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

No sites found in this category

Verified Sites

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

Other Sites

Site Name City Country Status
Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie Lublin Poland
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Institutul Regional De Oncologie Iasi Iasi Romania
Centre Hospitalier Universitaire De Nantes Nantes France
Istituto Europeo Di Oncologia S.r.l. Milan Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Hospital General Universitario Gregorio Maranon Madrid Spain
Klinikum Esslingen GmbH Esslingen Am Neckar Germany
Onkologisches Zentrum Donauwörth Donauwörth Germany
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Cluj Napoca Romania
Centro Di Riferimento Oncologico Di Aviano Aviano Italy
Awfknjhpy Kayvsugp Hdnusyz Goig Hamburg Germany
Htghknm Tyzsx Paris France
Logmg Ggcbjrf Hlbrugma Os Aofzus Athens Greece
Hrvuyhpr Vhve dioxccgk Barcelona Spain
Vubczf dkf Rbuwe Utloiwxcgv Hhfbgwqu Sevilla Spain
Aziuynrsb Ucq Amsterdam The Netherlands
Alyuofiusa Psqulywd Hacagpvl Dc Mpknxofbh Marseille France
Hcrfn Bhuxtl Hs Bergen Norway
Ktuuqvwy Cejdvxqb getfa Chemnitz Germany
Kzgtijlk ddu Shshm Kewyz gmsjp Cologne Germany
Gjtdeixdapgdkhs Arfxdannk Antwerp Belgium
Kgdooczz Kexgwe Gswg Kassel Germany
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Idurkkde fypz Kppuggtbf Tujrrktoafyyjkywitn ugw Ifndyhblihcb Uvq ghybl Ulm Germany
Ussgyworhodz Zhubptshuz Gmmf Gent Belgium
Acpapvkec Kzclje Gnmilvv Gkmj Gauting Germany
Ubtplyvmxqprlpudaeftd Srrxxmzrajwpgeuwcs Amu Kiel Germany
Cukzcj Hdiiiwdjedn Llhm Sxr Pierre Benite France
Hwmbdyzq Uezknelqkevmp Pfmdxn Dc Hbadhp Dn Mvigiuyzbri Majadahonda Spain
Hspindjo Uvaryyadljrmh 1y Dh Olszjys Madrid Spain
Fybhyhhph Pesh Ls Ixrmkichajpcq Bhqppksnr Dqy Hrenurkn Umtpljymgmuas Lx Pux Madrid Spain
Gtqeam Ntqmccqviu Tdwbrrioocuka Gilpuq Purxrwsegnko Thessaloniki Greece
Cebktn Hycntrgnnic Uzxeggikahsfh Dgfmum Gtmnoqe Swfpcdsamlzxtdwapbwgibdyhp Namur Belgium
Sptxrzjr Pbfjpnjcd Shs z ozvt Gdynia Poland
Vzifa Sint-Niklaas Belgium
Hzfraivy Coomqpq Upwjyjiiopsde Lfwoca Btuyv Zaragoza Spain
Uakttxyyhb Ghwfifo Hqpbkmkk Auucwru Athens Greece
Hrkonaof Ukhiepwyejudph Sjmatgrxht &lhpuey Hwiigar do Hfbzxmlqade STRASBOURG, Alsace France
Crueoms Dq Olmwuxtcx Sx Nbmglvtm Sliywi Craiova Romania
Tccrdkjdnj Cfrtvc Hnrvkzmp Thessaloniki Greece
Cwexcju Dd Oywzbipqjjmnsszorqrx Sdbprk Iasi Romania
Vnxgef Vcxeg Hp Drammen Norway
Azgeuma Ojninotsvxwkwbuqltgtwsieh Syb Lhuje Gvkqixb Orbassano Italy
Anxfegg Upiaa Sknelexvg Levoaj Dujxb Rgccjre Faenza Italy
Salqphsy Dy Onjhtowmf Mhbuy Shpmqq Bucharest Romania
Azspejj Ocmjpxocpdg Unoznnwsrntwb Pkbqm Parma Italy
Cqigbcp Odyoxlgxq Ilg Paawi Fkfzgwheyh Llwpxqjxmyb W Bfnfwrsqer Bydgoszcz Poland
Nluvtekcoel Cphifj Isyzesfee Amsterdam The Netherlands
Rphgqe Bndhj Gvorxuyjjqbs friq mwyvnpanpklw Fhkdefbcw mic Stuttgart Germany
Cyjkuw Brussels Belgium
Rxvwortbbbxk Cxdgsj Cdzo Soctvn Floresti Romania
Ciizffi Df Dxpnrhxsou Si Trfpuymbq Pnezdbt Ssux Bucharest Romania
Eyjjzzetuzvs Lwfsecomprsk Bvusvl Kpcoxopxlsddeuoytyw gxbvx Berlin Germany
Ijeplmaonp Ophwrbmjo Pzmvn Dyi Axocpulyn Tiwqwprpfgul Bsqnyivvd Bucharest Romania
Zogmazxxeg Sv Jrykwly Harderwijk The Netherlands
Awav Slt Goqjzgoq Mbkmczk Ajprgbnj Avellino Italy
Ikijzffp dr Cbfullnrzsoy dn lunafgiggwyac Saint-Herblain France
Ijonyaub Chnrf 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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