Obrixtamig and Pumitamig in Advanced Small Cell Lung Cancer (Dareon-Rosetta35)
Official title: A Phase Ib/II, Open-label, Safety and Tolerability Trial of Intravenous Obrixtamig in Combination With Pumitamig and Standard of Care (Carboplatin, Etoposide) in Patients With Extensive-stage Small Cell Lung Carcinoma
Run by Boehringer Ingelheim · NCT07843940 · Data updated 2026-11-12
This trial tests whether obrixtamig with pumitamig, alone or with standard chemotherapy, can help people with extensive-stage small cell lung cancer tolerate treatment and shrink tumors.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 55 (estimated) |
| Sponsor | Boehringer Ingelheim Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 27 sites (Miami, Florida and 26 other locations) |
| Status | Recruiting |
| Started | October 1, 2026 |
| Main results expected | April 17, 2030 |
| Study ends | April 21, 2030 |
| Registry record updated | November 10, 2026 |
| Trial ID | NCT07843940 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 years or older with histologically or cytologically confirmed extensive-stage small cell lung cancer who meet all inclusion criteria and can comply with study procedures.
✕Probably not a fit
Patients whose disease does not respond to the combination or who experience intolerable toxicity may not benefit and could discontinue treatment.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study involves adults with extensive-stage small cell lung cancer. It compares two treatment arms: obrixtamig with pumitamig alone, and obrixtamig with pumitamig plus standard chemotherapy (carboplatin and etoposide). Treatments are given by intravenous infusion and participants may receive the regimen for up to two years if beneficial and tolerable. Regular site visits monitor safety and tumor response, and the trial includes multiple clinical sites in the United States. The study aims to assess safety, tolerability, and signs of tumor response in this patient population.
Why it matters
Potential benefit: If successful, participants could experience tumor shrinkage and longer periods of disease control with a treatment regimen tailored to their cancer.
How similar studies have gone: Prior studies in similar immunotherapy combinations have shown mixed but encouraging signals for tumor control in SCLC, making this investigation exploratory and potentially practice-changing.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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START New Jersey
East Brunswick, New Jersey, United States Recruiting -
Hospital Clinico De Valencia (INCLIVA)
Valencia, Spain Recruiting -
University of Miami
Miami, Florida, United States Not yet recruiting -
Dana-Farber Cancer Institute
Boston, Massachusetts, United States Not yet recruiting -
New York University Langone Medical Center
New York, New York, United States Not yet recruiting -
SCRI Oncology Partners
Nashville, Tennessee, United States Not yet recruiting
Show 21 more locations
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Chris Obrien Lifehouse
Camperdown, New South Wales, Australia Not yet recruiting -
Townsville University Hospital
Douglas, Queensland, Australia Not yet recruiting -
Cliniques Universitaires Saint-Luc
Brussels, Belgium Not yet recruiting -
Universitair Ziekenhuis Gent
Ghent, Belgium Not yet recruiting -
Sichuan Cancer Hospital
Chengdu, China Not yet recruiting -
Harbin Medical University Cancer Hospital
Harbin, China Not yet recruiting -
Shanghai Chest Hospital
Shanghai, China Not yet recruiting -
CTR Leon Berard
Lyon, France Not yet recruiting -
HOP Timone
Marseille, France Not yet recruiting -
Institut Gustave Roussy
Villejuif, France Not yet recruiting -
Technische Universität Dresden
Dresden, Germany Not yet recruiting -
Universitätsklinikum Essen AöR
Essen, Germany Not yet recruiting -
Universitätsklinikum Tübingen
Tübingen, Germany Not yet recruiting -
Okayama University Hospital
Okayama, Okayama, Japan Not yet recruiting -
Kansai Medical University Hospital
Osaka, Hirakata, Japan Not yet recruiting -
Shizuoka Cancer Center
Shizuoka, Sunto-gun, Japan Not yet recruiting -
Universitair Medisch Centrum Groningen
Groningen, Netherlands Not yet recruiting -
Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
Brzozów, Poland Not yet recruiting -
Lower Silesian Oncology Centre
Wroclaw, Poland Not yet recruiting -
Hospital Clínic de Barcelona
Barcelona, Spain Not yet recruiting -
Hospital Universitario 12 de Octubre
Madrid, Spain Not yet recruiting
Study contacts
- Study coordinator: Boehringer Ingelheim
- Email: clintriage.rdg@boehringer-ingelheim.com
- Phone: 1-800-243-0127
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.