A study to test whether different doses of BI 764532 help people with small cell lung cancer or other neuroendocrine cancers

JRCT ID: jRCT2041230084

Registered date:29/09/2023

Basic Information

• Recruitment status: Recruiting

Health condition(s) or Problem(s) studied

SCLC
epNEC (except patients with MCC, MTC and NEPC)
LCNEC

• Date of first enrollment: 16/10/2023
• Target sample size: 120
• Countries of recruitment: Belgium,Japan,Bulgaria,Japan,China,Japan,France,Japan,Germany,Japan,Italy,Japan,Poland,Japan,Portugal,Japan,South Korea,Japan,Spain,Japan,Taiwan,Japan,UK,Japan,US,Japan
• Study type: Interventional
• Intervention(s): different doses of BI 764532 is administered.

Outcome(s)

Primary Outcome

- Objective response (OR), defined as a best overall response of confirmed complete response (CR) or confirmed partial response (PR)
- Occurrence of treatment-emergent adverse events (TEAEs) during the on-treatment period

Secondary Outcome

- Duration of objective response (DOR) based on investigator assessment
- Progression-free survival (PFS) based on investigator assessment
- Disease control (DC), defined as best overall response of CR or PR or stable disease (SD) based on investigator assessment
- Overall survival (OS), defined as the time from treatment start until death from any cause
- Change from baseline in EORTC QLQ-C30 physical functioning domain score
- Change from baseline in EORTC QLQ-C30 role functioning domain score
- Occurrence of treatment-emergent AEs leading to study drug discontinuation during the on-treatment period

Key inclusion & exclusion criteria

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

Include criteria

1. Male or female participants 18 years old and over and at least at the legal age of consent in countries where it is greater than 18 years at the time of signature of the informed consent form (ICF).
2. Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
3. Histologically Histologically or cytologically confirmed, cancer of the following histologies:
a) Small cell lung cancer (SCLC)
b) Extra-pulmonary neuroendocrine carcinoma (epNEC) (except Merkel cell carcinoma (MCC), Medullary thyroid cancer (MTC) and Neuroendocrine prostate cancer (NEPC))
c) Large cell neuroendocrine carcinoma (LCNEC) of the lung Patients with tumours with mixed histologies for any above type are eligible only if the neuroendocrine carcinoma/small tumour cells component is predominant and represents at least 50 percent of the overall tumour tissue.
4. Patients must have progressed or recurred after standard of care therapy
- SCLC: after at least two prior lines of therapy, including at least one platinum-based regimen
- epNEC/LCNEC: after at least one platinum-based regimen
5. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.
6. Measurable lesions as defined per Response Evaluation Criteria In Solid Tumours (RECIST) v 1.1 within 21 days prior to the first dose of BI 764532.
7. Availability of archival tumour tissue sample.
8. Adequate organ function as defined in the protocol.
9. All toxicities related to previous anti-cancer therapies have resolved = Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 prior to trial treatment administration (except for alopecia and peripheral neuropathy which must be = CTCAE Grade 2 and amenorrhea/menstrual disorders which can be any grade).
10. Women of childbearing potential (WOCBP)and men able to father a child must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria and instructions on the duration of their use is provided in the participant information

Exclude criteria

1. Untreated or symptomatic brain metastases. Participants with treated, stable brain metastases are eligible provided they meet the following criteria:
- Radiotherapy or surgery for brain metastases was completed at least 2 weeks prior to the first administration of BI 764532.
- Patient is off steroids for at least 7 days (physiologic doses of steroids are permitted), and the patient is off anti-epileptic drugs for at least 7 days or on stable doses of anti-epileptic drugs for malignant central nervous system (CNS) disease.
2. Presence of leptomeningeal disease.
3. Active/previous history of interstitial lung disease or non-infectious pneumonitis (any grade).
4. Participants who experienced severe, life-threatening immune-mediated adverse events or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immuno-oncology agents.
5. Prior anti-cancer therapy:
- Patients who have been treated with any other anti-cancer drug within 4 weeks or within 5 half-life periods (whichever is shorter) prior to first administration of BI 764532.
- Patients who have been treated with extensive field radiotherapy including whole brain irradiation within 2 weeks prior to first administration of BI 764532.
6. Previous treatment with Delta-like ligand 3 (DLL3)-targeting T cell engagers or cell therapies.
7. Diagnosis of immunodeficiency or systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of BI 764532. Physiological replacement of steroids is allowed.
8. Unresolved toxicity from prior anti-tumour therapy, defined as per protocol. Further exclusion criteria apply.

Related Information

• Primary Sponsor: Yamamoto Akiko