Testing safety and effects of telisotuzumab and docetaxel in Lung Cancer patients

Recruting new patients

Select region:

Navigation:

    What is this study about?

    This study is for adults who have been treated before for a type of lung cancer called non-small cell lung cancer (NSCLC). The aim is to see if a new drug, called telisotuzumab vedotin, works better and is as safe as a common drug called docetaxel. In this study, cancer activity and any side-effects will be observed closely. The treatment will be given by a drip into a vein.The researchers will randomly decide whether each participant will get telisotuzumab vedotin or docetaxel, with an equal chance of getting either drug. While in the study, each person will have regular hospital or clinic visits to check how they are doing with tests and questionnaires.

    Learn more about this Trial

      I accept the Terms of Use and Privacy Policy*

       I consent to the Service Operator sending commercial information*

      I consent to the Service Operator using telecommunications terminal devices and automatic calling systems in marketing communications*

      Success

      Your form submitted successfully!

      Error

      Sorry! your form was not submitted properly, Please check the errors above.

      Locations

      Where does the clinical trial take place?

      Linz , Austria

      Wels , Austria

      Feldkirch , Austria

      Vienna , Austria

      Vienna , Austria

      Salzburg , Austria

      Edegem , Belgium

      Charleroi , Belgium

      La Louviu00e8re , Belgium

      Brasschaat , Belgium

      Gent , Belgium

      Hasselt , Belgium

      Namur , Belgium

      Burgas , Bulgaria

      Plovdiv , Bulgaria

      Sofia , Bulgaria

      Varna , Bulgaria

      Brno , Czechia

      Novy Jicin , Czechia

      Roskilde , Denmark

      Odense C , Denmark

      Pessac , France

      Paris CEDEX 14 , France

      Montpellier Cedex 5 , France

      Paris , France

      Mannheim , Germany

      Gieu00dfen , Germany

      Jena , Germany

      Berlin , Germany

      Hamburg , Germany

      Hamburg , Germany

      Heidelberg , Germany

      Kassel , Germany

      Athens , Greece

      Piraeus , Greece

      Piraeus , Greece

      Thessaloniki , Greece

      Rome , Italy

      Perugia , Italy

      Bari , Italy

      Cremona , Italy

      Varese , Italy

      Den Haag , Netherlands

      Harderwijk , Netherlands

      Maastricht , Netherlands

      Zwolle , Netherlands

      Lodz , Poland

      Rzeszow , Poland

      Olsztyn , Poland

      Lisboa , Portugal

      Porto , Portugal

      Porto , Portugal

      Porto , Portugal

      Porto , Portugal

      Cluj-Napoca , Romania

      Otopeni , Romania

      Timisoara , Romania

      Brasov , Romania

      Craiova , Romania

      Suceava , Romania

      Banska Bystrica , Slovakia

      Las Palmas de Gran Canaria , Spain

      Alcorcon , Spain

      Avila , Spain

      Barcelona , Spain

      Barcelona , Spain

      Jaen , Spain

      Madrid , Spain

      Valencia , Spain

      Gothenburg , Sweden

      Stockholm , Sweden

      London , United Kingdom

      Nottingham , United Kingdom

      London , United Kingdom

      Manchester , United Kingdom

      You can join this study in:

      Study Steps

      How Complex Will My Study Be and What Phases Will I Go Through?

      In the clinical trial, as a patient, you will need to follow these steps:

      1. Receive Intravenous (IV) telisotuzumab vedotin every 2 weeks, or
      2. Receive IV docetaxel every 3 weeks.

      This treatment regimen will continue until you meet the study drug discontinuation criteria.

      Additionally, you will be required to attend regular visits during the study at a hospital or clinic.


      Diseases Under Investigation

      What Conditions Qualify Me for This Study?

      To be eligible to join the study based on disease criteria, you must:

      1. Have c-Met overexpressing non-small cell lung cancer (NSCLC) as assessed by an AbbVie designated immunohistochemistry (IHC) laboratory using the VENTANA MET (SP44) RxDx assay.
      2. Have a histologically documented non-squamous cell NSCLC that is locally advanced or metastatic.
      3. Have a known epidermal growth factor receptor (EGFR) activating mutation status.
      4. Have actionable alterations in genes other than EGFR.
      5. Have progressed on at least one line of prior therapy for locally advanced/metastatic NSCLC.

      Please note that there are also specific criteria for your general health condition and previous treatments that must be met to qualify for the study.


      Terms and conditions

      What Requirements I Have to Meet To Join This Study?

      When Am I Eligible to Join the Study?

      Inclusion Criteria:

