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Compares treatment options for Small Cell Lung Cancer (SCLC)
Official title DAREON ® -Lung-1: A Study in People With Advanced Small Cell Lung Cancer to Compare Obrixtamig Plus Atezolizumab, Carboplatin, and Etoposide Treatment With Standard Chemotherapy
ClinicalTrials.gov ID: NCT07472517
What this study is testing
What is obrixtamig?
obrixtamig is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for small cell lung cancer (sclc).
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
- This study is open to adults with advanced small cell lung cancer (SCLC). The purpose of this study is to find out if a study medicine called obrixtamig plus standard treatment (atezolizumab, carboplatin, and etoposide) improves survival when compared to standard treatment alone.
- Phase 3: a large, late-stage study
- Time commitment: about 3 years
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
- Patients with histologically confirmed Extensive-stage Small Cell Lung Cancer (ES-SCLC)
- Patients without any previous systematic anti-cancer treatment for ES-SCLC. Patients who received previous systematic anti-cancer treatment during...
- Adequate archival formalin-fixed paraffin-embedded (FFPE) tumour tissue, as specified in the Laboratory Manual, must be available for central...
- Patients with asymptomatic brain metastasis are eligible if they meet one of the following criteria:
- Treatment for brain metastases (e.g. whole brain radiation therapy, stereotactic radiotherapy, or radiosurgery) completed at least 14 days prior to...
You likely can't join if
- Presence of leptomeningeal disease and/or carcinomatous meningitis
- Previous treatment targeting DLL3 (e.g. T cell engagers (TcEs), cell therapies, antibody-drug conjugates, or radiopharmaceuticals)
- Radiotherapy of any anatomical sites within 14 days prior to randomisation
- Persistent toxicity from previous treatments that has not resolved to ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 (except for...
- Patient with active autoimmune disease or a documented history of autoimmune disease that requires systemic treatment (e.g. glucocorticoids or...
See the full eligibility criteria
- Patients with histologically confirmed Extensive-stage Small Cell Lung Cancer (ES-SCLC)
- Patients without any previous systematic anti-cancer treatment for ES-SCLC. Patients who received previous systematic anti-cancer treatment during limited stage are eligible if the treatment has been completed more than...
- Adequate archival formalin-fixed paraffin-embedded (FFPE) tumour tissue, as specified in the Laboratory Manual, must be available for central laboratory analysis of Delta-like ligand 3 (DLL3) expression status and other...
- Patients with asymptomatic brain metastasis are eligible if they meet one of the following criteria:
- Treatment for brain metastases (e.g. whole brain radiation therapy, stereotactic radiotherapy, or radiosurgery) completed at least 14 days prior to randomisation and neurologically stable without the use of...
- Untreated brain metastases that do not require treatment and are neurologically stable without the use of glucocorticoids or therapeutic anti-convulsant for at least 28 days prior to randomisation
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
- Eligible for continuing carboplatin + etoposide + atezolizumab regimen as first-line Standard of care (SoC) treatment within 28 days after the start of the initial cycle of standard therapy
- Eligible to receive treatment with full dose of atezolizumab, carboplatin, and etoposide as first-line SoC treatment, in accordance with the approved Summary of Product Characteristics if provided centrally or approved...
- Presence of leptomeningeal disease and/or carcinomatous meningitis
- Previous treatment targeting DLL3 (e.g. T cell engagers (TcEs), cell therapies, antibody-drug conjugates, or radiopharmaceuticals)
- Radiotherapy of any anatomical sites within 14 days prior to randomisation
- Persistent toxicity from previous treatments that has not resolved to ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 (except for alopecia, asthenia/fatigue, amenorrhea/menstrual disorders, CTCAE Grade...
- Patient with active autoimmune disease or a documented history of autoimmune disease that requires systemic treatment (e.g. glucocorticoids or immunosuppressive drugs). Patients with vitiligo, resolved childhood...
The study team makes the final eligibility decision.
Where it's taking place
- Mobile, Alabama, United States
- Little Rock, Arkansas, United States
- Hialeah, Florida, United States
- Atlanta, Georgia, United States
- Louisville, Kentucky, United States
- Pikeville, Kentucky, United States
- Monroe, Louisiana, United States
- New Orleans, Louisiana, United States
- Shreveport, Louisiana, United States
- Baltimore, Maryland, United States
- Ann Arbor, Michigan, United States
- Kansas City, Missouri, United States
- Omaha, Nebraska, United States
- Fayetteville, North Carolina, United States
- Pittsburgh, Pennsylvania, United States
- Memphis, Tennessee, United States
- Madison, Wisconsin, United States
- CABA, Argentina
- Munro, Argentina
- Nueva Córdoba, Argentina
+ 186 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 - confirm specifics with the study team.
How long does this study last?
The study runs about 3 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you 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?
Study sites include Mobile, Alabama, United States; Little Rock, Arkansas, United States; Hialeah, Florida, United States; Atlanta, Georgia, United States; Louisville, Kentucky, United States; Pikeville, Kentucky, United States and 200 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.