Study new combination therapy in advanced lung cancer

Recruting new patients

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    What is this study about?

    This study is about testing a new drug mix to help people with advanced lung cancer (NSCLC) that doesn’t have special gene changes. The research aims to determine whether a combination of three drugs, namely Datopotamab Deruxtecan (Dato-DXd), Durvalumab, and Carboplatin, demonstrates superior efficacy compared to an alternative drug mixture. The people in this study have stage IIIB, IIIC, or IV lung cancer. They will be split in two groups. One group will get Datopotamab Deruxtecan, Durvalumab, and Carboplatin. The other group gets Pembrolizumab and some specific chemo drugs. he primary objective is to assess whether the new three-drug combination can effectively delay cancer growth and extend overall survival time.

    Learn more about this Trial

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      Locations

      Where does the clinical trial take place?

      Graz , Austria

      Rankweil , Austria

      Wien , Austria

      Wien , Austria

      Plovdiv , Bulgaria

      Sofia , Bulgaria

      Sofia , Bulgaria

      Varna , Bulgaria

      Brest , France

      Clermont-Ferrand , France

      Creteil , France

      Montpellier , France

      Nimes , France

      Paris , France

      Rouen , France

      Saint-Quentin cedex , France

      Strasbourg Cedex , France

      Toulon Cedex 9 , France

      Toulouse , France

      Tours , France

      Villefranche-sur-Sau00f4ne cedex , France

      Bad Berka , Germany

      Berlin , Germany

      Berlin , Germany

      Frankfurt A. Main , Germany

      Gauting , Germany

      Gu00fctersloh , Germany

      Hamburg , Germany

      Kassel , Germany

      Kiel , Germany

      Koblenz , Germany

      Minden , Germany

      Mu00f6nchengladbach , Germany

      Rosenheim , Germany

      Velbert , Germany

      Wu00fcrzburg , Germany

      Athens , Greece

      Athens , Greece

      Peiraias , Greece

      Thessaloniki , Greece

      Thessaloniki , Greece

      Budapest , Hungary

      Budapest , Hungary

      Gyu00f6ngyu00f6s – Mu00e1trahu00e1za , Hungary

      Kaposvu00e1r , Hungary

      Pu00e9cs , Hungary

      Szekszu00e1rd , Hungary

      Szolnok , Hungary

      Tu00f6ru00f6kbu00e1lint , Hungary

      Firenze , Italy

      Lecco , Italy

      Messina , Italy

      Napoli , Italy

      Orbassano , Italy

      Padova , Italy

      Parma , Italy

      Peschiera Del Garda , Italy

      Rozzano , Italy

      Bydgoszcz , Poland

      Bystra , Poland

      Grudziu0105dz , Poland

      Kielce , Poland

      Koszalin , Poland

      Olsztyn , Poland

      Poznau0144 , Poland

      Przemysl , Poland

      Racibu00f3rz , Poland

      Radom , Poland

      Siedlce , Poland

      Girona , Spain

      Las Palmas de Gran Canaria , Spain

      Lugo , Spain

      Madrid , Spain

      Santander , Spain

      Sevilla , Spain

      Valencia , Spain

      Zaragoza , Spain

      Gu00e4vle , Sweden

      Linku00f6ping , Sweden

      Lund , Sweden

      Stockholm , Sweden

      Uppsala , Sweden

      Aberdeen , United Kingdom

      Cambridge , United Kingdom

      Cardiff , United Kingdom

      Cheltenham , United Kingdom

      Edinburgh , United Kingdom

      London , United Kingdom

      London , United Kingdom

      Manchester , United Kingdom

      Middlesborough , United Kingdom

      Newcastle-Upon-Tyne , United Kingdom

      Taunton , United Kingdom


      Study Steps

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

      During this clinical trial, patients will follow these steps for treatment:

      1. Datopotamab deruxtecan (Dato-DXd) : Intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
      2. Durvalumab: Intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
      3. Carboplatin: Intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle for up to 4 cycles.

