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

NCT07843940 | Not Yet Recruiting Phase 1 FDA Drug

• 3 other identifiers: 1438-0035U1111-1334-71052026-525459-99-00
• Study Type: interventional
• Target: 55
• Locations: 10 countries
• Sites: 27

Brief 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.

Conditions

Advanced Small Cell Lung Cancer; Extensive-stage Small Cell Lung Carcinoma

Outcome Measures

Primary Outcomes (1)

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

  up to 27 months

Secondary Outcomes (8)

• Occurrence of dose-limiting toxicities (DLTs) during the DLT evaluation period

  up to 27 months

• Occurrence of treatment-emergent DLTs

  up to 27 months

• Occurrence of treatment-emergent adverse events of special interest (AESIs)

  up to 27 months

• Occurrence of treatment-emergent adverse events (AEs) Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥3

  up to 27 months

• Objective response (OR)

  up to 44 months

Study Arms (2)

Cohort 1

EXPERIMENTAL

Combination of obrixtamig and pumitamig in patients with extensive stage small cell lung carcinoma (ES-SCLC) who progressed on or after a platinum-containing first line (1L) treatment or on or after one additional line of therapy (second line (2L) or third line (3L) patients).

Drug: Obrixtamig; Drug: Pumitamig

Cohort 2

EXPERIMENTAL

Combination of obrixtamig, pumitamig and chemotherapy (i.e., carboplatin and etoposide) in 1L ES-SCLC patients.

Drug: Obrixtamig; Drug: Pumitamig; Drug: Carboplatin; Drug: Etoposide

Interventions

Obrixtamig DRUG

Obrixtamig

Also known as: BI 764532

Cohort 1; Cohort 2

Pumitamig DRUG

Pumitamig

Also known as: BNT327

Cohort 1; Cohort 2

Carboplatin DRUG

Carboplatin

Cohort 2

Etoposide DRUG

Etoposide

Cohort 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to any trial-specific procedures, sampling, or analyses.
• 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).
• 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.
• Histologically or cytologically confirmed Extensive Stage Small Cell Lung Carcinoma (ES-SCLC) \[using the AJCC (American Joint Committee on Cancer) tumour node metastasis staging system combined with Veterans Administration Lung Study Group (VALG)'s two stage classification scheme\].
• 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.
• 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).
• Availability of an archival tumour sample (except China).

You may not qualify if:

• 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.
• Histologically or cytologically confirmed SCLC with combined histology, diagnosis of Merkel cell carcinoma, medullary thyroid carcinoma or neuroendocrine prostate cancer.
• Presence of leptomeningeal disease and/or carcinomatous meningitis.
• 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.
• 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.
• 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).
• Prior organ or tissue allograft.
• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead
• BioNTech SE: collaborator

Study Sites (27)

University of Miami

Miami, Florida, 33136, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

START New Jersey

East Brunswick, New Jersey, 08816, United States

Location

New York University Langone Medical Center

New York, New York, 10016, United States

Location

SCRI Oncology Partners

Nashville, Tennessee, 37203, United States

Location

Chris Obrien Lifehouse

Camperdown, New South Wales, 2050, Australia

Location

Townsville University Hospital

Douglas, Queensland, 4814, Australia

Location

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Location

Sichuan Cancer Hospital

Chengdu, 610041, China

Location

Harbin Medical University Cancer Hospital

Harbin, 150081, China

Location

Shanghai Chest Hospital

Shanghai, 200030, China

Location

CTR Leon Berard

Lyon, 69008, France

Location

HOP Timone

Marseille, 13005, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

Technische Universität Dresden

Dresden, 01307, Germany

Location

Universitätsklinikum Essen AöR

Essen, 45147, Germany

Location

Universitätsklinikum Tübingen

Tübingen, 72076, Germany

Location

Okayama University Hospital

Okayama, Okayama, 700-8558, Japan

Location

Kansai Medical University Hospital

Osaka, Hirakata, 573-1191, Japan

Location

Shizuoka Cancer Center

Shizuoka, Sunto-gun, 411-8777, Japan

Location

Universitair Medisch Centrum Groningen

Groningen, 9713 GZ, Netherlands

Location

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

Brzozów, 36-200, Poland

Location

Lower Silesian Oncology Centre

Wroclaw, 53439, Poland

Location

Hospital Clínic de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Clinico De Valencia (INCLIVA)

Valencia, 46010, Spain

Location

Related Links

• Related Info

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Carboplatin; Etoposide

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Central Study Contacts

Boehringer Ingelheim

CONTACT

1-800-243-0127; clintriage.rdg@boehringer-ingelheim.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2026
• First Posted: September 28, 2026
• Study Start (Estimated): October 5, 2026
• Primary Completion (Estimated): April 17, 2030
• Study Completion (Estimated): April 21, 2030
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
• Access Criteria: For study documents -upon signing of a 'Document Sharing Agreement'. For study data -1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

Locations

JP (3); NL (1); BE (2); US (5); FR (3); DE (3); AU (2); PL (2); CN (3); ES (3)