Evaluating treatment strategies for small-cell lung cancer: A clinical trial with lurbinectedin, irinotecan, and topotecan

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    What is this study about?

    This is a large test the researchers are running to help people with a certain type of lung cancer (called Small-cell Lung Cancer) that’s come back after they’ve had one type of treatment that contains platinum. The researchers are using three different ways of giving medicine to see which is best. The first way is to give only lurbinectedin. The second way is to give lurbinectedin and irinotecan together. The third way is to let the doctor decide to use topotecan or irinotecan alone. People’s selection to these groups will be by chance.

    Learn more about this Trial

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      Locations

      Where does the clinical trial take place?

      Salzburg , Austria

      Vienna , Austria

      Edegem , Belgium

      Brasschaat , Belgium

      Charleroi , Belgium

      Liu00e8ge , Belgium

      Liu00e8ge , Belgium

      Liu00e8ge , Belgium

      Mechelen , Belgium

      Mons , Belgium

      Sofia , Bulgaria

      Plovdiv , Bulgaria

      Sofia , Bulgaria

      Sofia , Bulgaria

      Aalborg , Denmark

      Nu00e6stved , Denmark

      Su00f8nderborg , Denmark

      Vejle , Denmark

      Besancon , France

      Boulogne-Billancourt , France

      Brest , France

      Caen , France

      Caen , France

      Cru00e9teil , France

      Limoges , France

      Nantes , France

      Paris , France

      Reims , France

      Strasbourg , France

      Suresnes , France

      Villejuif , France

      Grou00dfhansdorf , Germany

      Bad Berka , Germany

      Berlin , Germany

      Berlin , Germany

      Bremen , Germany

      Duisburg , Germany

      Esslingen , Germany

      Freiburg , Germany

      Gauting , Germany

      Halle (saale) , Germany

      Halle , Germany

      Heidelberg , Germany

      Karlsruhe , Germany

      Kassel , Germany

      Lu00f6wenstein , Germany

      Mannheim , Germany

      Mu00fcnchen , Germany

      Offenbach , Germany

      Debrecen , Hungary

      Farkasgyepu0171 , Hungary

      Kecskemu00e9t , Hungary

      Szolnok , Hungary

      Tu00f6ru00f6kbu00e1lint , Hungary

      Alessandria , Italy

      Ancona , Italy

      Aviano , Italy

      Bologna , Italy

      Catania , Italy

      Cuneo , Italy

      Florence , Italy

      Genova , Italy

      Milan , Italy

      Napoli , Italy

      Novara , Italy

      Orbassano , Italy

      Padova , Italy

      Piacenza , Italy

      Rionero In Vulture , Italy

      Roma , Italy

      Roma , Italy

      Siena , Italy

      Sondrio , Italy

      Varese , Italy

      Biau0142ystok , Poland

      Gdynia , Poland

      Lublin , Poland

      Prabuty , Poland

      Rzeszu00f3w , Poland

      Tomaszu00f3w Mazowiecki , Poland

      u0141u00f3du017a , Poland

      Baia Mare , Romania

      Cluj-Napoca , Romania

      Craiova , Romania

      Craiova , Romania

      Ovidiu , Romania

      Timiu015foara , Romania

      Badalona , Spain

      L’Hospitalet De Llobregat , Spain

      Santander , Spain

      Las Palmas De Gran Canaria , Spain

      Pamplona , Spain

      Vigo , Spain

      A Coruu00f1a , Spain

      Barcelona , Spain

      Cu00f3rdoba , Spain

      Lugo , Spain

      Madrid , Spain

      Madrid , Spain

      Madrid , Spain

      Madrid , Spain

      Madrid , Spain

      Madrid , Spain

      Madrid , Spain

      Madrid , Spain

      Madrid , Spain

      Mu00e1laga , Spain

      Sevilla , Spain

      Valencia , Spain

      Valladolid , Spain

      Zaragoza , Spain

      Belfast , United Kingdom

      Harlow , United Kingdom

      London , United Kingdom

      Manchester , United Kingdom

      Nottingham , United Kingdom

      Wirral , United Kingdom

      Wolverhampton , United Kingdom


      Study Steps

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

      W badaniu klinicznym pacjenci będą mieli następujące kroki do wykonania:

      – Pacjenci w grupie “Lurbinectedin plus Irinotecan” otrzymają irynotekan w dawce 75 mg/m² podaną dożylnie w dniach 1 i 8 co 3 tygodnie.
      – Pacjenci otrzymają również lurbinectedynę w dawce 3,2 mg/m², która będzie podawana dożylnie w dniu 1 co 3 tygodnie.

