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Phase 2 Study of Imzokitug with drug combination as First‑Line Treatment for Adults with Locally Advanced or Metastatic Non‑Small Cell Lung Cancer (NSCLC)

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 focuses on Non-Small Cell Lung Cancer, a common type of lung cancer that has grown beyond the original site or spread to other parts of the body. This condition can cause symptoms such as coughing, shortness of breath, and chest pain, and it is usually treated with a combination of medicines that try to shrink or stop the growth of the tumor.

Participants will receive an intravenous infusion of a new medicine called Imzokitug together with Pumitamig and a chemotherapy regimen known as Platinum-Doublet Chemotherapy. The chemotherapy uses two platinum‑based drugs that work by damaging the DNA of cancer cells, making it harder for them to grow. In the comparison group, patients will receive only Pumitamig and the same chemotherapy without the experimental drug. All medicines are given through a vein, usually every few weeks, and doctors will watch for side effects such as nausea, fatigue, or changes in blood counts.

The purpose of the trial is to see whether adding the experimental drug improves the proportion of patients whose tumors shrink or disappear, a measure called the objective response rate. Throughout the study, doctors will measure tumor size with imaging scans and evaluate the changes using criteria called RECIST, which provide a standard way to decide if a tumor has gotten smaller, stayed the same, or grown. Participants will be followed for several months after treatment to track how long any tumor shrinkage lasts, how long they stay without disease worsening, and overall survival, while safety is continually monitored.

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

    Initial enrollment and baseline assessments

    After you agree to participate, you will complete a consent form and undergo required screening procedures.

    Baseline assessments include physical examination, blood tests, and imaging scans to document the size and location of the lung cancer before any study medication is given.

  2. Step 2

    First treatment cycle

    You will receive an intravenous infusion of imzokitug. the exact dose and infusion time are defined in the study protocol and will be administered by a qualified health professional.

    Immediately after, you will receive an intravenous infusion of pumitamig at the dose specified by the study protocol.

    You will also receive a platinum‑doublet chemotherapy regimen, which includes a platinum drug (such as carboplatin or cisplatin) combined with a second chemotherapy agent (such as paclitaxel or pemetrexed). each drug is given at the dose and schedule described in the protocol and is administered as an infusion during the same visit.

  3. Step 3

    Subsequent treatment cycles

    Treatment cycles are repeated at regular intervals, typically every three weeks, for the number of cycles determined by the study design.

    Each cycle includes the same three infusions: imzokitug, pumitamig, and the platinum‑doublet chemotherapy combination.

    The total duration of treatment continues until the planned number of cycles is completed, disease progression is observed, or unacceptable side effects occur.

  4. Step 4

    Regular monitoring and response evaluation

    Before each new cycle, you will have blood tests and a brief physical check to ensure you are fit for the next infusion.

    Imaging scans (such as CT scans) are performed at predefined intervals, usually after several cycles, to assess tumor size.

    The study doctor will calculate the objective response rate, which measures how much the tumor has shrunk or disappeared, using standard criteria.

  5. Step 5

    Completion of treatment phase

    Once the planned treatment period ends, you will stop receiving the study drugs.

    A final set of assessments, including imaging and laboratory tests, will be performed to document the overall outcome of the therapy.

  6. Step 6

    Post‑treatment follow‑up

    After treatment ends, you will attend scheduled follow‑up visits for several months.

    These visits include physical examinations, blood tests, and periodic imaging to monitor for any delayed effects or disease recurrence.

Who can join the trial?

5 criteria

  • Must have locally advanced or metastatic non‑small cell lung cancer.
  • Must have tumors that can be measured on scans, using the standard called RECIST version 1.1 (a set of rules doctors use to determine the size of cancer).
  • Must have an ECOG Performance Status of 0 or 1, which means you are fully active (0) or able to do light work (1) and are not bedridden.
  • Must not have received any cancer‑treating medicines for advanced or metastatic disease before joining the study.
  • Must be an adult patient (male or female) who meets the trial’s age requirements.

Who cannot join the trial?

