DAREON®-NEC-1: A Study in People With Advanced Extrapulmonary Neuroendocrine Cancer (epNEC) to Compare Obrixtamig Plus Carboplatin and Etoposide Treatment With Standard Chemotherapy

July 21, 2026 updated by: Boehringer Ingelheim

A Phase III, Multi-center, Open-label, Randomised, Controlled Trial of Intravenous Obrixtamig in Combination With Carboplatin and Etoposide vs. Carboplatin and Etoposide as First-line Therapy in DLL3-positive Patients With Unresectable Locally Advanced or Metastatic Extrapulmonary Neuroendocrine Carcinomas

This study is open to adults with advanced extrapulmonary neuroendocrine cancer. The purpose of this study is to find out if a study medicine called obrixtamig plus standard chemotherapy (carboplatin and etoposide) improves survival when compared to standard chemotherapy (carboplatin and etoposide) alone. Obrixtamig is an antibody-like molecule that may help the immune system fight cancer. Another purpose of the study is to test a medical device being developed to measure levels of the tumour marker delta-like ligand 3 (DLL3).

Participants are put into 2 groups randomly, which means by chance. One group (treatment arm) receives obrixtamig and standard chemotherapy followed by obrixtamig alone for up to 3 years. The other group (control arm) receives standard chemotherapy without obrixtamig for about 4 months. All treatments are given as infusions into a vein.

During the study, participants in both groups visit the study site regularly. Participants in the treatment arm stay overnight at the study site following the first 2 obrixtamig treatments. The doctors regularly check participants' health and take note of any unwanted effects. At some of the visits, doctors check the size of the tumour(s). The results are compared between the 2 groups to see whether the treatment works.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

