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Extensive-stage Small Cell Lung CarcinomaPhase 1/2NCT07843940

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

A Phase 1/2 study testing Obrixtamig, Pumitamig and Carboplatin in people with Extensive-stage Small Cell Lung Carcinoma and Advanced Small Cell Lung Cancer, run by Boehringer Ingelheim at 27 sites in 10 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Obrixtamig, Pumitamig and Carboplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
27 sitesin 10 countries
Study dates
1 Oct 2026to 21 Apr 2030
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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).
  • Adequate organ function. Further inclusion criteria apply.

Who cannot join

  • 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).
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  • 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.
  • Further exclusion criteria apply.

Trial locations and contacts

27 sites in 10 countries. Contact the study team or a site near you to ask about taking part.

Boehringer Ingelheim contact

1-800-243-0127

clintriage.rdg@boehringer-ingelheim.com

27 sites in 10 countries

United States5 sites, 5 recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

    Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com

    Not yet recruiting

  • START New Jersey

    East Brunswick, New Jersey, 08816

    Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com

    Recruiting

  • University of Miami

    Miami, Florida, 33136

    Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com

    Not yet recruiting

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203

    Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com

    Not yet recruiting

  • New York University Langone Medical Center

    New York, New York, 10016

    Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com

    Not yet recruiting

Other trials in United States

China3 sites, 3 recruiting

  • Sichuan Cancer Hospital

    Chengdu, 610041

    Boehringer Ingelheim, 4001200553, china@bitrialsupport.com

    Not yet recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, 150081

    Boehringer Ingelheim, 4001200553, china@bitrialsupport.com

    Not yet recruiting

  • Shanghai Chest Hospital

    Shanghai, 200030

    Boehringer Ingelheim, 4001200553, china@bitrialsupport.com

    Not yet recruiting

Other trials in China

France3 sites, 3 recruiting

  • CTR Leon Berard

    Lyon, 69008

    Boehringer Ingelheim, 0805102354, france@bitrialsupport.com

    Not yet recruiting

  • HOP Timone

    Marseille, 13005

    Boehringer Ingelheim, 0805102354, france@bitrialsupport.com

    Not yet recruiting

  • Institut Gustave Roussy

    Villejuif, 94805

    Boehringer Ingelheim, 0805102354, france@bitrialsupport.com

    Not yet recruiting

Other trials in France

Germany3 sites, 3 recruiting

  • Technische Universität Dresden

    Dresden, 01307

    Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com

    Not yet recruiting

  • Universitätsklinikum Essen AöR

    Essen, 45147

    Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com

    Not yet recruiting

  • Universitätsklinikum Tübingen

    Tübingen, 72076

    Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com

    Not yet recruiting

Other trials in Germany

Japan3 sites, 3 recruiting

  • Okayama University Hospital

    Okayama, Okayama, 700-8558

    Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com

    Not yet recruiting

  • Kansai Medical University Hospital

    Osaka, Hirakata, 573-1191

    Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com

    Not yet recruiting

  • Shizuoka Cancer Center

    Shizuoka, Sunto-gun, 411-8777

    Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com

    Not yet recruiting

Other trials in Japan

Spain3 sites, 3 recruiting

  • Hospital Clínic de Barcelona

    Barcelona, 08036

    Boehringer Ingelheim, 900876092, espana@bitrialsupport.com

    Not yet recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

    Boehringer Ingelheim, 900876092, espana@bitrialsupport.com

    Not yet recruiting

  • Hospital Clinico De Valencia (INCLIVA)

