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
DAREON ® -Lung-1: A Phase III Multi-center, Open-label, Randomised Trial of Intravenous Obrixtamig in Combination With Atezolizumab, Carboplatin, and Etoposide vs. Atezolizumab, Carboplatin, and Etoposide as First-line Treatment in Patients With Extensive-stage Small Cell Lung Cancer
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 3 years
- Procedures mentioned: Infusions
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "All treatments are given as infusions into a vein."
- "Participants are in the study for up to 3 years."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study is for adults with small cell lung cancer that has spread widely. It tests whether adding obrixtamig to standard treatment helps people live longer than standard treatment alone. It also tests a device that measures DLL3, a marker in cancer tissue.
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. Obrixtamig is an antibody-like molecule that may help the immune system fight cancer. Another purpose of the study is to test a medical device being developed to measure levels of the tumour marker DLL3. Participants are put into 2 groups randomly, which means by chance. One group receives obrixtamig and standard treatment. The other group receives standard treatment without obrixtamig. All treatments are given as infusions into a vein. Participants are in the study for up to 3 years. During this time, they visit the study site regularly. Participants in the group receiving obrixtamig stay overnight at the study site following the first 2 obrixtamig treatments. At the visits, doctors check the size of the tumour(s). The results are compared between the 2 groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have small cell lung cancer that has spread widely, confirmed by a tissue test.
- Have had no previous whole-body cancer treatment for this advanced stage. Treatment for earlier-stage disease is allowed if it ended more than 6 months before the advanced-stage diagnosis.
- Have a stored tumor sample for DLL3 and other tests. The DLL3 result must be ready before you are assigned to a study group.
- Cancer that has spread to the brain must cause no symptoms. If treated, treatment must have ended at least 7 days before group assignment, with stable brain function and no steroids or seizure medicines for at least 7 days. If untreated, it must not need treatment, with the same stability and medicine limits for at least 28 days.
- Be fully active, or able to walk and do light work despite limits on hard physical activity.
- Be able to continue carboplatin, etoposide, and atezolizumab within 28 days after starting the first treatment cycle.
- Be able to receive full doses of all three standard medicines under the approved drug rules.
- Other entry rules apply.
Who can't join
- Have cancer in the layers or fluid around the brain or spinal cord.
- Have had treatment that targets DLL3.
- Have had radiation treatment anywhere in the body within 7 days before study group assignment.
- Have side effects from past treatment that have not improved to mild or your usual level. Some exceptions apply, including certain stable side effects. Side effects from the first standard treatment cycle may be allowed if your organs work well enough.
- Have an active autoimmune disease, where the immune system attacks the body, or a history of one needing whole-body treatment. Some skin conditions, resolved childhood asthma or allergies, treated low thyroid levels, and controlled type 1 diabetes may be allowed.
- Other rules may keep you from joining.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria : 1. Patients with histologically confirmed Extensive-stage Small Cell Lung Cancer (ES-SCLC) 2. 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 months before the diagnosis of ES-SCLC. 3. 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 biomarkers. The central laboratory investigational VENTANA DLL3 (SP347) RxDx test result must be available prior to randomisation. 4. 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 7 days prior to randomisation and the patient is neurologically stable without the use of glucocorticoids or therapeutic anti-convulsant for at least 7 days prior to randomisation * 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 5. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 6. 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 7. 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 local product label if provided by the trial site Further inclusion criteria apply. Exclusion Criteria : 1. Presence of leptomeningeal disease and/or carcinomatous meningitis 2. Previous treatment targeting DLL3 (e.g. T cell engagers (TcEs), cell therapies, antibody-drug conjugates, or radiopharmaceuticals) 3. Radiotherapy of any anatomical site within 7 days prior to randomisation 4. Toxicity from previous treatments that has not resolved to ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or baseline. Patients with alopecia, any grade, CTCAE ≤Grade 2, asthenia/fatigue, amenorrhea/menstrual disorders any grade, CTCAE Grade ≤2 peripheral neuropathy, and/or CTCAE Grade 2 endocrinopathies controlled by replacement therapy, and toxicities, which are considered irreversible but stable for at least 4 weeks prior to randomisation, per investigator judgment may be eligible. Note: Patients who developed toxicity from the cycle of standard therapy received prior to randomisation are eligible if adequate organ function is ensured as described 5. 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 asthma/atopy, alopecia, or any chronic skin condition that does not require systemic therapy, patients with autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone and/or controlled Type 1 diabetes mellitus on a stable insulin regimen may be included if in the opinion of the investigator it is appropriate and safe to do so. Further exclusion criteria apply.
