search
Back to results

Clinical Trial of Lurbinectedin as Single-agent or in Combination With Irinotecan Versus Topotecan or Irinotecan in Patients With Relapsed Small-cell Lung Cancer (LAGOON)

Primary Purpose

Relapsed Small Cell Lung Cancer

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Irinotecan
Lurbinectedin
Irinotecan
Topotecan
Lurbinectedin
Sponsored by
PharmaMar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsed Small Cell Lung Cancer focused on measuring Relapsed Small Cell Lung Cancer, PharmaMar, Lurbinectedin, Irinotecan, Topotecan

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Voluntary written informed consent of the patient obtained before any study-specific procedure
  2. Age≥18 years
  3. Histologically or cytologically confirmed diagnosis of SCLC.
  4. One prior line of platinum-containing chemotherapy with/without anti-PD-1 or anti-PD-L1 (Note: at least 70% of patients included in the study have to be pretreated with anti-PD-1 or anti-PD-L1)
  5. Chemotherapy-free interval (CTFI, time from the last dose of first-line platinum-containing chemotherapy to the occurrence of progressive disease) ≥ 30 days (independent of the immunotherapy maintenance, if applicable)
  6. Patients with history of Central Nervous System (CNS) metastases can participate provided they are pretreated and radiologically stable (i.e., without evidence of progression) for at least 4 weeks by repeated imaging (note: repeated imaging should be performed during study screening), asymptomatic, and without requirement of steroid treatment for at least 7 days before the first dose of study treatment
  7. Eastern Cooperative Oncology Group (ECOG) PS ≤ 2

  8. Adequate hematological, renal, metabolic and hepatic function:

    1. Hemoglobin ≥ 9.0 g/dL [patients may have received prior red blood cell (RBC) transfusion, if clinically indicated]; absolute neutrophil count (ANC) ≥ 2.0 x 10^9/L, and platelet count ≥ 100 x 10^9/L.
    2. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 x upper limit of normal (ULN).
    3. Total bilirubin ≤ 1.5 x ULN or direct bilirubin ≤ ULN.
    4. Albumin ≥ 3.0 g/dL.
    5. Calculated creatinine clearance (CrCL) ≥ 30 mL/min (using Cockcroft and Gault's formula).
  9. At least three weeks since last prior antineoplastic treatment and recovery to grade ≤ 1 from any adverse event (AE) related to previous anticancer treatment (excluding sensory neuropathy, anemia, asthenia and alopecia, all grade ≤ 2) according to the National Cancer InstituteCommon Terminology Criteria for Adverse Events (NCICTCAE) v.5.
  10. Prior radiotherapy (RT): At least two weeks since completion of prophylactic cranial irradiation (PCI), and to any other site not previously specified.
  11. Evidence of non-childbearing status for women of childbearing potential (WOCBP). WOCBP must agree to use a highly effective contraceptive measure up to six months after treatment discontinuation. Fertile male patients with WOCBP partners should use condoms during treatment and for four months following the last investigational medicinal product (IMP) dose.

Exclusion Criteria:

  1. Platinum-naïve patients or patients pretreated with more than one prior chemotherapy regimen (including patients re-challenged with same initial regimen).
  2. Prior treatment with lurbinectedin, trabectedin, PM14, or topoisomerase I inhibitors (irinotecan, topotecan, etc.).
  3. Active or untreated CNS metastases and/or carcinomatous meningitis.
  4. Patients with limited-stage disease who are candidates for local or regional therapy, including PCI, thoracic RT or both, must have been offered that option and completed treatment or refused it prior to randomization.

  5. Concomitant diseases/conditions:

    1. History or presence of unstable angina, myocardial infarction, congestive heart failure, or clinically significant valvular heart disease within last year.
    2. Symptomatic arrhythmia or any uncontrolled arrhythmia requiring ongoing treatment.
    3. Ongoing chronic alcohol consumption or cirrhosis with Child-Pugh score B or C.
    4. Known Gilbert's disease.
    5. Active uncontrolled infection. Serious non-healing wound, ulcer or bone fracture. Presence of external drainages.
    6. Ongoing, treatment-requiring, non-neoplastic chronic liver disease of any origin. For Hepatitis B, this includes positive tests for both Hepatitis B surface antigen (HBsAg) and quantitative Hepatitis B polymerase chain reaction (PCR). For Hepatitis C, this includes positive tests for both Hepatitis C antibody and quantitative Hepatitis C PCR. Subjects taking hepatitis related antiviral therapy within six months prior to the first dose of study drugs will also be excluded.
    7. Intermittent or continuous oxygen requirement within two weeks prior to randomization. Patients with confirmed or suspected diagnosis of diffuse interstitial lung disease or pulmonary fibrosis.
    8. Patients with a second invasive malignancy treated with chemotherapy and/or RT. Patients with a previous malignancy that was completely resected with curative intention three or more years prior to randomization, except treated in situ carcinoma of the cervix, basal or squamous cell skin carcinoma, and in situ transitional cell bladder carcinoma and who has been continuously in remission since then will be permitted.
    9. Limitation of the patient's ability to comply with the treatment or to follow the protocol.
    10. Documented or suspected invasive fungal infections requiring systemic treatment within 12 weeks of randomization.
    11. Known human immunodeficiency virus (HIV) infection.
    12. Any past or present chronic inflammatory colon and/or liver disease, past intestinal obstruction, pseudo or subocclusion or paralysis.
    13. Evident symptomatic pulmonary fibrosis or interstitial pneumonitis, pleural or cardiac effusion rapidly increasing and/or necessitating prompt local treatment within seven days.
    14. Active COVID-19 disease (this includes positive test for SARS-CoV-2 in nasopharyngeal/oropharyngeal swabs or nasal swabs by PCR).
    15. Any other major illness that, in the Investigator's judgment, will substantially increase the risk associated with the patient's participation in this study.
  6. RT in more than 35% of the bone marrow.
  7. History of previous bone marrow and/or stem cell transplantation and allogenic transplant.
  8. Patient has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
  9. Impending need for RT (e.g., painful bone metastasis and/or risk of spinal cord compression).
  10. History of allergy or hypersensitivity to any of the study drugs or any of their excipients.
  11. Women who are pregnant or breast feeding and fertile patients (men and women) who are not able to use an effective method of contraception