      Opisane działania będą się powtarzać cyklicznie co trzy tygodnie w ramach badania klinicznego.


      Diseases Under Investigation

      What Conditions Qualify Me for This Study?

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

      1. A histologically or cytologically confirmed diagnosis of Small Cell Lung Cancer (SCLC).
      2. One prior line of platinum-containing chemotherapy with or without anti-PD-1 or anti-PD-L1, provided at least 70% of the patients included in the study have been treated with anti-PD-1 or anti-PD-L1.

      Additionally, there are certain conditions that would exclude you from participating:

      1. If you are platinum-naïve (have not been treated with platinum-based chemotherapy) or have been treated with more than one prior chemotherapy regimen.
      2. If you have had prior treatment with specific drugs such as lurbinectedin, trabectedin, PM14, or topoisomerase I inhibitors like irinotecan and topotecan.
      3. If you have active or untreated Central Nervous System (CNS) metastases and/or carcinomatous meningitis.
      4. Patients with limited-stage disease who are candidates for specific local or regional therapies must have completed those treatments or refused them before randomization.
      5. If you have certain concomitant diseases/conditions, which also could count as exclusion criteria, including but not limited to unstable angina, myocardial infarction, congestive heart failure, clinically significant valvular heart disease, uncontrolled arrhythmias requiring treatment, ongoing chronic alcohol consumption, or cirrhosis with a certain Child-Pugh score and known Gilbert’s disease.

      Please note that this list is specific to the disease itself and does not include other non-disease related conditions that may affect your eligibility for the study.


      Terms and conditions

      What Requirements I Have to Meet To Join This Study?

      When Am I Eligible to Join the Study?

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

      1. Voluntary Written Informed Consent: Consent must be given by the patient voluntarily and in writing before any study-specific procedures are carried out.
      2. Age Requirement: You must be of age 18 years or older.
      3. Diagnosis Confirmation: You should have a histologically or cytologically confirmed diagnosis of small cell lung cancer (SCLC). Histology and cytology are the study of the microscopic anatomy of cells and tissues, respectively.
      4. Prior Treatment with Chemotherapy: You must have had one prior line of platinum-containing chemotherapy, with or without anti-PD-1 or anti-PD-L1. Anti-PD-1 or anti-PD-L1 are drugs that help the immune system to destroy cancer cells.
      5. Chemotherapy-Free Interval (CTFI): There should be a period of at least 30 days from the last dose of the first-line platinum-containing chemotherapy to the occurrence of progressive disease, regardless of any maintenance immunotherapy received.
      6. Central Nervous System (CNS) Metastases: Patients with CNS metastases may be included if they have been pretreated, are radiologically stable for at least 4 weeks, are asymptomatic, and do not require steroid treatment for at least 7 days before the initial dose of study treatment.
      7. Performance Status: Your Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) must be 0 to 2. This scale measures your ability to perform daily activities.
      8. Adequate Organ Function: Your body should have adequate hematological (blood), renal (kidney), metabolic, and hepatic (liver) function, determined by specific lab tests and clinical criteria provided.
      9. Recovery from Prior Treatment: It must be at least three weeks since your last antineoplastic (cancer) treatment, and you should have recovered to a specified level from any adverse events caused by previous cancer treatments.
      10. Prior Radiotherapy (RT): If you have had prophylactic cranial irradiation (PCI) or any other radiotherapy, it must be completed at least two weeks prior to joining the study.
      11. Contraception: If you are a woman of childbearing potential, you must provide evidence of non-childbearing status or agree to use a highly effective contraceptive measure until seven months after treatment discontinuation. Male patients with partners of childbearing potential must use condoms during treatment and for four months after the last dose of the study drug.

      The explanations of the medical terms are included in the descriptions above. If you meet all of these criteria, you may be eligible to participate in the study.

      What Reasons Could Exclude Me from the Study?

