search
Back to results

Clinical Trial of Lurbinectedin (PM01183)/Doxorubicin Versus CAV or Topotecan as Treatment in Patients With Small-Cell Lung Cancer (ATLANTIS)

Primary Purpose

Small-cell Lung Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lurbinectedin (PM01183)
Doxorubicin (DOX)
Cyclophosphamide (CTX)
Vincristine (VCR)
Topotecan
Sponsored by
PharmaMar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Small-cell Lung Cancer

Eligibility Criteria

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

Inclusion Criteria:

  1. Voluntary written informed consent
  2. Adult patients ≥ 18 years
  3. Histologically or cytologically confirmed diagnosis of limited or extensive stage SCLC which failed one prior platinum-containing regimen and with a chemotherapy-free interval (CTFI, time from the last dose of first-line chemotherapy to the occurrence of progressive disease) ≥ 30 days. Small-cell carcinoma of unknown primary site with or without neuroendocrine features confirmed in histology test(s) performed on metastatic lesion(s) are eligible, if Ki-67/MIB-1 is expressed in >50% of tumor cells.
  4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 2.
  5. Adequate hematological, renal, metabolic and hepatic function within 7-10 days prior to randomization
  6. At least three weeks since last prior anticancer treatment and adequate recovery from prior treatment toxicity
  7. Prior radiotherapy (RT): At least four weeks since completion of whole-brain irradiation, at least two weeks since completion of prophylactic cranial irradiation, and to any other site.
  8. Evidence of non-childbearing status for women of childbearing potential (WOCBP). WOCBP must agree to use a highly effective contraceptive measure up to six weeks after treatment discontinuation. Fertile male patients with WOCBP partners should use condoms during treatment and for four months following the last investigational medicinal product dose.

Exclusion Criteria:

  1. More than one prior chemotherapy-containing line(re-challenge with the same initial regimen is not allowed)
  2. Patients who never received platinum-containing regimen for Small-cell Lung Cancer (SCLC)
  3. Prior treatment with PM01183, topotecan or anthracyclines.
  4. Limited-stage patients who are candidates for local or regional therapy
  5. Impending need for palliative RT or surgery for pathological fractures and/or for medullary compression within four weeks prior to randomization.
  6. Symptomatic or progressing or steroid requiring Central Nervous System (CNS) involvement disease at least four weeks prior to randomization

  7. Concomitant diseases/conditions:

    Angina, myocardial infarction, congestive heart failure or clinically significant valvular heart disease, arrhythmia, immunodeficiency (including known HIV seropositive), ongoing or treatment-requiring chronic liver disease, active infection, oxygen requirement within two weeks prior to randomization, diffuse interstitial lung disease (ILD) or pulmonary fibrosis, second invasive malignancy treated with chemotherapy and/or radiotherapy, invasive fungal infections requiring systemic treatment within 12 weeks of randomization.

