Small Cell Lung Carcinoma study: BI vs Ventana DLL3 RxDx assay
Official title DAREON™-5: A Study to Test Whether Different Doses of BI 764532 Help People With Small Cell Lung Cancer or Other Neuroendocrine Cancers
ClinicalTrials.gov ID: NCT05882058
What this study is testing
What is BI 764532?
an investigational drug being studied as a potential treatment for small cell lung carcinoma and other neuroendocrine tumors is designed to bind DLL3 on tumor cells and CD3 on T‑cells, directing the immune system to attack the cancer
Also referred to as Obrixtamig.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to find a safe and tolerable dose of BI 764532 and to see if it can shrink tumors in people whose cancer has progressed after other treatments.
- Who it's for
- Adults with advanced small‑cell lung cancer or other neuroendocrine tumors who have not responded to prior therapy or have no standard options.
- What's involved
- Participants receive the drug by IV infusion, with the first treatment requiring an overnight stay for safety monitoring, followed by regular clinic visits for infusions, health checks, and side‑effect reporting.
- Time commitment
- The trial lasts until the drug is no longer tolerated or the study ends, with multiple visits over several months and an initial overnight stay.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local...
- Small cell lung cancer (SCLC)
- Extra-pulmonary neuroendocrine carcinoma (epNEC) (except Merkel cell carcinoma (MCC), Medullary thyroid cancer (MTC) and Neuroendocrine prostate...
- Large cell neuroendocrine carcinoma (LCNEC) of the lung Patients with tumours with mixed histologies for any above type are eligible only if the...
You likely can't join if
- 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...
- Presence of leptomeningeal disease or, part 2 and part 3: epidural disease including spinal cord compression.
- Part 1: Active/previous history of interstitial lung disease or non-infectious pneumonitis (any grade).
- Participants who experienced severe, life-threatening immune-mediated adverse events or infusion-related reactions including those that lead to...
- 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...
See the full eligibility criteria
- 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).
- 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.
- 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...
- 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...
- 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. Part 2 and part 3: Histologically or cytologically confirmed epNEC (except MCC, MTC and NEPC) with centrally assessed DLL3 high expression status.
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.,
- 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.
- Part 1: Availability of archival tumour tissue sample Part 2 and part 3: Availability of archival formalin-fixed paraffin-embedded (FFPE) tumour tissue sample.
- Adequate organ function as defined in the protocol.
- 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...
- Women of childbearing potential (WOCBP) and men able to father a child must be ready and able to use acceptable methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when...
- For Cycle 1, patients should be willing to stay within 1 hour driving distance for 48 hours after IMP administration and confirm availability of a caregiver for the same timeframe.
- Patients should be considered suitable by the investigator to follow instructions applicable to the reduced monitoring cohort, such as taking their temperature and administration of oral medication at home if needed.
- 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...
- Presence of leptomeningeal disease or, part 2 and part 3: epidural disease including spinal cord compression.
- Part 1: Active/previous history of interstitial lung disease or non-infectious pneumonitis (any grade).
- 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.
- 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.
- Previous treatment with Delta-like ligand 3 (DLL3)-targeting T cell engagers or cell therapies.
- 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.
- Unresolved toxicity from prior anti-tumour therapy, defined in the inclusion criteria. Further exclusion criteria apply.
The study team makes the final eligibility decision.
Where it is enrolling
- Mobile, Alabama, United States
- Phoenix, Arizona, United States
- Los Angeles, California, United States
- San Francisco, California, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Tampa, Florida, United States
- Lexington, Kentucky, United States
- Baltimore, Maryland, United States
- Rochester, Minnesota, United States
- The Bronx, New York, United States
- Richmond, Virginia, United States
- Ghent, Belgium
- Leuven, Belgium
- Chengdu, China
- Hangzhou, China
- Jinan, China
- Nanchang, China
- Shanghai, China
- Dresden, Germany
+ 16 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Mobile, Alabama, United States; Phoenix, Arizona, United States; Los Angeles, California, United States; San Francisco, California, United States; Jacksonville, Florida, United States; Miami, Florida, United States and 30 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.