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Liposarcoma, DedifferentiatedPhase 2/3NCT05218499

Brightline-1: A Study to Compare Brigimadlin (BI 907828) With Doxorubicin in People With a Type of Cancer Called Dedifferentiated Liposarcoma

A Phase 2/3 study testing Brigimadlin and Doxorubicin in people with Liposarcoma, Dedifferentiated, run by Boehringer Ingelheim at 109 sites in 22 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study is open to people with a type of cancer called dedifferentiated liposarcoma. People with advanced liposarcoma aged 18 or older who are not receiving any other cancer treatment can participate. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Liposarcoma, Dedifferentiated
What is being tested?
Brigimadlin and Doxorubicin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
109 sitesin 22 countries
Study dates
31 Mar 2022to 26 Jan 2026
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Provision of signed and dated, written informed consent form (ICF) in accordance with ICH-GCP and local legislation prior to any trial-specific procedures, sampling, or analyses.
  • Male or female patients ≥18 years old at the time of signature of the informed consent form (ICF). Women of childbearing potential (WOCBP) and men able to father a child must be ready and able to use 2 medically acceptable methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly beginning at screening, during trial participation, and until 6 months and 12 days after last dose for women and 102 days after last dose for men. A list of contraception methods meeting these criteria is provided in the patient information.
  • Histologically proven locally advanced or metastatic, unresectable (surgery morbidity would outweigh potential benefits), progressive or recurrent dedifferentiated liposarcoma (DDLPS). Locally performed histopathological diagnosis will be accepted for entry into this trial but will be confirmed by independent pathological review while the patients receive treatment in this trial.
  • Written pathology report indicating the diagnosis of DDLPS with positive mouse double minute 2 homolog (MDM2) immunohistochemistry or MDM2 amplification as demonstrated by fluorescence in situ hybridization or next generation sequencing (NGS) must be available.
  • Formalin fixed paraffin embedded tumor blocks or slides must be available for retrospective histopathological central review.
  • Presence of at least one measurable target lesion according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. In patients who only have one target lesion, the baseline imaging must be performed at least 2 weeks after any biopsy of the target lesion.
Show all 10Show fewer
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
  • Patient must be willing to donate blood samples for the pharmacokinetics, pharmacodynamics, and tumor mutation analysis.
  • Patient willing to undergo a mandatory tumor biopsy at the time point specified in the flowchart unless exempt.
  • Adequate organ function.

Who cannot join

  • Known mutation in the TP53 gene (screening for TP53 status is not required).
  • Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to randomization or planned within 6 months after screening.
  • Prior systemic therapy for liposarcoma in any setting (including adjuvant, neoadjuvant, maintenance, palliative).
  • Previous or concomitant malignancies other than DDLPS or WDLPS, treated within the previous 5 years, except effectively treated non-melanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ, or other malignancy that is considered cured by local treatment.
  • Previous treatment with anthracyclines in any setting (systemic treatment with other anticancer agents is allowed if completed at least 5 years prior to study entry with the exception of hormone therapy).
  • Patients who must or intend to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial.
Show all 9Show fewer
  • Currently enrolled in another investigational device or drug trial, or less than 30 days since ending another investigational device or drug trial(s) or receiving other investigational treatment(s).
  • Patients not expected to comply with the protocol requirements or not expected to complete the trial as scheduled (e.g. chronic alcohol or drug abuse or any other condition that, in the investigator's opinion, makes the patient an unreliable trial participant).
  • Further exclusion criteria apply

Trial locations and contacts

109 sites in 22 countries.

109 sites in 22 countries

United States20 sites

  • University of Michigan Health System

    Ann Arbor, Michigan, 48109

  • Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Precision NextGen Oncology

    Beverly Hills, California, 90212

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • University Hospitals of Cleveland

    Cleveland, Ohio, 44106

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • City of Hope-Duarte-56419

    Duarte, California, 91010

  • Mayo Clinic Cancer Center

    Jacksonville, Florida, 32224

  • University of Southern California

    Los Angeles, California, 90033

  • Froedtert and The Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Henry-Joyce Cancer Clinic