      Please note that the provided steps might vary based on the specific treatment arm a patient is assigned to and the drugs mentioned in different arms. For a complete and detailed schedule, including all possible interventions such as other drugs (pembrolizumab, cisplatin, pemetrexed, and paclitaxel) and their respective cycles, we would require more information or further details from the clinical trial documents.


      Diseases Under Investigation

      What Conditions Qualify Me for This Study?

      To join the study, you need to have one of the following:

      1. Histologically or cytologically documented non-small cell lung cancer (NSCLC) that, at the time of randomization, is Stage IIIB or IIIC disease not amenable to surgical resection or definitive chemoradiation, or Stage IV metastatic disease.
      2. Your NSCLC must lack sensitizing EGFR tumor tissue mutation and ALK and ROS1 rearrangements.
      3. You must not have documented tumor genomic alterations in NTRK, BRAF, RET, MET, or other actionable driver oncogenes for which there are approved and available therapies.

      These are the specific diseases required to be eligible for the study.


      Terms and conditions

      What Requirements I Have to Meet To Join This Study?

      When Am I Eligible to Join the Study?

      Here are the conditions you must meet to participate in the study, along with explanations of the medical terms:

      Inclusion Criteria:

      1. Participants must be at least 18 years old at the time of screening.
      2. A histologically or cytologically documented NSCLC (Non-Small Cell Lung Cancer) that at the time of randomization is Stage IIIB or IIIC disease not amenable to surgical resection or definitive chemoradiation, or Stage IV metastatic disease.
        • Stage IIIB/IIIC: This implies an advanced stage of lung cancer where the cancer has spread into nearby structures in the chest, and cannot be removed by surgery.
        • Stage IV: This indicates metastatic disease where cancer has spread to distant parts of the body.
      3. The patient lacks sensitizing EGFR tumor tissue mutation and ALK and ROS1 rearrangements, and has no documented tumor genomic alterations in NTRK, BRAF, RET, MET, or other actionable driver oncogenes with approved and available therapies (actionable genomic alterations).
        • EGFR mutation: Changes in the EGFR gene that can promote cancer growth.
        • ALK and ROS1: Gene rearrangements that can lead to the development of cancer.
        • NTRK, BRAF, RET, MET: Gene mutations or alterations that are known to drive cancer growth; treatments targeted against these are often available.

        Testing is not required for tumors with squamous histology, with exceptions.

      4. ECOG PS of 0 or 1:
        • ECOG PS (Eastern Cooperative Oncology Group Performance Status): A scale used to assess how a patient’s disease is progressing and how the disease affects the daily living abilities of the patient. ECOG PS 0 means fully active without restrictions, and ECOG PS 1 means some restriction in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature.
      5. Availability of archival tumor tissue for study-related testing.
      6. Must have adequate bone marrow reserve and organ function within 7 days before randomization. This typically refers to normal blood cell counts and proper function of organs like the liver and kidneys to ensure you can safely receive the treatment.

      These criteria ensure that participants are suitable for the therapies being studied and can safely undergo the treatment in the clinical trial.

      What Reasons Could Exclude Me from the Study?

      Here are the conditions under which you cannot take part in the study, with explanations of the medical terms where necessary:

      1. Mixed small-cell lung cancer and NSCLC histology: Having a combination of both small-cell lung cancer (a fast-growing type of lung cancer) and non-small cell lung cancer (NSCLC, which is more common and grows more slowly).
      2. Sarcomatoid variant of NSCLC: A rare type of non-small cell lung cancer that has certain features similar to sarcoma (a type of cancer that originates in the bones or soft tissues).
      3. History of another primary malignancy: Having had another type of cancer that is not related to the current diagnosis, with some exceptions permissible.
      4. Persistent toxicities caused by previous anti-cancer therapy: Ongoing side effects from previous cancer treatments that have not improved to a mild severity (Grade ≤ 1) or returned to how they were before treatment, with some exceptions permissible.
      5. Spinal cord compression: A condition where there is pressure on the spinal cord that may affect nerve function.
      6. Clinically or radiologically active brain metastases: If there are symptoms or imaging evidence of cancer that has spread to the brain and is currently causing problems.
      7. History of leptomeningeal carcinomatosis: A condition where cancer has spread to the membranes covering the brain and spinal cord.
      8. Known active or uncontrolled hepatitis B or C virus infection: Having a current infection with either hepatitis B or C virus that is not being successfully managed or treated.

      Please let me know if you need further information or clarification on any other point.


      Investigational Medicinal Product

      What Products Are Being Used in This Study?

      The drugs involved in the study along with a brief description of each active substance are as follows:

      1. Datopotamab Deruxtecan (Dato-DXd): This is an antibody-drug conjugate composed of a humanized anti-TROP2 antibody linked to a topoisomerase I inhibitor payload. TROP2 is a protein overexpressed in various types of cancers, including NSCLC (non-small cell lung cancer), and the drug is designed to deliver the chemotherapeutic directly to the cancer cells.
      2. Durvalumab (Imfinzi): Durvalumab is a human monoclonal antibody that blocks the interaction of PD-L1 with PD-1 and CD80. By inhibiting this interaction, durvalumab is designed to help the immune system recognize and attack cancer cells.
      3. Carboplatin: Carboplatin is a chemotherapy medication used to treat various forms of cancer. Carboplatin works by interfering with the DNA of cancer cells, which stops them from dividing and growing.
      4. Pembrolizumab: Pembrolizumab is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2. It is an immune checkpoint inhibitor, which helps to reactivate immune responses against cancer cells.
      5. Cisplatin: Cisplatin is a platinum-based chemotherapy drug used to treat various types of cancers. Similar to carboplatin, it disrupts the DNA structure within cancer cells, preventing them from replicating and leading to cell death.
      6. Pemetrexed: Pemetrexed is a folate antimetabolite chemotherapy drug. It inhibits several enzymes that are necessary for nucleotide and DNA synthesis, which is necessary for cancer cell replication.
      7. Paclitaxel: Paclitaxel is a chemotherapy medication that interferes with the normal function of microtubule breakdown. It prevents the cell cycle from progressing, thereby inhibiting cell division and promoting apoptosis or programmed cell death in cancer cells.

      These drugs are being studied for their effectiveness when used alone or in combination to treat locally advanced or metastatic non-small cell lung cancer (NSCLC) without actionable genomic alterations.

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

      It seems there was an issue with quoting the necessary information from the document. Let’s try again to quote the required details on the active substances used in the clinical trial. I will manually list out the substances mentioned previously:

      1. Datopotamab Deruxtecan (Dato-DXd): This is an experimental drug under investigation in this clinical trial. It is an antibody-drug conjugate which means it is a combination of an antibody with a cytotoxic substance designed to target and kill cancer cells.
      2. Durvalumab: This drug is known in medical literature and is used for the treatment of certain types of cancer. It is an immunotherapy drug that works by helping your immune system to fight cancer cells.
      3. Carboplatin: Carboplatin is a chemotherapy drug that is well-known and frequently used in the treatment of various types of cancer. It works by damaging the DNA of cancer cells, which stops them from dividing and growing.
      4. Pembrolizumab: Pembrolizumab is also known in the medical literature as an immunotherapy drug used to treat cancers. It works by blocking a specific pathway to promote the immune system’s ability to fight cancer cells.
      5. Cisplatin: This is a chemotherapy medication widely used to treat a variety of cancers. Similar to carboplatin, it binds to the DNA in cancer cells, preventing them from replicating and growing.
      6. Pemetrexed: Known in medical literature, pemetrexed is used as a chemotherapy agent primarily for treating lung cancer. It disrupts folate-dependent metabolic processes essential for cell replication.
      7. Paclitaxel: Paclitaxel is a well-known chemotherapy drug that interferes with the normal function of microtubules during cell division.

      Each of these substances has been studied and is known to the medical literature, with some already approved for use in various diseases. The clinical trial aims to assess the efficacy and safety of a specific combination of these drugs in treating patients with non-small cell lung cancer (NSCLC).


      Study ID

      CT-EU-00042026

      Recruitment status

      Recruting new patients

      Start of the trial

      1 year ago