390

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • CABA, Argentina, 1280AEB
        • Not yet recruiting
        • Hospital Britanico de Buenos Aires
        • Contact:
      • CABA, Argentina, 1015
      • Munro, Argentina, B1605
        • Not yet recruiting
        • Clinica Privada Independencia
        • Contact:
      • Rosario, Argentina, S2000DSV
  • Australia
    • New South Wales
      • St Leonards, New South Wales, Australia, 2065
    • South Australia
      • Bedford Park, South Australia, Australia, 5042
    • Victoria
      • Melbourne, Victoria, Australia, 3000
        • Not yet recruiting
        • Peter MacCallum Cancer Centre
        • Contact:
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
  • Austria
      • Graz, Austria, 8036
      • Vienna, Austria, 1090
  • Belgium
      • Brussels, Belgium, 1200
        • Not yet recruiting
        • Cliniques Universitaires Saint-Luc
        • Contact:
      • Edegem, Belgium, 2650
        • Recruiting
        • Universitair Ziekenhuis Antwerpen
        • Contact:
      • Leuven, Belgium, 3000
      • Liège, Belgium, 4000
        • Not yet recruiting
        • Centre Hospitalier Universitaire de Liège
        • Contact:
  • Brazil
      • Barretos, Brazil, 14784-400
        • Not yet recruiting
        • Hospital de Amor
        • Contact:
      • Recife, Brazil, 50070-480
        • Not yet recruiting
        • Instituto D'Or de Pesquisa E Ensino - Pe
        • Contact:
      • São José do Rio Preto, Brazil, 15090-000
        • Not yet recruiting
        • Fundação Faculdade Regional de Medicina de São José do Rio Preto
        • Contact:
      • São Paulo, Brazil, 01246-000
        • Not yet recruiting
        • ICESP - Instituto do Cancer do Estado de Sao Paulo
        • Contact:
      • São Paulo, Brazil, 01509-010
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Not yet recruiting
        • Sunnybrook Health Sciences Centre
        • Contact:
  • Chile
      • Providencia, Chile
        • Not yet recruiting
        • Instituto Oncológico FALP
        • Contact:
      • Recoleta, Chile, 8420383
        • Not yet recruiting
        • Bradford Hill- Centro de Investigación Clínica
        • Contact:
      • Santiago, Chile, 7650568
        • Not yet recruiting
        • Clínica Alemana de Santiago S.A.
        • Contact:
  • China
      • Beijing, China, 100142
        • Recruiting
        • Beijing Cancer Hospital
        • Contact:
      • Beijing, China, 102200
        • Not yet recruiting
        • Beijing Gobroad Hospital
        • Contact:
      • Changchun, China, 130021
        • Not yet recruiting
        • The First Hospital of Jilin University
        • Contact:
      • Changsha, China, 410008
        • Not yet recruiting
        • Xiangya Hospital, Central South University
        • Contact:
      • Changsha, China, 410013
        • Not yet recruiting
        • Hunan Province Tumor Hospital
        • Contact:
      • Chengdu, China, 610041
        • Recruiting
        • West China Hospital, Sichuan University
        • Contact:
      • Chengdu, China, 610041
        • Not yet recruiting
        • Sichuan Cancer Hospital
        • Contact:
      • Chongqing, China, 400000
        • Not yet recruiting
        • Chongqing University Affiliated Cancer Hospital
        • Contact:
      • Fuzhou, China, 350014
        • Not yet recruiting
        • Fujian Cancer Hospital
        • Contact:
      • Guangzhou, China, 510080
        • Not yet recruiting
        • The First Affiliated Hospital,Sun Yat-sen University
        • Contact:
      • Hangzhou, China, 310016
        • Not yet recruiting
        • Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
        • Contact:
      • Harbin, China, 150081
        • Not yet recruiting
        • Harbin Medical University Cancer Hospital
        • Contact:
      • Jinan, China, 250117
        • Not yet recruiting
        • Shandong Cancer Hospital
        • Contact:
      • Jinan, China, 250012
        • Recruiting
        • Qilu Hospital, Shangdong University
        • Contact:
      • Linyi, China, 276034
        • Recruiting
        • Linyi Cancer Hospital
        • Contact:
      • Luoyang, China, 471003
        • Not yet recruiting
        • The First Affiliated Hospital of Henan University of Science And Technology
        • Contact:
      • Nanning, China, 530021
        • Not yet recruiting
        • The Affiliated Cancer Hospital, Guangxi Medical University
        • Contact:
      • Shanghai, China, 200080
        • Recruiting
        • Shanghai General Hospital
        • Contact:
      • Wuhan, China, 430000
        • Not yet recruiting
        • Hubei Cancer Hospital
        • Contact:
      • Xi'an, China, 710061
        • Not yet recruiting
        • First Affiliated Hospital of Xi'an JiaoTong University
        • Contact:
      • Xiamen, China, 361003
        • Not yet recruiting
        • First Affiliated Hospital of Xiamen University
        • Contact:
      • Zhengzhou, China, 450052
        • Not yet recruiting
        • The First Affiliated Hospital of Zhengzhou University
        • Contact:
      • Zhengzhou, China, 450003
        • Not yet recruiting
        • Henan Cancer Hospital
        • Contact:
  • Czechia
      • Brno, Czechia, 65653
        • Not yet recruiting
        • Masaryk Memorial Cancer Institute
        • Contact:
      • Hradec Králové, Czechia, 50005
        • Not yet recruiting
        • University Hospital Hradec Kralove (FNHK)
        • Contact:
  • Denmark
      • Aarhus N, Denmark, 8200
        • Not yet recruiting
        • Aarhus University Hospital
        • Contact:
      • Copenhagen, Denmark, 2100
      • Odense C, Denmark, 5000
        • Not yet recruiting
        • Odense University Hospital
        • Contact:
  • Finland
      • Helsinki, Finland, 00290
        • Not yet recruiting
        • Helsinki University Hospital
        • Contact:
      • Kuopio, Finland, 70029
        • Not yet recruiting
        • KYS Sädesairaala
        • Contact:
      • Tampere, Finland, 33520
        • Not yet recruiting
        • Tampere University Hospital
        • Contact:
      • Turku, Finland, 20520
        • Not yet recruiting
        • Turku University Hospital / TYKS
        • Contact:
  • France
      • Clichy, France, 92110
      • Dijon, France, 21000
        • Not yet recruiting
        • HOP François Mitterrand
        • Contact:
      • Lyon, France, 69437
        • Not yet recruiting
