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

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)

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.

Study Overview

• Status: Completed
• Conditions: Small-cell Lung Cancer
• Intervention / Treatment: Drug: Topotecan; Drug: Lurbinectedin (PM01183); Drug: Doxorubicin (DOX); Drug: Cyclophosphamide (CTX); Drug: Vincristine (VCR)

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.

• Study Type: Interventional
• Enrollment (Actual): 613
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Córdoba, Argentina, X5000HLX
    • Instituto Oncologico de Cordoba (IONC)
  • La Rioja, Argentina, F5300COE
    • CORI - Centro Oncológico Riojano Integral
  • Santa Fe, Argentina, S3000FFU
    • ISIS Centro Especializado De Luce S.A.
  • Buenos Aires
    • C.a.b.a., Buenos Aires, Argentina, C1426ANZ
      • Instituto Médico Especializado Alexander Fleming
  • Tucumán
    • San Miguel de Tucumán, Tucumán, Argentina, T4000GTB
      • Centro Para la Atención Integral del Paciente Oncologico (CAIPO)
• Austria
  • Salzburg, Austria, 5020
    • Universitätsklinik für Innere Medizin III der PMU
  • Wien, Austria, 1090
    • Medizinische Universität Wien / AKH Wien, Universitätsklinik für Innere Medizin I, Abteilung für klinische Onkologie
• Belgium
  • Gent, Belgium, 9000
    • AZ Maria Middelares
  • Herstal, Belgium, 4040
    • Clinique Andre Renard
  • Liege, Belgium, 4000
    • CHR de la Citadelle
  • Liege, Belgium, 4000
    • CHU de Liège - Sart Tilman
  • Mons, Belgium, 7000
    • CHU Ambroise Paré
  • Roeselare, Belgium, 8800
    • AZ Delta Campus Wilgenstraat
• Brazil
  • BA
    • Salvador, BA, Brazil, 40170-110
      • Núcleo de Oncologia da Bahia
  • Paraná
    • Curitiba, Paraná, Brazil, 80530-010
      • lOP- Instituto de oncologia do paraná
  • RJ
    • Rio de Janeiro, RJ, Brazil, 20231-092
      • Coordenação de Pesquisa Clínica / Instituto Nacional de Câncer
    • Rio de Janeiro, RJ, Brazil, 22793-080
      • Instituto COl de Pesquisa, Educação e Gestão
  • RS
    • Ijui, RS, Brazil, 98700-000
      • Associacao Hospital de Caridade de Ijui
    • Porto Alegre, RS, Brazil, 90610-000
      • Hospital Sao Lucas da PUCRS
    • Porto Alegre, RS, Brazil, 90020-090
      • lrmandade da Santa Casa de Misericórdia de Porto Alegre
    • Pôrto Alegre, RS, Brazil, 90.035-903
      • Hospital de Clínicas de Porto Alegre
  • São Paulo
    • Barretos, São Paulo, Brazil, 14784-400
      • Fundação PlO XII - Hospital de Câncer de Barretos
    • Sao Paulo, São Paulo, Brazil, 01236-030
      • lnstituto de Ensino e Pesquisa Säo Lucas - IEP Säo Lucas
• Bulgaria
  • Panagyurishte, Bulgaria, 4500
    • Multiprofile Hospital for Active Treatment - Uni Hospital, Panagyurishte
  • Sofia, Bulgaria, 1330
    • Multiprofile Hospital for Active Treatment of Women Health - "Nadezhda", Sofia; Clinic of Medical Oncology
  • Sofia, Bulgaria, 1431
    • University Multiprofile Hospital for Active Treatment "Sv. Ivan Rilski", Sofia
  • Sofia, Bulgaria, 1784
    • Acibadem City Clinic University Multiprofile Hospital for Active Treatment. EOOD, Sofia; Clinic of Medical Oncology
• Canada
  • Ontario
    • Newmarket, Ontario, Canada, L3Y 2P9
      • Southlake Regional Health Centre - Stronach Regional Cancer Centre
    • Oshawa, Ontario, Canada, L1G 2B9
      • R.S. Mc Laughlin Durham Regional Cancer Centre, Lakeridge Health
  • Quebec
    • Greenfield Park, Quebec, Canada, J4V 2H1
      • Centre Integre de sante et de services sociaux de la Monteregie Centre
    • Mont-Royal, Quebec, Canada, H3P 3H5
      • Biron (Clinique René Laennec)
    • Montreal, Quebec, Canada, H1M 1B1
      • Montreal Oncology Research Inc.
    • Montréal, Quebec, Canada, H4A 3J1
      • McGill University Health Centre
• Czechia
  • Ostrava, Czechia, 703 84
    • Vitkovicka nemocnice, a.s., Plicni oddeleni
  • Usti nad Labem, Czechia, 401 13
    • Krajska zdravotni a.s. Masarykova nemocnice o.z.