  8. Pregnant or breast feeding women

Sites / Locations

  • Alabama Oncology
  • Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers
  • St Jude Hospital Yorba Linda dba St Joseph Heritage Healthcare
  • Loma Linda University Medica! Center
  • Innovative Clinical Research Institute (ICRI)
  • Boca Raton Regional Hospital Lynn Cancer Institute
  • Holy Cross Hospital - Michael and Dianne Bienes Comprehensive Cancer Center
  • H. Lee Moffitt Cancer Center & Research Institute
  • Joliet Oncology-Hematology Associates, Ltd.
  • Healthcare Research Network III, LLC
  • Carle Cancer Center
  • Norton Cancer Institute
  • Montgomery Cancer Center
  • East Jefferson Hematology-Oncology Metairie Physicians Services, Inc
  • Anne Arundel Medical Center Oncology and Hematology
  • Massachusetts General Hospital
  • QUEST Research Institute
  • Comprehensive Cancer Centers of Nevada
  • Dartmouth-Hitchcock Medical Center/Mary Hitchcock Memorial Hospital
  • Summit Medical Group, P.A.
  • FirstHealth Outpatient Cancer Center
  • Gabrail Cancer Center Research
  • Oklahoma Cancer Specialists and Research Institute, LLC
  • Associates in Hematology and Oncology, P.C.
  • The Center for Cancer and Blood Disorders
  • Tyler Hematology-Oncology PA
  • Medical Oncology Associates PS (dba Summit Cancer Centers)
  • MultiCare Institute for Research & Innovation
  • Froedtert Hospital & the Medical College of Wisconsin
  • Instituto Médico Especializado Alexander Fleming
  • Centro para la Atención Integral del Paciente Oncológico (CAIPO)
  • Instituto Oncológico de Córdoba (IONC)
  • CORI - Centro Oncológico Riojano Integral
  • ISIS Centro Especializado de Luce S.A.
  • Universitätsklinik für Innere Medizin III der PMU
  • Medizinische Universität Wien / AKH Wien, Universitätsklinik für Innere Medizin I, Abteilung für klinische Onkologie
  • AZ Maria Middelares
  • Clinique André Renard
  • CHR de la citadelle
  • CHU de Liege - Sart Tilman
  • CHU Ambroise Paré
  • AZ Delta Campus Wilgenstraat
  • Nucleo de Oncologia da Bahia
  • lOP- Instituto de oncologia do paraná
  • Coordenação de Pesquisa Clínica / Instituto Nacional de Câncer
  • Instituto COl de Pesquisa, Educação e Gestão
  • Associação Hospital de Caridade de Ijuí
  • lrmandade da Santa Casa de Misericórdia de Porto Alegre
  • Hospital São Lucas da PUCRS
  • Hospital de clínicas de Porto alegre
  • Fundação PlO XII - Hospital de Câncer de Barretos
  • lnstituto de Ensino e Pesquisa Säo Lucas - IEP Säo Lucas
  • Multiprofile Hospital for Active Treatment - Uni Hospital, Panagyurishte
  • Multiprofile Hospital for Active Treatment of Women Health - "Nadezhda", Sofia; Clinic of Medical Oncology
  • University Multiprofile Hospital for Active Treatment "Sv. Ivan Rilski", Sofia
  • Acibadem City Clinic University Multiprofile Hospital for Active Treatment. EOOD, Sofia; Clinic of Medical Oncology
  • Southlake Regional Health Centre - Stronach Regional Cancer Centre
  • R.S. Mc Laughlin Durham Regional Cancer Centre, Lakeridge Health
  • Centre intégré de santé et de services sociaux de la Montérégie Centre
  • Biron (Clinique René Laennec)
  • Montreal Oncology Research Inc.
  • McGill University Health Centre
  • Vitkovicka nemocnice, a.s., Plicni oddeleni
  • Krajska zdravotni a.s. Masarykova nemocnice o.z.
  • Institut Bergonié
  • Centre François Baclesse
  • Centre Hospitalier Intercommunal de Créteil
  • Centre Hospitalier Lyon Sud - Service de Pneumologie
  • Hôpital Nord - Service Oncologie Multidisciplinaire et Innovations Thérapeutiques
  • Centre Antoine Lacassagne
  • CHU de Rennes Hôpital Pontchaillou
  • Central Clinic of Bad Berka
  • Vivantes Klinikum am Urban, Hämatologie und Onkologie
  • Evangelische Lungenklinik Berlin
  • Uniklinik Freiburg, Hämatologie, Onkologie & Stammzellransplantation
  • Asklepios-Fachkliniken München Gauting
  • Center for Pneumology and Thoracic Surgery
  • Thoraxklinik Heidelberg GmbH
  • Lungenklinik Hemer
  • VIDIA Christliche Kliniken Karlsruhe
  • Katholisches Klinikum Koblenz-Montabaur, Marienhof Koblenz
  • Onkologische Schwerpunktpraxis Leer-Emden
  • Klinik Löwenstein gGmbH, Med. Klinik II Onkologie
  • Uniklinikum Mannheim, TTZ, Medizinische Fakultät Mannheim
  • Johannes Wesling Klinikum Minden, Klinik für Hämatologie, Onkologie und Palliativmedizin
  • University of Munich LMU, Dpt. of Medicine V
  • Städtisches Krankenhaus München Neuperlach
  • Klinikum Bogenhausen, Städt. Klinikum München GmbH, Klinik für Pneumologie und Pneumologische Onkologie
  • Klinikum Nürnberg Nord - Pneumologische Onkologie
  • Universitätsklinikum Ulm - Klinik für Innere Medizin II, Pneumologie
  • Medizinische Klinik I
  • University General Hospital of Heraklion - General Hospital "Venizeleio"
  • General Hospital of Chest Diseases of Athens "Sotiria"
  • General Oncology Hospital of Kifissia "Agioi Anargiroi", 2nd Internal Medicine-Oncology Clinic
  • General Hospital of Thessaloniki "G. Papanikolaou", Pulmonary Clinic, Aristotle University of Thessaloniki
  • Országos Korányi TBC és Pulmonológiai Intézet, 6. Pulmonológia és Bronchologia
  • Országos Korányi TBC és Pulmonológiai lntézet, 14. Pulmonológia
  • Veszprém Megyei Tüdögyógyintézet, 3. Pulmonológiai Osztály
  • Mátrai Gyógyintézet, Bronchológia
  • Miskolci Semmelweis Kórház és Egyetemi Oktatókórház, Pulmonológiai Osztály
  • Fejér Megyei Szent György Egyetemi Oktató Kórház, I. Pulmonológiai Osztály
  • Markusovszky Egyetemi Oktatókórház, Pulmonológiai Osztály
  • Szent Borbála Kórház, Pulmonológiai osztály
  • Zala Megyei Kórház, Pulmonologia
  • ASST Grande Ospedale Metropolitano Niguarda
  • IRCCS CROB (Istituto di Ricovero e Cura a Carattere Scientifico)
  • Centro di Riferimento Oncologico di Aviano
  • Azienda Ospedaliero - Universitaria "Policlinico - Vittorio Emanuele" - Presidio G. Rodolico
  • AOU Maggiore della Carità - SC Oncologia
  • Istituto Oncologico Veneto
  • lRCCS-Arcispedale Santa Maria Nuova
  • Policlinico Universitario Campus Bio-Medico
  • ASST della Valtellina e dell' Alto Lario P.O. Di Sondrio
  • Ain Wazein Hospital
  • American University of Beirut Medical Center
  • Hotel Dieu de France
  • Centre Hospitalier Universitaire Notre Dame de Secours
  • Hammoud Hospital University Medical Center
  • The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
  • Spaarne Gasthuis
  • MUMC
  • Maxima Medisch Centrum
  • Bialostockie Centrum Onkologii im. Marii Sklodowskiej-Curie; Oddzial Onkologii Klinicznej im. dr Ewy Pileckiej z pododdzialem
  • Szpitale Pomorskie Sp. z o.o., Oddzial Onkologii Klinicznej, Oddzial Onkologii i Radioterapii
  • Mazowieckie Centrum Leczenia Chorób Pluc i Gruźlicy Oddzial III Chorób Pluc z Pododdzialem Onkologicznym
  • Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. K.Marcinkowskiego w Poznaniu, Oddzial Chemioterapii
  • Centro Clínico Champalimaud - Fundação Champalimaud
  • Centro Hospitalar Lisboa Norte, EPE- Hospital Pulido Valente
  • Centro Hospitalar do Porto, EPE - Hospital de Santo António
  • Hospital CUF Porto
  • Instituto Português de Oncologia do Porto Francisco Gentil, EPE
  • Centro Hospitalar de São João, EPE
  • SC Centrul de Oncologie Sf. Nectarie SRL, Departament Oncologie Medícala
  • Spitalul Clinic Judetean de Urgenta "Sf. Apostol Andrei"
  • SC Oncolab SRL
  • Spitalul Judetean de Urgenta "Dr. Constantin Opris", Sectia Oncologie Medicala
  • Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca, Departament Oncologie Medicala
  • Institutul Oncologic "Prof. Dr. lon Chiricuta" Cluj-Napoca, Dcpartamentul Oncologie Medicala
  • Institutul Oncologic "Prof. Dr. lon Chiricuta" Cluj-Napoca, Sectia Oncologic Medicala
  • Hospital Universitari Germans Trias i Pujol ICO
  • Corporació Sanitaria Parc Taulí-Hospital de Sabadell
  • Hospital Universitario Puerta de Hierro Majadahonda
  • Hospital Universitari Vall d' Hebron
  • Hospital Universitario Reina Sofia
  • MD Anderson Cancer Center Madrid
  • Hospital Universitario Ramón y Cajal
  • Hospital Universitario Clínico San Carlos
  • Hospital Universitario Fundación Jiménez Díaz
  • Hospital Universitario 12 de Octubre
  • Hospital Regional Universitario de Malaga
  • Complejo hospitalario regional virgen rocío
  • Hospital General Universitario de Valencia
  • Hospital Universitario La Fe de Valencia
  • Hospital Universitario Miguel Servet
  • The Christie NHS Fundation Trust
  • The Clatterbridge Cancer Centre NHS Foundation Trust
  • Bristol Cancer Institute, UHB NHS Foundation Trust
  • University College London Hospitals NHS Foundation Trust
  • Sarah Cannon Research Institute UK
  • Worcestershire Acute Hospitals NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Experimental Arm