Sites / Locations

  • Ironwood Cancer & Research CentersRecruiting
  • Genesis Cancer and BloodRecruiting
  • Florida Cancer Specialists
  • Florida Cancer Specialists
  • Florida Cancer Specialists
  • Duly Health and CareRecruiting
  • Norton Cancer Institue, DowntownRecruiting
  • Dana-Farber Cancer InstituteRecruiting
  • Oncology Hematology West, PC (Grand Island)Recruiting
  • Oncology Hematology West, PC dba Nebraska Cancer SpecialistsRecruiting
  • FirstHealth Outpatient Cancer CenterRecruiting
  • Utah Cancer SpecialistsRecruiting
  • MultiCare Regional Cancer Center - TacomaRecruiting
  • Froedtert Hospital/Medical College of WisconsinRecruiting
  • The Chris Obrien LifehouseRecruiting
  • BRICC - Ballarat Health ServicesRecruiting
  • Box Hill Hospital Eastern Health Clinical SchoolRecruiting
  • Northern Beaches HospitalRecruiting
  • Gosford Hospital GH - Central Coast Cancer CentreRecruiting
  • Austin Hospital- Medical Oncology UnitRecruiting
  • St John of God Murdoch HospitalRecruiting
  • Southern Medical Day Care CentreRecruiting
  • University Hospital SalzburgRecruiting
  • Medizinische Universitaet Wien
  • Antwerp University HospitalRecruiting
  • Algemeen Ziekenhuis AZ Klina - BorstkliniekRecruiting
  • Grand Hopital de Charleroi GHdC - Hopital Saint JosephRecruiting
  • Centre Hospitalier Chretien CHC - MontLegiaRecruiting
  • CHR de la CitadelleRecruiting
  • CHU LiegeRecruiting
  • Az Sint Maarten MechelenRecruiting
  • Centre Hospitalier Universitaire (CHU) Ambroise PareRecruiting
  • Oncocentro-Centro de Oncologia do ParanaRecruiting
  • UPCO - Hospital de Clinicas de Porto Alegre
  • Nucleo de Oncologia da Bahia - NOBRecruiting
  • Fundacao Pio XII - Hospital de Cancer de Barretos - Hospital de AmorRecruiting
  • ONCOSITE - Centro de Pesquisa Clinica em Oncologia LtdaRecruiting
  • Irmandade daSanta Casa de Misericordia de Porto AlegreRecruiting
  • Hospital Sao Lucas da PUCRSRecruiting
  • Instituto Nacional de Cancer - Ministrio da Sade
  • Multiprofile Hospital for Active Treatment - Uni Hospital OOD Department of Medical OncologyRecruiting
  • Complex Oncology Center - Plovdiv EOOD, First Department of Medical Oncology and Oncological Diseases in GastroenterologyRecruiting
  • Specialized hospital for active treatment of oncological diseasesRecruiting
  • Multiprofile Hospital for Active Treatment Serdika EOOD Second Department of Medical OncologyRecruiting
  • McGill University Health Centre (MUHC)Recruiting
  • University Health Network - Princess Margaret Hospital
  • SIM-CRRC
  • Clinical Research Chile SpA
  • Centro de Estudios Clínicos SAGA
  • Clinica Alemana de Santiago
  • Clínica Santa María
  • Fundación Arturo López Pérez
  • Hospital Clinico Universidad de Chile
  • Aalborg University HospitalRecruiting
  • Sjællands UniversitetshospitalRecruiting
  • Sønderborg SygehusRecruiting
  • Vejle HospitalRecruiting
  • Hopital Jean MinjozRecruiting
  • AssAP-HP - Hopital Ambroise-PareRecruiting
  • Hopital Morvan CHU de BrestRecruiting
  • Centre François BaclesseRecruiting
  • CHU de Caen - Hopital Cote de NacreRecruiting
  • Centre Hospitalier Intercommunal de Creteil (CHIC)Recruiting
  • Centre Hospitalier Universitaire CHU De LimogesRecruiting
  • CHU de NantesRecruiting
  • Bichat-Claude Bernard HospitalRecruiting
  • CHU Reims - Hpital Maison BlancheRecruiting
  • Hopital Civil / Nouvel Hopital CivilRecruiting
  • Hospital FochRecruiting
  • Gustave RoussyRecruiting
  • High Technology Hospital MedcenterRecruiting
  • Todua ClinicRecruiting
  • New HospitalsRecruiting
  • Institute Of Clinical OncologyRecruiting
  • JSC Evex Hospitals "Caraps Medline"Recruiting
  • LTD Cancer Research CentreRecruiting
  • LungenClinic GrosshansdorfRecruiting
  • Zentralklinik Bad Berka GmbH
  • Evangelische Lungenklinik Berlin
  • Charite - Universitaetsmedizin Berlin
  • Klinikum Bremen Ost
  • Helios St. Johannes Klinikum
  • Klinikum Esslingen GmbHRecruiting
  • Universittsklinikum Freiburg
  • Asklepios Fachklinik München-GautingRecruiting
  • Krankenhaus Martha-Maria Halle gGmbHRecruiting
  • Universitaetsklinikum Halle SaaleRecruiting
  • Thoraxclinic Heidelberg GmbHRecruiting
  • Vincentius-Diakonissen-Kliniken gAG KarlsruheRecruiting
  • Klinikum Kassel - Medizinische Klinik IVRecruiting
  • Klinik Loewenstein gGmbH
  • Universitaetsmedizin MannheimRecruiting
  • Staedtisches Klinikum München - Bogenhausen
  • Sana Klinikum Offenbach
  • Debreceni Egyetem - Klinikai KozpontRecruiting
  • Veszprem Megyei Tudogyogyintezet FarkasgyepuRecruiting
  • Bacs-Kiskun County HospitalRecruiting
  • Hetenyi G Korhaz, Onkologiai KozpontRecruiting
  • Pulmonology Hospital TorokbalintRecruiting
  • Rambam Health Care Campu
  • Shaare Zedek Medical Center
  • Rabin Medical Center
  • The Chaim Sheba Medical Center
  • Tel Aviv Sourasky Medical Center
  • A.O. SS. Antonio e Biagio e Cesare Arrigo di AlessandriaRecruiting
  • Azienda Ospedaliero Universitaria delle MarcheRecruiting
  • IRCCS Centro di Riferimento OncologicoRecruiting
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola Malpighi Oncologia medicaRecruiting
  • Azienda Ospedaliera Univ. Policlinico G Rodolico San Marco
  • A.O. Santa Croce e Carle, Ospedale CarleRecruiting
  • AOU CareggiRecruiting
  • ASL 3 Genovese Oncologia Medica Villa ScassiRecruiting
  • IRCCS Istituto Clinico Humanitas - Cancer CenterRecruiting
  • Universita degli Studi della Campania Luigi Vanvitelli
  • Ospedale Maggiore di NovaraRecruiting
  • Azienda Ospedaliero-Universitaria San Luigi GonzagaRecruiting
  • Oncologia Medica II Istituto Oncologico Veneto IRCCSRecruiting
  • Azienda USL di PiacenzaRecruiting
  • Irccs-CrobRecruiting
  • Fondazione Policlinico Universitario Campus Bio-MedicoRecruiting
  • IFO Regina ElenaRecruiting
  • Azienda Ospedaliera Univ. Senese Policlinico Le Scotte
  • ASST Valtellina e Alto Lario Ospedale di SondrioRecruiting
  • ASST Sette LaghiRecruiting
  • Chungbuk National University HospitalRecruiting
  • CHA Bundang Medical Center, CHA University
  • The Catholic University of Korea, St.Vincents Hospital
  • Gachon University Gil Medical Center
  • Inha University HospitalRecruiting
  • Kangbuk Samsung HospitalRecruiting
  • Asan Medical Center
  • The Catholic University of Korea, Seoul St. Mary's Hospital
  • Seoul Metropolitan Government-Seoul National University Boramae Medical Center
  • II Klinika Chorob Pluc i Gruzlicy
  • Szpitale Pomorskie Sp. z o.o., Oddzial Onkologii KRecruiting
  • Specjalistyczna Praktyka Lekarska Slawomir MandziukaRecruiting
  • Szpital Specjalistyczny w Prabutach Sp. z o.oRecruiting
  • Mrukmed. Lekarz Beata Madej-Mruk i Partner. Sp.pRecruiting
  • Specjalistyczny Szpital Onkologiczny NU-MED sp. Z
  • Wojewódzkie Wielospecjalistyczne Centrum OnkologiiRecruiting
  • Sc Oncopremium Team SrlRecruiting
  • Medisprof srlRecruiting
  • Oncolab SRLRecruiting
  • Centrul de Oncologie Sfantu NectarieRecruiting
  • Ovidius Clinical Hospital
  • Oncocenter Oncologie clinica S.R.LRecruiting
  • Institut Català d Oncologia (ICO) - Hospital Germans Trias i PujolRecruiting
  • Institut Catala d'Oncologia (ICO) - Hospital Duran i ReynalsRecruiting
  • Hospital Universitario Marqués de ValdecillaRecruiting
  • Complejo Hospitalario Materno-Insular de Gran CanariaRecruiting
  • Clínica Universidad de NavarraRecruiting
  • Complexo Hospitalario Universitario De Vigo (CHUVI) - Hospital XeralRecruiting
  • Hospital Teresa Herrera C.H.U.A.Recruiting
  • Hospital Universitari Vall d'HebronRecruiting
  • Hospital Universitario Reina SofíaRecruiting
  • Hospital Universitario Lucus AugustiRecruiting
  • Hospital Universitario La PazRecruiting
  • Hospital General Universitario Gregorio MarañónRecruiting
  • Clínica Universidad de NavarraRecruiting
  • MD Anderson Cancer CenterRecruiting
  • Hospital Universitario Ramón y CajalRecruiting
  • Hospital Clínico San CarlosRecruiting
  • Hospital Universitario Fundación Jimenez DíazRecruiting
  • Hospital Universitario 12 de OctubreRecruiting
  • Hospital Universitario HM SanchinarroRecruiting
  • Hospital Regional Universitario Málaga Hospital CivilRecruiting
  • Hospital Universitario Virgen del RocíoRecruiting
  • Hospital Universitari i Politècnic La FeRecruiting
  • Hospital Clínico Universitario de ValladolidRecruiting
  • Hospital Clínico Universitario Lozano BlezaRecruiting
  • University Hospital Basel
  • Istituto Oncologico della Svizzera Italiana
  • Spital Thurgau - Kantonspital Frauenfeld
  • Centre Hospitalier Universitaire VaudoisRecruiting
  • Kantonsspital Baselland
  • Spital Thurgau - Kantonsspital MuensterlingenRecruiting
  • HFR Freiburg Kantonsspital
  • Medicalpark Seyhan Hospital
  • Liv Hospital Ankara
  • Bagcilar Medipol Mega University Hospital
  • Goztepe Prof. Dr. Suleyman Yalcin City Hospital
  • Kocaeli University Hospital
  • Belfast Health and Social Care Trust
  • The Princess Alexandra HospitalRecruiting
  • Guys and St Thomas NHS Foundation TrustRecruiting
  • The Christie NHS Foundation TrustRecruiting
  • Nottingham University Hospitals NHS TrustRecruiting
  • Clatterbridge HospitalRecruiting
  • The Royal Wolverhampton NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Lurbinectedin