• France
  • Bordeaux, France, 33076
    • Institut Bergonié
  • Caen, France, 14076
    • Centre François Baclesse
  • Creteil, France, 94010
    • Centre Hospitalier Intercommunal de Créteil
  • Lyon, France, 69310
    • Centre Hospitalier Lyon Sud - Service de Pneumologie
  • Marseille, France, 13915
    • Hôpital Nord - Service Oncologie Multidisciplinaire et Innovations Thérapeutiques
  • Nice Cedex 2, France, 06189
    • Centre Antoine Lacassagne
  • Rennes, France, 35033
    • CHU de Rennes Hopital Pontchaillou
• Germany
  • Bad Berka, Germany, 99437
    • Central Clinic of Bad Berka
  • Berlin, Germany, 13125
    • Evangelische Lungenklinik Berlin
  • Berlin, Germany, 10967
    • Vivantes Klinikum am Urban, Hämatologie und Onkologie
  • Freiburg, Germany, 79106
    • Uniklinik Freiburg, Hämatologie, Onkologie & Stammzellransplantation
  • Gauting, Germany, 82131
    • Asklepios-Fachkliniken München Gauting
  • Gerlingen, Germany, 70839
    • Center for Pneumology and Thoracic Surgery
  • Heidelberg, Germany, 69126
    • Thoraxklinik Heidelberg GmbH
  • Hemer, Germany, 58675
    • Lungenklinik Hemer
  • Karlsruhe, Germany, 76137
    • ViDia Christliche Kliniken Karlsruhe
  • Koblenz, Germany, 56073
    • Katholisches Klinikum Koblenz-Montabaur, Marienhof Koblenz
  • Leer, Germany, 26789
    • Onkologische Schwerpunktpraxis Leer-Emden
  • Löwenstein, Germany, 74245
    • Klinik Löwenstein gGmbH, Med. Klinik II Onkologie
  • Mannheim, Germany, 68167
    • Uniklinikum Mannheim, TTZ, Medizinische Fakultät Mannheim
  • Minden, Germany, 32429
    • Johannes Wesling Klinikum Minden, Klinik für Hämatologie, Onkologie und Palliativmedizin
  • Munchen, Germany, 80336
    • University of Munich LMU, Dpt. of Medicine V
  • Munchen, Germany, 81737
    • Städtisches Krankenhaus München Neuperlach
  • Munchen, Germany, 81925
    • Klinikum Bogenhausen, Städt. Klinikum München GmbH, Klinik für Pneumologie und Pneumologische Onkologie
  • Nuremberg, Germany, 90419
    • Klinikum Nürnberg Nord - Pneumologische Onkologie
  • Ulm, Germany, 89081
    • Universitätsklinikum Ulm - Klinik für Innere Medizin II, Pneumologie
  • Wuppertal, Germany, 42283
    • Medizinische Klinik I
• Greece
  • Athens, Greece, 11527
    • General Hospital of Chest Diseases of Athens "Sotiria"
  • Athens, Greece, 14564
    • General Oncology Hospital of Kifissia "Agioi Anargiroi", 2nd Internal Medicine-Oncology Clinic
  • Thessaloniki, Greece, 57010
    • General Hospital of Thessaloniki "G. Papanikolaou", Pulmonary Clinic, Aristotle University of Thessaloniki
  • Crete
    • Heraklion, Crete, Greece, 71110
      • University General Hospital of Heraklion - General Hospital "Venizeleio"
• Hungary
  • Budapest, Hungary, 1121
    • Országos Korányi TBC és Pulmonológiai Intézet, 6. Pulmonológia és Bronchologia
  • Budapest, Hungary, 1121
    • Országos Korányi TBC és Pulmonológiai lntézet, 14. Pulmonológia
  • Farkasgyepu, Hungary, 8582
    • Veszprém Megyei Tüdögyógyintézet, 3. Pulmonológiai Osztály
  • Matrahaza, Hungary, 3233
    • Mátrai Gyógyintézet, Bronchológia
  • Miskolc, Hungary, 3529
    • Miskolci Semmelweis Kórház és Egyetemi Oktatókórház, Pulmonológiai Osztály
  • Szekesfehervar, Hungary, 8000
    • Fejér Megyei Szent György Egyetemi Oktató Kórház, I. Pulmonológiai Osztály
  • Szombathely, Hungary, 9700
    • Markusovszky Egyetemi Oktatókórház, Pulmonológiai Osztály
  • Tatabanya, Hungary, 2800
    • Szent Borbála Kórház, Pulmonológiai osztály
  • Zalaegerszeg, Hungary, 8900
    • Zala Megyei Kórház, Pulmonologia
• Italy
  • Aviano, Italy, 33081
    • Centro di Riferimento Oncologico di Aviano
  • Catania, Italy, 95123
    • Azienda Ospedaliero - Universitaria "Policlinico - Vittorio Emanuele" - Presidio G. Rodolico
  • Novara, Italy, 28100
    • AOU Maggiore della Carità - SC Oncologia
  • Padova, Italy, 35128
    • Istituto Oncologico Veneto
  • Reggio Emilia, Italy, 42123
    • lRCCS-Arcispedale Santa Maria Nuova
  • Roma, Italy, 00128
    • Policlinico Universitario Campus Bio-Medico
  • Sondrio, Italy, 23100
    • ASST della Valtellina e dell' Alto Lario P.O. Di Sondrio
  • MI
    • Milano, MI, Italy, 20162
      • ASST Grande Ospedale Metropolitano Niguarda
  • PZ
