Trial · NCT03468426
A Study to Test Different Doses of BI 836880 Combined With Ezabenlimab in Patients With Advanced Non-small Cell Lung Cancer Followed by Other Types of Advanced Solid Tumours
NCT03468426, Phase 1, Completed, Boehringer Ingelheim; results first posted 2025-11-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Test Different Doses of BI 836880 Combined With Ezabenlimab in Patients With Advanced Non-small Cell Lung Cancer Followed by Other Types of Advanced Solid Tumours. Trials, record NCT03468426. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03468426
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Test Different Doses of BI 836880 Combined With Ezabenlimab in Patients With Advanced Non-small Cell Lung Cancer Followed by Other Types of Advanced Solid Tumours
- NCT number
- NCT03468426
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 252 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Non-squamous, Non-Small-Cell Lung Cancer, Neoplasms
- Interventions
- BI 836880, Ezabenlimab
- First posted
- 2018-03-16
- Last updated
- 2025-11-10
- Other registries' IDs
- eudract:2017-001378-41
- Results first posted
- 2025-11-10
Source ClinicalTrials.gov
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 1 - Number of Patients With Dose Limiting Toxicity (DLT) Within the First Cycle of Treatment | The first treatment cycle, up to 21 days. | Number of patients with dose limiting toxicity (DLT) within the first cycle of treatment. |
| Primary | Part 2 - Objective Response (OR) | Up to 778 days. | Objective Response (OR) defined as best overall response (Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1)) of complete response (CR) or partial response (PR) from first treatment infusion until the earliest of disease progression, death or last evaluable tumor assessment before start of subsequent anticancer therapy, lost to follow-up, or withdrawal of consent. In case of recurrent glioblastoma (GBM), assessment will be based on RANO (Response Assessment in Neuro-Oncology) criteria. |
| Secondary | Part 1 - Adverse Events (AEs) | Up to 1263 days. | The number of patients with any adverse events (AEs). |
| Secondary | Part 1 - Drug Related AEs | Up to 1263 days. | The number of patients with any drug related adverse events (AEs). |
| Secondary | Part 1 - Drug Related AEs Leading to Dose Reduction or Discontinuation | Up to 1263 days. | The number of patients with any drug related adverse events (AEs) leading to dose reduction or discontinuation. |
| Secondary | Part 2 - Adverse Events (AEs) | Up to 778 days. | The number of patients with any adverse events (AEs). |
| Secondary | Part 2 - Drug Related AEs | Up to 778 days. | The number of patients with any drug related adverse events (AEs). |
| Secondary | Part 2 - Drug Related AEs Leading to Dose Reduction or Discontinuation | Up to 778 days. | The number of patients with any drug related adverse events (AEs) leading to dose reduction or discontinuation. |
| Secondary | Part 2 - Disease Control (DC) | Up to 778 days. | Disease control (DC), defined as best overall response of CR, PR, or stable disease (SD) (Response Assessment in Neuro-Oncology (RANO for GBM \& RECIST1.1 for all other cohorts). |
| Secondary | Part 2 - Duration of Objective Response (DoR) | Up to 84.4 weeks. | Duration of objective response (DoR), defined as the time from first documented CR or PR (RANO for GBM \& RECIST1.1 for all other cohorts) until the earliest of disease progression or death among patients with OR. |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 registered outcomesOutcomes29
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Part 1 - Adverse Events (AEs) | Up to 1263 days. | All patients enrolled in part 1 of the trial who were documented to have received at least one dose of ezabenlimab or BI 836880. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part 1 - Drug Related AEs | Up to 1263 days. | All patients enrolled in part 1 of the trial who were documented to have received at least one dose of ezabenlimab or BI 836880. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part 1 - Drug Related AEs Leading to Dose Reduction or Discontinuation | Up to 1263 days. | All patients enrolled in part 1 of the trial who were documented to have received at least one dose of ezabenlimab or BI 836880. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part 2 - Adverse Events (AEs) | Up to 778 days. | All patients enrolled in part 2 of the trial who were documented to have received at least one dose of ezabenlimab or BI 836880. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part 2 - Drug Related AEs | Up to 778 days. | All patients enrolled in part 2 of the trial who were documented to have received at least one dose of ezabenlimab or BI 836880. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part 2 - Drug Related AEs Leading to Dose Reduction or Discontinuation | Up to 778 days. | All patients enrolled in part 2 of the trial who were documented to have received at least one dose of ezabenlimab or BI 836880. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part 2 - Disease Control (DC) | Up to 778 days. | All patients enrolled in part 2 of the trial who were documented to have received at least one dose of ezabenlimab or BI 836880. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part 2 - Duration of Objective Response (DoR) | Up to 84.4 weeks. | All patients with an objective response enrolled in part 2 of the trial who were documented to have received at least one dose of ezabenlimab or BI 836880. | weeks | MEDIAN |