Lurbinectedin plus Irinotecan

Control arm

Arm Description

Patients will consecutively receive lurbinectedin on Day 1 q3wk (every three weeks = one treatment cycle)

Patients will consecutively receive the following q3wk (every three weeks = one treatment cycle): Irinotecan (Day 1 and Day 8) Lurbinectedin (Day 1)

Best Investigator's choice prior to randomization between: Irinotecan on Day 1 q3wk Topotecan on Days 1-5 q3wk

Outcomes

Primary Outcome Measures

Overall survival
Overall survival (OS) will be calculated from the date of randomization to the date of death or last contact (in this case, survival will be censored on that date).

Secondary Outcome Measures

Progression-free survival
Progression-free survival (PFS) will be calculated from the date of randomization to the date of documented progression per RECIST v.1.1 (Progressive disease is declared when there is an increase in sum of target disease ≥ 20%) or death (regardless of the cause of death). If the patient receives further antitumor therapy, withdraws from the study, or is lost to follow-up before progressive disease (PD), PFS will be censored at the date of last evaluable tumor assessment before the date of subsequent antitumor therapy.
Overall response rate
Overall response rate (ORR) will be the best response obtained in any evaluation according to RECIST v.1.1. Progressive disease is declared when there is an increase in sum of target disease ≥ 20%, stable disease when the change is > -30% and ≤ 20%, partial response when there is a decrease in sum of target disease ≥ 30%, and complete response when all lesions have disappeared or all lesions have disappeared and all nodal disease is < 10 mm each.
Overall survival rate at 12 months
Overall survival rate at 12 months is defined as the percentage of people who are still alive at 12 months after randomization.
Overall survival rate at 24 months
Overall survival rate at 24 months is defined as the percentage of people who are still alive at 24 months after randomization.
Progression-free survival rate at 6 months
Progression-free survival rate at 6 months is defined as the percentage of people who remain free from progression at 6 months after randomization
Progression-free survival rate at 12 months
Progression-free survival rate at 12 months is defined as the percentage of people who remain free from progression at 12 months after randomization
Duration of response
Duration of response (DoR) will be calculated from the date of first documentation of response per RECIST v.1.1 (complete or partial response, whichever occurs first) to the date of documented PD or death. Progressive disease is declared when there is an increase in sum of target disease ≥ 20%, stable disease when the change is > -30% and ≤ 20%, partial response when there is a decrease in sum of target disease ≥ 30%, and complete response when all lesions have disappeared or all lesions have disappeared and all nodal disease is < 10 mm each.
Patient-reported outcomes
To measure the quality of life of patients, the Lung Cancer Symptom Scale (LCSS) questionnaire will be analyzed.