        • Hopital Edouard Herriot
        • Contact:
      • Marseille, France, 13009
        • Not yet recruiting
        • INS Paoli-Calmettes
        • Contact:
      • Pessac, France, 33604
        • Not yet recruiting
        • HOP Haut-Lévêque
        • Contact:
      • Rennes, France, 35042
        • Not yet recruiting
        • CTR Eugène Marquis
        • Contact:
      • Toulouse, France, 31059
        • Not yet recruiting
        • Hôpital Rangueil - CHU de Toulouse
        • Contact:
      • Villejuif, France, 94800
  • Germany
      • Berlin, Germany, 12559
      • Bonn, Germany, 53127
      • Cologne, Germany, 50937
      • Dresden, Germany, 01307
      • Düsseldorf, Germany, 40225
      • Erlangen, Germany, 91054
      • Freiburg im Breisgau, Germany, 79106
      • Hamburg, Germany, 20099
      • Heidelberg, Germany, 69120
      • Mainz, Germany, 55131
        • Not yet recruiting
        • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
        • Contact:
      • Münster, Germany, 48149
        • Not yet recruiting
        • Westfälische Wilhelms-Universität Münster
        • Contact:
      • Tübingen, Germany, 72076
      • Würzburg, Germany, 97078
        • Not yet recruiting
        • Universitätsklinikum Würzburg AÖR
        • Contact:
  • Hong Kong
      • Hong Kong, Hong Kong, 999077
      • Hong Kong, Hong Kong, 999077
        • Not yet recruiting
        • Prince of Wales Hospital-Hong Kong-20715
        • Contact:
  • Israel
      • Beersheba, Israel, 84101
        • Not yet recruiting
        • Soroka Univ. Medical Center
        • Contact:
      • Haifa, Israel, 3109601
        • Not yet recruiting
        • Rambam Health Care Campus
        • Contact:
      • Jerusalem, Israel, 9112001
        • Not yet recruiting
        • Hadassah Medical Center, Ein-Karem
        • Contact:
      • Tel Aviv, Israel, 6093246
        • Not yet recruiting
        • Sourasky Medical Center
        • Contact:
  • Italy
      • Bari, Italy, 70124
        • Not yet recruiting
        • Azienda Universitaria Ospedaliera Consorziale Policlinico Bari
        • Contact:
      • Florence, Italy, 50134
        • Not yet recruiting
        • A. O. Universitaria Careggi
        • Contact:
      • Milan, Italy, 20133
        • Not yet recruiting
        • Fondazione IRCCS Istituto Nazionale dei Tumori
        • Contact:
      • Milan, Italy, 20141
        • Not yet recruiting
        • Istituto Europeo Di Oncologia
        • Contact:
      • Naples, Italy, 80131
        • Not yet recruiting
        • Istituto Nazionale IRCCS Tumori Fondazione Pascale
        • Contact:
      • Palermo, Italy, 90129
        • Not yet recruiting
        • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
        • Contact:
      • Roma, Italy, 00128
        • Not yet recruiting
        • Fondazione Policlinico Universitario Campus Bio-Medico
        • Contact:
      • Verona, Italy, 37134
        • Not yet recruiting
        • Centro Ricerche Cliniche di Verona s.r.l.
        • Contact:
  • Japan
      • Aichi, Nagoya, Japan, 464-8681
        • Not yet recruiting
        • Aichi Cancer Center Hospital
        • Contact:
      • Chiba, Kashiwa, Japan, 277-8577
        • Not yet recruiting
        • National Cancer Center Hospital East
        • Contact:
      • Ehime, Matsuyama, Japan, 791-0280
        • Not yet recruiting
        • Shikoku Cancer Center
        • Contact:
      • Fukuoka, Fukuoka, Japan, 812-8582
        • Recruiting
        • Kyushu University Hospital
        • Contact:
      • Hokkaido, Sapporo, Japan, 060-8648
        • Recruiting
        • Hokkaido University Hospital
        • Contact:
      • Ishikawa, Kanazawa, Japan, 920-8641
        • Not yet recruiting
        • Kanazawa University Hospital
        • Contact:
      • Kanagawa, Yokohama, Japan, 241-8515
        • Not yet recruiting
        • Kanagawa Cancer Center
        • Contact:
      • Kyoto, Kyoto, Japan, 606-8507
        • Not yet recruiting
        • Kyoto University Hospital
        • Contact:
      • Miyagi, Sendai, Japan, 980-8574
        • Not yet recruiting
        • Tohoku University Hospital
        • Contact:
      • Okayama, Okayama, Japan, 700-8558
        • Not yet recruiting
        • Okayama University Hospital
        • Contact:
      • Osaka, Osaka, Japan, 541-8567
        • Not yet recruiting
        • Osaka International Cancer Institute
        • Contact:
      • Shizuoka, Sunto-gun, Japan, 411-8777
        • Not yet recruiting
        • Shizuoka Cancer Center
        • Contact:
      • Tokyo, Chuo-ku, Japan, 104-0045
        • Not yet recruiting
        • National Cancer Center Hospital
        • Contact:
  • Mexico
      • Mexico City, Mexico, 03100
        • Not yet recruiting
        • Health Pharma Professional Research S.A. de C.V.
        • Contact:
  • Netherlands
      • Amsterdam, Netherlands, 1066CX
        • Not yet recruiting
        • Nederlands Kanker Instituut - Antoni van Leeuwenhoek Amsterdam (METC AVL)
        • Contact:
      • Groningen, Netherlands, 9713 GZ
        • Not yet recruiting
        • Universitair Medisch Centrum Groningen
        • Contact:
      • Maastricht, Netherlands, 6229 HX
        • Not yet recruiting
        • Maastricht University Medisch Centrum
        • Contact:
      • Rotterdam, Netherlands, 3015 GD
  • New Zealand
      • Grafton / Auckland, New Zealand, 1023
  • Norway
      • Bergen, Norway, 5021
        • Not yet recruiting
        • Haukeland Universitetssykehus
        • Contact:
      • Oslo, Norway, N-0379
        • Not yet recruiting
        • Oslo Universitetssykehus HF, Radiumhospitalet
        • Contact:
      • Stavanger, Norway, 4011
        • Not yet recruiting
        • Helse Stavanger, Stavanger Universitetssykehus
        • Contact:
      • Trondheim, Norway, 7030
        • Not yet recruiting
        • St. Olavs Hospital, Universitetssykehuset i Trondheim
        • Contact:
  • Poland
      • Gdansk, Poland, 80-214
        • Not yet recruiting
        • Medical University Gdansk
        • Contact:
      • Katowice, Poland, 40514
        • Not yet recruiting
        • Silesian Medical University in Katowice
        • Contact:
  • Portugal
      • Lisbon, Portugal, 1500-458
      • Lisbon, Portugal, 1099-023
        • Not yet recruiting
        • IPO Lisboa Francisco Gentil, EPE
        • Contact:
      • Lisbon, Portugal, 1699-035
        • Not yet recruiting
        • Unidade Local de Saúde Santa Maria