    • Rionero in Vulture, PZ, Italy, 85028
      • IRCCS CROB (Istituto di Ricovero e Cura a Carattere Scientifico)
• Lebanon
  • Beirut, Lebanon
    • American University of Beirut Medical Center
  • Beirut, Lebanon
    • Hotel Dieu de France
  • Biblos, Lebanon
    • Centre Hospitalier universitaire Notre Dame de secours
  • Sidon, Lebanon
    • Hammoud Hospital University Medical Center
  • El Chouf
    • Ain Wazein, El Chouf, Lebanon
      • Ain Wazein Hospital
• Netherlands
  • Amsterdam, Netherlands, 1066 CX
    • The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
  • Hoofddorp, Netherlands, 2134 TM
    • Spaarne Gasthuis
  • Maastricht, Netherlands, 6229 HX
    • MUMC
  • Veldhoven, Netherlands, 5504 DB
    • Maxima Medisch Centrum
• Poland
  • Białystok, Poland, 15-027
    • Bialostockie Centrum Onkologii im. Marii Sklodowskiej-Curie; Oddzial Onkologii Klinicznej im. dr Ewy Pileckiej z pododdzialem
  • Gdynia, Poland, 81-519
    • Szpitale Pomorskie Sp. z o.o., Oddzial Onkologii Klinicznej, Oddzial Onkologii i Radioterapii
  • Otwock, Poland, 05-400
    • Mazowieckie Centrum Leczenia Chorób Pluc i Gruźlicy Oddzial III Chorób Pluc z Pododdzialem Onkologicznym
  • Poznań, Poland, 60-569
    • Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. K.Marcinkowskiego w Poznaniu, Oddzial Chemioterapii
• Portugal
  • Lisboa, Portugal, 1400-038
    • Centro Clínico Champalimaud - Fundação Champalimaud
  • Lisboa, Portugal, 1769-001
    • Centro Hospitalar Lisboa Norte, EPE- Hospital Pulido Valente
  • Porto, Portugal, 4100-180
    • Hospital Cuf porto
  • Porto, Portugal, 4200-072
    • Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE
  • Porto, Portugal, 4200-319
    • Centro Hospitalar de São João, EPE
  • Porto, Portugal, 4099-001
    • Centro Hospitalar do Porto, EPE - Hospital de Santo António
• Romania
  • Cluj, Romania, 400015
    • Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca, Departament Oncologie Medicala
  • Cluj, Romania, 400015
    • Institutul Oncologic "Prof. Dr. lon Chiricuta" Cluj-Napoca, Dcpartamentul Oncologie Medicala
  • Cluj, Romania, 400015
    • Institutul Oncologic "Prof. Dr. lon Chiricuta" Cluj-Napoca, Sectia Oncologic Medicala
  • Dolj
    • Craiova, Dolj, Romania, 200347
      • SC Centrul de Oncologie Sf. Nectarie SRL, Departament Oncologie Medícala
  • Judet Constanta
    • Constanta, Judet Constanta, Romania, 900591
      • Spitalul Clinic Judetean de Urgenta "Sf. Apostol Andrei"
  • Judet Dolj
    • Craiova, Judet Dolj, Romania, 200385
      • Sc Oncolab Srl
  • Maramures
    • Baia Mare, Maramures, Romania, 430031
      • Spitalul Judetean de Urgenta "Dr. Constantin Opris", Sectia Oncologie Medicala
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d' Hebrón
  • Cordoba, Spain, 14004
    • Hospital Universitario Reina Sofia
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon y Cajal
  • Madrid, Spain, 28040
    • Hospital Universitario Fundación Jiménez Díaz
  • Madrid, Spain, 28041
    • Hospital Universitario 12 De Octubre
  • Madrid, Spain, 28040
    • Hospital Universitario Clinico San Carlos
  • Madrid, Spain, 28033
    • MD Anderson Cancer Center Madrid
  • Malaga, Spain, 29010
    • Hospital Regional Universitario de Málaga
  • Sevilla, Spain, 41013
    • Complejo hospitalario regional virgen rocío
  • Valencia, Spain, 46026
    • Hospital Universitario La Fe de Valencia
  • Valencia, Spain, 46014
    • Hospital General Universitario de Valencia
  • Zaragoza, Spain, 50009
    • Hospital Universitario Miguel Servet
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Hospital Universitari Germans Trias i Pujol ICO
    • Sabadell, Barcelona, Spain, 08208
      • Corporació Sanitaria Parc Taulí-Hospital de Sabadell
  • Madrid
    • Majadahonda, Madrid, Spain, 28222
      • Hospital Universitario Puerta de Hierro Majadahonda
• United Kingdom
  • Bristol, United Kingdom, BS2 8ED
    • Bristol Cancer Institute, UHB NHS Foundation Trust
  • London, United Kingdom, W1G 6AD
    • Sarah Cannon Research Institute UK
  • London, United Kingdom, NW1 2PG
    • University College London Hospitals NHS Foundation Trust
  • Worcester, United Kingdom, WR5 1DO
    • Worcestershire Acute Hospitals NHS Trust
  • Greater Manchester
