18 and older, any sex, with Liposarcoma, Dedifferentiated. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Progression-free Survival (PFS)Primary· Up to 20.6 months.
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 l
Group
Value
95% CI
Brigimadlin 30 mg q3w
8.18
2.96 – 16.66
Brigimadlin 45 mg q3w
8.38
3.94 – NA
Doxorubicin
7.16
2.63 – 11.33
Objective Response (OR)Secondary· Up to 20.6 months.
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.
Parti
Group
Value
95% CI
Brigimadlin 30 mg q3w
13
Brigimadlin 45 mg q3w
33
Doxorubicin
14
Duration of Objective Response (DOR)Secondary· Up to 20.6 months.
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.
Group
Value
95% CI
Brigimadlin 30 mg q3w
NA
8.51 – NA
Brigimadlin 45 mg q3w
9.92
9.72 – NA
Doxorubicin
9.99
9.89 – 15.41
Disease Control (DC)Secondary· Up to 20.6 months.
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.
Group
Value
95% CI
Brigimadlin 30 mg q3w
71
Brigimadlin 45 mg q3w
128
Doxorubicin
117
Change in Health-Related Quality of Life at Week 6 and 18Secondary· Baseline (cycle 1 day 1), week 6 and week 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 measu
Physical functioning - Change from baseline at Week 6
Group
Value
95% CI
Brigimadlin 45 mg q3w
-2.1
± 17.4
Doxorubicin
-5.5
± 17.9
Physical functioning - Change from baseline at Week 18
Group
Value
95% CI
Brigimadlin 45 mg q3w
-5.9
± 20.8
Doxorubicin
-7.5
± 16.3
Pain - Change from baseline at Week 6
Group
Value
95% CI
Brigimadlin 45 mg q3w
-3.7
± 20.2
Doxorubicin
0.8
± 25.2
Pain - Change from baseline at Week 18
Group
Value
95% CI
Brigimadlin 45 mg q3w
1.4
± 26.0
Doxorubicin
-1.0
± 26.7
Fatigue - Change from baseline at Week 6
Group
Value
95% CI
Brigimadlin 45 mg q3w
3.4
± 21.2
Doxorubicin
10.5
± 23.5
Fatigue - Change from baseline at Week 18
Group
Value
95% CI
Brigimadlin 45 mg q3w
8.1
± 27.5
Doxorubicin
14.1
± 27.5
Global health status / quality of life - Change from baseline at Week 6
Group
Value
95% CI
Brigimadlin 45 mg q3w
-0.6
± 18.6
Doxorubicin
-8.9
± 22.4
Global health status / quality of life - Change from baseline at Week 18
Group
Value
95% CI
Brigimadlin 45 mg q3w
-5.8
± 24.5
Doxorubicin
-8.0
± 20.8
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to approximately 20.8 months..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06619509 — A Study to Test Long-term Treatment With Brigimadlin in People With Solid Tumours Who Took Part in a Previous Study With
· Phase 2
· active not recruiting
NCT06370871 — Brightline-3: A Study to Find Out Whether Brigimadlin in Combination With Ezabenlimab Helps People With Advanced Soft Ti
· Phase 3
· withdrawn
NCT06058793 — Brightline-4: A Study to Test How Well Brigimadlin is Tolerated by People With a Type of Cancer Called Dedifferentiated
· Phase 3
· completed
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· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 2 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05218499.