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NCT07843940PHASE1, PHASE2Recruiting

A Study to Test Obrixtamig in Combination With Pumitamig in People With Advanced Small Cell Lung Cancer (Dareon®-Rosetta35)

Boehringer Ingelheim

Start Date

10/1/2026

Completion Date

4/21/2030

Summary

This study is open to adults with extensive-stage small cell lung cancer. The purpose of this study is to find out how well people with this type of cancer tolerate taking study medicines called obrixtamig and pumitamig. Another purpose is to check whether the combination study treatment can make tumours shrink. Obrixtamig and pumitamig are being developed to help the immune system fight cancer. Participants are put into 2 groups. One group gets obrixtamig and pumitamig. The other group gets obrixtamig and pumitamig with standard chemotherapy (carboplatin and etoposide). All study treatments are given as infusions into a vein. This study does not have a fixed duration. Participants can receive obrixtamig and pumitamig for up to 2 years if they benefit from treatment and can tolerate it. Participants visit the study site regularly, with some overnight stays required. During this time, doctors regularly check for health problems that could be caused by the study treatment. They also monitor the size of the tumour(s) and take laboratory tests.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion criteria: 1. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to any trial-specific procedures, sampling, or analyses. 2. Male or female participants ≥18 years old and at least at the legal age of consent in countries where it is greater than 18 years at the time of signature of the Informed Consent Form (ICF). 3. Willing and able to comply with scheduled visits, treatment schedule, the planned trial assessments, laboratory tests, restrictions regarding prohibited medications, lifestyle restrictions, and other requirements related to the trial. This includes that they are able to understand and follow trial-related instructions. 4. Histologically or cytologically confirmed Extensive Stage Small Cell Lung Carcinoma (ES-SCLC) \[using the AJCC (American Joint Committee on Cancer) tumour node metastasis staging system combined with Veterans Administration Lung Study Group (VALG)'s two stage classification scheme\]. 5. Prior systemic anti-cancer treatment for ES-SCLC: * For Cohort 1 - must have received at least one line of platinum-containing treatment but no more than 2 lines of treatment per local standard of care for the treatment of ES-SCLC. * For Cohort 2 - must have received no prior systemic therapy for ES-SCLC. Participants with prior chemoradiotherapy for limited stage (LS)-SCLC must have been treated with curative intent and had a treatment-free interval of at least 6 months after the last chemotherapy, radiotherapy, or chemoradiotherapy before diagnosis of ES-SCLC to be eligible. 6. At least one measurable lesion outside of the Central Nervous System (CNS) as defined per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. Previously treated lesions after local therapy (radiotherapy, ablation, interventional procedures, etc.) are generally not considered target lesions. If the lesion with prior local treatment is the only measurable lesion, radiologic evidence must be provided to demonstrate disease progression for selection as target lesion (an isolated blastic bone metastasis or a singular central nervous system metastasis should not be considered as a measurable lesion). 7. Availability of an archival tumour sample (except China). 8. Adequate organ function. Further inclusion criteria apply. Exclusion criteria: 1. Serious concomitant disease or medical condition such as neurologic, psychiatric (including substance use disorder), active ulcers (gastrointestinal tract or skin) or laboratory abnormalities that may negatively impact patient safety during trial participation, affect compliance with trial requirements or invalidate assessments relevant for the investigation of the safety and preliminary efficacy of the investigational drugs. 2. Histologically or cytologically confirmed SCLC with combined histology, diagnosis of Merkel cell carcinoma, medullary thyroid carcinoma or neuroendocrine prostate cancer. 3. Presence of leptomeningeal disease and/or carcinomatous meningitis. 4. Known hypersensitivity to the trial drugs or their excipients, prior severe, life-threatening hypersensitivity reaction(s) to monoclonal antibodies, or significant risk of allergic or anaphylactic reaction(s) to any of the investigated drug products according to the investigator's judgement. 5. Participants who experienced severe, life-threatening immune-mediated adverse events, e.g. serious Grade 3 or higher immune-mediated adverse event (imAE) or infusion-related reactions, that led to permanent discontinuation while on treatment with immuno-oncology agents. 6. Persistent toxicity from previous treatments that has not resolved to ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 (except for alopecia, asthenia/fatigue, amenorrhea/menstrual disorders, CTCAE Grade 2 peripheral neuropathy, and CTCAE Grade 2 endocrinopathies controlled by replacement therapy, and toxicities, which are considered irreversible but stable for at least 4 weeks, per investigator judgment). 7. Prior organ or tissue allograft. 8. History of or active interstitial lung disease, pulmonary fibrosis, organizing pneumonia or non-infectious pneumonitis (any grade) or any other condition resulting in significant impairment in lung function. Further exclusion criteria apply.

Interventions

DRUG

Obrixtamig

DRUG

Pumitamig

DRUG

Carboplatin

DRUG

Etoposide

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Conditions

Extensive-stage Small Cell Lung CarcinomaAdvanced Small Cell Lung Cancer

Locations

University of Miami

Miami, Florida 33136

United States

Dana-Farber Cancer Institute

Boston, Massachusetts 02215

United States

START New Jersey

East Brunswick, New Jersey 08816

United States

New York University Langone Medical Center

New York, New York 10016

United States

SCRI Oncology Partners

Nashville, Tennessee 37203

United States

Chris Obrien Lifehouse

Camperdown, New South Wales 2050

Australia

Townsville University Hospital

Douglas, Queensland 4814

Australia

Cliniques Universitaires Saint-Luc

Brussels, 1200

Belgium

Universitair Ziekenhuis Gent

Ghent, 9000

Belgium

Sichuan Cancer Hospital

Chengdu, 610041

China

Harbin Medical University Cancer Hospital

Harbin, 150081

China

Shanghai Chest Hospital

Shanghai, 200030

China

CTR Leon Berard

Lyon, 69008

France

HOP Timone

Marseille, 13005

France

Institut Gustave Roussy

Villejuif, 94805

France

Technische Universität Dresden

Dresden, 01307

Germany

Universitätsklinikum Essen AöR

Essen, 45147

Germany

Universitätsklinikum Tübingen

Tübingen, 72076

Germany

Okayama University Hospital

Okayama, Okayama, 700-8558

Japan

Kansai Medical University Hospital

Osaka, Hirakata, 573-1191

Japan

Shizuoka Cancer Center

Shizuoka, Sunto-gun, 411-8777

Japan

Universitair Medisch Centrum Groningen

Groningen, 9713 GZ

Netherlands

Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza

Brzozów, 36-200

Poland

Lower Silesian Oncology Centre

Wroclaw, 53439

Poland

Hospital Clínic de Barcelona

Barcelona, 08036

Spain

Hospital Universitario 12 de Octubre

Madrid, 28041

Spain

Hospital Clinico De Valencia (INCLIVA)

Valencia, 46010

Spain