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

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What is this study about?

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.

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 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 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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

Site Name City Country Status
Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie Lublin Poland

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France
Oslo Universitetssykehus HF Oslo Norway
Hospital Universitario Y Politecnico La Fe Valencia Spain
Oncopole Claudius Regaud Toulouse France
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Asklepios Kliniken Hamburg GmbH Hamburg Germany
Hopital Tenon Paris France
Centrul De Oncologie-Euroclinic S.R.L. Iasi Romania
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy Bydgoszcz Poland
Centro Di Riferimento Oncologico Di Aviano Aviano Italy
Netherlands Cancer Institute Amsterdam The Netherlands
Istituto Europeo Di Oncologia S.r.l. Milan Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Universitair Ziekenhuis Gent Gent Belgium
Asklepios Klinik Gauting GmbH Gauting Germany
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Hospital Universitario 12 De Octubre Madrid Spain
Geniko Nosokomeio Thessalonikis George Papanikolaou Thessaloniki Greece
Vitaz Sint-Niklaas Belgium
Hospital Clinico Universitario Lozano Blesa Zaragoza Spain
Radiotherapy Center Cluj S.R.L. Floresti Romania
Klinikum Esslingen GmbH Esslingen Am Neckar Germany
Evangelische Lungenklinik Berlin Krankenhausbetriebs gGmbH Berlin Germany
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti Bucharest Romania
Ziekenhuis St Jansdal Harderwijk The Netherlands
AORN San Giuseppe Moscati Avellino Avellino Italy
Chirec Brussels Belgium
Robert Bosch Gesellschaft fuer medizinische Forschung mbH Stuttgart Germany
Centrul De Diagnostic Si Tratament Provita S.A. Bucharest Romania
Centrul De Oncologie SF Nectarie S.R.L. Craiova Romania
Institutul Regional De Oncologie Iasi Iasi Romania
Virgen del Rocío University Hospital Sevilla Spain
Vestre Viken HF Drammen Norway
Azienda Ospedaliero-Universitaria San Luigi Gonzaga Orbassano Italy
Klinikum Chemnitz gGmbH Chemnitz Germany
Kliniken der Stadt Koeln gGmbH Cologne Germany
Gasthuiszusters Antwerpen Antwerp Belgium
Klinikum Kassel GmbH Kassel Germany
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Cluj Napoca Romania
Centre Hospitalier Universitaire De Nantes Nantes France
Azienda Unita Sanitaria Locale Della Romagna Faenza Italy
Spitalul De Oncologie Monza S.R.L. Bucharest Romania
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Centre Hospitalier Lyon Sud Pierre Benite France
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Namur Belgium
Onkologisches Zentrum Donauwörth Donauwörth Germany
Institut de Cancérologie de l’Ouest Saint-Herblain France
Aiudsan Ofiyohdzlvc Uyfypwhbrzekh Pxrft Parma Italy
Sbopuvfm Pwkuwnnmo Soy z okrr Gdynia Poland
Ttfrlschzs Cyxkvw Hzellhun Thessaloniki Greece
Lvwym Gecffgk Hdccgrae Oy Aabthc Athens Greece
Atvtyicqy Uto Amsterdam The Netherlands
Anfxkhijqr Ptbkbizt Hybbfcic De Mebvgdpbs Marseille France
Hzgbq Bgmkys Ht Bergen Norway
Hajfufck Dy Ll Szfwy Ceze I Spjw Pyf Barcelona Spain
Fsjmsuwbt Pqsm Ly Izaikfnkmcwoz Bbhdqpjpl Ddu Hchjopfk Uwxjbrdgrwtdb Lq Psi Madrid Spain
Htkkucyh Vyae drmrfhoy Barcelona Spain
Ubqwtdwtop Gfqjcuw Hzuokebg Azhzfmb Athens Greece
Hsgwlttt Uyjylxkkaxnbmp Slhagytgnk &tihuqi Hnaksye dh Hwjhrbrzwuk STRASBOURG, Alsace France
Ifanscwn Cvwzg Paris France

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Not yet recruiting
12.01.2026
France France
Not yet recruiting
12.01.2026
Germany Germany
Not yet recruiting
12.01.2026
Greece Greece
Not yet recruiting
12.01.2026
Italy Italy
Not yet recruiting
12.01.2026
Norway Norway
Not yet recruiting
12.01.2026
Poland Poland
Not yet recruiting
12.01.2026
Romania Romania
Not yet recruiting
12.01.2026
Spain Spain
Not yet recruiting
12.01.2026
The Netherlands The Netherlands
Not yet recruiting
12.01.2026

Trial locations

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.

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 ID:
2025-521908-22-00
Protocol code:
CA244-0010
Trial Phase:
Therapeutic use (Phase IV)

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