      1. Participants must have c-Met overexpressing non-small cell lung cancer (NSCLC) as assessed by an AbbVie designated immunohistochemistry (IHC) laboratory using the VENTANA MET (SP44) RxDx assay.
        • c-Met is a protein that may be involved in the growth and spread of cancer cells.
        • Non-small cell lung cancer (NSCLC) is the most common type of lung cancer.
        • Immunohistochemistry (IHC) is a lab test that uses antibodies to check for certain antigens (proteins) in a sample of tissue.
      2. Archival or fresh tumor material must be submitted for assessment of c-Met levels during the Pre-Screening period. Tumor material from the primary tumor site and/or metastatic sites are allowed.
      3. A histologically documented non-squamous cell NSCLC that is locally advanced or metastatic.
        • Non-squamous cell refers to cancer cells that are not flat cells that line the surface of airways in the lungs.
        • Locally advanced means cancer has spread to nearby tissues or lymph nodes.
        • Metastatic means cancer has spread from where it started to other parts of the body.
      4. A known epidermal growth factor receptor (EGFR) activating mutation status.
        • EGFR activating mutation refers to changes in the EGFR gene that can lead to enhanced growth of cancer cells.
      5. Actionable alterations in genes other than EGFR.
      6. Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
        • RECIST 1.1 is a standard way to measure how well a cancer treatment is working by looking at changes in the size of tumors.
      7. An Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
        • ECOG Performance Status is a scale to assess how a patient’s disease affects their daily living abilities.
      8. Have received no more than 1 line of prior systemic cytotoxic chemotherapy in the locally advanced or metastatic setting.
        • Systemic cytotoxic chemotherapy refers to drugs that kill rapidly dividing cells, including cancer cells, used throughout the body.
      9. Have progressed on at least 1 line of prior therapy for locally advanced/metastatic NSCLC.
      10. Must be considered appropriate for docetaxel therapy based on the assessment of the treating physician.
        • Docetaxel therapy is a type of chemotherapy used to treat various cancers including NSCLC.
      11. Participants with metastases to the central nervous system (CNS) are eligible only after definitive therapy (such as surgery or radiotherapy) and are asymptomatic and off or on a stable or reducing dose of systemic steroids and/or anticonvulsants for at least 2 weeks prior to first dose of the study drug.
        • CNS metastases are cancer cells that have spread to the brain or spinal cord.
        • Definitive therapy is treatment with the intent to cure.
        • Systemic steroids and anticonvulsants are medications that can be used to reduce swelling in the brain and control seizures, respectively.

      Please let me know if you wish to have more detailed explanations for any of the medical terms or any other questions related to the trial.

      What Reasons Could Exclude Me from the Study?

      Conditions that prevent participation in the study:

      1. Adenosquamous histology: A mixed type of lung cancer that contains two types of cells—adenocarcinoma and squamous cell carcinoma.
      2. Actionable epidermal growth factor receptor (EGFR) activating mutations: Specific changes in the EGFR gene that can be targeted by certain treatments.
      3. Prior c-Met-targeted antibodies, telisotuzumab vedotin, or antibody-drug conjugates (ADC) targeting c-Met or consisting of monomethylauristatin E: Previous treatments with certain drugs aimed at the c-Met protein on cancer cells or drugs linked to a cell-killing agent.
      4. Prior docetaxel therapy: Previous treatment with a chemotherapy drug called docetaxel.
      5. History of other malignancies with exceptions:
        • Cancer treated with the intent to cure and no active disease for ≥2 years before the study drug’s first dose, considered low risk for coming back.
        • Non-melanoma skin cancer or lentigo maligna adequately treated, with no sign of disease.
        • Carcinoma in situ adequately treated, with no sign of disease.
      6. History of idiopathic pulmonary fibrosis, organizing pneumonia (like bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis: Conditions involving lung scarring or inflammation without a known cause or as a reaction to medication.
      7. Active pneumonitis: Inflammation of the lung tissue, detectable on a screening chest CT scan.
      8. Unresolved adverse event (AE) ≥ Grade 2 from prior anticancer therapy: Ongoing side effects from previous cancer treatment that are moderate or worse, except for hair loss or anemia.
      9. Major surgery within 21 days prior to the first dose of telisotuzumab vedotin: Significant surgical procedures done within three weeks before starting the treatment in the study.
      10. Clinically significant conditions: Other serious health issues as described in the trial protocol.

      Investigational Medicinal Product

      What Products Are Being Used in This Study?

      The drugs involved in the study are:

      1. Telisotuzumab Vedotin (ABBV-399): An experimental biological drug being developed for the treatment of non-small cell lung cancer (NSCLC). It is received by participants every 2 weeks until meeting study drug discontinuation criteria.
      2. Docetaxel: An active chemotherapy agent used as a treatment for a variety of cancers including NSCLC. Participants will receive docetaxel every 3 weeks until meeting study drug discontinuation criteria.

      Have the Medicinal Substances Used in the Trial Been Previously Studied in Medicine?

      The clinical trial involves the following active substances:

      1. Met-targeted antibodies: These are antibodies that are designed to target the c-Met receptor, which is known to play a role in the growth, invasion, and metastasis of tumors.
      2. Telisotuzumab vedotin: This is an antibody-drug conjugate which consists of an antibody targeting c-Met, linked to a cytotoxic agent. Telisotuzumab vedotin is known to bind to c-Met expressing cells, such as certain cancer cells, and deliver the cytotoxic agent to induce cell death.
      3. Monomethylauristatin E (MMAE): This is the cytotoxic agent used in some antibody-drug conjugates, including telisotuzumab vedotin. It is designed to be released inside the target cells to cause cell death. MMAE is a known anti-cancer agent with a mechanism of action similar to that of traditional chemotherapy, disrupting microtubules and thus inhibiting cell division.

      These substances are indeed known to medicine and have been described in medical literature. Antibody-drug conjugates, and particularly those using MMAE, represent an advanced approach to targeted cancer therapy by combining the specificity of antibodies with the cell-killing activity of cytotoxic drugs.


      Study ID

      CT-EU-00054335

      Recruitment status

      Recruting new patients

      Start of the trial

      2 years ago

      Study phase

      Phase
      III

      Medicinal Product