Izalontamab Brengitecan + Osimertinib for Non-Small Cell Lung Cancer

Not yet recruiting at 208 trial locations
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Overseen ByFirst line of the email MUST contain NCT # and Site #.
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Bristol-Myers Squibb
Must be taking: Osimertinib
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

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.12345

Why 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.12345

Who Is on the Research Team?

BS

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

My cancer has an EGFR mutation that responds to EGFR-TKI treatment.
I have cancer outside the brain that can be measured on scans.
I have confirmed non-squamous NSCLC that is advanced, metastatic, or has come back.
See 1 more

Exclusion Criteria

Other protocol-defined inclusion/exclusion criteria apply
I do not have serious heart disease.
I do not have unstable or uncontrolled cancer in my brain or spinal cord.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either izalontamab brengitecan combined with osimertinib, osimertinib alone, or osimertinib with platinum-based chemotherapy

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

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

Group I: Arm AExperimental Treatment2 Interventions
Group II: Arm BActive Control4 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Bristol-Myers Squibb

Lead Sponsor

Trials
2,731
Recruited
4,127,000+
Headquarters
New York City, USA
Known For
Oncology & Cardiovascular
Top Products
Eliquis, Opdivo, Revlimid, Orencia
Christopher Boerner profile image

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 profile image

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.

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41779981/

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 ...

FDA 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 ...