Control Arm 1

Control Arm 2

Arm Description

Lurbinectedin (PM01183) / Doxorubicin

CAV (Cyclophosphamide (CTX), Doxorubicin (DOX) and Vincristine (VCR))

Topotecan

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Difference in Overall Survival Between Lurbinectedin/Doxorubicin (DOX) and CAV in Patients With CAV as Best Investigator's Choice: Overall Survival Rate at 12 Months
Overall survival (OS) will be calculated from the date of randomization to the date of death (death event) or last contact(in this case, survival will be censored on that date).
Difference in Overall Survival Between Lurbinectedin/DOX and CAV in Patients With CAV as Best Investigator's Choice: Overall Survival Rate at 18 Months
Overall survival (OS) will be calculated from the date of randomization to the date of death (death event) or last contact(in this case, survival will be censored on that date).
Difference in Overall Survival Between Lurbinectedin/DOX and CAV in Patients With CAV as Best Investigator's Choice: Overall Survival Rate at 24 Months
Overall survival (OS) will be calculated from the date of randomization to the date of death (death event) or last contact(in this case, survival will be censored on that date).
Progression-free Survival (PFS) by Independent Review Committee
Progression-free survival (PFS) is defined as the time from the date of randomization to the date of documented progression per RECIST v.1.1 or death (regardless of the cause of death). If the patient receives further antitumor therapy or is lost to follow-up before PD, PFS will be censored at the date of last tumor assessment before the date of subsequent antitumor therapy.
Progression-free Survival Rate at 6 Months by Independent Review Committee
Progression-free survival (PFS) is defined as the time from the date of randomization to the date of documented progression per RECIST v.1.1 or death (regardless of the cause of death). If the patient receives further antitumor therapy or is lost to follow-up before PD, PFS will be censored at the date of last tumor assessment before the date of subsequent antitumor therapy.
Progression-free Survival Rate at 12 Months by Independent Review Committee
Progression-free survival (PFS) is defined as the time from the date of randomization to the date of documented progression per RECIST v.1.1 or death (regardless of the cause of death). If the patient receives further antitumor therapy or is lost to follow-up before PD, PFS will be censored at the date of last tumor assessment before the date of subsequent antitumor therapy.
Best Antitumor Response by Independent Review Committee
Best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1. CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown
Overall Response Rate by Independent Review Committee
Overall response rate is defined as the proportion of patients who have a partial or complete response in the best antitumor response. The best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1. CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown
Duration of Response by Independent Review Committee
Duration of Response is defined as the time that patients who have a partial or complete response in the best antitumor response. The best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1. CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown
Overall Survival in Patients With Chemotherapy-free Interval ≥ 90 Days
Overall survival (OS) will be calculated from the date of randomization to the date of death (death event) or last contact(in this case, survival will be censored on that date).
Progression-free Survival in Patients With Chemotherapy-free Interval ≥90 Days
Progression-free survival (PFS) is defined as the time from the date of randomization to the date of documented progression per RECIST v.1.1 or death (regardless of the cause of death). If the patient receives further antitumor therapy or is lost to follow-up before PD, PFS will be censored at the date of last tumor assessment before the date of subsequent antitumor therapy.
Best Antitumor Response in Patients With Chemotherapy-free Interval ≥ 90 Days
Best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1. CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown
Overall Response Rate in Patients With Chemotherapy-free Interval ≥ 90 Days
Overall response rate is defined as the proportion of patients who have a partial or complete response in the best antitumor response. The best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1. CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown
Duration of Response in Patients With Chemotherapy-free Interval ≥ 90 Days
Duration of Response is defined as the time that patients who have a partial or complete response in the best antitumor response. The best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1. CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown
Overall Survival in Patients With Chemotherapy-free Interval < 90 Days
Overall survival (OS) will be calculated from the date of randomization to the date of death (death event) or last contact(in this case, survival will be censored on that date).
Progression-free Survival in Patients With Chemotherapy-free Interval <90 Days
Progression-free survival (PFS) is defined as the time from the date of randomization to the date of documented progression per RECIST v.1.1 or death (regardless of the cause of death). If the patient receives further antitumor therapy or is lost to follow-up before PD, PFS will be censored at the date of last tumor assessment before the date of subsequent antitumor therapy.
Best Antitumor Response in Patients With Chemotherapy-free Interval <90 Days
Best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1. CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown
Overall Response Rate in Patients With Chemotherapy-free Interval <90 Days
Overall response rate is defined as the proportion of patients who have a partial or complete response in the best antitumor response. The best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1. CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown
Duration of Response in Patients With Chemotherapy-free Interval <90 Days
Duration of Response is defined as the time that patients who have a partial or complete response in the best antitumor response. The best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1. CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown
Overall Survival in Patients Without Central Nervous System Involvement at Baseline
Overall survival (OS) will be calculated from the date of randomization to the date of death (death event) or last contact(in this case, survival will be censored on that date).
Progression-free Survival in Patients Without Central Nervous System Involvement at Baseline
Progression-free survival (PFS) is defined as the time from the date of randomization to the date of documented progression per RECIST v.1.1 or death (regardless of the cause of death). If the patient receives further antitumor therapy or is lost to follow-up before PD, PFS will be censored at the date of last tumor assessment before the date of subsequent antitumor therapy.
Best Antitumor Response in Patients Without Central Nervous System Involvement at Baseline
Best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1. CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown
Overall Response Rate in Patients Without Central Nervous System Involvement at Baseline
Overall response rate is defined as the proportion of patients who have a partial or complete response in the best antitumor response. The best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1. CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown
Duration of Response in Patients Without Central Nervous System Involvement at Baseline
Duration of Response is defined as the time that patients who have a partial or complete response in the best antitumor response. The best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1. CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown
Overall Survival in Patients With Central Nervous System Involvement at Baseline
Overall survival (OS) will be calculated from the date of randomization to the date of death (death event) or last contact(in this case, survival will be censored on that date).
Progression-free Survival in Patients With Central Nervous System Involvement at Baseline
Progression-free survival (PFS) is defined as the time from the date of randomization to the date of documented progression per RECIST v.1.1 or death (regardless of the cause of death). If the patient receives further antitumor therapy or is lost to follow-up before PD, PFS will be censored at the date of last tumor assessment before the date of subsequent antitumor therapy.
Best Antitumor Response in Patients With Central Nervous System Involvement at Baseline
Best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1. CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown
Overall Response Rate in Patients With Central Nervous System Involvement at Baseline
Overall response rate is defined as the proportion of patients who have a partial or complete response in the best antitumor response. The best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1. CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown
Duration of Response in Patients With Central Nervous System Involvement at Baseline
Duration of Response is defined as the time that patients who have a partial or complete response in the best antitumor response. The best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1. CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown

