DAREON-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

DAREON-8: A Phase I, open-label, dose escalation and expansion trial of repeated intravenous infusions of BI 764532 combined with standard of care (platinum, etoposide, and anti-PDL1) in patients with extensive-stage small cell lung carcinoma

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031230615

Enrollment

Registered

2024-02-01

Start date

2024-02-22

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Histologically or cytologically confirmed ES-SCLC

Interventions

Part A - Administer BI 764532 in combination with SoC with platinum, etoposide, and anti-PD-L1 antibody. Part B - Administer BI 764532 in combination with standard treatment regimens (chemotherapy and

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Signed and dated written informed consent form in accordance with ICH-GCP and local legislation prior to any trial-specific procedures, sampling, or analyses - Patients must be eligible for platinum+etoposide + anti-PD-L1 regimen as first line SoC treatment: In Part A, patients must be eligible to receive carboplatin + etoposide + atezolizumab In Part B, patients must be eligible to receive etoposide, carboplatin or cisplatin, atezolizumab or durvalumab - Adequate liver, bone marrow, and renal function

Exclusion criteria

Exclusion criteria: - Previous treatment with DLL3-targeting T cell engagers and cell therapies - Persistent toxicity from previous treatments that has not resolved to NYHA II). - Women who are pregnant, nursing, or who plan to become pregnant while in the trial

Design outcomes

Primary

Measure	Time frame
Part A - Dose escalation Primary endpoint: occurrence of dose-limiting toxicities (DLTs) in the MTD evaluation period Part B - Dose expansion Primary endpoint: occurrence of DLTs during the on-treatment period	—

Secondary

Measure	Time frame
Part A - Dose escalation Secondary endpoints - Occurrence of DLTs during the on-treatment period Part B - Dose expansion Secondary endpoints - Objective response,defined as a best overall response of confirmed complete response or confirmed partial response according to RECIST1.1 from the date of treatment start until the earliest date of disease progression, death, or last evaluable tumour assessment before start of subsequent anticancer therapy, loss to follow-up, or withdrawal of consent - Duration of response, defined as the time from first documented confirmed objective response until the earliest date of disease progression or death among patients with confirmed objective response	—

Measure

Time frame

Part A - Dose escalation Secondary endpoints - Occurrence of DLTs during the on-treatment period Part B - Dose expansion Secondary endpoints - Objective response,defined as a best overall response of confirmed complete response or confirmed partial response according to RECIST1.1 from the date of treatment start until the earliest date of disease progression, death, or last evaluable tumour assessment before start of subsequent anticancer therapy, loss to follow-up, or withdrawal of consent - Duration of response, defined as the time from first documented confirmed objective response until the earliest date of disease progression or death among patients with confirmed objective response

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Countries

Belgium, France, Germany, Japan, Poland, Spain, Switzerland, United State

Contacts

Public ContactTetsuya Katakabe

Nippon Boehringer Ingelheim Co., Ltd.

medchiken.jp@boehringer-ingelheim.com+81-120-189-779

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026