Trial comparing treatments 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 Chemoimmunotherapy
ClinicalTrials.gov ID: NCT07472517
What this study is testing
What is obrixtamig?
obrixtamig is an investigational medicine being studied to see if it helps treat advanced small cell lung cancer. obrixtamig is designed to help the immune system fight cancer.
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 wants to see if adding obrixtamig to standard chemo‑immunotherapy helps people live longer than standard treatment alone. It also tests a new device that measures a tumor marker called DLL3.
- Who it's for
- Adults who have extensive‑stage small cell lung cancer.
- What's involved
- You will be randomly assigned to receive either obrixtamig with standard chemo‑immunotherapy or just the standard chemo‑immunotherapy. All medicines are given by IV infusion, and the first two obrixtamig doses require an overnight stay at the study site. Doctors will check tumor size and monitor your health at each visit.
- Time commitment
- The study lasts up to 3 years with regular visits to the study site, including overnight stays after the first two obrixtamig infusions.
- 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 systemic anti-cancer treatment for ES-SCLC.
- Adequate archival formalin-fixed paraffin-embedded (FFPE) tumour tissue, as specified in the Laboratory Manual, must be available for central...
- Treatment for brain metastases (e.g. whole brain radiation therapy, stereotactic radiotherapy, or radiosurgery) completed at least 7 days prior to...
- Untreated brain metastases that do not require treatment and the patient is neurologically stable without the use of glucocorticoids or therapeutic...
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 site within 7 days prior to randomisation
- Toxicity from previous treatments that has not resolved to ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or baseline.
- Patient with active autoimmune disease or a documented history of autoimmune disease that requires systemic treatment (e.g.
See the full eligibility criteria
- Patients with histologically confirmed Extensive-stage Small Cell Lung Cancer (ES-SCLC)
- Patients without any previous systemic anti-cancer treatment for ES-SCLC. Patients who received previous systemic anti-cancer treatment during limited stage are eligible if the treatment has been completed more than 6...
- 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...
- Treatment for brain metastases (e.g. whole brain radiation therapy, stereotactic radiotherapy, or radiosurgery) completed at least 7 days prior to randomisation and the patient is neurologically stable without the use...
- Untreated brain metastases that do not require treatment and the patient is 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 site within 7 days prior to randomisation
- Toxicity from previous treatments that has not resolved to ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or baseline.
- Patient with active autoimmune disease or a documented history of autoimmune disease that requires systemic treatment (e.g. glucocorticoids or immunosuppressive drugs).
The study team makes the final eligibility decision.
Where it is enrolling
- Hialeah, Florida, United States
- Atlanta, Georgia, United States
- Louisville, Kentucky, United States
- Monroe, Louisiana, United States
- Shreveport, Louisiana, United States
- Baltimore, Maryland, United States
- Kansas City, Missouri, United States
- Omaha, Nebraska, United States
- Fayetteville, North Carolina, United States
- Pittsburgh, Pennsylvania, United States
- Memphis, Tennessee, United States
- CABA, Argentina
- Munro, Argentina
- Nueva Córdoba, Argentina
- Rosario, Argentina
- Randwick, New South Wales, Australia
- Adelaide, South Australia, Australia
- Ballarat, Victoria, Australia
- Linz, Austria
- Vienna, Austria
+ 124 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 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?
This study is enrolling now at Hialeah, Florida, United States; Atlanta, Georgia, United States; Louisville, Kentucky, United States; Monroe, Louisiana, United States; Shreveport, Louisiana, United States; Baltimore, Maryland, United States and 138 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.