3 criteria

  • Untreated symptomatic central nervous system metastases: you cannot join if cancer from your lungs has spread to the brain or spinal cord and is causing symptoms (such as headaches, weakness, or vision changes) and has not been treated.
  • Actionable genomic alterations (AGAs) such as EGFR, ALK, ROS1, NTRK, MET, BRAF, or RET mutations: you cannot join if you have any of these specific genetic changes that could be treated with special medicines called targeted therapies.
  • Other medical conditions that increase risk: you cannot join if you have any other health problem that the doctor believes would make participation riskier for you, would interfere with giving the study drug safely, or would make it difficult to understand the study’s safety results.
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Investigated drugs

  • Imzokitug

    is an experimental medicine being studied for the first time in patients with advanced lung cancer. In this trial it is given together with other cancer drugs to see if it helps shrink tumors more effectively than the standard treatment alone.

  • Pumitamig

    is a new therapy that targets specific pathways that cancer cells use to grow. In the study it is tested both alone with chemotherapy and in combination with the experimental drug Imzokitug to determine which approach works better.

  • Anti‑CCR8 NF mAb (BMS‑986340)

    is a monoclonal antibody that blocks a protein called CCR8, which can be involved in the body’s immune response to cancer. It is given by injection and is being evaluated as an additional option to boost the effect of chemotherapy.

  • Carboplatin

    is a chemotherapy medicine that contains platinum. It works by damaging the DNA of cancer cells, which stops them from multiplying. In this trial it is part of the standard “platinum‑doublet” chemotherapy regimen used as a comparison.

  • Cisplatin

    is another platinum‑based chemotherapy drug. Like carboplatin, it interferes with the DNA of cancer cells and is commonly used in treating lung cancer. It is included in the background chemotherapy treatments for the study.

  • Paclitaxel

    is a chemotherapy agent that stops cancer cells from dividing by disrupting their internal structure. It is often combined with a platinum drug as part of the standard chemotherapy given to participants.

What is already known about the treatment

  • Vedolizumab

    This drug is given by intravenous infusion as a solution for infusion. It is an approved medicine used mainly for ulcerative colitis and Crohn’s disease. It works by blocking a protein called integrin α4β7, which helps immune cells enter the gut and cause inflammation. It belongs to the class of monoclonal antibodies that act as integrin antagonists.

  • Pumitamig

    This experimental agent is administered as a concentrate for solution for infusion given intravenously. It is currently being studied in clinical trials and is not yet approved for any indication. It is designed to modify the immune system to help fight cancer, though its exact target is still under investigation. It is classified as an investigational biologic therapy.

  • Paclitaxel

    Paclitaxel is delivered by intravenous infusion in a solution form. It is an approved chemotherapy drug used for many cancers, including lung cancer. It works by stabilizing tiny structures called microtubules inside cells, which stops cancer cells from dividing. It is classified as a taxane‑type chemotherapeutic agent.

  • Carboplatin

    Carboplatin is given by intravenous infusion as a sterile solution. It is an approved chemotherapy drug for several cancers such as lung and ovarian cancer. It damages cancer cells by attaching to DNA and forming cross‑links that prevent the cells from multiplying. It belongs to the class of platinum‑based anticancer agents.

  • Infliximab

    Infliximab is administered by intravenous infusion in a solution. It is an approved medication for autoimmune diseases like rheumatoid arthritis and Crohn’s disease. It works by neutralizing a protein called tumor necrosis factor‑alpha (TNF‑α), which reduces inflammation. It is a monoclonal antibody that acts as a TNF‑α inhibitor.

  • Cisplatin

    Cisplatin is given by intravenous infusion as a sterile solution. It is an approved chemotherapy drug used for many solid tumors, including lung cancer. It kills cancer cells by forming cross‑links in their DNA, which blocks cell growth and triggers cell death. It is classified as a platinum‑based chemotherapeutic agent.

Investigated diseases

Locally advanced or metastatic non‑small cell lung cancer (NSCLC) - This disease originates from the larger airway cells of the lung and does not have the tiny cells seen in small‑cell lung cancer. In the locally advanced stage, the tumor has grown beyond the lung but has not yet spread widely to distant organs. When it becomes metastatic, cancer cells travel through the bloodstream or lymph system and form new tumors in other parts of the body. The condition usually progresses slowly, with the primary tumor enlarging and additional sites of spread appearing over time. As the disease advances, patients may notice worsening cough, shortness of breath, or other respiratory symptoms.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2026-525170-19-00Protocol codeCA0521000Estimated enrolment160 patientsSponsorBristol-Myers Squibb Services Unlimited Company

sourced from the EU Clinical Trials Register and site verification

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