Full Information

First Posted
November 29, 2021
Last Updated
October 5, 2023
Sponsor
PharmaMar
search

1. Study Identification

Unique Protocol Identification Number
NCT05153239
Brief Title
Clinical Trial of Lurbinectedin as Single-agent or in Combination With Irinotecan Versus Topotecan or Irinotecan in Patients With Relapsed Small-cell Lung Cancer (LAGOON)
Official Title
A Randomized, Multicenter, Open-label, Phase III Study of Lurbinectedin Single-Agent or Lurbinectedin in Combination With Irinotecan Versus Investigator's Choice (Topotecan or Irinotecan) in Relapsed Small Cell Lung Cancer Patients (LAGOON Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 22, 2022 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PharmaMar

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Multicenter, open-label, randomized, controlled phase III clinical trial to evaluate and compare the activity and safety of two experimental arms consisting of lurbinectedin as single agent (Group A) or the combination of lurbinectedin with irinotecan (Group B) versus Investigator's Choice (topotecan or irinotecan) as control arm (Group C), in Small-cell Lung Cancer (SCLC) patients who failed one prior platinum-containing line.
Detailed Description
Approximately 705 Adult SCLC patients with Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2 who have failed one prior platinum-containing line with CTFI ≥ 30 days and controlled asymptomatic Central Nervous System metastases will be enrolled and assigned to each treatment arm. Central randomization will be implemented; patients will be assigned to each treatment arm at a 1:1:1 ratio. An Independent Data Monitoring Committee (IDMC) will oversee the conduct of the study. The IDMC should have access to unblinded efficacy and safety data throughout the trial to enable timely and informed judgments about risks and benefits.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed Small Cell Lung Cancer
Keywords
Relapsed Small Cell Lung Cancer, PharmaMar, Lurbinectedin, Irinotecan, Topotecan