    Nashville, Tennessee, 37232

  • Nebraska Cancer Specialists-Omaha-69502

    Omaha, Nebraska, 68114

  • Oregon Health and Sciences University

    Portland, Oregon, 97239

  • Mayo Clinic, Rochester

    Rochester, Minnesota, 55905

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • Sarcoma Oncology Center

    Santa Monica, California, 90403

  • Barnes-Jewish Hospital

    St Louis, Missouri, 63110

  • University of Arizona

    Tucson, Arizona, 85719

Other trials in United States

Japan11 sites

  • Aichi Cancer Center Hospital

    Aichi, Nagoya, 464-8681

  • Nagoya University Hospital

    Aichi, Nagoya, 466-8560

  • National Cancer Center Hospital East

    Chiba, Kashiwa, 277-8577

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, Fukuoka, 811-1395

  • Kyushu University Hospital

    Fukuoka, Fukuoka, 812-8582

  • Tohoku University Hospital

    Miyagi, Sendai, 980-8574

  • Okayama University Hospital

    Okayama, Okayama, 700-8558

  • Osaka International Cancer Institute

    Osaka, Osaka, 541-8567

  • Hokkaido Cancer Center

    Sapporo, Hokkaido, 003-0804

  • National Cancer Center Hospital

    Tokyo, Chuo-ku, 104-0045

  • Japanese Foundation for Cancer Research

    Tokyo, Koto-ku, 135-8550

Other trials in Japan

Spain10 sites

  • Hospital Santa Creu i Sant Pau

    Barcelona, 08026

  • Hospital Universitari Vall D Hebron

    Barcelona, 08035

  • Hospital Duran i Reynals

    L'Hospitalet de Llobregat, 08907

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007

  • Fundación Jiménez Díaz

    Madrid, 28040

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Universitario HM Sanchinarro

    Madrid, 28050

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010

  • Hospital Clínico de Santiago

    Santiago de Compostela, 15706

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

China9 sites

  • Cancer Hospital of Chinese Academy of Medical Science

    Beijing, 100021

  • Beijing Cancer Hospital

    Beijing, 100142

  • The First Hospital of Jilin University

    Changchun, 130021

  • West China Hospital, Sichuan University

    Chengdu, 610041

  • Sun Yat-Sen University Cancer Center

    Guangzhou, 510060

  • Zhejiang Cancer Hospital

    Hangzhou, 310022

  • Harbin Medical University Cancer Hospital

    Harbin, 150081

  • Zhongshan Hospital Affiliated to Fudan University

    Shanghai, 200032

  • Wuhan Union Hospital

    Wuhan, 430022

Other trials in China

Germany9 sites

  • Helios Klinikum Bad Saarow

    Bad Saarow, 15526

  • Helios Klinikum Berlin-Buch

    Berlin, 13125

  • Technische Universität Dresden

    Dresden, 01307

  • Universitätsklinikum Essen AöR

    Essen, 45147

  • Asklepios Kliniken GmbH & Co. KGaA

    Hamburg, 22763

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Universitätsklinikum Mannheim GmbH

