Clinical trial NCT05990738: DAREON™-9: A Study to Test How Well Different Doses of BI 764532 Are Tolerated by People With Small Cell Lung Cancer When Taken Together With a Single Agent Chemotherapy
Official title: DAREON™-9: A Phase Ib Open-label Dose Escalation and Dose Confirmation Safety Study of Intravenous BI 764532 in Combination With a Single Agent Chemotherapy for the Treatment of Patients With Relapsed/Refractory Small Cell Lung Cancer After Platinum-based Chemotherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Small Cell Lung Carcinoma (SCLC)
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2023-08-14
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This study is open to adults with extensive stage small cell lung cancer. The study is in people with advanced cancer that had previously received platinum-based chemotherapy and are eligible to receive a single agent chemotherapy treatment.

The purpose of this study is to find the highest dose of BI 764532 that people can tolerate when taken together with a single agent chemotherapy. BI 764532 is an antibody-like molecule that may help the immune system fight cancer.

Participants may continue to take BI 764532 as long as they benefit from treatment and can tolerate it. 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.


Eligibility criteria: 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 Conference of Harmonization-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
3. Histologically or cytologically confirmed small cell lung cancer (SCLC). Patients with tumours with mixed histology are eligible only if SCLC component is predominant and represent at least 50% of the overall tumour tissue.
4. Extensive stage - small cell lung cancer (ES-SCLC) that progressed or recurred following platinum-based treatment, and anti- programmed cell death protein 1 (PD-1) or programmed cell death ligand 1 (PD-L1) as applicable.
5. Patients must be eligible for single agent chemotherapy treatment (used in the trial) according to label.
6. Availability of archival tumour tissue sample.
7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. Further inclusion criteria apply.

Exclusion Criteria:

1. Previous treatment in this trial.
2. Current enrolment in another investigational device or drug trial, or \<30 days since ending another investigational device or drug trial(s).
3. Untreated or symptomatic brain metastases. Participants with treated, stable brain metastases are eligible provided they meet the following criteria:

   * Radiotherapy or major surgery for brain metastases was completed at least 2 weeks (for radiotherapy) or 4 weeks (for major brain metastases surgery) 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.
4. Presence of leptomeningeal carcinomatosis.
5. Prior participation in clinical trials of BI 764532, including receiving standard of care in these trials OR prior treatment with T cell engager (TcE) or cell therapies targeting delta-like ligand 3 (DLL3).
6. Persistent toxicity from previous treatments that has not resolved to ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 (except for alopecia, asthenia/fatigue, CTCAE Grade 2 neuropathy, or Grade 2 endocrinopathies controlled by replacement therapy).
7. Major surgery (major according to the investigator's assessment) within 28 days prior to first administration of BI 764532 or planned during treatment period, e.g. hip replacement.
8. Previous or concomitant malignancies other than the one treated in this trial within the last 2 years except

   1. effectively treated non-melanoma skin cancers
   2. effectively treated carcinoma in situ of the cervix
   3. effectively treated ductal carcinoma in situ
   4. other effectively treated malignancy that is considered cured by local treatment Further exclusion criteria apply.

Primary outcomes:
measure: Part A: Occurrence of dose limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period
timeFrame: up to 9 weeks
measure: Part B: Occurrence of DLTs during the on-treatment period
timeFrame: up to 36 months
measure: Part B: Occurrence of AEs during the on-treatment period
timeFrame: up to 36 months
Secondary outcomes:
measure: Part A: Occurrence of DLTs during the on-treatment period
timeFrame: up to 36 months
measure: Part A: Occurrence of AEs during the on-treatment period
timeFrame: up to 36 months
measure: Part B: Objective response
timeFrame: up to 36 months
measure: Part B: Duration of response
timeFrame: up to 36 months
Other outcomes:
Locations:
city: Washington
country: United States
facility: MedStar Georgetown University Hospital
state: District of Columbia
city: Jacksonville
country: United States
facility: Mayo Clinic - Florida
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Westwood
country: United States
facility: University of Kansas Cancer Center
state: Kansas
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
city: Paris
country: France
facility: INS Curie
city: Strasbourg
country: France
facility: HOP Civil
city: Villejuif
country: France
facility: INS Gustave Roussy
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus Dresden
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
city: Heidelberg
country: Germany
facility: Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
city: Mainz
country: Germany
facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg AÖR
city: Lodz
country: Poland
facility: Polish Mother's Memorial Hospital - Research Institute
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary
Study officials:
References: