Examining repotrectinib vs crizotinib in advanced lung cancer treatment

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    What is this study about?

    This trial is named TRIDENT-3, it’s for people who have a particular type of lung cancer that has spread beyond the lungs (advanced or metastatic). The lung cancer for this study is called ‘Non-Small Cell Lung Cancer’ (NSCLC) and it’s positive for an important part of the cells called ‘ROS1.’ The trial will compare two medicines: repotrectinib and crizotinib. People participating in the trial have not been treated with a group of drugs called ‘Tyrosine Kinase Inhibitors’ (TKIs) before. The main goal of this study is to see how effective and safe these two drugs are for these patients.

    Learn more about this Trial

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      Locations

      Where does the clinical trial take place?

      Wien , Austria

      Strasbourg , France

      Pessac , France

      Dijon , France

      Rouen , France

      La Tronche , France

      Saint-Herblain , France

      Pierre-Bu00e9nite , France

      Paris , France

      Esslingen , Germany

      Wuerzburg , Germany

      Oldenburg , Germany

      Dresden , Germany

      Berlin , Germany

      Gauting , Germany

      Immenhausen , Germany

      Ku00f6ln , Germany

      Mainz , Germany

      Patras , Greece

      Athens , Greece

      Chaidari , Greece

      Thessaloniki , Greece

      Budapest , Hungary

      Milan , Italy

      Monza , Italy

      Naples , Italy

      Rome , Italy

      Aviano , Italy

      Lublin , Poland

      Olsztyn , Poland

      Bucharest , Romania

      Craiova , Romania

      Bucureu0219ti , Romania

      Cluj , Romania

      Iau0219i , Romania

      A Coruu00f1a , Spain

      Santiago de Compostela , Spain

      Barcelona , Spain

      Madrid , Spain

      Majadahonda , Spain

      Mu00e1laga , Spain

      Sevilla , Spain

      Valu00e8ncia , Spain

      You can join this study in:

      Study Steps

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

      The clinical trial involves two arms of intervention:

      1. Arm A (Experimental): In this arm, patients will be given the drug Repotrectinib at a specified dose on specified days.
      2. Arm B (Active Comparator): In this arm, patients will be given the drug Crizotinib, also at a specified dose on specified days.

      The exact dosing schedule is not stated in the provided snippet, but it is indicated that the doses are predefined and will be taken according to a specific schedule.


      Diseases Under Investigation

      What Conditions Qualify Me for This Study?

      To join the study, you need to have a diagnosis of locally advanced or metastatic non-small cell lung cancer (NSCLC) with a ROS1 gene rearrangement/fusion.


      Terms and conditions

      What Requirements I Have to Meet To Join This Study?

      When Am I Eligible to Join the Study?

      To join the study, you must meet the following inclusion criteria:

      1. Confirmed diagnosis of NSCLC: You must have a histologically or cytologically confirmed diagnosis of locally advanced or metastatic non-small cell lung cancer (NSCLC). Histology and cytology refer to the microscopic examination of tissue or cells to identify the disease.
      2. ROS1 gene rearrangement/fusion: You must have a ROS1 gene rearrangement or fusion as detected by a local test. This refers to a specific genetic alteration where parts of the ROS1 gene have become rearranged or fused with another gene, which can drive cancer growth.
      3. Measurable lesion: You must have at least one measurable lesion according to RECIST v1.1, as assessed by the investigator. RECIST v1.1 stands for Response Evaluation Criteria in Solid Tumors and is a set of standardized criteria for measuring the response of solid tumors to treatment with respect to their size.
      4. No previous exposure to certain TKIs: You must not have been exposed previously to tyrosine kinase inhibitors (TKIs) that have shown activity in ROS1-positive NSCLC. TKIs are a type of targeted therapy that blocks certain enzymes involved in cell division and growth, particularly in cancer cells.
      5. Limited prior systemic treatment: Up to one prior line of systemic treatment for NSCLC is permitted. This means you can have received one previous treatment that circulates throughout the body to target cancer cells.
      6. ECOG Performance Status ≤ 2: Your performance status, as measured by the Eastern Cooperative Oncology Group (ECOG), should be 2 or lower. This scale is used to assess how a patient’s disease is affecting their daily living abilities.

      What Reasons Could Exclude Me from the Study?

      Based on the clinical trial document, here is a list of conditions under which you cannot take part in the study, along with explanations for medical terms where necessary:

      1. Symptomatic brain metastases or symptomatic leptomeningeal involvement: If you have brain metastases (cancer that has spread to the brain) or leptomeningeal involvement (cancer spread to the membranes covering the brain and spinal cord) that are causing symptoms, you cannot participate.
      2. History of previous cancer requiring therapy within the previous 2 years: If you have had another type of cancer for which you received treatment in the past two years, you may be excluded. However, certain skin cancers (squamous cell or basal-cell carcinoma) or any localized cancer that has been completely removed are not included in this exclusion.
      3. Known tumor targetable co-mutations or rearrangements: If you have other genetic changes in your tumor that can be targeted by specific treatments, you may not be eligible for this trial.
      4. Clinically significant cardiovascular disease (either active or within 6 months prior to enrollment): If you have important heart or blood vessel disease that is currently active or has been active within the past six months, you cannot take part in the study.

      Please note that there may be other protocol-defined inclusion/exclusion criteria that apply.


      Investigational Medicinal Product

      What Products Are Being Used in This Study?

      The clinical study involves two drugs:

      1. Repotrectinib (BMS-986472): a next-generation tyrosine kinase inhibitor targeting the ROS1 and TRK kinases. It is designed to effectively inhibit mutations that can cause resistance to other ROS1 inhibitors, potentially offering a new treatment option for patients with ROS1-positive cancers.
      2. Crizotinib (Xalkori): an oral tyrosine kinase inhibitor that targets ALK and ROS1. It is already approved for the treatment of certain types of non-small cell lung cancer (NSCLC) that express these genetic alterations. Crizotinib works by blocking the activity of the ALK or ROS1 protein, thereby preventing the cancer cells from growing and spreading.

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

      The two active substances being studied in the clinical trial are:

      1. Repotrectinib: This substance is known in the medical literature, and in the context of this trial, it is being administered at a specified dose on specified days to participants in the experimental Arm A. It is also referenced with another name, BMS-986472.
      2. Crizotinib: Also known in the medical literature, Crizotinib, marketed under the brand name Xalkori, is the active substance being used as an active comparator in Arm B of the trial, also given at a specified dose on specified days.

      Both substances are known and have been mentioned previously in medical literature. Crizotinib, in particular, has been approved by regulatory authorities for the treatment of certain types of non-small cell lung cancer. Repotrectinib is under investigation in this clinical trial for its efficacy and safety.


      Study ID

      CT-EU-00042124

      Recruitment status

      Recruting new patients

      Start of the trial

      6 months ago

      Study phase

      Phase
      III

      Medicinal Product