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Phase III Study of Izalontamab Brengitecan with Drug Combination versus Osimertinib Alone in First‑Line EGFR‑Mutated Advanced or Metastatic Non‑Small Cell Lung Cancer

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

The study examines patients with EGFR‑mutant non‑small cell lung cancer that is locally advanced or has spread to other parts of the body. An EGFR mutation is a genetic change that can cause the cancer to grow faster. Standard first‑line treatment often includes platinum‑based chemotherapy, which may contain drugs such as pemetrexed, carboplatin or cisplatin. This trial is testing a new antibody‑drug conjugate called izalontamab brengitecan together with the targeted oral medication osimertinib.

The purpose of the study is to find out whether the combination of izalontamab brengitecan and osimertinib can keep the cancer from getting worse for a longer time than either osimertinib alone or osimertinib combined with platinum‑based chemotherapy. Participants receive the assigned treatment in regular cycles, attend clinic visits for safety checks, and have imaging scans to monitor the disease. The study follows patients to record how long they live without disease progression and overall survival.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline Assessments

    After enrollment, you will undergo a series of baseline assessments that include a review of your medical history, physical examination, laboratory blood tests, and imaging studies to document the extent of the lung cancer.

  2. Step 2

    Start Oral Osimertinib

    You will begin taking osimertinib mesylate by mouth at a dose of 9999 mg once each day. The medication is taken continuously throughout the study unless your doctor decides to stop it.

  3. Step 3

    Intravenous Izalontamab Brengitecan (Combination Arm)

    If you are assigned to the combination arm, you will receive an intravenous infusion of izalontamab brengitecan at a dose of 9999 mg per kilogram of body weight. The infusion is given on Day 1 of each treatment cycle, which typically repeats every three weeks.

  4. Step 4

    Intravenous Platinum‑Based Chemotherapy (Comparator Arm)

    If you are assigned to the chemotherapy comparator arm, you will receive the following intravenous drugs on Day 1 of each cycle:

    Carboplatin 750 mg, Cisplatin 75 mg per square meter of body‑surface area, and Pemetrexed 500 mg per square meter of body‑surface area. The chemotherapy is administered every three weeks while you continue daily oral osimertinib.

  5. Step 5

    Supportive Pegfilgrastim Injection

    After each chemotherapy cycle, you will receive a subcutaneous injection of pegfilgrastim at a dose of 9999 mg. This medication helps reduce the risk of low white‑blood‑cell counts caused by chemotherapy.

  6. Step 6

    Regular Monitoring Visits

    Throughout the study you will attend scheduled clinic visits every six to eight weeks. During these visits you will have blood tests, safety assessments, and imaging scans to evaluate how the cancer is responding and to monitor for side effects.

  7. Step 7

    Continuation of Treatment

    You will continue to receive the assigned study medications—daily oral osimertinib and, depending on your group, either the intravenous izalontamab brengitecan infusion or the platinum‑based chemotherapy with supportive pegfilgrastim—for as long as the medication is tolerated and until your disease progresses or unacceptable toxicity occurs.

  8. Step 8

    End‑of‑Study Assessments

    When treatment stops, you will undergo final assessments that include a physical exam, laboratory tests, and imaging to document the overall outcome of the study for you.

Who can join the trial?

3 criteria

  • Be 18 years or older and have a type of lung cancer called non‑squamous non‑small cell lung cancer that is locally advanced or has spread (metastatic), with a confirmed genetic change called an EGFR exon 19 deletion or an exon 21 L858R substitution.
  • Have at least one tumor that can be measured on scans outside the brain, be able to carry out normal daily activities with little or no limitation (a score of 0 or 1 on the ECOG Performance Status scale), and have a sample of tumor tissue available for testing before treatment begins.
  • If you have previously received extra (adjuvant) treatment after surgery, you may have had platinum‑based chemotherapy at least 4 weeks before the study starts, or immunotherapy at least 8 weeks before the study starts; however, if your cancer got worse within 12 months after finishing platinum‑based chemotherapy, you cannot receive that chemotherapy again in this study.

Who cannot join the trial?

5 criteria

  • Having active, symptomatic, or uncontrolled brain metastases (cancer that has spread to the brain and is currently causing problems or not well‑controlled).
  • Having another cancer at the same time (concurrent malignancy) or a previous cancer that was active within the last two years.
  • Having a serious or uncontrolled medical problem, an active infection, or important abnormal results on a physical exam or lab tests.
  • Having an altered mental status (confusion or reduced awareness) or a psychiatric condition that could make it hard to follow the study.
  • Having already received systemic antitumor therapy as the first treatment (first‑line treatment) for advanced disease.
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Investigated drugs

  • PEGFILGRASTIM

    is given as a subcutaneous injection to help the bone marrow make more white blood cells. In this study it is used to prevent low white‑blood‑cell counts that can happen after chemotherapy, making it safer for patients to receive their cancer treatment.

  • PEMETREXED

    is an intravenous chemotherapy drug that interferes with the cancer cells’ ability to grow and divide. In the trial it is part of a standard chemotherapy regimen that is compared with the new experimental combination.

  • CARBOPLATIN

    is another intravenous chemotherapy medication. It works by damaging the DNA of cancer cells, which stops them from multiplying. It is used together with pemetrexed in the standard chemotherapy arm of the study.

  • OSIMERTINIB MESYLATE

    is an oral targeted therapy that blocks a specific mutant form of the EGFR protein that drives many lung cancers. Patients in the trial receive this drug either alone, with standard chemotherapy, or together with the experimental drug to see which approach works best.

  • BMS-986507

    (also known as izalontamab brengitecan) is an investigational antibody‑drug conjugate given by IV infusion. It is designed to find and bind to cancer cells and then deliver a chemotherapy payload directly to them. In the study it is tested in combination with osimertinib to see if this new pairing can keep the cancer from growing longer than current treatments.

  • CISPLATIN

    is an intravenous chemotherapy agent that also damages DNA in cancer cells, preventing them from dividing. It is included in one of the standard chemotherapy combinations used as a comparison for the experimental treatment.

What is already known about the treatment

  • Pegfilgrastim

    Pegfilgrastim is given as a subcutaneous injection to help the body produce more white blood cells during chemotherapy; it is an approved medication widely used in oncology. It works by mimicking a natural protein that tells the bone marrow to make neutrophils, which fight infections. This drug belongs to the class of colony‑stimulating factors and is used mainly to prevent low white‑cell counts in cancer patients.

  • Pemetrexed

    Pemetrexed is administered by intravenous infusion and is an approved chemotherapy for non‑small cell lung cancer and malignant mesothelioma. It blocks several enzymes needed for making DNA, which stops cancer cells from growing. It is classified as an antifolate antimetabolite and is used as a standard part of lung‑cancer treatment regimens.

  • Carboplatin

    Carboplatin is given as an intravenous infusion and is an approved platinum‑based chemotherapy for many cancers, including lung cancer. It creates cross‑links in the DNA of tumor cells, preventing them from dividing and leading to cell death. It belongs to the class of platinum compounds and is commonly combined with other drugs in cancer therapy.

  • Osimertinib

    Osimertinib is taken as an oral tablet and is FDA‑approved for EGFR‑mutated non‑small cell lung cancer. It binds irreversibly to the mutant EGFR protein, blocking the signal that makes cancer cells grow. This drug is a third‑generation EGFR tyrosine‑kinase inhibitor and is used as a targeted first‑line treatment for this type of lung cancer.

  • Izalontamab brengitecan

    Izalontamab brengitecan is delivered by intravenous infusion of a solution for infusion and is currently an investigational antibody‑drug conjugate in clinical trials for EGFR‑mutant lung cancer. It links an antibody that seeks out tumor cells with a chemotherapy payload that cuts DNA, delivering the toxic drug directly to cancer cells. It is classified as an antibody‑drug conjugate and is being studied as a new treatment option in combination with osimertinib.

  • Cisplatin

    Cisplatin is given by intravenous infusion and is an approved platinum chemotherapy used for many solid tumors, including lung cancer. It forms cross‑links in DNA, which stops cancer cells from copying their genetic material and leads to cell death. This medication belongs to the class of platinum alkylating agents and remains a cornerstone of many cancer‑treatment regimens.

Investigated diseases

EGFR‑mutated locally advanced or metastatic non‑small cell lung cancer - It is a form of lung cancer that originates in the larger airways and does not have the small cell appearance under the microscope. The cancer cells carry an activating mutation in the epidermal growth factor receptor (EGFR) gene, which drives their growth. In the locally advanced stage, the tumor has spread to nearby structures in the chest but not to distant organs. In the metastatic stage, cancer cells have traveled through the bloodstream or lymph system to other parts of the body. The disease typically progresses by increasing tumor size and forming new lesions in other organs.
Trial detailsLast updated 8 Nov 2026
Age18+ yearsPhasePhase IIITrial ID2026-526486-21-00Protocol codeCA244-0020Estimated enrolment773 patientsSponsorBristol-Myers Squibb Services Unlimited Company

sourced from the EU Clinical Trials Register and site verification

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