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

JRCT ID: jRCT2031230615

Registered date:01/02/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Histologically or cytologically confirmed ES-SCLC
• Date of first enrollment: 22/02/2024
• Target sample size: 60
• Countries of recruitment: United State,Japan,Spain,Japan,Poland,Japan,Switzerland,Japan,Germany,Japan,France,Japan,Belgium,Japan
• Study type: Interventional

Intervention(s)

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 different standard treatment regimens (chemotherapy and anti-PD-L1 antibodies).

Outcome(s)

Primary Outcome

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 Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude criteria

- Previous treatment with DLL3-targeting T cell engagers and cell therapies
- Persistent toxicity from previous treatments that has not resolved to <=CTCAE Grade 1 (except for alopecia, CTCAE Grade 2 neuropathy, asthenia/fatigue, or Grade 2 endocrinopathies controlled by replacement therapy)
- History of/active non-infectious pneumonitis/interstitial lung disease
- Diagnosis of immunodeficiency, or systemic glucocorticoid therapy, or intake of any form of immunosuppressive therapy within 7 days prior to the first dose of BI 764532.
Physiological replacement of steroids is allowed (glucocorticoid dose needed by a patient to maintain
physiological steroid levels in the body)
- Significant cardiovascular/cerebrovascular diseases (e.g. uncontrolled hypertension, unstable angina, history of infarction within past 6 months, congestive heart failure >NYHA II).
- Women who are pregnant, nursing, or who plan to become pregnant while in the trial

Related Information

• Primary Sponsor: Tsunoda Toru