Obrixtamig + Standard Treatment for Small Cell Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new medicine, obrixtamig, for individuals with advanced small cell lung cancer (SCLC) to determine if it extends survival when combined with standard treatments. Participants will randomly receive either the experimental treatment with obrixtamig plus standard care or standard care alone. The study also tests a device that measures a tumor marker called DLL3. Individuals diagnosed with extensive-stage small cell lung cancer who have not received previous systemic treatment may be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to potentially groundbreaking treatment advancements.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss your specific situation with the trial team or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that obrixtamig, the treatment being tested in this study, demonstrated "manageable safety and tolerability" in earlier trials. These trials included patients with neuroendocrine carcinomas, such as small cell lung cancer. In these studies, patients tolerated doses ranging from 90 to 1,080 micrograms well, suggesting the treatment might be safe for further testing.
The other treatments in the trial—atezolizumab, carboplatin, and etoposide—are already standard therapies for small cell lung cancer. Doctors are familiar with their general effects on patients, as these treatments have established safety profiles.
While researchers continue to study obrixtamig, the results so far are promising for its safety. However, like any treatment, there may be risks and side effects, making ongoing trials essential to understand patient responses.12345Why do researchers think this study treatment might be promising?
Unlike the standard of care for small cell lung cancer, which typically involves a combination of atezolizumab, carboplatin, and etoposide, Obrixtamig introduces a new active ingredient into the mix. Researchers are excited about Obrixtamig because it targets cancer cells in a novel way that could enhance the effectiveness of existing treatments. This new approach has the potential to improve patient outcomes by making the cancer cells more susceptible to the effects of the traditional chemotherapy drugs. By integrating Obrixtamig, there is hope for better overall survival rates and improved quality of life for patients battling this aggressive form of lung cancer.
What evidence suggests that this trial's treatments could be effective for small cell lung cancer?
This trial will compare the effectiveness of two treatment regimens for small cell lung cancer (SCLC). One group will receive obrixtamig combined with atezolizumab, carboplatin, and etoposide. Studies have shown that obrixtamig can help treat SCLC, with up to 70% of patients experiencing tumor shrinkage when used with another drug. This treatment targets a protein called DLL3, often found in SCLC, and aids the immune system in fighting the cancer. The other group will receive atezolizumab, carboplatin, and etoposide without obrixtamig. Although early results are promising, more research is needed to confirm the long-term effectiveness of obrixtamig.13456
Are You a Good Fit for This Trial?
This trial is for adults with advanced small cell lung cancer who have not had previous treatment for this stage. Participants must be well enough to receive standard chemo and immunotherapy, have stable brain metastases if present, and provide a tumor sample for testing.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive intravenous infusions of obrixtamig in combination with atezolizumab, carboplatin, and etoposide or standard treatment alone
Follow-up
Participants are monitored for safety and effectiveness after treatment
Extension/Long-term follow-up
Participants may continue to be monitored for overall survival and progression-free survival
What Are the Treatments Tested in This Trial?
Interventions
- Atezolizumab
- Carboplatin
- Etoposide
- Obrixtamig
Trial Overview
The study compares adding obrixtamig (an immune-boosting drug) to standard treatment—atezolizumab, carboplatin, and etoposide—versus the standard treatment alone. Treatments are given by IV infusion. People are randomly assigned to one of the two groups.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Boehringer Ingelheim
Lead Sponsor
Citations
Dose Escalation Trial Yields Encouraging Results for SCLC ...
Julien Mazières reported that while obrixtamig plus ezabenlimab showed encouraging responses at the clinically effective dose, efficacy peaked ...
DAREONTM-9, a phase Ib study of obrixtamig plus ...
We report the first safety and preliminary efficacy data for the dose escalation part of the Dareon-9 trial, investigating the combination of obrixtamig and ...
Phase I Dose-Escalation Results for the Delta-Like Ligand ...
With Regimens B2/B3, ORRs were 21% (95% CI, 12.9% to 33.1%), 27% (95% CI, 17.4% to 39.6%), and 70% (95% CI, 39.7% to 89.2%) for SCLC, epNECs, ...
4.
lungcancerstoday.com
lungcancerstoday.com/post/elcc-2026-phase-1-dose-escalation-trial-evaluates-obrixtamig-plus-ezabenlimab-finds-encouraging-efficacy-in-sclcELCC 2026: Phase 1 Dose Escalation Trial Evaluates ...
Obrixtamig plus ezabenlimab showed “manageable safety and tolerability” in patients with pretreated DLL3-positive neuroendocrine carcinomas, ...
NCT05879978 | A Study to Test How Well Different Doses ...
This study is open to adults with small cell lung cancer and other neuroendocrine tumours that are positive for the tumour marker Delta-like 3 (DLL3).
Efficacy and safety of the DLL3/CD3 T-cell engager ...
Efficacy and safety of the DLL3/CD3 T-cell engager obrixtamig in patients with genitourinary extrapulmonary neuroendocrine carcinomas with high ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.