RecruitingPhase I/II🇵🇱 PolandEN originalLung cancerMetastatic / advanced

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

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • •Wiek co najmniej 18 lat
  • •Potwierdzony rozległy drobnokomórkowy rak płuc
  • •Wcześniejsze leczenie systemowe (dla grupy 1: 1-2 poprzednie leczenia; dla grupy 2: brak wcześniejszego leczenia systemowego)
  • •Co najmniej jeden widoczny guz poza mózgiem
  • •Zdolność uczestniczenia w regularnych wizytach i przestrzegania protokołu badania
  • •Podpisana świadoma zgoda na uczestnictwo

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
October 13, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (27)

University of Miami

Miami, United States

Dana-Farber Cancer Institute

Boston, United States

START New Jersey

East Brunswick, United States

New York University Langone Medical Center

New York, United States

SCRI Oncology Partners

Nashville, United States

Chris Obrien Lifehouse

Camperdown, Australia

Townsville University Hospital

Douglas, Australia

Cliniques Universitaires Saint-Luc

Brussels, Belgium

Universitair Ziekenhuis Gent

Ghent, Belgium

Sichuan Cancer Hospital

Chengdu, China

Harbin Medical University Cancer Hospital

Harbin, China

Shanghai Chest Hospital

Shanghai, China

CTR Leon Berard

Lyon, France

HOP Timone

Marseille, France

Institut Gustave Roussy

Villejuif, France

Technische Universität Dresden

Dresden, Germany

Universitätsklinikum Essen AöR

Essen, Germany

Universitätsklinikum Tübingen

Tübingen, Germany

Okayama University Hospital

Okayama, Okayama, Japan

Kansai Medical University Hospital

Osaka, Hirakata, Japan

Shizuoka Cancer Center

Shizuoka, Sunto-gun, Japan

Universitair Medisch Centrum Groningen

Groningen, Netherlands

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

Brzozów, Poland

Lower Silesian Oncology Centre

Wroclaw, Poland

Hospital Clínic de Barcelona

Barcelona, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Clinico De Valencia (INCLIVA)

Valencia, Spain

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 10/14/2026.

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