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Multicenter, open-label, randomized, controlled
Masking
None (Open Label)
Allocation
Randomized
Enrollment
705 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lurbinectedin
Arm Type
Experimental
Arm Description
Patients will consecutively receive lurbinectedin on Day 1 q3wk (every three weeks = one treatment cycle)
Arm Title
Lurbinectedin plus Irinotecan
Arm Type
Experimental
Arm Description
Patients will consecutively receive the following q3wk (every three weeks = one treatment cycle): Irinotecan (Day 1 and Day 8) Lurbinectedin (Day 1)
Arm Title
Control arm
Arm Type
Active Comparator
Arm Description
Best Investigator's choice prior to randomization between: Irinotecan on Day 1 q3wk Topotecan on Days 1-5 q3wk
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Intervention Description
Irinotecan 75 mg/m² intravenously Days 1 & 8 q3wk
Intervention Type
Drug
Intervention Name(s)
Lurbinectedin
Other Intervention Name(s)
PM01183
Intervention Description
Lurbinectedin 3.2 mg/m² will be administered intravenously on Day 1 q3wk
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Intervention Description
Irinotecan 350 mg/m² intravenously Day 1 q3wk
Intervention Type
Drug
Intervention Name(s)
Topotecan
Intervention Description
Topotecan 2.3 mg/m² oral or 1.5 mg/m² intravenously Days 1-5 q3wk
Intervention Type
Drug
Intervention Name(s)
Lurbinectedin
Other Intervention Name(s)
PM01183
Intervention Description
Lurbinectedin 2.0 mg/m² will be administered intravenously on Day 1 q3wk
Primary Outcome Measure Information:
Title
Overall survival
Description
Overall survival (OS) will be calculated from the date of randomization to the date of death or last contact (in this case, survival will be censored on that date).
Time Frame
From the date of randomization to the date of death or last contact, up to 39 months
Secondary Outcome Measure Information:
Title
Progression-free survival
Description
Progression-free survival (PFS) will be calculated from the date of randomization to the date of documented progression per RECIST v.1.1 (Progressive disease is declared when there is an increase in sum of target disease ≥ 20%) or death (regardless of the cause of death). If the patient receives further antitumor therapy, withdraws from the study, or is lost to follow-up before progressive disease (PD), PFS will be censored at the date of last evaluable tumor assessment before the date of subsequent antitumor therapy.
Time Frame
From the date of randomization to the date of progressive disease, death or last tumor assessment or further anticancer treatment, up to 39 months
Title
Overall response rate
Description
Overall response rate (ORR) will be the best response obtained in any evaluation according to RECIST v.1.1. Progressive disease is declared when there is an increase in sum of target disease ≥ 20%, stable disease when the change is > -30% and ≤ 20%, partial response when there is a decrease in sum of target disease ≥ 30%, and complete response when all lesions have disappeared or all lesions have disappeared and all nodal disease is < 10 mm each.
Time Frame
From the date of randomization to the date of death or last contact, up to 39 months
Title
Overall survival rate at 12 months
Description
Overall survival rate at 12 months is defined as the percentage of people who are still alive at 12 months after randomization.
Time Frame
At 12 months
Title
Overall survival rate at 24 months
Description
Overall survival rate at 24 months is defined as the percentage of people who are still alive at 24 months after randomization.
Time Frame
At 24 months
Title
Progression-free survival rate at 6 months
Description
Progression-free survival rate at 6 months is defined as the percentage of people who remain free from progression at 6 months after randomization
Time Frame
At 6 months
Title
Progression-free survival rate at 12 months
Description
Progression-free survival rate at 12 months is defined as the percentage of people who remain free from progression at 12 months after randomization
Time Frame
At 12 months
Title
Duration of response
Description
Duration of response (DoR) will be calculated from the date of first documentation of response per RECIST v.1.1 (complete or partial response, whichever occurs first) to the date of documented PD or death. Progressive disease is declared when there is an increase in sum of target disease ≥ 20%, stable disease when the change is > -30% and ≤ 20%, partial response when there is a decrease in sum of target disease ≥ 30%, and complete response when all lesions have disappeared or all lesions have disappeared and all nodal disease is < 10 mm each.
Time Frame
From the date of first documentation of complete or partial response to the date of documented progression disease, death or last contact, up to 39 months
Title
Patient-reported outcomes
Description
To measure the quality of life of patients, the Lung Cancer Symptom Scale (LCSS) questionnaire will be analyzed.
Time Frame
At baseline and every six weeks (± one week) until end of treatment, up to 39 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Voluntary written informed consent of the patient obtained before any study-specific procedure Age≥18 years Histologically or cytologically confirmed diagnosis of SCLC. One prior line of platinum-containing chemotherapy with/without anti-PD-1 or anti-PD-L1 (Note: at least 70% of patients included in the study have to be pretreated with anti-PD-1 or anti-PD-L1) Chemotherapy-free interval (CTFI, time from the last dose of first-line platinum-containing chemotherapy to the occurrence of progressive disease) ≥ 30 days (independent of the immunotherapy maintenance, if applicable) Patients with history of Central Nervous System (CNS) metastases can participate provided they are pretreated and radiologically stable (i.e., without evidence of progression) for at least 4 weeks by repeated imaging (note: repeated imaging should be performed during study screening), asymptomatic, and without requirement of steroid treatment for at least 7 days before the first dose of study treatment Eastern Cooperative Oncology Group (ECOG) PS ≤ 2 Adequate hematological, renal, metabolic and hepatic function: Hemoglobin ≥ 9.0 g/dL [patients may have received prior red blood cell (RBC) transfusion, if clinically indicated]; absolute neutrophil count (ANC) ≥ 2.0 x 10^9/L, and platelet count ≥ 100 x 10^9/L. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 x upper limit of normal (ULN). Total bilirubin ≤ 1.5 x ULN or direct bilirubin ≤ ULN. Albumin ≥ 3.0 g/dL. Calculated creatinine clearance (CrCL) ≥ 30 mL/min (using Cockcroft and Gault's formula). At least three weeks since last prior antineoplastic treatment and recovery to grade ≤ 1 from any adverse event (AE) related to previous anticancer treatment (excluding sensory neuropathy, anemia, asthenia and alopecia, all grade ≤ 2) according to the National Cancer InstituteCommon Terminology Criteria for Adverse Events (NCICTCAE) v.5. Prior radiotherapy (RT): At least two weeks since completion of prophylactic cranial irradiation (PCI), and to any other site not previously specified. Evidence of non-childbearing status for women of childbearing potential (WOCBP). WOCBP must agree to use a highly effective contraceptive measure up to seven months after treatment discontinuation. Fertile male patients with WOCBP partners should use condoms during treatment and for four months following the last investigational medicinal product (IMP) dose. Exclusion Criteria: Platinum-naïve patients or patients pretreated with more than one prior chemotherapy regimen (including patients re-challenged with same initial regimen). Prior treatment with lurbinectedin, trabectedin, PM14, or topoisomerase I inhibitors (irinotecan, topotecan, etc.). Active or untreated CNS metastases and/or carcinomatous meningitis. Patients with limited-stage disease who are candidates for local or regional therapy, including PCI, thoracic RT or both, must have been offered that option and completed treatment or refused it prior to randomization. Concomitant diseases/conditions: History or presence of unstable angina, myocardial infarction, congestive heart failure, or clinically significant valvular heart disease within last year. Symptomatic arrhythmia or any uncontrolled arrhythmia requiring ongoing treatment. Ongoing chronic alcohol consumption or cirrhosis with Child-Pugh score B or C. Known Gilbert's disease. Active uncontrolled infection. Serious non-healing wound, ulcer or bone fracture. Presence of external