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DAREONᵀᴹ-8: A Study to Test How Well Different Doses of BI 764532 in Addition to Standard of Care Are Tolerated by People With Advanced Small Cell Lung Cancer

Study acronym: DAREONᵀᴹ-8
StatusActive, Not Recruiting
PhasePhase 1
Started2024-02-14
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 6 months later Sep 1, 2026 → Mar 31, 2027
See other at-risk trials from Boehringer Ingelheim

Amendment history

2026-09-03
Study Identification, Study Status, Contacts/Locations v41
Primary completion pushed: 2026-09-01 → 2027-03-31
Study sites21 entries, revised
HôpitalHopital Louis Pradel
2026-07-06
4 amendments v37-v40
4 re-verifications since 2026-05-11, no change to tracked fields
2026-04-13
Study Status v36
Completion pushed: 2026-09-01 → 2027-04-01
2026-03-31
Study Status, Study Design, Arms and Interventions, Contacts/Locations, IPDSharing, References v35
Trial arms changed: 7 → 5
Enrollment target45→46
InterventionsAtezolizumab (Drug), BI 764532 (Drug), Carboplatin (Drug), Cisplatin (Drug), Durvalumab (Drug), Etoposide (Drug)→Atezolizumab (Drug), BI 764532 (Drug), Carboplatin (Drug), Etoposide (Drug)
Study sites21 entries, revised
HOPHôpital Louis Pradel INSInstitut Gustave Roussy
2026-01-05
Study Status v34
Re-verified, no change to tracked fields
Show 33 earlier versions
2025-12-18
Study Status, Study Design v33
Enrollment target46→45
2025-12-15
Study Status v32
Primary completion date2025-12-01→2026-09-01
Completion date2026-06-25→2026-09-01
2025-11-09
Study Status, Contacts/Locations v31
Study sites22→21
2025-09-26
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v30
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 47→confirmed 46
Study sites22 entries, revised
Hospital RamónUniversitario yRamon Y Cajal
2025-09-04
Study Status, Study Description, Contacts/Locations v29
Study sites22 entries, revised
BrusselsCliniques - UNIVUniversitaires Saint-Luc
2025-08-05
Study Status v28
Re-verified, no change to tracked fields
2025-07-04
Study Status, Study Design, Contacts/Locations v27
Primary completion date2025-08-20→2025-12-01
Enrollment target60→47
Study sitescontacts updated at 3 of 22 sites
2025-05-27
Study Status, Contacts/Locations v26
Study sites21→22
2025-05-12
Study Status, Contacts/Locations v25
Study sitesdetails revised at 1 of 21 sites
2025-04-15
Study Status, Contacts/Locations v24
Study sites17→21
2025-03-20
Study Status, Contacts/Locations v23
Study sites14→17
2025-03-05
Study Status, Contacts/Locations v22
Study sites16→14
2025-02-17
Study Status, Contacts/Locations v21
Study sites14→16
2025-02-05
Study Status, Contacts/Locations v20
Study sites14 entries, revised
UniversitätsklinikumFundación GießenJiménez und Marburg GmbHDíaz
2025-01-07
Study Status, Contacts/Locations v19
Study sitescontacts updated at 2 of 14 sites
2024-12-10
Study Status, Contacts/Locations v18
Study sites13→14
2024-11-25
Study Status, Contacts/Locations v17
Study sites11→13
2024-11-19
Study Status, Contacts/Locations v16
Start date2024-01-11→2024-02-14
Study sites19→11
2024-09-16
Study Status, Arms and Interventions, Contacts/Locations v15
Study sites17→19
2024-08-05
Study Status, Contacts/Locations v14
Study sites16→17
2024-07-22
Study Status, Contacts/Locations v13
Study sites15→16
2024-05-27
Study Status, Contacts/Locations v12
Study sites14→15
2024-04-30
Study Status, Contacts/Locations v11
Study sites13→14
2024-04-02
Study Status, Contacts/Locations v10
Study sites10→13
2024-03-18
Study Status, Contacts/Locations v9
Study sites9→10
2024-03-15
Study Status, Eligibility, Contacts/Locations v8
Study sites6→9
Eligibility criteria+1 characters
[...] field radiotherapy including whole brain irradiation within 12 weekweeks prior to first administration of BI 764532 Persistent toxic [...]
2024-03-04
Study Status, Contacts/Locations v7
Study sites1→6
2024-01-22
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v6
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-01-25→confirmed 2024-01-11
Study sites0→1
2024-01-08
Study Status, Eligibility v5
Eligibility criteria-1 characters
[...] igational drug within 28 days or 5 half-lives (whichever is shorterlonger) of the first administration of trial medication Presence o [...]
2023-12-11
Study Status v4
Start date2024-01-04→2024-01-25
2023-11-20
Study Status, Eligibility v3
Eligibility criteria+32 characters
[...] apply. Exclusion Criteria: Previous treatment in this trial CurrentTreatment enrolmentwith ina anothersystemic anti-cancer therapy or investigational devicedrug within 28 days or drug5 half-lives (whichever is shorter) of the first administration of trial, or <30 days since ending another investigational device or drug trial(s)medication Presence of leptomeningeal carcinomatosis Previous treatmen [...]
2023-11-07
Study Status v2
Start date2023-11-30→2024-01-04
2023-10-17
Study Status, Study Design v1
Completion date2025-10-01→2026-06-25
Start date2023-11-20→2023-11-30
Enrollment target55→60
2023-10-05
Original filing
This study is open to adults with extensive stage small cell lung cancer. The study is in people with advanced cancer that are eligible for standard of care including chemotherapy and anti-PD-L1 (Programmed Cell Death Ligand 1) immunotherapy. The purpose of this study is to find out the highest dose of BI 764532 (also called obrixtamig) that people can tolerate when taken together with standard of care. BI 764532 is an antibody-like molecule that may help the immune system fight cancer. Participants get BI 764532 and different standard treatments as infusions into a vein. If there is benefit for the participants and if they can tolerate it, the treatment is given for the entire duration of the study. During this time, participants visit the study site regularly. The visits also depend on the response to the treatment. At the study visits, the doctors check the health of the participants, take necessary laboratory tests, and note any health problems that could have been caused by the study treatment.
Trial Details
NCT Number NCT06077500
Lead Sponsor Boehringer Ingelheim
Conditions Small Cell Lung Carcinoma (SCLC)
Enrollment 46 participants
Start Date 2024-02-14
Primary Completion 2027-03-31 (estimated)
Study Completion 2027-04-01 (estimated)
Updated on ClinicalTrials.gov 2026-09-30