Full Information

First Posted
September 24, 2015
Last Updated
September 29, 2021
Sponsor
PharmaMar
search

1. Study Identification

Unique Protocol Identification Number
NCT02566993
Brief Title
Clinical Trial of Lurbinectedin (PM01183)/Doxorubicin Versus CAV or Topotecan as Treatment in Patients With Small-Cell Lung Cancer
Acronym
ATLANTIS
Official Title
Phase III Randomized Clinical Trial of Lurbinectedin (PM01183)/Doxorubicin Versus Cyclophosphamide, Doxorubicin and Vincristine (CAV) or Topotecan as Treatment in Patients With Small-Cell Lung Cancer (SCLC) Who Failed One Prior Platinum-containing Line (ATLANTIS)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
August 30, 2016 (Actual)
Primary Completion Date
February 24, 2020 (Actual)
Study Completion Date
February 24, 2020 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
Phase III randomized clinical trial of lurbinectedin (PM01183)/doxorubicin (DOX) versus cyclophosphamide (CTX), doxorubicin (DOX) and vincristine (VCR) (CAV) or topotecan as treatment in patients with small-cell lung cancer (SCLC) who failed one prior platinum-containing line.
Detailed Description
Multicenter, open-label, randomized, controlled phase III clinical trial to evaluate and compare the activity and safety of an experimental arm consisting of PM01183/DOX combination followed by PM01183 alone, if applicable vs. best Investigator's choice between CAV or topotecan as a control arm, in SCLC patients who failed one prior platinum-containing line but no more than one prior chemotherapy-containing line.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small-cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
613 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Arm
Arm Type
Experimental
Arm Description
Lurbinectedin (PM01183) / Doxorubicin
Arm Title
Control Arm 1
Arm Type
Active Comparator
Arm Description
CAV (Cyclophosphamide (CTX), Doxorubicin (DOX) and Vincristine (VCR))
Arm Title
Control Arm 2
Arm Type
Active Comparator
Arm Description
Topotecan
Intervention Type
Drug
Intervention Name(s)
Lurbinectedin (PM01183)
Intervention Type
Drug
Intervention Name(s)
Doxorubicin (DOX)
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide (CTX)
Intervention Type
Drug
Intervention Name(s)
Vincristine (VCR)
Intervention Type
Drug
Intervention Name(s)
Topotecan
Primary Outcome Measure Information:
Title
Overall Survival (OS)
Description
Overall survival (OS) will be calculated from the date of randomization to the date of death (death event) or last contact(in this case, survival will be censored on that date).
Time Frame
Every three months up to death or study termination, a period of approximately 3.5 years
Secondary Outcome Measure Information:
Title
Difference in Overall Survival Between Lurbinectedin/Doxorubicin (DOX) and CAV in Patients With CAV as Best Investigator's Choice: Overall Survival Rate at 12 Months
Description
Overall survival (OS) will be calculated from the date of randomization to the date of death (death event) or last contact(in this case, survival will be censored on that date).
Time Frame
At 12 months
Title
Difference in Overall Survival Between Lurbinectedin/DOX and CAV in Patients With CAV as Best Investigator's Choice: Overall Survival Rate at 18 Months
Description
Overall survival (OS) will be calculated from the date of randomization to the date of death (death event) or last contact(in this case, survival will be censored on that date).
Time Frame
At 18 months
Title
Difference in Overall Survival Between Lurbinectedin/DOX and CAV in Patients With CAV as Best Investigator's Choice: Overall Survival Rate at 24 Months
Description
Overall survival (OS) will be calculated from the date of randomization to the date of death (death event) or last contact(in this case, survival will be censored on that date).
Time Frame
At 24 months
Title
Progression-free Survival (PFS) by Independent Review Committee
Description
Progression-free survival (PFS) is defined as the time from the date of randomization to the date of documented progression per RECIST v.1.1 or death (regardless of the cause of death). If the patient receives further antitumor therapy or is lost to follow-up before PD, PFS will be censored at the date of last tumor assessment before the date of subsequent antitumor therapy.
Time Frame
Every six weeks up to progression disease, a period of approximately 3.5 years
Title
Progression-free Survival Rate at 6 Months by Independent Review Committee
Description
Progression-free survival (PFS) is defined as the time from the date of randomization to the date of documented progression per RECIST v.1.1 or death (regardless of the cause of death). If the patient receives further antitumor therapy or is lost to follow-up before PD, PFS will be censored at the date of last tumor assessment before the date of subsequent antitumor therapy.
Time Frame
At 6 months
Title
Progression-free Survival Rate at 12 Months by Independent Review Committee
Description
Progression-free survival (PFS) is defined as the time from the date of randomization to the date of documented progression per RECIST v.1.1 or death (regardless of the cause of death). If the patient receives further antitumor therapy or is lost to follow-up before PD, PFS will be censored at the date of last tumor assessment before the date of subsequent antitumor therapy.
Time Frame
at 12 months
Title
Best Antitumor Response by Independent Review Committee
Description
Best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1. CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown
Time Frame
Every three months up to death or study termination, a period of approximately 3.5 years
Title
Overall Response Rate by Independent Review Committee
Description
Overall response rate is defined as the proportion of patients who have a partial or complete response in the best antitumor response. The best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1. CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown
Time Frame
Every three months up to death or study termination, a period of approximately 3.5 years
Title
Duration of Response by Independent Review Committee
Description
Duration of Response is defined as the time that patients who have a partial or complete response in the best antitumor response. The best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1. CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown
Time Frame
Every three months up to death or study termination, a period of approximately 3.5 years
Title
Overall Survival in Patients With Chemotherapy-free Interval ≥ 90 Days
Description
Overall survival (OS) will be calculated from the date of randomization to the date of death (death event) or last contact(in this case, survival will be censored on that date).
Time Frame
Every three months up to death or study termination, a period of approximately 3.5 years
Title
Progression-free Survival in Patients With Chemotherapy-free Interval ≥90 Days
Description
Progression-free survival (PFS) is defined as the time from the date of randomization to the date of documented progression per RECIST v.1.1 or death (regardless of the cause of death). If the patient receives further antitumor therapy or is lost to follow-up before PD, PFS will be censored at the date of last tumor assessment before the date of subsequent antitumor therapy.
