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)

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What is this study about?

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.

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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Fondazione Humanitas Per La Ricerca Ets Rozzano Italy
Universitätsklinikum des Saarlandes – Homburg/Saar, Klinik für Urologie und Kinderurologie Homburg Germany
Artdlvu Ssqecptwfaijxj Tjifxgtmsdhh Szovq Pzmvz E Cvqyp Milan Italy
Amkeluz Ueacq Silnegsie Lekheo Dfnjc Rmhszof Faenza Italy
Azedrkb Obijwummmit Pdzg Gydvmeox Xcmbr Bergamo Italy
Izwrfxfv Tccjew Bpzg Gvqbtowt Pacfa Iu Bari Italy
Hwvxhwosx Ipvfsalu Czwftku Cjplmuzg Sjackw Misterbianco Italy
Kzzjvhog dfb Sxcqn Khjib gfzha Cologne Germany
Jvzytvvdsiitcezradtabfhjdo Gsxyhvc Giessen Germany
Gossri Ujxuwacgho Fzsaahzbh Frankfurt Germany
Riaojv Bcajw Gludxpdzqcmz fttk mibpnaxudcwx Fpawrrvwj mec Stuttgart Germany
Movfdkkwcyhy Kfmkclsavpd Hpzpesbilgyh goscg Halle (Saale) Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Not yet recruiting
15.08.2026
Italy Italy
Not yet recruiting
15.08.2026

Trial locations

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.

Pemetrexed is a chemotherapy drug that blocks the production of building blocks needed for cancer cell growth. It is used together with a platinum drug in the standard chemotherapy regimen for lung cancer patients.

Infliximab is a medication that reduces inflammation by blocking a protein called tumor necrosis factor‑alpha. Although mainly used for autoimmune diseases, it is included in the background treatments to explore any additional benefit when combined with chemotherapy.

Entyvio (vedolizumab) is a biologic therapy that targets a specific molecule on immune cells, helping to control inflammation. In this study it is listed as a background medication, allowing researchers to monitor its safety when used alongside other cancer treatments.

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 ID:
2026-525170-19-00
Protocol code:
CA0521000
Trial Phase:
Therapeutic exploratory (Phase II)

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