Clinical trial Recruiting at 2 sites Phase1; Phase2 Interventional Ages 18 and up

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.

More NSCLC (Advanced Non-small Cell Lung Cancer) trials

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment55 (estimated)
SponsorBoehringer Ingelheim
Industry-sponsored
Drugs / interventionschemotherapy
Locations27 sites (Miami, Florida and 26 other locations)
StatusRecruiting
StartedOctober 1, 2026
Main results expectedApril 17, 2030
Study endsApril 21, 2030
Registry record updatedNovember 10, 2026
Trial IDNCT07843940 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

  • 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
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.