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Study of Izalontamab Brengitecan versus Platinum-based Chemotherapy for Patients with EGFR-mutated Non-small Cell Lung Cancer after EGFR Inhibitor Treatment

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study involves patients with a specific type of lung cancer called non-small cell lung cancer that has a particular change in a gene known as an EGFR mutation. This cancer has continued to grow despite treatment with medications called EGFR tyrosine kinase inhibitors. The study will compare a new treatment called izalontamab brengitecan, which may also be referred to by its code name BMS-986507, with standard chemotherapy treatments that are based on platinum drugs. The platinum-based chemotherapy options include either cisplatin or carboplatin given together with another drug called pemetrexed. Some patients may also receive pegfilgrastim, which is a medication used to help manage certain side effects of chemotherapy.

The purpose of the study is to find the best dose of izalontamab brengitecan in the first part of the study and then to compare how well this new treatment works compared to platinum-based chemotherapy in preventing the cancer from getting worse. The study is divided into two phases. In the first phase, researchers will look at the safety and effectiveness of different doses of izalontamab brengitecan to determine the recommended dose for the second phase. In the second phase, patients will be randomly assigned to receive either izalontamab brengitecan at the recommended dose or platinum-based chemotherapy, and the study will measure how long patients live without their cancer getting worse.

During the study, patients will receive their assigned treatment through infusions into a vein, with some medications also given as injections under the skin. The treatments will be given in cycles over an extended period, and patients will be monitored regularly to check how the cancer responds to treatment and to watch for any side effects. The study will collect information about survival, how long the cancer stays under control, and the overall safety of the treatments being tested.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Treatment assignment

    Upon joining the study, you will be randomly assigned to one of two treatment groups. This process is called randomization and ensures fairness in the study.

    You will receive either izalontamab brengitecan (also called BL-B01D1 or BMS-986507) or a platinum-based chemotherapy combination. The platinum-based chemotherapy consists of either cisplatin or carboplatin combined with pemetrexed.

    The study is open-label, which means you and your doctor will know which treatment you are receiving.

  2. Step 2

    Phase 2 treatment period

    If you join during the first phase of the study (Phase 2), the main goal is to determine the recommended dose of izalontamab brengitecan for the next phase.

    You will receive your assigned treatment through an intravenous infusion, which means the medication will be given directly into your vein.

    If you are assigned to the platinum-based chemotherapy group, carboplatin or cisplatin will be given through an intravenous infusion, and pemetrexed will also be given through an intravenous infusion.

    Additionally, you may receive pegfilgrastim as a subcutaneous injection, which means it will be injected under your skin.

    Your treatment will continue in cycles, and your doctor will monitor your response to the medication and any side effects you experience.

  3. Step 3

    Phase 3 treatment period

    If you join during the second phase of the study (Phase 3), the main goal is to compare how well izalontamab brengitecan works compared to platinum-based chemotherapy in delaying disease progression.

    You will receive your assigned treatment in the same manner as described in Phase 2.

    Izalontamab brengitecan will be given through an intravenous infusion.

    If you are assigned to the chemotherapy group, you will receive either carboplatin or cisplatin combined with pemetrexed, all given through intravenous infusions.

    Pegfilgrastim may be given as a subcutaneous injection to help support your immune system during treatment.

    Your treatment will continue in cycles until your disease progresses, you experience unacceptable side effects, or you and your doctor decide to stop treatment.

  4. Step 4

    Regular monitoring and assessments

    Throughout the study, you will have regular appointments to monitor your health and how the treatment is affecting your cancer.

    Your doctor will perform imaging scans to check the size and status of your tumor. These assessments will follow a standard method called RECIST v1.1, which is a set of rules used to measure how tumors respond to treatment.

    The scans will be reviewed by independent experts who do not know which treatment you are receiving. This is called Blinded Independent Central Review.

    Your doctor will also monitor you for any side effects or unwanted reactions to the medication.

    Blood tests and other examinations may be performed to assess how your body is responding to the treatment.