Time Frame
Every six weeks up to progression disease, a period of approximately 3.5 years
Title
Best Antitumor Response in Patients With Chemotherapy-free Interval ≥ 90 Days
Description
Best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1. CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown
Time Frame
Every three months up to death or study termination, a period of approximately 3.5 years
Title
Overall Response Rate in Patients With Chemotherapy-free Interval ≥ 90 Days
Description
Overall response rate is defined as the proportion of patients who have a partial or complete response in the best antitumor response. The best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1. CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown
Time Frame
Every three months up to death or study termination, a period of approximately 3.5 years
Title
Duration of Response in Patients With Chemotherapy-free Interval ≥ 90 Days
Description
Duration of Response is defined as the time that patients who have a partial or complete response in the best antitumor response. The best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1. CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown
Time Frame
Every three months up to death or study termination, a period of approximately 3.5 years
Title
Overall Survival in Patients With Chemotherapy-free Interval < 90 Days
Description
Overall survival (OS) will be calculated from the date of randomization to the date of death (death event) or last contact(in this case, survival will be censored on that date).
Time Frame
Every three months up to death or study termination, a period of approximately 3.5 years
Title
Progression-free Survival in Patients With Chemotherapy-free Interval <90 Days
Description
Progression-free survival (PFS) is defined as the time from the date of randomization to the date of documented progression per RECIST v.1.1 or death (regardless of the cause of death). If the patient receives further antitumor therapy or is lost to follow-up before PD, PFS will be censored at the date of last tumor assessment before the date of subsequent antitumor therapy.
Time Frame
Every six weeks up to progression disease, a period of approximately 3.5 years
Title
Best Antitumor Response in Patients With Chemotherapy-free Interval <90 Days
Description
Best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1. CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown
Time Frame
Every three months up to death or study termination, a period of approximately 3.5 years
Title
Overall Response Rate in Patients With Chemotherapy-free Interval <90 Days
Description
Overall response rate is defined as the proportion of patients who have a partial or complete response in the best antitumor response. The best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1. CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown
Time Frame
Every three months up to death or study termination, a period of approximately 3.5 years
Title
Duration of Response in Patients With Chemotherapy-free Interval <90 Days
Description
Duration of Response is defined as the time that patients who have a partial or complete response in the best antitumor response. The best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1. CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown
Time Frame
Every three months up to death or study termination, a period of approximately 3.5 years
Title
Overall Survival in Patients Without Central Nervous System Involvement at Baseline
Description
Overall survival (OS) will be calculated from the date of randomization to the date of death (death event) or last contact(in this case, survival will be censored on that date).
Time Frame
Every three months up to death or study termination, a period of approximately 3.5 years
Title
Progression-free Survival in Patients Without Central Nervous System Involvement at Baseline
Description
Progression-free survival (PFS) is defined as the time from the date of randomization to the date of documented progression per RECIST v.1.1 or death (regardless of the cause of death). If the patient receives further antitumor therapy or is lost to follow-up before PD, PFS will be censored at the date of last tumor assessment before the date of subsequent antitumor therapy.
Time Frame
Every six weeks up to progression disease, a period of approximately 3.5 years
Title
Best Antitumor Response in Patients Without Central Nervous System Involvement at Baseline
Description
Best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1. CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown
Time Frame
Every three months up to death or study termination, a period of approximately 3.5 years
Title
Overall Response Rate in Patients Without Central Nervous System Involvement at Baseline
Description
Overall response rate is defined as the proportion of patients who have a partial or complete response in the best antitumor response. The best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1. CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown
Time Frame
Every three months up to death or study termination, a period of approximately 3.5 years
Title
Duration of Response in Patients Without Central Nervous System Involvement at Baseline
Description
Duration of Response is defined as the time that patients who have a partial or complete response in the best antitumor response. The best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1. CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown
Time Frame
Every three months up to death or study termination, a period of approximately 3.5 years
Title
Overall Survival in Patients With Central Nervous System Involvement at Baseline
Description
Overall survival (OS) will be calculated from the date of randomization to the date of death (death event) or last contact(in this case, survival will be censored on that date).
Time Frame
Every three months up to death or study termination, a period of approximately 3.5 years
Title
Progression-free Survival in Patients With Central Nervous System Involvement at Baseline
Description
Progression-free survival (PFS) is defined as the time from the date of randomization to the date of documented progression per RECIST v.1.1 or death (regardless of the cause of death). If the patient receives further antitumor therapy or is lost to follow-up before PD, PFS will be censored at the date of last tumor assessment before the date of subsequent antitumor therapy.
Time Frame
Every six weeks up to progression disease, a period of approximately 3.5 years
Title
Best Antitumor Response in Patients With Central Nervous System Involvement at Baseline
Description
Best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1. CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown
Time Frame
Every three months up to death or study termination, a period of approximately 3.5 years
Title
Overall Response Rate in Patients With Central Nervous System Involvement at Baseline
Description
Overall response rate is defined as the proportion of patients who have a partial or complete response in the best antitumor response. The best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1. CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown
Time Frame
Every three months up to death or study termination, a period of approximately 3.5 years