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

      Exclusion Criteria:

      1. Platinum-naïve patients or patients pretreated with more than one prior chemotherapy regimen: This refers to patients who have not received platinum-based chemotherapy or those who have been treated with more than one line of chemotherapy before.
      2. Prior treatment with certain drugs: If you have been treated with lurbinectedin, trabectedin, PM14, or topoisomerase I inhibitors (such as irinotecan or topotecan), you are excluded from the trial.
      3. Active or untreated CNS metastases and/or carcinomatous meningitis: These are cancer cells that have spread to the central nervous system (brain and spinal cord) that are either active or have not been treated, or cancer cells present in the membranes surrounding the brain and spinal cord.
      4. Limited-stage disease suitable for other treatments: If your disease is at a limited stage and you are a candidate for localized treatments like prophylactic cranial irradiation or thoracic radiation therapy, you must have completed or declined these treatments before enrollment.
      5. Concomitant diseases/conditions: The following conditions disqualify you from participating:

        1. Significant heart diseases such as unstable angina, heart attacks, congestive heart failure, or severe valve diseases within the past year.
        2. Symptomatic arrhythmias or any heart rhythm disturbances that are not well controlled with treatment.
        3. Ongoing heavy alcohol use or liver cirrhosis with a Child-Pugh score of B or C, indicating more advanced liver disease.
        4. Known Gilbert’s syndrome, a common liver condition that affects how the liver processes bilirubin.
        5. Active, uncontrolled infections; serious wounds or fractures that are not healing; or the presence of external tubes for drainage.
        6. Chronic liver diseases that are non-cancerous but require treatment (specific criteria for Hepatitis B and C).
        7. Need for constant oxygen or diagnosis of lung conditions like diffuse interstitial lung disease or pulmonary fibrosis.
        8. Having a second active cancer that has been treated with chemotherapy or radiation therapy.
        9. Inability to comply with the treatment or study protocol for any reason.
        10. Documented or suspected serious fungal infections needing treatment within 12 weeks of starting the study.
        11. Known HIV infection.
        12. Chronic inflammatory diseases of the colon or liver, past intestinal blockages, or paralysis of the intestines.
        13. Obvious and symptomatic lung scarring or fluid accumulation in the lungs or around the heart needing quick treatment.
        14. Any major illness that makes it significantly riskier for you to participate, in the opinion of the study investigator (e.g., COVID-19).
      6. Radiation therapy affecting a large portion of the bone marrow: If you’ve had radiation treatment to more than 35% of your bone marrow, you are excluded.
      7. History of bone marrow or stem cell transplants: Individuals who have had a bone marrow or stem cell transplant are not eligible.
      8. Recent vaccination with live or live-attenuated vaccines: If you’ve received a live or weakened live vaccine within 30 days before the first dose of the study drug, you cannot participate. However, inactivated vaccines are allowed.
      9. Impending need for radiation therapy: If you are likely to need radiation therapy soon, for reasons like bone pain or risk of spinal cord compression, you are not eligible.
      10. Allergies or hypersensitivity to study drugs or their components: If you have a known allergy or adverse reaction to any of the drugs used in the study or their ingredients.
      11. Pregnancy and breastfeeding: Women who are pregnant or breastfeeding cannot participate. Additionally, if you or your partner can become pregnant and cannot use effective contraception, you are excluded.

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


      Investigational Medicinal Product

      What Products Are Being Used in This Study?

      The drugs involved in the clinical trial are:

      1. Lurbinectedin (PM01183): This is an experimental anti-cancer drug that works by binding to the minor groove of DNA and halting the transcription process. It is being tested as both a single agent and in combination with Irinotecan in the study.
      2. Irinotecan (CPT-11): A chemotherapy drug that is used to treat various types of cancer. It works by inhibiting the enzyme topoisomerase I, which is necessary for DNA replication and transcription. In the study, Irinotecan is used both as a monotherapy and in combination with Lurbinectedin.
      3. Topotecan: A topoisomerase inhibitor used to treat certain types of cancer, including lung, ovarian, and cervical cancer. It works similarly to Irinotecan by inhibiting topoisomerase I, leading to DNA damage and cell death. Topotecan is used as part of the control arm in the study.

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

      The active substances participating in the clinical trial are as follows:

      1. Irinotecan: This substance is known to the medical literature as a chemotherapy drug used for the treatment of various types of cancer. It works by inhibiting the enzyme topoisomerase I, which is essential for DNA replication.
      2. Topotecan: Similar to Irinotecan, Topotecan is also a well-known chemotherapeutic agent in medical literature. It specifically targets and inhibits topoisomerase I, thereby preventing DNA replication and inducing cancer cell death.

      Both of these active substances are known and utilized in the field of medicine, and they operate by interfering with the DNA replication process in cancer cells. Their mechanism of action is through the inhibition of the enzyme topoisomerase I, which is critical for cellular DNA function. This mechanism qualifies them as topoisomerase inhibitors, a class of drugs with significant importance in cancer therapy.


      Study ID

      CT-EU-00041733

      Recruitment status

      Recruting new patients

      Start of the trial

      2 years ago

      Study phase

      Phase
      III