| SECONDARY | Part 2 - Progression-free Survival (PFS) | Up to 778 days. | All patients enrolled in part 2 of the trial who were documented to have received at least one dose of ezabenlimab or BI 836880. | weeks | MEDIAN |
| SECONDARY | Part 1 - Maximum Measured Concentration of BI 836880 in Plasma (Cmax) After the First Infusion Cycle | 5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the first cycle. | PK analysis set (PKS) part 1: This patient set included all patients in part 1 of the trial in the treated set who provide at least one evaluable observation for at least one PK endpoint and no PK relevant protocol deviation. Only subjects with available data were included, subjects were excluded due to various reasons, e.g., sample time deviations, deviations in dose or dosing time or too high predose concentrations. | microgram/milliliter | GEOMETRIC_MEAN |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 outcomesResults by group169
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Part 1 - Adverse Events (AEs) | Part 1 - BI 836880 360 mg | 3 | Participants | ||
| Part 1 - Adverse Events (AEs) | Part 1 - BI 836880 500 mg | 3 | Participants | ||
| Part 1 - Adverse Events (AEs) | Part 1 - BI 836880 720 mg | 8 | Participants | ||
| Part 1 - Adverse Events (AEs) | Part 1 - total | 14 | Participants | ||
| Part 1 - Drug Related AEs | Part 1 - BI 836880 360 mg | 3 | Participants | ||
| Part 1 - Drug Related AEs | Part 1 - BI 836880 500 mg | 2 | Participants | ||
| Part 1 - Drug Related AEs | Part 1 - BI 836880 720 mg | 7 | Participants | ||
| Part 1 - Drug Related AEs | Part 1 - total | 12 | Participants | ||
| Part 1 - Drug Related AEs Leading to Dose Reduction or Discontinuation | Part 1 - BI 836880 360 mg | Subjects with AEs leading to dose reduction of trial drug | 0 | Participants | |
| Part 1 - Drug Related AEs Leading to Dose Reduction or Discontinuation | Part 1 - BI 836880 500 mg | Subjects with AEs leading to dose reduction of trial drug | 0 | Participants |
1 to 10 of 169Source ClinicalTrials.gov
See all 169 results by groupParticipant flow33
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Part 1 - BI 836880 360 mg | 3 | |
| Overall Study | STARTED | Part 1 - BI 836880 500 mg | 3 | |
| Overall Study | STARTED | Part 1 - BI 836880 720 mg | 8 | |
| Overall Study | STARTED | Part 2 - Cohort A, 2nd line NSCLC | 42 | |
| Overall Study | STARTED | Part 2 - Cohort B, 3rd line NSCLC | 40 | |
| Overall Study | STARTED | Part 2 - Cohort C, SCLC | 31 | |
| Overall Study | STARTED | Part 2 - Cohort D, glioblastoma | 31 | |
| Overall Study | STARTED | Part 2 - Cohort E, Melanoma | 32 | |
| Overall Study | STARTED | Part 2 - Cohort F, 2nd line Hepatocellular Carcinoma | 30 | |
| Overall Study | STARTED | Part 2 - Cohort G, 1st line Hepatocellular Carcinoma (HCC) | 31 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 participant flowAdverse events3,333
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 | Part 1 - BI 836880 360 mg | 1 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1 - BI 836880 500 mg | 0 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1 - BI 836880 720 mg | 1 | 8 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 2 - Cohort A, 2nd line NSCLC | 5 | 42 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 2 - Cohort B, 3rd line NSCLC | 5 | 40 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 2 - Cohort C, SCLC | 0 | 31 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 2 - Cohort D, glioblastoma | 0 | 31 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 2 - Cohort E, Melanoma | 3 | 32 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 2 - Cohort F, 2nd line Hepatocellular Carcinoma | 2 | 30 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 2 - Cohort G, 1st line Hepatocellular Carcinoma | 1 | 31 |
1 to 10 of 3,333Source ClinicalTrials.gov
See all 3,333 adverse eventsAdverse event totals33
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part 1 - BI 836880 360 mg | 0 | 3 |
| Total, all-cause mortality | Part 1 - BI 836880 500 mg | 1 | 3 |
| Total, all-cause mortality | Part 1 - BI 836880 720 mg | 1 | 8 |
| Total, all-cause mortality | Part 2 - Cohort A, 2nd line NSCLC | 4 | 42 |
| Total, all-cause mortality | Part 2 - Cohort B, 3rd line NSCLC | 2 | 40 |
| Total, all-cause mortality | Part 2 - Cohort C, SCLC | 5 | 31 |
| Total, all-cause mortality | Part 2 - Cohort D, glioblastoma | 1 | 31 |
| Total, all-cause mortality | Part 2 - Cohort E, Melanoma | 2 | 32 |
| Total, all-cause mortality | Part 2 - Cohort F, 2nd line Hepatocellular Carcinoma | 4 | 30 |
| Total, all-cause mortality | Part 2 - Cohort G, 1st line Hepatocellular Carcinoma | 5 | 31 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT03468426
GET https://conductscience.org/api/trials/v1/NCT03468426/registered?page=2