    Valencia, 46010

    Boehringer Ingelheim, 900876092, espana@bitrialsupport.com

    Not yet recruiting

Other trials in Spain

Australia2 sites, 2 recruiting

  • Chris Obrien Lifehouse

    Camperdown, New South Wales, 2050

    Boehringer Ingelheim, 1800271035, australia@bitrialsupport.com

    Not yet recruiting

  • Townsville University Hospital

    Douglas, Queensland, 4814

    Boehringer Ingelheim, 1800271035, australia@bitrialsupport.com

    Not yet recruiting

Other trials in Australia

Belgium2 sites, 2 recruiting

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

    Boehringer Ingelheim, 080049616, belgique@bitrialsupport.com

    Not yet recruiting

  • Universitair Ziekenhuis Gent

    Ghent, 9000

    Boehringer Ingelheim, 080049616, belgique@bitrialsupport.com

    Not yet recruiting

Other trials in Belgium

Poland2 sites, 2 recruiting

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

    Brzozów, 36-200

    Boehringer Ingelheim, 008001218830, polska@bitrialsupport.com

    Not yet recruiting

  • Lower Silesian Oncology Centre

    Wroclaw, 53439

    Boehringer Ingelheim, 008001218830, polska@bitrialsupport.com

    Not yet recruiting

Other trials in Poland

Netherlands1 site, 1 recruiting

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 GZ

    Boehringer Ingelheim, 08000204613, nederland@bitrialsupport.com

    Not yet recruiting

Other trials in Netherlands

About this study

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

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.

Being tested
Obrixtamig, Pumitamig, Carboplatin, Etoposide
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ObrixtamigDrug

    Also called BI 764532

    Obrixtamig

  • PumitamigDrug

    Also called BNT327

    Pumitamig

  • CarboplatinDrug

    Carboplatin

  • EtoposideDrug

    Etoposide

Study groups in NCT07843940
Study groupRoleWhat they receive
Cohort 1ExperimentalCombination 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).
Receives: Drug: Obrixtamig; Drug: Pumitamig
Cohort 2ExperimentalCombination of obrixtamig, pumitamig and chemotherapy (i.e., carboplatin and etoposide) in 1L ES-SCLC patients.
Receives: Drug: Obrixtamig; Drug: Pumitamig; Drug: Carboplatin; Drug: Etoposide

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: up to 27 months

Secondary outcomes (8)

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

    Measured: up to 27 months

  2. Occurrence of treatment-emergent DLTs

    Measured: up to 27 months

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

    Measured: up to 27 months

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

    Measured: up to 27 months

  5. Objective response (OR)

    Defined as a best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to response evaluation criteria in solid tumors (RECIST) version 1.1 (based on investigator assessments), from the first investigational medicinal product (IMP) administration until the earliest date of disease progression, death, last evaluable tumour assessment before the start of the next line of anti-cancer treatment, loss to follow-up, or withdrawal of consent.

    Measured: up to 44 months

  6. Duration of response (DoR)

    Defined as the time from the first documented OR according to RECIST 1.1 until the earliest date of disease progression or death among patients with confirmed objective response based on investigator assessments.

    Measured: up to 44 months

  7. Disease control (DC)

    Defined as best overall response of complete response (CR) or partial response (PR) or stable disease (SD) where best overall response is defined according to RECIST 1.1 based on investigator assessments, from the first IMP administration until the earliest date of disease progression, death or last evaluable tumour assessment before start of the next line of anti-cancer treatment, loss to follow-up or withdrawal of consent.

    Measured: up to 44 months

  8. Progression-free survival (PFS)

    Defined as the time from first IMP administration until the earliest date of disease progression according to RECIST 1.1 based on investigator assessments or death from any cause, whichever occurs first.

    Measured: up to 44 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2026
  2. Study start1 Oct 2026
  3. Primary completion17 Apr 2030 (estimated)
  4. Study completion21 Apr 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
55 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07843940
Sponsor's protocol ID
1438-0035
Other IDs
U1111-1334-7105, 2026-525459-99-00
Status last verified
Oct 2026
First submitted
22 Sep 2026
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Obrixtamig, Pumitamig and Carboplatin in people with Extensive-stage Small Cell Lung Carcinoma and Advanced Small Cell Lung Cancer, run by Boehringer Ingelheim at 27 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United States, China, France, Germany, Japan and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Boehringer Ingelheim (1-800-243-0127, clintriage.rdg@boehringer-ingelheim.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of treatment-emergent adverse events (AEs) leading to trial medication discontinuation or dose modification (time frame: up to 27 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07843940.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.

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