    Mannheim, 68167

  • Klinikum der Universität München AÖR

    München, 81377

  • Robert Bosch Gesellschaft für medizinische Forschung mbH

    Stuttgart, 70376

Other trials in Germany

France8 sites

  • INS Bergonie

    Bordeaux, 33000

  • CTR Oscar Lambret

    Lille, 59020

  • CTR Leon Berard

    Lyon, 69373

  • HOP Timone

    Marseille, 13385

  • Hôpital Cochin

    Paris, 75014

  • CTR Eugène Marquis

    Rennes, 35042

  • INS Claudius Regaud IUCT-Oncopole

    Toulouse, 31059

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

Italy8 sites

  • Humanitas Gavazzeni

    Bergamo, 24125

  • Istituto Di Candiolo

    Candiolo (TO), 10060

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133

  • Istituto Nazionale IRCCS Tumori Fondazione Pascale

    Naples, 80131

  • AOU San Luigi Gonzaga

    Orbassano (TO), 10043

  • Istituto Oncologico Veneto IRCCS

    Padova, 35128

  • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

    Palermo, 90129

  • Università Campus Bio-Medico - ROMA

    Roma, 00128

Other trials in Italy

United Kingdom5 sites

  • Addenbrooke's Hospital

    Cambridge, CB2 0QQ

  • Velindre Cancer Centre

    Cardiff, CF14 2TL

  • Churchill Hospital

    Headington, OX3 9DS

  • University College Hospital

    London, NW1 2BU

  • The Royal Marsden Hospital, Chelsea

    London, SW3 6JJ

Other trials in United Kingdom

Australia4 sites

  • Ashford Cancer Centre Research

    Kurralta Park, South Australia, 5037

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000

  • Prince of Wales Hospital-Randwick-66496

    Randwick, New South Wales, 2031

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

Canada4 sites

  • Maisonneuve-Rosemont Hospital

    Montreal, Quebec, H1T 2M4

  • The Ottawa Hospital

    Ottawa, Ontario, K1H 8L6

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

  • BC Cancer Agency - Vancouver

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Czechia3 sites

  • Masaryk Memorial Cancer Institute

    Brno, 65653

  • University Hospital Olomouc

    Olomouc, 77900

  • University Hospital Motol

    Prague, 150 06

Other trials in Czechia

Greece3 sites

  • Hippokration General Hospital of Athen

    Athens, 115 27

  • "Attikon" University General Hospital of Attica

    Haidari, 12462

  • Bioclinic Thessaloniki

    Thessaloniki, 54622

Other trials in Greece

Finland2 sites

  • HUCH Comprehensive Cancer Center, building 2

    Helsinki, 00290

  • Tampere University Hospital

    Tampere, 33520

Other trials in Finland

Netherlands2 sites

  • Nederlands Kanker Instituut

    Amsterdam, 1066 CX

  • Leids Universitair Medisch Centrum (LUMC)

    Leiden, 2333 ZA

Other trials in Netherlands

Portugal2 sites

  • IPO Lisboa Francisco Gentil, EPE

    Lisbon, 1099-023

  • ULS de Santa Maria, E.P.E

    Lisbon, 1649-035

Other trials in Portugal

Sweden2 sites

  • Skånes universitetssjukhus

    Lund, 22185

  • Karolinska Universitetssjukhuset Stockholm

    Stockholm, 17177

Other trials in Sweden

Taiwan2 sites

  • National Taiwan University Hospital

    Taipei, 100

  • Taipei Veterans General Hospital

    Taipei, 11217

Other trials in Taiwan

Belgium1 site

  • UZ Leuven

    Leuven, 3000

Other trials in Belgium

Denmark1 site

  • Herlev and Gentofte Hospital

    Herlev, 2730

Other trials in Denmark

Hong Kong1 site

  • Prince of Wales Hospital-Hong Kong-20715

    Hong Kong

Other trials in Hong Kong

Norway1 site

  • Oslo Universitetssykehus HF, Radiumhospitalet

    Oslo, N-0379

Other trials in Norway

Turkey (Türkiye)1 site

  • Abdurrahman Yurtaslan Oncology Training and Research Hospital

    Ankara, 06200

Other trials in Turkey (Türkiye)

About this study

Official title: Brightline-1: A Phase II/III, Randomized, Open-label, Multi-center Study of Brigimadlin (BI 907828) Compared to Doxorubicin as First Line Treatment of Patients With Advanced Dedifferentiated Liposarcoma

This study is open to people with a type of cancer called dedifferentiated liposarcoma. People with advanced liposarcoma aged 18 or older who are not receiving any other cancer treatment can participate.

The purpose of this study is to compare a medicine called brigimadlin (BI 907828) with doxorubicin in people with liposarcoma. Brigimadlin (BI 907828) is a so-called MDM2 inhibitor that is being developed to treat cancer. Doxorubicin is a medicine already used to treat cancer including liposarcoma.

Read more

During the study, participants get either brigimadlin (BI 907828) or doxorubicin. Every 3 weeks, participants take brigimadlin (BI 907828) as tablets or doxorubicin as an infusion into a vein. Participants can switch to brigimadlin (BI 907828) treatment if they did not benefit from doxorubicin treatment.

Participants can continue treatment in the study as long as they benefit from it and can tolerate it.

Doctors regularly check the size of the tumour and check whether it has spread to other parts of the body. The doctors also regularly check participants' health and take note of any unwanted effects.

Being tested
Brigimadlin, Doxorubicin
Medical subject headings
Liposarcoma

What participants receive

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

  • BrigimadlinDrug

    Also called BI 907828

    Brigimadlin taken orally on day 1 of each 21-day cycle (q3w).