Title
Duration of Response in Patients With Central Nervous System Involvement at Baseline
Description
Duration of Response is defined as the time that patients who have a partial or complete response in the best antitumor response. The best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1. CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown
Time Frame
Every three months up to death or study termination, a period of approximately 3.5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Voluntary written informed consent Adult patients ≥ 18 years Histologically or cytologically confirmed diagnosis of limited or extensive stage SCLC which failed one prior platinum-containing regimen and with a chemotherapy-free interval (CTFI, time from the last dose of first-line chemotherapy to the occurrence of progressive disease) ≥ 30 days. Small-cell carcinoma of unknown primary site with or without neuroendocrine features confirmed in histology test(s) performed on metastatic lesion(s) are eligible, if Ki-67/MIB-1 is expressed in >50% of tumor cells. Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 2. Adequate hematological, renal, metabolic and hepatic function within 7-10 days prior to randomization At least three weeks since last prior anticancer treatment and adequate recovery from prior treatment toxicity Prior radiotherapy (RT): At least four weeks since completion of whole-brain irradiation, at least two weeks since completion of prophylactic cranial irradiation, and to any other site. Evidence of non-childbearing status for women of childbearing potential (WOCBP). WOCBP must agree to use a highly effective contraceptive measure up to six weeks after treatment discontinuation. Fertile male patients with WOCBP partners should use condoms during treatment and for four months following the last investigational medicinal product dose. Exclusion Criteria: More than one prior chemotherapy-containing line(re-challenge with the same initial regimen is not allowed) Patients who never received platinum-containing regimen for Small-cell Lung Cancer (SCLC) Prior treatment with PM01183, topotecan or anthracyclines. Limited-stage patients who are candidates for local or regional therapy Impending need for palliative RT or surgery for pathological fractures and/or for medullary compression within four weeks prior to randomization. Symptomatic or progressing or steroid requiring Central Nervous System (CNS) involvement disease at least four weeks prior to randomization Concomitant diseases/conditions: Angina, myocardial infarction, congestive heart failure or clinically significant valvular heart disease, arrhythmia, immunodeficiency (including known HIV seropositive), ongoing or treatment-requiring chronic liver disease, active infection, oxygen requirement within two weeks prior to randomization, diffuse interstitial lung disease (ILD) or pulmonary fibrosis, second invasive malignancy treated with chemotherapy and/or radiotherapy, invasive fungal infections requiring systemic treatment within 12 weeks of randomization. Pregnant or breast feeding women
Facility Information:
Facility Name
Alabama Oncology
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35243
Country
United States
Facility Name
Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
St Jude Hospital Yorba Linda dba St Joseph Heritage Healthcare
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Loma Linda University Medica! Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Innovative Clinical Research Institute (ICRI)
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Facility Name
Boca Raton Regional Hospital Lynn Cancer Institute
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Holy Cross Hospital - Michael and Dianne Bienes Comprehensive Cancer Center
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
H. Lee Moffitt Cancer Center & Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Joliet Oncology-Hematology Associates, Ltd.
City
Joliet
State/Province
Illinois
ZIP/Postal Code
60435
Country
United States
Facility Name
Healthcare Research Network III, LLC
City
Tinley Park
State/Province
Illinois
ZIP/Postal Code
60487
Country
United States
Facility Name
Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Norton Cancer Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Montgomery Cancer Center
City
Mount Sterling
State/Province
Kentucky
ZIP/Postal Code
40353
Country
United States
Facility Name
East Jefferson Hematology-Oncology Metairie Physicians Services, Inc
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Anne Arundel Medical Center Oncology and Hematology
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
QUEST Research Institute
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center/Mary Hitchcock Memorial Hospital
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Summit Medical Group, P.A.
City
Florham Park
State/Province
New Jersey
ZIP/Postal Code
07932
Country
United States
Facility Name
FirstHealth Outpatient Cancer Center
City
Pinehurst
State/Province
North Carolina
ZIP/Postal Code
28374
Country
United States
Facility Name
Gabrail Cancer Center Research
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Oklahoma Cancer Specialists and Research Institute, LLC
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74146
Country
United States
Facility Name
Associates in Hematology and Oncology, P.C.
City
Upland
State/Province
Pennsylvania
ZIP/Postal Code
19013
Country
United States
Facility Name
The Center for Cancer and Blood Disorders
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Tyler Hematology-Oncology PA
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
Medical Oncology Associates PS (dba Summit Cancer Centers)
City
Spokane
State/Province
Washington
ZIP/Postal Code
99208
Country
United States
Facility Name
MultiCare Institute for Research & Innovation
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Froedtert Hospital & the Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Instituto Médico Especializado Alexander Fleming
City
C.a.b.a.
State/Province
Buenos Aires
ZIP/Postal Code
C1426ANZ
Country
Argentina
Facility Name
Centro para la Atención Integral del Paciente Oncológico (CAIPO)
City
San Miguel de Tucumán
State/Province
Tucumán
ZIP/Postal Code
T4000GTB
Country
Argentina
Facility Name
Instituto Oncológico de Córdoba (IONC)
City
Córdoba
ZIP/Postal Code
X5000HLX
Country
Argentina
Facility Name
CORI - Centro Oncológico Riojano Integral
City
La Rioja
ZIP/Postal Code
F5300COE
Country
Argentina
Facility Name
ISIS Centro Especializado de Luce S.A.
City
Santa Fe
ZIP/Postal Code
S3000FFU
Country
Argentina
Facility Name
Universitätsklinik für Innere Medizin III der PMU
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Medizinische Universität Wien / AKH Wien, Universitätsklinik für Innere Medizin I, Abteilung für klinische Onkologie
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
AZ Maria Middelares
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Clinique André Renard
City
Herstal
ZIP/Postal Code
4040
Country
Belgium
Facility Name
CHR de la citadelle
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
CHU de Liege - Sart Tilman
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
CHU Ambroise Paré
City
Mons
ZIP/Postal Code
7000
Country
Belgium
Facility Name
