Ireland
--:--IST
Recruiting Phase 1/2

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

NCT07843940 · tracked via the Priya Life Science Germany tracker
Phase
Phase 1/2
Started
2026-10-01
Last updated
2026-10-13

Condition(s) studied

Extensive-stage Small Cell Lung CarcinomaAdvanced Small Cell Lung Cancer

Investigational drug(s) / intervention(s)

Obrixtamig →Pumitamig →Carboplatin →Etoposide →

Obrixtamig: Obrixtamig

Pumitamig: Pumitamig

Carboplatin: Carboplatin

Etoposide: Etoposide

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Occurrence of treatment-emergent adverse events (AEs) leading to trial medication discontinuation or dose modification — up to 27 months

Trial sites (27)

FacilityCityRegionStatus
University of Miami Miami Florida Not Yet Recruiting
Dana-Farber Cancer Institute Boston Massachusetts Not Yet Recruiting
START New Jersey East Brunswick New Jersey Recruiting
New York University Langone Medical Center New York New York Not Yet Recruiting
SCRI Oncology Partners Nashville Tennessee Not Yet Recruiting
Chris Obrien Lifehouse Camperdown New South Wales Not Yet Recruiting
Townsville University Hospital Douglas Queensland 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
Hospital Clinico De Valencia (INCLIVA) Valencia Spain Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07843940 on ClinicalTrials.gov ↗ ← All trials in Germany