drainages. Ongoing, treatment-requiring, non-neoplastic chronic liver disease of any origin. For Hepatitis B, this includes positive tests for both Hepatitis B surface antigen (HBsAg) and quantitative Hepatitis B polymerase chain reaction (PCR). For Hepatitis C, this includes positive tests for both Hepatitis C antibody and quantitative Hepatitis C PCR. Subjects taking hepatitis related antiviral therapy within six months prior to the first dose of study drugs will also be excluded. Intermittent or continuous oxygen requirement within two weeks prior to randomization. Patients with confirmed or suspected diagnosis of diffuse interstitial lung disease or pulmonary fibrosis. Patients with a second invasive malignancy treated with chemotherapy and/or RT. Patients with a previous malignancy that was completely resected with curative intention three or more years prior to randomization, except treated in situ carcinoma of the cervix, basal or squamous cell skin carcinoma, and in situ transitional cell bladder carcinoma and who has been continuously in remission since then will be permitted. Limitation of the patient's ability to comply with the treatment or to follow the protocol. Documented or suspected invasive fungal infections requiring systemic treatment within 12 weeks of randomization. Known human immunodeficiency virus (HIV) infection. Any past or present chronic inflammatory colon and/or liver disease, past intestinal obstruction, pseudo or subocclusion or paralysis. Evident symptomatic pulmonary fibrosis or interstitial pneumonitis, pleural or cardiac effusion rapidly increasing and/or necessitating prompt local treatment within seven days. Any other major illness that, in the Investigator's judgment, will substantially increase the risk associated with the patient's participation in this study (e.g.; COVID-19 disease). RT in more than 35% of the bone marrow. History of previous bone marrow and/or stem cell transplantation and allogenic transplant. Patient has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of inactivated vaccines is allowed. Impending need for RT (e.g., painful bone metastasis and/or risk of spinal cord compression). History of allergy or hypersensitivity to any of the study drugs or any of their excipients. Women who are pregnant or breast feeding and fertile patients (men and women) who are not able to use a highly effective method of contraception
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
José Antonio Lopez-Vilariño, MD
Phone
0034 91 823 4564
Email
jalopez-vilarino@pharmamar.com
Facility Information:
Facility Name
Ironwood Cancer & Research Centers
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Individual Site Status
Recruiting
Facility Name
Genesis Cancer and Blood
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida Cancer Specialists
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Florida Cancer Specialists
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Florida Cancer Specialists
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Florida C Specialists
Facility Name
Duly Health and Care
City
Joliet
State/Province
Illinois
ZIP/Postal Code
60435
Country
United States
Individual Site Status
Recruiting
Facility Name
Norton Cancer Institue, Downtown
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Recruiting
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Name
Oncology Hematology West, PC (Grand Island)
City
Grand Island
State/Province
Nebraska
ZIP/Postal Code
68803
Country
United States
Individual Site Status
Recruiting
Facility Name
Oncology Hematology West, PC dba Nebraska Cancer Specialists
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Individual Site Status
Recruiting
Facility Name
FirstHealth Outpatient Cancer Center
City
Pinehurst
State/Province
North Carolina
ZIP/Postal Code
28374
Country
United States
Individual Site Status
Recruiting
Facility Name
Utah Cancer Specialists
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Individual Site Status
Recruiting
Facility Name
MultiCare Regional Cancer Center - Tacoma
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Individual Site Status
Recruiting
Facility Name
Froedtert Hospital/Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Name
The Chris Obrien Lifehouse
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Individual Site Status
Recruiting
Facility Name
BRICC - Ballarat Health Services
City
Ballarat Central
State/Province
Victoria
ZIP/Postal Code
3350
Country
Australia
Individual Site Status
Recruiting
Facility Name
Box Hill Hospital Eastern Health Clinical School
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Individual Site Status
Recruiting
Facility Name
Northern Beaches Hospital
City
Frenchs Forest
ZIP/Postal Code
NSW 2086
Country
Australia
Individual Site Status
Recruiting
Facility Name
Gosford Hospital GH - Central Coast Cancer Centre
City
Gosford
ZIP/Postal Code
2250
Country
Australia
Individual Site Status
Recruiting
Facility Name
Austin Hospital- Medical Oncology Unit
City
Heidelberg
ZIP/Postal Code
VIC 3084
Country
Australia
Individual Site Status
Recruiting
Facility Name
St John of God Murdoch Hospital
City
Murdoch
ZIP/Postal Code
WA 6150
Country
Australia
Individual Site Status
Recruiting
Facility Name
Southern Medical Day Care Centre
City
Wollongong
ZIP/Postal Code
NSW 2500
Country
Australia
Individual Site Status
Recruiting
Facility Name
University Hospital Salzburg
City
Salzburg
ZIP/Postal Code
A-5020
Country
Austria
Individual Site Status
Recruiting
Facility Name
Medizinische Universitaet Wien
City
Vienna
ZIP/Postal Code
A-1090
Country
Austria
Individual Site Status
Not yet recruiting
Facility Name
Antwerp University Hospital
City
Edegem
State/Province
Antwerp
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Algemeen Ziekenhuis AZ Klina - Borstkliniek
City
Brasschaat
ZIP/Postal Code
2930
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Grand Hopital de Charleroi GHdC - Hopital Saint Joseph
City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Chretien CHC - MontLegia
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
CHR de la Citadelle
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
CHU Liege
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Az Sint Maarten Mechelen
City
Mechelen
ZIP/Postal Code
2800
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire (CHU) Ambroise Pare
City
Mons
ZIP/Postal Code
7000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Oncocentro-Centro de Oncologia do Parana
City
Curitiba
State/Province
Parana
ZIP/Postal Code
82305-100
Country
Brazil
Individual Site Status
Recruiting
Facility Name
UPCO - Hospital de Clinicas de Porto Alegre
City
Santa Cecília
State/Province
Porto Alegre
ZIP/Postal Code
RS 90035-903
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
Nucleo de Oncologia da Bahia - NOB
City
Ondina
State/Province
Salvador
ZIP/Postal Code
BA 40170-110
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Fundacao Pio XII - Hospital de Cancer de Barretos - Hospital de Amor
City
Barretos
ZIP/Postal Code
SP 14784-400
Country
Brazil
Individual Site Status
Recruiting
Facility Name
ONCOSITE - Centro de Pesquisa Clinica em Oncologia Ltda
City
Ijuí
ZIP/Postal Code
98700-00
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Irmandade daSanta Casa de Misericordia de Porto Alegre
City
Porto Alegre
ZIP/Postal Code
90050-170
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital Sao Lucas da PUCRS
City
Porto Alegre
ZIP/Postal Code
90610-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Instituto Nacional de Cancer - Ministrio da Sade
City
Rio De Janeiro
ZIP/Postal Code
20231-050
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
Multiprofile Hospital for Active Treatment - Uni Hospital OOD Department of Medical Oncology
City
Sofia
State/Province
Dianabad
ZIP/Postal Code
1797 NPZ
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Complex Oncology Center - Plovdiv EOOD, First Department of Medical Oncology and Oncological Diseases in Gastroenterology
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Specialized hospital for active treatment of oncological diseases
City
Sofia
ZIP/Postal Code
1233
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Multiprofile Hospital for Active Treatment Serdika EOOD Second Department of Medical Oncology
City
Sofia
ZIP/Postal Code
1303
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
McGill University Health Centre (MUHC)
City
Montréal
ZIP/Postal Code
H4A 3J1
Country
Canada
Individual Site Status
Recruiting
Facility Name
University Health Network - Princess Margaret Hospital
City
Toronto
ZIP/Postal Code
ON M5G 2C1
