Izalontamab Brengitecan + Osimertinib for Non-Small Cell Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new drug combination for certain types of lung cancer. Specifically, it examines the effectiveness of izalontamab brengitecan (a potential new drug) combined with osimertinib, compared to osimertinib alone or with chemotherapy. The trial targets individuals with non-small cell lung cancer that has specific genetic changes (EGFR mutations) and has not yet received treatment. It suits those whose cancer has spread and cannot be removed by surgery or effectively treated with radiation. As a Phase 3 trial, this study represents the final step before FDA approval, offering patients access to potentially groundbreaking treatment.
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 this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that izalontamab brengitecan (iza-bren) generally has a manageable safety profile. In previous studies, about 38.6% of patients experienced diarrhea as a common side effect. More serious side effects, such as low blood platelet count (thrombocytopenia), low red blood cell count (anemia), and low white blood cell count (neutropenia), appeared in around 44-52% of participants.
Osimertinib, another treatment in the trial, has also undergone extensive research. It is usually well-tolerated, with serious side effects occurring in about 21.77% of patients. Common side effects include rash and diarrhea.
Both treatments have proven effective in treating non-small cell lung cancer and generally maintain a manageable safety profile, according to prior research.12345Why are researchers excited about this trial's treatments?
Researchers are excited about Izalontamab Brengitecan paired with Osimertinib for non-small cell lung cancer because it combines a novel antibody-drug conjugate with a well-established EGFR inhibitor. Izalontamab Brengitecan (BMS-986507) is unique because it delivers a potent chemotherapy directly to cancer cells, potentially reducing side effects compared to traditional chemotherapy. Osimertinib is already known for targeting specific cancer mutations effectively. This combination aims to enhance cancer cell targeting and destruction while minimizing harm to healthy cells, offering a promising new approach for patients who have mutations that make them resistant to other treatments.
What evidence suggests that this trial's treatments could be effective for non-small cell lung cancer?
Research has shown that izalontamab brengitecan, which participants in this trial may receive, may effectively treat certain types of lung cancer. In studies, about 63% of patients with EGFR-mutated non-small cell lung cancer (NSCLC) experienced tumor shrinkage with this treatment, meaning more than half saw their tumors get smaller.
Osimertinib, another treatment option in this trial, is already recognized for its effectiveness. For patients with untreated EGFR-mutated NSCLC, it has been shown to prevent cancer from worsening for about 20.5 months on average, indicating its potential to slow cancer progression significantly. Both treatments in this trial have demonstrated positive results in shrinking tumors and delaying cancer growth.12345Who Is on the Research Team?
Bristol-Myers Squibb
Principal Investigator
Bristol-Myers Squibb
Are You a Good Fit for This Trial?
This trial is for adults with locally advanced or metastatic non-small cell lung cancer that has a specific EGFR mutation and who have not received prior treatment for this condition.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either izalontamab brengitecan combined with osimertinib, osimertinib alone, or osimertinib with platinum-based chemotherapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Carboplatin
- Cisplatin
- Izalontamab Brengitecan (BMS-986507)
- Osimertinib
- Pemetrexed
Trial Overview
The study compares three treatments: (1) izalontamab brengitecan plus osimertinib, (2) osimertinib alone, and (3) osimertinib with platinum-based chemotherapy. Participants are randomly assigned to one of these groups.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bristol-Myers Squibb
Lead Sponsor
Christopher Boerner
Bristol-Myers Squibb
Chief Executive Officer since 2023
PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis
Deepak L. Bhatt
Bristol-Myers Squibb
Chief Medical Officer since 2024
MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania
Citations
NCT07100080 | Study of Izalontamab Brengitecan (BMS- ...
A Study of Izalontamab Brengitecan (BMS-986507) versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer after failure of EGFR TKI Therapy.
Izalontamab Brengitecan in Locally Advanced or Metastatic ...
One case of grade 2 interstitial lung disease was observed. The confirmed ORR was 39.7%, and the DCR was 85.9%. The median PFS was 7.0 months (95% CIs, 5.4 to ...
3.
appliedclinicaltrialsonline.com
appliedclinicaltrialsonline.com/view/fda-grants-breakthrough-therapy-designation-izalontamab-brengitecan-egfr-mutated-nsclcFDA Grants Breakthrough Therapy Designation to ...
In Phase I results, NSCLC patients with EGFR exon 20 insertions had an 86% confirmed response rate, and KRAS G12C patients also showed ...
Izalontamab Brengitecan in Locally Advanced or Metastatic ...
Patients with EGFR exon20ins or other nonclassical mutations achieved an ORR of 69.2% with a median PFS of 10.5 months (95% CI, 6.9 to not ...
Izalontamab Brengitecan (EGFRxHER3 ADC) Granted ...
While EGFR TKIs have shown clinical efficacy in the frontline setting, most patients eventually see their cancer progress after about 18 months ...
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