        • Contact:
      • Porto, Portugal, 4100-180
      • Porto, Portugal, 4200-072
        • Not yet recruiting
        • IPO Porto Francisco Gentil, EPE
        • Contact:
  • South Korea
      • Seoul, South Korea, 05505
      • Seoul, South Korea, 03080
        • Recruiting
        • Seoul National University Hospital
        • Contact:
      • Seoul, South Korea, 06351
      • Seoul, South Korea, 03722
  • Spain
      • Badalona, Spain, 8916
        • Not yet recruiting
        • Institut Català d'Oncologia de Badalona
        • Contact:
      • Barcelona, Spain, 08035
        • Not yet recruiting
        • Hospital Universitari Vall d'Hebron
        • Contact:
      • Madrid, Spain, 28034
        • Not yet recruiting
        • Hospital Universitario Ramon y Cajal
        • Contact:
      • Madrid, Spain, 28040
        • Not yet recruiting
        • Hospital Universitario Fundación Jimenez Díaz
        • Contact:
      • Madrid, Spain, 28041
        • Not yet recruiting
        • Hospital Universitario 12 de Octubre
        • Contact:
      • Málaga, Spain, 29010
        • Not yet recruiting
        • Hospital Regional Universitario de Malaga
        • Contact:
      • Pamplona, Spain, 31008
        • Not yet recruiting
        • Complejo Hospitalario de Navarra
        • Contact:
      • Santander, Spain, 39008
        • Not yet recruiting
        • Hospital Universitario Marqués de Valdecilla
        • Contact:
      • Seville, Spain, 41013
        • Not yet recruiting
        • Hospital Virgen del Rocío
        • Contact:
      • Valencia, Spain, 46010
        • Not yet recruiting
        • Hospital Clinico De Valencia (INCLIVA)
        • Contact:
  • Sweden
      • Gothenburg, Sweden, 41345
        • Not yet recruiting
        • Sahlgrenska Universitetsjukhuset
        • Contact:
      • Lund, Sweden, 22185
        • Not yet recruiting
        • Skanes universitetssjukhus
        • Contact:
      • Uppsala, Sweden, 751 85
        • Not yet recruiting
        • Uppsala University Hospital
        • Contact:
  • Taiwan
      • Tainan, Taiwan, 70403
        • Recruiting
        • National Cheng Kung University Hospital
        • Contact:
      • Taipei, Taiwan, 112201
        • Not yet recruiting
        • Taipei Veterans General Hospital
        • Contact:
      • Taoyuan City, Taiwan, 333
        • Not yet recruiting
        • Chang Gung Memorial Hospital, Linkou
        • Contact:
  • United Kingdom
      • Cambridge, United Kingdom, CB2 0QQ
      • Edinburgh, United Kingdom, EH4 2XU
      • London, United Kingdom, SE1 9RT
      • Manchester, United Kingdom, M20 4BX
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
    • California
      • Duarte, California, United States, 91010
      • Palo Alto, California, United States, 94304
      • San Francisco, California, United States, 94158
        • Not yet recruiting
        • University of California San Francisco
        • Contact:
      • Santa Monica, California, United States, 90404
    • Florida
      • Jacksonville, Florida, United States, 32224
    • Georgia
      • Atlanta, Georgia, United States, 30322
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Not yet recruiting
        • The Skip Viragh Outpatient Cancer Research Building
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
    • Minnesota
      • Rochester, Minnesota, United States, 55905
    • Missouri
      • St Louis, Missouri, United States, 63108
        • Not yet recruiting
        • Washington University School of Medicine
        • Contact:
    • New York
      • New York, New York, United States, 10029
        • Not yet recruiting
        • Icahn School of Medicine at Mount Sinai
        • Contact:
      • New York, New York, United States, 10022
        • Not yet recruiting
        • Memorial Sloan-Kettering Cancer Center
        • Contact:
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • Not yet recruiting
        • University of Pittsburgh Medical Center
        • Contact:
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
      • Nashville, Tennessee, United States, 37232
      • Nashville, Tennessee, United States, 37203
    • Texas
      • Dallas, Texas, United States, 75246
      • Houston, Texas, United States, 77030
        • Not yet recruiting
        • The University of Texas MD Anderson Cancer Center
        • Contact:
    • Utah
      • Salt Lake City, Utah, United States, 84112
    • Washington
      • Seattle, Washington, United States, 98109
        • Not yet recruiting
        • Fred Hutchinson Cancer Research Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients with poorly differentiated unresectable locally advanced or metastatic extrapulmonary neuroendocrine carcinoma (epNEC) with Ki-67 >20% or mitotic rate mitotic rate with number of mitoses >20 per 2 mm2, regardless of primary site (including site of unknown origin)
  2. Patients with tumours with mixed histologies are eligible only if neuroendocrine carcinoma component is predominant and represents more than 70% of the overall tumour tissue
  3. No prior systemic treatment for unresectable locally advanced or metastatic epNEC (except for the completed one cycle of standard platinum + etoposide). Prior peri-operative chemotherapy or -radiation for curative intention is allowed if at least 6 months have elapsed between completion of this therapy and diagnosis of unresectable locally advanced or metastatic disease
  4. Patients who have finished one cycle of standard platinum + etoposide regimen as first-line treatment (Cycle 0: etoposide with carboplatin or cisplatin, administered at a minimum dose of cisplatin 75 mg/m2 or carboplatin area under the curve (AUC) 5 and etoposide 80 mg/m2) prior to randomisation
  5. Patients must comply with criteria for receiving further chemotherapy treatment as first-line standard of care (SoC) treatment within 28 days after the start of the initial chemotherapy (Cycle 0)
  6. Adequate archival Formalin-Fixed Paraffin-Embedded (FFPE) tumour tissue, as specified in the Laboratory Manual, must be available for central laboratory analysis of Delta-like ligand 3 (DLL3) expression status. Tumours must be positive (as defined in the diagnostic study protocol) for DLL3 expression status assessed by investigational VENTANA DLL3 (SP347) RxDx Assay
  7. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
  8. 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) Further inclusion criteria apply.