  5. Step 5

    Continuation of treatment

    You will continue receiving your assigned treatment as long as it is working to control your cancer and you are tolerating it well.

    Your doctor will regularly evaluate whether the treatment should continue based on your scan results and overall health.

    If your cancer progresses or you experience side effects that are too difficult to manage, your treatment may be stopped or adjusted.

  6. Step 6

    End of treatment and follow-up

    Once your treatment ends, you will enter a follow-up period.

    During this time, your doctor will continue to monitor your health and cancer status.

    The purpose of the follow-up is to collect information about your overall survival, which means how long you live after starting the treatment, and to track any long-term effects of the treatment.

    Follow-up appointments may include physical examinations, imaging scans, and questionnaires about your well-being.

Who can join the trial?

5 criteria

  • You must have non-squamous non-small cell lung cancer, which is a specific type of lung cancer based on how the cells look under a microscope, and your disease cannot be treated with the goal of curing it completely.
  • You must have proof through testing that your cancer has a specific change in a gene called EGFR mutation, specifically either an exon 19 deletion or L858R mutation, which are particular genetic changes in your cancer cells.
  • Your cancer must have gotten worse while taking or after taking a type of medication called a 3rd-generation EGFR-TKI, such as osimertinib, furmonertinib, or lazertinib, which are targeted drugs that block signals that help cancer cells grow. This must have been your most recent cancer treatment, whether given after surgery, for locally advanced disease, or for cancer that has spread to other parts of the body.
  • You must be suitable to receive a platinum-based doublet chemotherapy regimen, which means a combination of two chemotherapy drugs: either cisplatin or carboplatin together with pemetrexed. These are standard cancer-fighting medications given through an infusion into your vein.
  • You must be an adult, as the study accepts both male and female participants who are 18 years of age or older.

Who cannot join the trial?

3 criteria

  • The study does not list specific reasons that would prevent you from participating
  • Your doctor will review your individual medical situation to determine if this trial is appropriate for you
  • General factors that may affect your ability to join will be discussed with the research team during screening
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Investigated drugs

  • Izalontamab Brengitecan

    (also known as BMS-986507) is an investigational medication being studied for the treatment of non-small cell lung cancer. This medication is designed to target cancer cells in patients whose tumors have specific genetic changes called EGFR mutations and whose disease has gotten worse despite previous treatment with targeted therapies called tyrosine kinase inhibitors.

  • Platinum-based Chemotherapy

    refers to standard cancer treatment medications that contain platinum compounds. These are commonly used chemotherapy drugs that work by damaging the DNA of cancer cells to stop them from growing and dividing. This type of chemotherapy is a well-established treatment option for lung cancer patients.

What is already known about the treatment

Izalontamab Brengitecan – This medication is administered intravenously and is currently being studied in clinical trials for treating a specific type of lung cancer called EGFR-mutated non-small cell lung cancer, particularly in patients whose disease has progressed after previous targeted therapy treatments. It belongs to a class of drugs known as antibody-drug conjugates, which work by combining a targeted antibody that finds cancer cells with a chemotherapy drug that kills them, delivering the treatment directly to the tumor while minimizing damage to healthy cells. The study aims to determine the best dose for this medication and compare its effectiveness against standard platinum-based chemotherapy in slowing down cancer progression.

Investigated diseases

EGFR-mutated Non-small Cell Lung Cancer – This is a specific type of lung cancer that occurs when cells in the lung grow abnormally and contain changes in a gene called EGFR. The disease affects the larger airways of the lungs and is different from small cell lung cancer in how it behaves and spreads. The mutation in the EGFR gene causes cells to multiply uncontrollably, forming tumors in the lung tissue. As the disease progresses, the cancer cells can spread to nearby tissues and lymph nodes. In advanced stages, the cancer may spread to other parts of the body through the bloodstream or lymphatic system. This condition requires ongoing monitoring as it can develop resistance to certain medications over time.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2025-521908-22-00Protocol codeCA244-0010Estimated enrolment513 patientsSponsorBristol-Myers Squibb Services Unlimited Company

sourced from the EU Clinical Trials Register and site verification

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