AZ Delta Campus Wilgenstraat
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
Nucleo de Oncologia da Bahia
City
Salvador
State/Province
BA
ZIP/Postal Code
40170-110
Country
Brazil
Facility Name
lOP- Instituto de oncologia do paraná
City
Curitiba
State/Province
Paraná
ZIP/Postal Code
80530-010
Country
Brazil
Facility Name
Coordenação de Pesquisa Clínica / Instituto Nacional de Câncer
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
20231-092
Country
Brazil
Facility Name
Instituto COl de Pesquisa, Educação e Gestão
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
22793-080
Country
Brazil
Facility Name
Associação Hospital de Caridade de Ijuí
City
Ijui
State/Province
RS
ZIP/Postal Code
98700-000
Country
Brazil
Facility Name
lrmandade da Santa Casa de Misericórdia de Porto Alegre
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90020-090
Country
Brazil
Facility Name
Hospital São Lucas da PUCRS
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Hospital de clínicas de Porto alegre
City
Pôrto Alegre
State/Province
RS
ZIP/Postal Code
90.035-903
Country
Brazil
Facility Name
Fundação PlO XII - Hospital de Câncer de Barretos
City
Barretos
State/Province
São Paulo
ZIP/Postal Code
14784-400
Country
Brazil
Facility Name
lnstituto de Ensino e Pesquisa Säo Lucas - IEP Säo Lucas
City
Sao Paulo
State/Province
São Paulo
ZIP/Postal Code
01236-030
Country
Brazil
Facility Name
Multiprofile Hospital for Active Treatment - Uni Hospital, Panagyurishte
City
Panagyurishte
ZIP/Postal Code
4500
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment of Women Health - "Nadezhda", Sofia; Clinic of Medical Oncology
City
Sofia
ZIP/Postal Code
1330
Country
Bulgaria
Facility Name
University Multiprofile Hospital for Active Treatment "Sv. Ivan Rilski", Sofia
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Acibadem City Clinic University Multiprofile Hospital for Active Treatment. EOOD, Sofia; Clinic of Medical Oncology
City
Sofia
ZIP/Postal Code
1784
Country
Bulgaria
Facility Name
Southlake Regional Health Centre - Stronach Regional Cancer Centre
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 2P9
Country
Canada
Facility Name
R.S. Mc Laughlin Durham Regional Cancer Centre, Lakeridge Health
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1G 2B9
Country
Canada
Facility Name
Centre intégré de santé et de services sociaux de la Montérégie Centre
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H1
Country
Canada
Facility Name
Biron (Clinique René Laennec)
City
Mont-Royal
State/Province
Quebec
ZIP/Postal Code
H3P 3H5
Country
Canada
Facility Name
Montreal Oncology Research Inc.
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1M 1B1
Country
Canada
Facility Name
McGill University Health Centre
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Vitkovicka nemocnice, a.s., Plicni oddeleni
City
Ostrava
ZIP/Postal Code
703 84
Country
Czechia
Facility Name
Krajska zdravotni a.s. Masarykova nemocnice o.z.
City
Usti nad Labem
ZIP/Postal Code
401 13
Country
Czechia
Facility Name
Institut Bergonié
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Centre François Baclesse
City
Caen
ZIP/Postal Code
14076
Country
France
Facility Name
Centre Hospitalier Intercommunal de Créteil
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
Centre Hospitalier Lyon Sud - Service de Pneumologie
City
Lyon
ZIP/Postal Code
69310
Country
France
Facility Name
Hôpital Nord - Service Oncologie Multidisciplinaire et Innovations Thérapeutiques
City
Marseille
ZIP/Postal Code
13915
Country
France
Facility Name
Centre Antoine Lacassagne
City
Nice Cedex 2
ZIP/Postal Code
06189
Country
France
Facility Name
CHU de Rennes Hôpital Pontchaillou
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Central Clinic of Bad Berka
City
Bad Berka
ZIP/Postal Code
99437
Country
Germany
Facility Name
Vivantes Klinikum am Urban, Hämatologie und Onkologie
City
Berlin
ZIP/Postal Code
10967
Country
Germany
Facility Name
Evangelische Lungenklinik Berlin
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
Uniklinik Freiburg, Hämatologie, Onkologie & Stammzellransplantation
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Asklepios-Fachkliniken München Gauting
City
Gauting
ZIP/Postal Code
82131
Country
Germany
Facility Name
Center for Pneumology and Thoracic Surgery
City
Gerlingen
ZIP/Postal Code
70839
Country
Germany
Facility Name
Thoraxklinik Heidelberg GmbH
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
Facility Name
Lungenklinik Hemer
City
Hemer
ZIP/Postal Code
58675
Country
Germany
Facility Name
VIDIA Christliche Kliniken Karlsruhe
City
Karlsruhe
ZIP/Postal Code
76137
Country
Germany
Facility Name
Katholisches Klinikum Koblenz-Montabaur, Marienhof Koblenz
City
Koblenz
ZIP/Postal Code
56073
Country
Germany
Facility Name
Onkologische Schwerpunktpraxis Leer-Emden
City
Leer
ZIP/Postal Code
26789
Country
Germany
Facility Name
Klinik Löwenstein gGmbH, Med. Klinik II Onkologie
City
Löwenstein
ZIP/Postal Code
74245
Country
Germany
Facility Name
Uniklinikum Mannheim, TTZ, Medizinische Fakultät Mannheim
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Johannes Wesling Klinikum Minden, Klinik für Hämatologie, Onkologie und Palliativmedizin
City
Minden
ZIP/Postal Code
32429
Country
Germany
Facility Name
University of Munich LMU, Dpt. of Medicine V
City
Munchen
ZIP/Postal Code
80336
Country
Germany
Facility Name
Städtisches Krankenhaus München Neuperlach
City
Munchen
ZIP/Postal Code
81737
Country
Germany
Facility Name
Klinikum Bogenhausen, Städt. Klinikum München GmbH, Klinik für Pneumologie und Pneumologische Onkologie
City
Munchen
ZIP/Postal Code
81925
Country
Germany
Facility Name
Klinikum Nürnberg Nord - Pneumologische Onkologie
City
Nuremberg
ZIP/Postal Code
90419
Country
Germany
Facility Name
Universitätsklinikum Ulm - Klinik für Innere Medizin II, Pneumologie
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Medizinische Klinik I
City
Wuppertal
ZIP/Postal Code
42283
Country
Germany
Facility Name
University General Hospital of Heraklion - General Hospital "Venizeleio"
City
Heraklion
State/Province
Crete
ZIP/Postal Code
71110
Country
Greece
Facility Name
General Hospital of Chest Diseases of Athens "Sotiria"
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
General Oncology Hospital of Kifissia "Agioi Anargiroi", 2nd Internal Medicine-Oncology Clinic
City
Athens
ZIP/Postal Code
14564
Country
Greece
Facility Name
General Hospital of Thessaloniki "G. Papanikolaou", Pulmonary Clinic, Aristotle University of Thessaloniki
City
Thessaloniki
ZIP/Postal Code
57010
Country
Greece
Facility Name
Országos Korányi TBC és Pulmonológiai Intézet, 6. Pulmonológia és Bronchologia
City
Budapest
ZIP/Postal Code
1121
Country
Hungary
Facility Name
Országos Korányi TBC és Pulmonológiai lntézet, 14. Pulmonológia
City
Budapest
ZIP/Postal Code
1121
Country
Hungary
Facility Name
Veszprém Megyei Tüdögyógyintézet, 3. Pulmonológiai Osztály
City
Farkasgyepu
ZIP/Postal Code
8582
Country
Hungary
Facility Name
Mátrai Gyógyintézet, Bronchológia
City
Matrahaza
ZIP/Postal Code
3233
Country
Hungary
Facility Name
Miskolci Semmelweis Kórház és Egyetemi Oktatókórház, Pulmonológiai Osztály
City
Miskolc
ZIP/Postal Code
3529
Country
Hungary
Facility Name
Fejér Megyei Szent György Egyetemi Oktató Kórház, I. Pulmonológiai Osztály
City
Szekesfehervar
ZIP/Postal Code
8000
Country
Hungary
Facility Name