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
SIM-CRRC
City
Temuco
State/Province
Araucania
ZIP/Postal Code
4780000
Country
Chile
Individual Site Status
Not yet recruiting
Facility Name
Clinical Research Chile SpA
City
Valdivia
State/Province
Los Ríos
ZIP/Postal Code
5090000
Country
Chile
Individual Site Status
Not yet recruiting
Facility Name
Centro de Estudios Clínicos SAGA
City
Santiago de Chile
Country
Chile
Individual Site Status
Not yet recruiting
Facility Name
Clinica Alemana de Santiago
City
Santiago de Chile
Country
Chile
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clínica S María
Facility Name
Clínica Santa María
City
Santiago de Chile
Country
Chile
Individual Site Status
Not yet recruiting
Facility Name
Fundación Arturo López Pérez
City
Santiago de Chile
Country
Chile
Individual Site Status
Not yet recruiting
Facility Name
Hospital Clinico Universidad de Chile
City
Santiago de Chile
Country
Chile
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clínica S María
Facility Name
Aalborg University Hospital
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Sjællands Universitetshospital
City
Næstved
ZIP/Postal Code
4700
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Sønderborg Sygehus
City
Sønderborg
ZIP/Postal Code
6400
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Vejle Hospital
City
Vejle
ZIP/Postal Code
7100
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Hopital Jean Minjoz
City
Besancon
ZIP/Postal Code
25030
Country
France
Individual Site Status
Recruiting
Facility Name
AssAP-HP - Hopital Ambroise-Pare
City
Boulogne-Billancourt
ZIP/Postal Code
92100
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Morvan CHU de Brest
City
Brest
ZIP/Postal Code
29200
Country
France
Individual Site Status
Recruiting
Facility Name
Centre François Baclesse
City
Caen
ZIP/Postal Code
14000
Country
France
Individual Site Status
Recruiting
Facility Name
CHU de Caen - Hopital Cote de Nacre
City
Caen
ZIP/Postal Code
14033
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Intercommunal de Creteil (CHIC)
City
Créteil
ZIP/Postal Code
94000
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire CHU De Limoges
City
Limoges
ZIP/Postal Code
87000
Country
France
Individual Site Status
Recruiting
Facility Name
CHU de Nantes
City
Nantes
ZIP/Postal Code
Cedex 01 44093
Country
France
Individual Site Status
Recruiting
Facility Name
Bichat-Claude Bernard Hospital
City
Paris
ZIP/Postal Code
75018
Country
France
Individual Site Status
Recruiting
Facility Name
CHU Reims - Hpital Maison Blanche
City
Reims
ZIP/Postal Code
51092
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Civil / Nouvel Hopital Civil
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Individual Site Status
Recruiting
Facility Name
Hospital Foch
City
Suresnes
ZIP/Postal Code
92150
Country
France
Individual Site Status
Recruiting
Facility Name
Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
Individual Site Status
Recruiting
Facility Name
High Technology Hospital Medcenter
City
Batumi
ZIP/Postal Code
6000
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Todua Clinic
City
Tbilisi
ZIP/Postal Code
112
Country
Georgia
Individual Site Status
Recruiting
Facility Name
New Hospitals
City
Tbilisi
ZIP/Postal Code
114
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Institute Of Clinical Oncology
City
Tbilisi
ZIP/Postal Code
156
Country
Georgia
Individual Site Status
Recruiting
Facility Name
JSC Evex Hospitals "Caraps Medline"
City
Tbilisi
ZIP/Postal Code
179
Country
Georgia
Individual Site Status
Recruiting
Facility Name
LTD Cancer Research Centre
City
Tbilisi
ZIP/Postal Code
186
Country
Georgia
Individual Site Status
Recruiting
Facility Name
LungenClinic Grosshansdorf
City
Großhansdorf
State/Province
Schleswig Holstein
ZIP/Postal Code
22927
Country
Germany
Individual Site Status
Recruiting
Facility Name
Zentralklinik Bad Berka GmbH
City
Bad Berka
ZIP/Postal Code
99437
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Evangelische Lungenklinik Berlin
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Charite - Universitaetsmedizin Berlin
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Klinikum Bremen Ost
City
Bremen
ZIP/Postal Code
28325
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Helios St. Johannes Klinikum
City
Duisburg
ZIP/Postal Code
74166
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Klinikum Esslingen GmbH
City
Esslingen
ZIP/Postal Code
73730
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universittsklinikum Freiburg
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Asklepios Fachklinik München-Gauting
City
Gauting
ZIP/Postal Code
82131
Country
Germany
Individual Site Status
Recruiting
Facility Name
Krankenhaus Martha-Maria Halle gGmbH
City
Halle (saale)
ZIP/Postal Code
06120
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Halle Saale
City
Halle
ZIP/Postal Code
06120
Country
Germany
Individual Site Status
Recruiting
Facility Name
Thoraxclinic Heidelberg GmbH
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
Individual Site Status
Recruiting
Facility Name
Vincentius-Diakonissen-Kliniken gAG Karlsruhe
City
Karlsruhe
ZIP/Postal Code
76137
Country
Germany
Individual Site Status
Recruiting
Facility Name
Klinikum Kassel - Medizinische Klinik IV
City
Kassel
ZIP/Postal Code
34125
Country
Germany
Individual Site Status
Recruiting
Facility Name
Klinik Loewenstein gGmbH
City
Löwenstein
ZIP/Postal Code
74245
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Universitaetsmedizin Mannheim
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Individual Site Status
Recruiting
Facility Name
Staedtisches Klinikum München - Bogenhausen
City
München
ZIP/Postal Code
81925
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Sana Klinikum Offenbach
City
Offenbach
ZIP/Postal Code
63069
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Debreceni Egyetem - Klinikai Kozpont
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Veszprem Megyei Tudogyogyintezet Farkasgyepu
City
Farkasgyepű
ZIP/Postal Code
8582
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Bacs-Kiskun County Hospital
City
Kecskemét
ZIP/Postal Code
6000
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Hetenyi G Korhaz, Onkologiai Kozpont
City
Szolnok
ZIP/Postal Code
5004
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Pulmonology Hospital Torokbalint
City
Törökbálint
ZIP/Postal Code
2045
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Rambam Health Care Campu
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Not yet recruiting
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Individual Site Status
Not yet recruiting
Facility Name
Rabin Medical Center
City
Petah tikva
ZIP/Postal Code
49100
Country
Israel
Individual Site Status
Not yet recruiting
Facility Name
The Chaim Sheba Medical Center
City
Ramat Gan
Country
Israel
Individual Site Status
Not yet recruiting
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Individual Site Status
Not yet recruiting
Facility Name
A.O. SS. Antonio e Biagio e Cesare Arrigo di Alessandria
City
Alessandria
ZIP/Postal Code
15121
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliero Universitaria delle Marche
City
Ancona
ZIP/Postal Code
60126
Country
Italy
Individual Site Status
Recruiting
Facility Name
IRCCS Centro di Riferimento Oncologico
City
Aviano
ZIP/Postal Code
33081
Country
Italy
Individual Site Status
Recruiting
Facility Name
IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola Malpighi Oncologia medica
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera Univ. Policlinico G Rodolico San Marco
City
Catania
ZIP/Postal Code
95125
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
A.O. Santa Croce e Carle, Ospedale Carle
City
Cuneo
ZIP/Postal Code
12100
Country
Italy
Individual Site Status
Recruiting
Facility Name
AOU Careggi
City
Florence
ZIP/Postal Code
50134
Country
Italy
Individual Site Status
Recruiting
Facility Name
ASL 3 Genovese Oncologia Medica Villa Scassi
City
Genova
ZIP/Postal Code
16149
Country
Italy
Individual Site Status
Recruiting
Facility Name
IRCCS Istituto Clinico Humanitas - Cancer Center
City
Milan
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Recruiting
Facility Name
Universita degli Studi della Campania Luigi Vanvitelli
City
Napoli
ZIP/Postal Code
80138
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Ospedale Maggiore di Novara
City
Novara
ZIP/Postal Code
28100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
City
Orbassano
ZIP/Postal Code
10043
Country
Italy
Individual Site Status
Recruiting
Facility Name
Oncologia Medica II Istituto Oncologico Veneto IRCCS
City