Study sites (17)
AL
- Infirmary Cancer Care · Mobile, AL 36607Boehringer Ingelheim · Study contact · 833-602-2368 · unitedstates@bitrialsupport.comMore trials in Mobile
AR
- University of Arkansas for Medical Sciences · Little Rock, AR 72205Boehringer Ingelheim · Study contact · 833-602-2368 · unitedstates@bitrialsupport.comMore trials in Little Rock
FL
- Bioresearch Partner - Hialeah Hospital · Hialeah, FL 33013Boehringer Ingelheim · Study contact · 833-602-2368 · unitedstates@bitrialsupport.comMore trials in Hialeah
GA
- Emory University · Atlanta, GA 30322Boehringer Ingelheim · Study contact · 833-602-2368 · unitedstates@bitrialsupport.comMore trials in Atlanta
KY
- Norton Cancer Institute, Downtown · Louisville, KY 40202Boehringer Ingelheim · Study contact · 833-602-2368 · unitedstates@bitrialsupport.comMore trials in Louisville
- Pikeville Medical Center · Pikeville, KY 41501Boehringer Ingelheim · Study contact · 833-602-2368 · unitedstates@bitrialsupport.comMore trials in Pikeville
LA
- Epic Medical Research - Monroe · Monroe, LA 71201Boehringer Ingelheim · Study contact · 833-602-2368 · unitedstates@bitrialsupport.comMore trials in Monroe
- Ochsner Medical Center · New Orleans, LA 70121Boehringer Ingelheim · Study contact · 833-602-2368 · unitedstates@bitrialsupport.comMore trials in New Orleans
- Epic Medical Research - Shreveport · Shreveport, LA 71105Boehringer Ingelheim · Study contact · 833-602-2368 · unitedstates@bitrialsupport.comMore trials in Shreveport
MD
- University of Maryland School of Medicine · Baltimore, MD 21201Boehringer Ingelheim · Study contact · 833-602-2368 · unitedstates@bitrialsupport.comMore trials in Baltimore
MI
- Veterans Affairs Ann Arbor Healthcare System · Ann Arbor, MI 48105Boehringer Ingelheim · Study contact · 833-602-2368 · unitedstates@bitrialsupport.comMore trials in Ann Arbor
MO
- HCA MidAmerica Division, Inc. · Kansas City, MO 64132Boehringer Ingelheim · Study contact · 833-602-2368 · unitedstates@bitrialsupport.comMore trials in Kansas City
NC
- Cape Fear Valley Cancer Center · Fayetteville, NC 28303Boehringer Ingelheim · Study contact · 833-602-2368 · unitedstates@bitrialsupport.comMore trials in Fayetteville
NE
- University of Nebraska Medical Center · Omaha, NE 68198Boehringer Ingelheim · Study contact · 833-602-2368 · unitedstates@bitrialsupport.comMore trials in Omaha
PA
- AHN Cancer Institute - Allegheny General · Pittsburgh, PA 15212Boehringer Ingelheim · Study contact · 833-602-2368 · unitedstates@bitrialsupport.comMore trials in Pittsburgh
TN
- Baptist Cancer Center - Memphis · Memphis, TN 38120Boehringer Ingelheim · Study contact · 833-602-2368 · unitedstates@bitrialsupport.comMore trials in Memphis
WI
- University of Wisconsin · Madison, WI 53792Boehringer Ingelheim · Study contact · 833-602-2368 · unitedstates@bitrialsupport.comMore trials in Madison