  • DoxorubicinDrug

    Intravenous infusion of 75 milligram per square meter (mg/m2) on Day 1 of each 21-day cycle (q3w) until a maximum cumulative dose of 450 mg/m2 (approximately 6 cycles).

Study groups in NCT05218499
Study groupRoleWhat they receive
Brigimadlin 30 mg q3wExperimentalPatients with advanced or metastatic dedifferentiated liposarcoma (DDLPS) received 30 milligram (mg) brigimadlin taken orally on day 1 of each 21-day cycle (q3w).
Receives: Drug: Brigimadlin
Brigimadlin 45 mg q3wExperimentalPatients with advanced or metastatic dedifferentiated liposarcoma (DDLPS) received 45 milligram (mg) brigimadlin taken orally on day 1 of each 21-day cycle (q3w).
Receives: Drug: Brigimadlin
DoxorubicinActive comparatorPatients with advanced or metastatic dedifferentiated liposarcoma (DDLPS) received one intravenous infusion of 75 milligram per square meter (mg/m2) on Day 1 of each 21-day cycle (q3w) until a maximum cumulative dose of 450 mg/m2 (approximately 6 cycles).
Receives: Drug: Doxorubicin

What is being measured

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

  1. Progression-free Survival (PFS)

    Progression-free survival (PFS) based on blinded central independent review. For each patient, PFS was defined as the time interval from randomization until tumor progression according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (solely based on blinded central independent review) or death from any cause, whichever occurs first.

    Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter. (Note: the appearance of one or more new lesions is also considered progression).

    Measured: Up to 20.6 months.

Secondary outcomes (4)

  1. Objective Response (OR)

    Objective response (OR), defined as a best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.1 (based on blinded central independent review) from the date of randomization until disease progression, death, or last evaluable tumor assessment before start of subsequent anti-cancer therapy, loss to follow-up, or withdrawal of consent, whichever occurs first.

    Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.

    Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

    Measured: Up to 20.6 months.

  2. Duration of Objective Response (DOR)

    Duration of objective response (DOR), defined as the time interval from first documented confirmed OR until disease progression or death among patients with confirmed OR (based on blinded central independent review), whichever occurs first.

    Measured: Up to 20.6 months.

  3. Disease Control (DC)

    Disease control (DC), defined as a best overall response of CR, PR, or stable disease (SD) according to RECIST version 1.1 (based on blinded central independent review).

    Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

    Measured: Up to 20.6 months.

  4. Change in Health-Related Quality of Life at Week 6 and 18

    Mean change from baseline to week 6 and 18 in the following European Organization for Research and Treatment on Cancer (EORTC) Quality of Life Core Questionnaire 30 items (QLQ-C30) scores:

    • Physical functioning (higher score is better)
    • Pain (higher score is worse)
    • Fatigue (higher score is worse)
    • Global health status / QoL (higher score is better) and the following scores obtained using items from the EORTC QLQ-C30 and EORTC Item Library (higher score is worse):
    • Fatigue symptoms
    • Fatigability
    • Fatigue impact
    • Pain descriptors
    • Pain impact

    All of the scales and single-item measures range in score from 0 to 100.

    Measured: Baseline (cycle 1 day 1), week 6 and week 18.

Timeline

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

  1. First posted1 Feb 2022
  2. Study start31 Mar 2022
  3. Primary completion16 Apr 2024
  4. Study completion26 Jan 2026

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
400 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05218499
Sponsor's protocol ID
1403-0008
Other IDs
2021-002392-20
Status last verified
Feb 2026
First submitted
18 Jan 2022
Last updated
2 Mar 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Once the time frame criteria given under number 4 are fulfilled, researchers can use the following link https://www.mystudywindow.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.

Publications

  • Schoffski P, Lahmar M, Lucarelli A, Maki RG. Brightline-1: phase II/III trial of the MDM2-p53 antagonist BI 907828 versus doxorubicin in patients with advanced DDLPS. Future Oncol. 2023 Mar;19(9):621-629. doi: 10.2217/fon-2022-1291. Epub 2023 Mar 29.

    PubMed 36987836

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Brigimadlin and Doxorubicin in people with Liposarcoma, Dedifferentiated, run by Boehringer Ingelheim at 109 sites in 22 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: finished, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 109 sites in United States, Japan, Spain, China, Germany and 17 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) (time frame: Up to 20.6 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 NCT05218499, which also lists 1 linked publication.

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 2 Mar 2026.

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