Trial · NCT05218499
Brightline-1: A Study to Compare Brigimadlin (BI 907828) With Doxorubicin in People With a Type of Cancer Called Dedifferentiated Liposarcoma
NCT05218499, Phase 2, Phase 3, Completed, Boehringer Ingelheim; results first posted 2025-07-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Brightline-1: A Study to Compare Brigimadlin (BI 907828) With Doxorubicin in People With a Type of Cancer Called Dedifferentiated Liposarcoma. Trials, record NCT05218499. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05218499
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Brightline-1: A Study to Compare Brigimadlin (BI 907828) With Doxorubicin in People With a Type of Cancer Called Dedifferentiated Liposarcoma
- NCT number
- NCT05218499
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 400 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Liposarcoma, Dedifferentiated
- Interventions
- Brigimadlin, Doxorubicin
- First posted
- 2022-02-01
- Last updated
- 2026-03-02
- Other registries' IDs
- eudract:2021-002392-20
- Results first posted
- 2025-07-04
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) | 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 least 5 millimeter. (Note: the appearance of one or more new lesions is also considered progression). |
| Secondary | Objective Response (OR) | 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. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| Secondary | Duration of Objective Response (DOR) | 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. |
| Secondary | Disease Control (DC) | 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. |
| Secondary | Change in Health-Related Quality of Life at Week 6 and 18 | 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 measures range in score from 0 to 100. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival (PFS) | Up to 20.6 months. | Randomised Set (RS): All patients randomized, regardless of whether they have received any trial medication or not. | Months | MEDIAN |
| SECONDARY | Objective Response (OR) | Up to 20.6 months. | Randomised Set (RS): All patients randomized, regardless of whether they have received any trial medication or not. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Objective Response (DOR) | Up to 20.6 months. | All patients randomized who had an objective response. | Months | MEDIAN |
| SECONDARY | Disease Control (DC) | Up to 20.6 months. | Randomised Set (RS): All patients randomized, regardless of whether they have received any trial medication or not. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in Health-Related Quality of Life at Week 6 and 18 | Baseline (cycle 1 day 1), week 6 and week 18. | Randomised Set (RS). As per protocol, the endpoint was performed as part of the Phase III of the trial, which only includes the selected investigational arm (brigimadlin 45 mg q3w) and the doxorubicin control arm. | Score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group48
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival (PFS) | Brigimadlin 30 mg q3w | 8.18 | Inter-Quartile Range 2.96 to 16.66 | Months | |
| Progression-free Survival (PFS) | Brigimadlin 45 mg q3w | 8.38 | Inter-Quartile Range 3.94 to NA | Months | |
| Progression-free Survival (PFS) | Doxorubicin | 7.16 | Inter-Quartile Range 2.63 to 11.33 | Months | |
| Objective Response (OR) | Brigimadlin 30 mg q3w | 13 | Participants | ||
| Objective Response (OR) | Brigimadlin 45 mg q3w | 33 | Participants | ||
| Objective Response (OR) | Doxorubicin | 14 | Participants | ||
| Duration of Objective Response (DOR) | Brigimadlin 30 mg q3w | NA | 95% Confidence Interval 8.51 to NA | Months | |
| Duration of Objective Response (DOR) | Brigimadlin 45 mg q3w | 9.92 | 95% Confidence Interval 9.72 to NA | Months | |
| Duration of Objective Response (DOR) | Doxorubicin | 9.99 | 95% Confidence Interval 9.89 to 15.41 | Months | |
| Disease Control (DC) | Brigimadlin 30 mg q3w | 71 | Participants |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Brigimadlin 30 mg q3w | 90 | |
| Overall Study | STARTED | Brigimadlin 45 mg q3w | 148 | |
| Overall Study | STARTED | Doxorubicin | 162 | |
| Overall Study | Doxorubicin Patients Who Crossed Over to Brigimadlin 30 mg q3w | Brigimadlin 30 mg q3w | 0 | |
| Overall Study | Doxorubicin Patients Who Crossed Over to Brigimadlin 30 mg q3w | Brigimadlin 45 mg q3w | 0 | |
| Overall Study | Doxorubicin Patients Who Crossed Over to Brigimadlin 30 mg q3w | Doxorubicin | 7 | |
| Overall Study | Doxorubicin Patients Who Crossed Over to Brigimadlin 45 mg q3w | Brigimadlin 30 mg q3w | 0 | |
| Overall Study | Doxorubicin Patients Who Crossed Over to Brigimadlin 45 mg q3w | Brigimadlin 45 mg q3w | 0 | |
| Overall Study | Doxorubicin Patients Who Crossed Over to Brigimadlin 45 mg q3w | Doxorubicin | 70 | |
| Overall Study | COMPLETED | Brigimadlin 30 mg q3w | 0 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events955
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Brigimadlin 30 mg q3w | 22 | 89 | |
| other | Anaemia | Blood and lymphatic system disorders | Brigimadlin 45 mg q3w | 52 | 147 | |
| other | Anaemia | Blood and lymphatic system disorders | Doxorubicin | 63 | 154 | |
| other | Anaemia | Blood and lymphatic system disorders | Doxorubicin - Brigimadlin 30 mg q3w | 1 | 7 | |
| other | Anaemia | Blood and lymphatic system disorders | Doxorubicin - Brigimadlin 45 mg q3w | 22 | 70 | |
| other | Leukopenia | Blood and lymphatic system disorders | Brigimadlin 30 mg q3w | 2 | 89 | |
| other | Leukopenia | Blood and lymphatic system disorders | Brigimadlin 45 mg q3w | 15 | 147 | |
| other | Leukopenia | Blood and lymphatic system disorders | Doxorubicin | 21 | 154 | |
| other | Leukopenia | Blood and lymphatic system disorders | Doxorubicin - Brigimadlin 30 mg q3w | 0 | 7 | |
| other | Leukopenia | Blood and lymphatic system disorders | Doxorubicin - Brigimadlin 45 mg q3w | 3 | 70 |
1 to 10 of 955Source ClinicalTrials.gov
See all 955 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Brigimadlin 30 mg q3w | 31 | 89 |
| Total, all-cause mortality | Brigimadlin 45 mg q3w | 40 | 147 |
| Total, all-cause mortality | Doxorubicin | 15 | 154 |
| Total, all-cause mortality | Doxorubicin - Brigimadlin 30 mg q3w | 5 | 7 |
| Total, all-cause mortality | Doxorubicin - Brigimadlin 45 mg q3w | 22 | 70 |
| Total, other adverse events | Brigimadlin 30 mg q3w | 89 | 89 |
| Total, other adverse events | Brigimadlin 45 mg q3w | 144 | 147 |
| Total, other adverse events | Doxorubicin | 153 | 154 |
| Total, other adverse events | Doxorubicin - Brigimadlin 30 mg q3w | 6 | 7 |
| Total, other adverse events | Doxorubicin - Brigimadlin 45 mg q3w | 67 | 70 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36987836 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05218499
GET https://conductscience.org/api/trials/v1/NCT05218499/results?page=2