLC)

Extensive-stage Small Cell Lung Cancer (ES-SCLC)

Study ID

NCT07472517

Start date

Apr 13, 2026

Status verified date

Aug, 2026

Completion date

Jul 30, 2029

Anticipated

Primary completion date

Sep 9, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria :

1. Patients with histologically confirmed Extensive-stage Small Cell Lung Cancer (ES-SCLC)
2. Patients without any previous systemic anti-cancer treatment for ES-SCLC. Patients who received previous systemic anti-cancer treatment during limited stage are eligible if the treatment has been completed more than 6 months before the diagnosis of ES-SCLC.
3. Adequate archival formalin-fixed paraffin-embedded (FFPE) tumour tissue, as specified in the Laboratory Manual, must be available for central laboratory analysis of Delta-like ligand 3 (DLL3) expression status and other biomarkers. The central laboratory investigational VENTANA DLL3 (SP347) RxDx test result must be available prior to randomisation.
4. Patients with asymptomatic brain metastasis are eligible if they meet one of the following criteria:

  • Treatment for brain metastases (e.g. whole brain radiation therapy, stereotactic radiotherapy, or radiosurgery) completed at least 7 days prior to randomisation and the patient is neurologically stable without the use of glucocorticoids or therapeutic anti-convulsant for at least 7 days prior to randomisation
  • Untreated brain metastases that do not require treatment and the patient is neurologically stable without the use of glucocorticoids or therapeutic anti-convulsant for at least 28 days prior to randomisation
5. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
6. Eligible for continuing carboplatin + etoposide + atezolizumab regimen as first-line Standard of care (SoC) treatment within 28 days after the start of the initial cycle of standard therapy
7. Eligible to receive treatment with full dose of atezolizumab, carboplatin, and etoposide as first-line SoC treatment, in accordance with the approved Summary of Product Characteristics if provided centrally or approved local product label if provided by the trial site Further inclusion criteria apply.

Exclusion Criteria :

1. Presence of leptomeningeal disease and/or carcinomatous meningitis
2. Previous treatment targeting DLL3 (e.g. T cell engagers (TcEs), cell therapies, antibody-drug conjugates, or radiopharmaceuticals)
3. Radiotherapy of any anatomical site within 7 days prior to randomisation
4. Toxicity from previous treatments that has not resolved to ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or baseline. Patients with alopecia, any grade, CTCAE ≤Grade 2, asthenia/fatigue, amenorrhea/menstrual disorders any grade, CTCAE Grade ≤2 peripheral neuropathy, and/or CTCAE Grade 2 endocrinopathies controlled by replacement therapy, and toxicities, which are considered irreversible but stable for at least 4 weeks prior to randomisation, per investigator judgment may be eligible. Note: Patients who developed toxicity from the cycle of standard therapy received prior to randomisation are eligible if adequate organ function is ensured as described
5. Patient with active autoimmune disease or a documented history of autoimmune disease that requires systemic treatment (e.g. glucocorticoids or immunosuppressive drugs). Patients with vitiligo, resolved childhood asthma/atopy, alopecia, or any chronic skin condition that does not require systemic therapy, patients with autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone and/or controlled Type 1 diabetes mellitus on a stable insulin regimen may be included if in the opinion of the investigator it is appropriate and safe to do so.

Further exclusion criteria apply.

Study Design

Enrollment

670 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: obrixtamig + atezolizumab, carboplatin, and etoposide treatment arm

experimental: atezolizumab, carboplatin, and etoposide control arm

Interventions

obrixtamig

obrixtamig

atezolizumab

atezolizumab

carboplatin

carboplatin

etoposide

etoposide

Primary outcome measure

  • Overall survival (OS) [ Time Frame: Up to 36 months ]

Central Contacts and Locations

Central contacts

Locations

Bioresearch Partner - Hialeah Hospital

Recruiting

Hialeah, Florida, United States, 33013

Contacts

Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

University of Maryland School of Medicine

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

HCA MidAmerica Division, Inc.

Recruiting

Kansas City, Missouri, United States, 64132

Contacts

AHN Cancer Institute - Allegheny General

Recruiting

Pittsburgh, Pennsylvania, United States, 15212

Contacts

Baptist Cancer Center - Memphis

Recruiting

Memphis, Tennessee, United States, 38120

Contacts

More Information

Sponsor

Boehringer Ingelheim

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Boehringer Ingelheim on 2026-08-19.