Markusovszky Egyetemi Oktatókórház, Pulmonológiai Osztály
City
Szombathely
ZIP/Postal Code
9700
Country
Hungary
Facility Name
Szent Borbála Kórház, Pulmonológiai osztály
City
Tatabanya
ZIP/Postal Code
2800
Country
Hungary
Facility Name
Zala Megyei Kórház, Pulmonologia
City
Zalaegerszeg
ZIP/Postal Code
8900
Country
Hungary
Facility Name
ASST Grande Ospedale Metropolitano Niguarda
City
Milano
State/Province
MI
ZIP/Postal Code
20162
Country
Italy
Facility Name
IRCCS CROB (Istituto di Ricovero e Cura a Carattere Scientifico)
City
Rionero in Vulture
State/Province
PZ
ZIP/Postal Code
85028
Country
Italy
Facility Name
Centro di Riferimento Oncologico di Aviano
City
Aviano
ZIP/Postal Code
33081
Country
Italy
Facility Name
Azienda Ospedaliero - Universitaria "Policlinico - Vittorio Emanuele" - Presidio G. Rodolico
City
Catania
ZIP/Postal Code
95123
Country
Italy
Facility Name
AOU Maggiore della Carità - SC Oncologia
City
Novara
ZIP/Postal Code
28100
Country
Italy
Facility Name
Istituto Oncologico Veneto
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
lRCCS-Arcispedale Santa Maria Nuova
City
Reggio Emilia
ZIP/Postal Code
42123
Country
Italy
Facility Name
Policlinico Universitario Campus Bio-Medico
City
Roma
ZIP/Postal Code
00128
Country
Italy
Facility Name
ASST della Valtellina e dell' Alto Lario P.O. Di Sondrio
City
Sondrio
ZIP/Postal Code
23100
Country
Italy
Facility Name
Ain Wazein Hospital
City
Ain Wazein
State/Province
El Chouf
Country
Lebanon
Facility Name
American University of Beirut Medical Center
City
Beirut
Country
Lebanon
Facility Name
Hotel Dieu de France
City
Beirut
Country
Lebanon
Facility Name
Centre Hospitalier Universitaire Notre Dame de Secours
City
Biblos
Country
Lebanon
Facility Name
Hammoud Hospital University Medical Center
City
Sidon
Country
Lebanon
Facility Name
The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands
Facility Name
Spaarne Gasthuis
City
Hoofddorp
ZIP/Postal Code
2134 TM
Country
Netherlands
Facility Name
MUMC
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
Maxima Medisch Centrum
City
Veldhoven
ZIP/Postal Code
5504 DB
Country
Netherlands
Facility Name
Bialostockie Centrum Onkologii im. Marii Sklodowskiej-Curie; Oddzial Onkologii Klinicznej im. dr Ewy Pileckiej z pododdzialem
City
Białystok
ZIP/Postal Code
15-027
Country
Poland
Facility Name
Szpitale Pomorskie Sp. z o.o., Oddzial Onkologii Klinicznej, Oddzial Onkologii i Radioterapii
City
Gdynia
ZIP/Postal Code
81-519
Country
Poland
Facility Name
Mazowieckie Centrum Leczenia Chorób Pluc i Gruźlicy Oddzial III Chorób Pluc z Pododdzialem Onkologicznym
City
Otwock
ZIP/Postal Code
05-400
Country
Poland
Facility Name
Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. K.Marcinkowskiego w Poznaniu, Oddzial Chemioterapii
City
Poznań
ZIP/Postal Code
60-569
Country
Poland
Facility Name
Centro Clínico Champalimaud - Fundação Champalimaud
City
Lisboa
ZIP/Postal Code
1400-038
Country
Portugal
Facility Name
Centro Hospitalar Lisboa Norte, EPE- Hospital Pulido Valente
City
Lisboa
ZIP/Postal Code
1769-001
Country
Portugal
Facility Name
Centro Hospitalar do Porto, EPE - Hospital de Santo António
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
Hospital CUF Porto
City
Porto
ZIP/Postal Code
4100-180
Country
Portugal
Facility Name
Instituto Português de Oncologia do Porto Francisco Gentil, EPE
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Facility Name
Centro Hospitalar de São João, EPE
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
SC Centrul de Oncologie Sf. Nectarie SRL, Departament Oncologie Medícala
City
Craiova
State/Province
Dolj
ZIP/Postal Code
200347
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgenta "Sf. Apostol Andrei"
City
Constanta
State/Province
Judet Constanta
ZIP/Postal Code
900591
Country
Romania
Facility Name
SC Oncolab SRL
City
Craiova
State/Province
Judet Dolj
ZIP/Postal Code
200385
Country
Romania
Facility Name
Spitalul Judetean de Urgenta "Dr. Constantin Opris", Sectia Oncologie Medicala
City
Baia Mare
State/Province
Maramures
ZIP/Postal Code
430031
Country
Romania
Facility Name
Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca, Departament Oncologie Medicala
City
Cluj
ZIP/Postal Code
400015
Country
Romania
Facility Name
Institutul Oncologic "Prof. Dr. lon Chiricuta" Cluj-Napoca, Dcpartamentul Oncologie Medicala
City
Cluj
ZIP/Postal Code
400015
Country
Romania
Facility Name
Institutul Oncologic "Prof. Dr. lon Chiricuta" Cluj-Napoca, Sectia Oncologic Medicala
City
Cluj
ZIP/Postal Code
400015
Country
Romania
Facility Name
Hospital Universitari Germans Trias i Pujol ICO
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Corporació Sanitaria Parc Taulí-Hospital de Sabadell
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro Majadahonda
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital Universitari Vall d' Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario Reina Sofia
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
MD Anderson Cancer Center Madrid
City
Madrid
ZIP/Postal Code
28033
Country
Spain
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario Clínico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario Fundación Jiménez Díaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Regional Universitario de Malaga
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Complejo hospitalario regional virgen rocío
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital General Universitario de Valencia
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Hospital Universitario La Fe de Valencia
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Hospital Universitario Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
The Christie NHS Fundation Trust
City
Manchester
State/Province
Greater Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
The Clatterbridge Cancer Centre NHS Foundation Trust
City
Bebington
State/Province
Wirral
ZIP/Postal Code
CH63 4JY
Country
United Kingdom
Facility Name
Bristol Cancer Institute, UHB NHS Foundation Trust
City
Bristol
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Facility Name
University College London Hospitals NHS Foundation Trust
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Facility Name
Sarah Cannon Research Institute UK
City
London
ZIP/Postal Code
W1G 6AD
Country
United Kingdom
Facility Name
Worcestershire Acute Hospitals NHS Trust
City
Worcester
ZIP/Postal Code
WR5 1DO
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
36252599
Citation
Aix SP, Ciuleanu TE, Navarro A, Cousin S, Bonanno L, Smit EF, Chiappori A, Olmedo ME, Horvath I, Grohe C, Farago AF, Lopez-Vilarino JA, Cullell-Young M, Nieto A, Vasco N, Gomez J, Kahatt C, Zeaiter A, Carcereny E, Roubec J, Syrigos K, Lo G, Barneto I, Pope A, Sanchez A, Kattan J, Zarogoulidis K, Waller CF, Bischoff H, Juan-Vidal O, Reinmuth N, Domine M, Paz-Ares L. Combination lurbinectedin and doxorubicin versus physician's choice of chemotherapy in patients with relapsed small-cell lung cancer (ATLANTIS): a multicentre, randomised, open-label, phase 3 trial. Lancet Respir Med. 2023 Jan;11(1):74-86. doi: 10.1016/S2213-2600(22)00309-5. Epub 2022 Oct 14.
Results Reference
derived

Learn more about this trial

Clinical Trial of Lurbinectedin (PM01183)/Doxorubicin Versus CAV or Topotecan as Treatment in Patients With Small-Cell Lung Cancer

We'll reach out to this number within 24 hrs