Inclusion criteria:
1. Male or female participants ≥18 years old 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 or cytologically confirmed, cancer of the following histologies:
- Small cell lung cancer (SCLC)
- Extra-pulmonary neuroendocrine carcinoma (epNEC) (except Merkel cell carcinoma
(MCC), Medullary thyroid cancer (MTC) and Neuroendocrine prostate cancer (NEPC))
- 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%
of the overall tumour tissue.
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; in countries where standard of care in first line therapy
includes PD-L1 inhibitor treatment patients should have received the combination
of platinum-based regimen plus PD-L1 inhibitor unless they have been unable to
receive checkpoint inhibitor treatment.
- epNEC/LCNEC: after at least one platinum-based regimen
4. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.
5. 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.
6. Availability of archival tumour tissue sample.
7. Adequate organ function as defined in the protocol.
8. 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, peripheral neuropathy, fatigue and
endocrinopathies controlled by replacement therapy which must be = CTCAE Grade 2 and
amenorrhea/menstrual disorders which can be any grade).
9. 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
Exclusion 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.
