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