Exclusion Criteria:

  1. Presence of leptomeningeal disease and/or carcinomatous meningitis
  2. Patients with diagnosis of Merkel cell carcinoma or medullary thyroid carcinoma
  3. Patients with neuroendocrine prostate cancer
  4. Patients with well-differentiated neuroendocrine tumours of any grade according to the world health organization (WHO) classification, 5th edition
  5. Patients with a history of well differentiated Neuroendocrine tumour (NET) tumour that transformed into poorly differentiated Neuroendocrine carcinoma (NEC)
  6. Previous treatment with obrixtamig or other DLL3-targeting therapies (e.g. T-cell engager (TcEs), cell therapies, antibody-drug conjugates, or radiopharmaceuticals)
  7. Previous treatment with anti-PD-1 or programmed death ligand 1 (PD-L1) therapies during the one cycle of standard platinum + etoposide first-line chemotherapy (Cycle 0)
  8. Toxicity from previous treatments that has not resolved to ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or grade prior to Cycle 0. Participants with alopecia any grade, CTCAE ≤Grade 2 asthenia/fatigue, amenorrhea/menstrual disorders any grade, CTCAE ≤Grade 2 peripheral neuropathy, and/or CTCAE ≤Grade 2 endocrinopathies controlled by replacement therapy, and toxicities, which are considered irreversible but stable for at least 4 weeks, per Investigator judgement may be eligible Further exclusion criteria apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Obrixtamig + carboplatin + etoposide
Treatment arm
Drug: Etoposide
Etoposide
Drug: Carboplatin
Carboplatin
Drug: Obrixtamig
Obrixtamig
Device: Ventana DLL3 RxDx assay
Ventana DLL3 RxDx assay
Active Comparator: Carboplatin + etoposide
Control arm
Drug: Etoposide
Etoposide
Drug: Carboplatin
Carboplatin
Device: Ventana DLL3 RxDx assay
Ventana DLL3 RxDx assay

