Izalontamab Brengitecan vs Platinum-Pemetrexed for Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment called Izalontamab Brengitecan for individuals with non-small cell lung cancer that has an EGFR mutation. The researchers aim to determine if this treatment is more effective than the standard chemotherapy combination of platinum and pemetrexed. Participants have previously received a treatment targeting EGFR and require another option after it ceased to be effective. Individuals with non-squamous lung cancer, who have this specific mutation and have undergone prior treatment, might be suitable candidates. As a Phase 2, Phase 3 trial, this research measures the treatment's effectiveness in an initial, smaller group and represents the final step before FDA approval, offering hope for a new effective treatment option.
Do I need to stop my current medications for the trial?
The trial information does not specify if you need to stop 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 has promising safety results from earlier studies. In one study with patients who had advanced solid tumors, the treatment was generally well-tolerated. The most common side effects were mild, such as tiredness and nausea. More serious side effects occurred less frequently.
For patients with advanced bladder cancer, Izalontamab Brengitecan effectively shrank tumors in many cases, with a 44.1% success rate. This indicates that while side effects can occur, the treatment's benefits might outweigh the risks for some individuals.
As this trial progresses into later stages, evidence suggests the treatment is fairly safe for humans. However, discussing potential risks and benefits with a healthcare provider is crucial before participating.12345Why are researchers excited about this trial's treatments?
Izalontamab Brengitecan is unique because it combines an innovative approach with targeted therapy to fight lung cancer. Unlike traditional treatments like platinum-based chemotherapy and pemetrexed, which attack rapidly dividing cells indiscriminately, Izalontamab Brengitecan specifically targets cancer cells with a novel mechanism of action. This targeted approach not only aims to enhance effectiveness but also has the potential to reduce side effects typically associated with standard chemotherapy. Researchers are excited about Izalontamab Brengitecan because it represents a new frontier in precision oncology, offering hope for better outcomes in lung cancer treatment.
What evidence suggests that this trial's treatments could be effective for EGFR-mutated non-small cell lung cancer?
Research shows that Izalontamab Brengitecan has promising results for treating EGFR-mutated non-small cell lung cancer. Combined with osimertinib, it achieved a 100% success rate in shrinking tumors, with 95% of patients responding well at a certain dose. Previous studies suggest it can be effective when other treatments, such as EGFR TKI therapy, have failed. The FDA has recognized its potential by granting it Breakthrough Therapy Designation, indicating it could be very helpful for patients with this type of lung cancer. In this trial, researchers are testing Izalontamab Brengitecan in several experimental arms, making it a strong option for those seeking new treatments after others have failed.12567
Who 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 non-small cell lung cancer that has a specific EGFR mutation and has worsened despite treatment with an EGFR TKI therapy. They must be able to receive platinum-based chemotherapy, have non-squamous NSCLC not treatable by surgery or radiation with curative intent, and good organ/bone marrow function.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 or Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Izalontamab Brengitecan
Trial Overview
The study compares Izalontamab Brengitecan (BMS-986507), a new drug, against the standard combination of Platinum-Pemetrexed chemotherapy in patients whose lung cancer progressed after EGFR TKI therapy. Participants are randomly assigned to one of these treatments.
How Is the Trial Designed?
5
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
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.
News
SystImmune, Inc. to Present New Clinical Data on Izalontamab Brengitecan and BL-M07D1 Highlighting Strength of Differentiated Antibody Drug ...
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onclive.com
onclive.com/view/iza-bren-plus-osimertinib-elicits-100-orr-in-frontline-egfr-mutant-nsclcFrontline Iza-Bren Plus Osimertinib Elicits 100% ORR in ...
Iza-bren plus osimertinib achieved a 100% objective response rate in EGFR-mutated NSCLC, with a confirmed ORR of 95% at a 2.5 mg/kg dose. The 12 ...
4.
appliedclinicaltrialsonline.com
appliedclinicaltrialsonline.com/view/fda-grants-breakthrough-therapy-designation-izalontamab-brengitecan-egfr-mutated-nsclcFDA Grants Breakthrough Therapy Designation to ...
The FDA granted Breakthrough Therapy Designation to iza-bren for EGFR-mutated NSCLC after EGFR TKI and platinum chemotherapy, based on data ...
Study of Izalontamab Brengitecan (BMS-986507) Versus ...
A Study of Izalontamab Brengitecan (BMS-986507) versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer after failure of EGFR TKI Therapy.
ESMO 2025: First Phase 1 Safety and Efficacy Data ...
The US-Lung-101 study (NCT05983432), a global, multi-center, phas 1 study, evaluated the safety and efficacy of Izalontamab Brengitecan in ...
7.
onclive.com
onclive.com/view/izalontamab-brengitecan-data-reinforce-the-value-of-adcs-in-advanced-urothelial-carcinomaIzalontamab Brengitecan Data Reinforce the Value of ...
Izalontamab brengitecan showed a 44.1% objective response rate and 88.2% disease control rate in advanced urothelial carcinoma patients. The ...
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