Padova
ZIP/Postal Code
35128
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda USL di Piacenza
City
Piacenza
ZIP/Postal Code
29121
Country
Italy
Individual Site Status
Recruiting
Facility Name
Irccs-Crob
City
Rionero In Vulture
ZIP/Postal Code
85028
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fondazione Policlinico Universitario Campus Bio-Medico
City
Roma
ZIP/Postal Code
00128
Country
Italy
Individual Site Status
Recruiting
Facility Name
IFO Regina Elena
City
Roma
ZIP/Postal Code
00128
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera Univ. Senese Policlinico Le Scotte
City
Siena
ZIP/Postal Code
53100
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
ASST Valtellina e Alto Lario Ospedale di Sondrio
City
Sondrio
ZIP/Postal Code
23100
Country
Italy
Individual Site Status
Recruiting
Facility Name
ASST Sette Laghi
City
Varese
ZIP/Postal Code
21100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Chungbuk National University Hospital
City
Cheongju-si
ZIP/Postal Code
28644
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
CHA Bundang Medical Center, CHA University
City
Gyeonggi-do
ZIP/Postal Code
13496
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
The Catholic University of Korea, St.Vincents Hospital
City
Gyeonggi-do
ZIP/Postal Code
16247
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Gachon University Gil Medical Center
City
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Inha University Hospital
City
Incheon
ZIP/Postal Code
22332
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kangbuk S Hospital
Facility Name
Kangbuk Samsung Hospital
City
Seoul
ZIP/Postal Code
03181
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
The Catholic University of Korea, Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Seoul Metropolitan Government-Seoul National University Boramae Medical Center
City
Seoul
ZIP/Postal Code
07061
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
II Klinika Chorob Pluc i Gruzlicy
City
Białystok
ZIP/Postal Code
15-569
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Szpitale Pomorskie Sp. z o.o., Oddzial Onkologii K
City
Gdynia
ZIP/Postal Code
81-519
Country
Poland
Individual Site Status
Recruiting
Facility Name
Specjalistyczna Praktyka Lekarska Slawomir Mandziuka
City
Lublin
ZIP/Postal Code
20-093
Country
Poland
Individual Site Status
Recruiting
Facility Name
Szpital Specjalistyczny w Prabutach Sp. z o.o
City
Prabuty
ZIP/Postal Code
82-550
Country
Poland
Individual Site Status
Recruiting
Facility Name
Mrukmed. Lekarz Beata Madej-Mruk i Partner. Sp.p
City
Rzeszów
ZIP/Postal Code
35-021
Country
Poland
Individual Site Status
Recruiting
Facility Name
Specjalistyczny Szpital Onkologiczny NU-MED sp. Z
City
Tomaszów Mazowiecki
ZIP/Postal Code
97-200
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Wojewódzkie Wielospecjalistyczne Centrum Onkologii
City
Łódź
ZIP/Postal Code
93-513
Country
Poland
Individual Site Status
Recruiting
Facility Name
Sc Oncopremium Team Srl
City
Baia Mare
ZIP/Postal Code
020945
Country
Romania
Individual Site Status
Recruiting
Facility Name
Medisprof srl
City
Cluj-Napoca
ZIP/Postal Code
400641
Country
Romania
Individual Site Status
Recruiting
Facility Name
Oncolab SRL
City
Craiova
ZIP/Postal Code
200385
Country
Romania
Individual Site Status
Recruiting
Facility Name
Centrul de Oncologie Sfantu Nectarie
City
Craiova
ZIP/Postal Code
200746
Country
Romania
Individual Site Status
Recruiting
Facility Name
Ovidius Clinical Hospital
City
Ovidiu
ZIP/Postal Code
9005900
Country
Romania
Individual Site Status
Not yet recruiting
Facility Name
Oncocenter Oncologie clinica S.R.L
City
Timişoara
ZIP/Postal Code
300166
Country
Romania
Individual Site Status
Recruiting
Facility Name
Institut Català d Oncologia (ICO) - Hospital Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Recruiting
Facility Name
Institut Catala d'Oncologia (ICO) - Hospital Duran i Reynals
City
L'Hospitalet De Llobregat
State/Province
Barcelona
ZIP/Postal Code
08908
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Marqués de Valdecilla
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Complejo Hospitalario Materno-Insular de Gran Canaria
City
Las Palmas De Gran Canaria
State/Province
Gran Canaria
ZIP/Postal Code
35016
Country
Spain
Individual Site Status
Recruiting
Facility Name
Clínica Universidad de Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Complexo Hospitalario Universitario De Vigo (CHUVI) - Hospital Xeral
City
Vigo
State/Province
Pontevedra
ZIP/Postal Code
36312
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Teresa Herrera C.H.U.A.
City
A Coruña
ZIP/Postal Code
15009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Reina Sofía
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Lucus Augusti
City
Lugo
ZIP/Postal Code
27003
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital General Universitario Gregorio Marañón
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Clínica Universidad de Navarra
City
Madrid
ZIP/Postal Code
28027
Country
Spain
Individual Site Status
Recruiting
Facility Name
MD Anderson Cancer Center
City
Madrid
ZIP/Postal Code
28033
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clínico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Fundación Jimenez Díaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario HM Sanchinarro
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Regional Universitario Málaga Hospital Civil
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen del Rocío
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari i Politècnic La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clínico Universitario de Valladolid
City
Valladolid
ZIP/Postal Code
47003
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clínico Universitario Lozano Bleza
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Individual Site Status
Recruiting
Facility Name
University Hospital Basel
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Individual Site Status
Not yet recruiting
Facility Name
Istituto Oncologico della Svizzera Italiana
City
Bellinzona
ZIP/Postal Code
6500
Country
Switzerland
Individual Site Status
Not yet recruiting
Facility Name
Spital Thurgau - Kantonspital Frauenfeld
City
Frauenfeld
ZIP/Postal Code
8501
Country
Switzerland
Individual Site Status
Not yet recruiting
Facility Name
Centre Hospitalier Universitaire Vaudois
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
Kantonsspital Baselland
City
Liestal
ZIP/Postal Code
4410
Country
Switzerland
Individual Site Status
Not yet recruiting
Facility Name
Spital Thurgau - Kantonsspital Muensterlingen
City
Münsterlingen
ZIP/Postal Code
8596
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
HFR Freiburg Kantonsspital
City
Villars-sur-Glâne
ZIP/Postal Code
1752
Country
Switzerland
Individual Site Status
Not yet recruiting
Facility Name
Medicalpark Seyhan Hospital
City
Seyhan
State/Province
Adana
ZIP/Postal Code
01140
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Name
Liv Hospital Ankara
City
Çankaya
State/Province
Ankara
ZIP/Postal Code
06680
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Name
Bagcilar Medipol Mega University Hospital
City
Bagcilar
State/Province
Istambul
ZIP/Postal Code
34214
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Name
Goztepe Prof. Dr. Suleyman Yalcin City Hospital
City
Kadıköy
State/Province
Istambul
ZIP/Postal Code
34722
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Name
Kocaeli University Hospital
City
İzmit
State/Province
Kocaeli
ZIP/Postal Code
41380
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Name
Belfast Health and Social Care Trust
City
Belfast
ZIP/Postal Code
BT9 7AB
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
The Princess Alexandra Hospital
City
Harlow
ZIP/Postal Code
CM20 1QX
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Guys and St Thomas NHS Foundation Trust
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
The Christie NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Nottingham University Hospitals NHS Trust
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Clatterbridge Hospital
City
Wirral
ZIP/Postal Code
CH63 4JY
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
The Royal Wolverhampton NHS Trust
City
Wolverhampton
ZIP/Postal Code
WV10 0QP
Country
United Kingdom
Individual Site Status
Not yet recruiting

12. IPD Sharing Statement

Learn more about this trial

Clinical Trial of Lurbinectedin as Single-agent or in Combination With Irinotecan Versus Topotecan or Irinotecan in Patients With Relapsed Small-cell Lung Cancer (LAGOON)

We'll reach out to this number within 24 hrs