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: Up to 38 months
defined as the time from randomisation until death from any cause
Up to 38 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS)
Time Frame: Up to 38 months
defined as the time from randomisation until the earliest date of disease progression according to RECIST 1.1 based on investigator assessments or death from any cause, whichever occurs first
Up to 38 months
Objective response (OR)
Time Frame: Up to 38 months
defined as a best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1 (based on investigator assessments) from randomisation until the earliest date of disease progression, death, last evaluable tumour assessment before the start of next line of anti-cancer treatment, loss to follow-up, or withdrawal of consent
Up to 38 months
Duration of response (DoR)
Time Frame: Up to 38 months
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 objective response based on investigator assessments
Up to 38 months
Disease control (DC)
Time Frame: Up to 38 months
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 randomisation until the earliest of disease progression, death or last evaluable tumour assessment before start of next line of anti-cancer treatment, loss to follow-up or withdrawal of consent
Up to 38 months
Occurrence of treatment-emergent Grade 3 or greater Cytokine release syndrome (CRS)
Time Frame: Up to 38 months
Up to 38 months
Occurrence of treatment-emergent Grade 3 or greater Immune cell associated neurotoxicity syndrome (ICANS)
Time Frame: Up to 38 months
Up to 38 months
Occurrence of treatment-emergent adverse events (AEs) leading to permanent discontinuation of trial medication during the on-treatment period
Time Frame: Up to 38 months
Up to 38 months
Occurrence of treatment-emergent AEs leading to dose modification of trial medication (i.e. dose interruption, dose delay, dose reduction)
Time Frame: Up to 38 months
Up to 38 months
Change from baseline to Week 19 in the physical functioning domain of the EORTC QLQ-C30
Time Frame: At baseline, up to week 19

European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) includes 1 global health status/QoL scale, 5 functional scales, 3 symptoms scales and 6 single items to assess dyspnea, insomnia, appetite loss, constipation, diarrhoea and financial difficulties.

Each score 0-100. Global health status higher = better, functional scale higher = better, symptom scale higher = worse
At baseline, up to week 19

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 10, 2026

Primary Completion (Estimated)

December 13, 2029

Study Completion (Estimated)

March 11, 2031

Study Registration Dates

First Submitted

April 16, 2026

First Submitted That Met QC Criteria

April 16, 2026

First Posted (Actual)

April 22, 2026

Study Record Updates

Last Update Posted (Actual)

July 22, 2026

Last Update Submitted That Met QC Criteria

July 21, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1438-0011
  • 2025-523869-22 (Registry Identifier: CTIS)
  • U1111-1328-6623 (Registry Identifier: WHO International Clinical Trials Registry Platform (ICTRP))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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