    • Manchester, Greater Manchester, United Kingdom, M20 4BX
      • The Christie NHS Fundation Trust
  • Wirral
    • Bebington, Wirral, United Kingdom, CH63 4JY
      • The Clatterbridge Cancer Centre NHS Foundation Trust
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35243
      • Alabama Oncology
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers
  • California
    • Fullerton, California, United States, 92835
      • St Jude Hospital Yorba Linda dba St Joseph Heritage Healthcare
    • Loma Linda, California, United States, 92354
      • Loma Linda University Medica! Center
    • Whittier, California, United States, 90603
      • Innovative Clinical Research Institute (ICRI)
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Boca Raton Regional Hospital Lynn Cancer Institute
    • Fort Lauderdale, Florida, United States, 33308
      • Holy Cross Hospital - Michael and Dianne Bienes Comprehensive Cancer Center
    • Tampa, Florida, United States, 33612
      • H. Lee Moffitt Cancer Center & Research Institute
  • Illinois
    • Joliet, Illinois, United States, 60435
      • Joliet Oncology-Hematology Associates, Ltd.
    • Tinley Park, Illinois, United States, 60487
      • Healthcare Research Network III, LLC
    • Urbana, Illinois, United States, 61801
      • Carle Cancer Center
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Norton Cancer Institute
    • Mount Sterling, Kentucky, United States, 40353
      • Montgomery Cancer Center
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • East Jefferson Hematology-Oncology Metairie Physicians Services, Inc
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Anne Arundel Medical Center Oncology and Hematology
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • Quest Research Institute
  • Nevada
    • Las Vegas, Nevada, United States, 89169
      • Comprehensive Cancer Centers of Nevada
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Medical Center/Mary Hitchcock Memorial Hospital
  • New Jersey
    • Florham Park, New Jersey, United States, 07932
      • Summit Medical Group, P.A.
  • North Carolina
    • Pinehurst, North Carolina, United States, 28374
      • FirstHealth Outpatient Cancer Center
  • Ohio
    • Canton, Ohio, United States, 44718
      • Gabrail Cancer Center Research
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74146
      • Oklahoma Cancer Specialists and Research Institute, LLC
  • Pennsylvania
    • Upland, Pennsylvania, United States, 19013
      • Associates in Hematology and Oncology, P.C.
  • Texas
    • Fort Worth, Texas, United States, 76104
      • The Center for Cancer and Blood Disorders
    • Tyler, Texas, United States, 75701
      • Tyler Hematology-Oncology PA
  • Washington
    • Spokane, Washington, United States, 99208
      • Medical Oncology Associates PS (dba Summit Cancer Centers)
    • Tacoma, Washington, United States, 98405
      • MultiCare Institute for Research & Innovation
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Froedtert Hospital & the Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Arm; Lurbinectedin (PM01183) / Doxorubicin	Drug: Lurbinectedin (PM01183); Drug: Doxorubicin (DOX)
Active Comparator: Control Arm 1; CAV (Cyclophosphamide (CTX), Doxorubicin (DOX) and Vincristine (VCR))	Drug: Doxorubicin (DOX); Drug: Cyclophosphamide (CTX); Drug: Vincristine (VCR)
Active Comparator: Control Arm 2; Topotecan	Drug: Topotecan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Every three months up to death or study termination, a period of approximately 3.5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	At 12 months
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).	At 18 months
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).	At 24 months
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.	Every six weeks up to progression disease, a period of approximately 3.5 years
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.	At 6 months
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.	at 12 months
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	Every three months up to death or study termination, a period of approximately 3.5 years
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	Every three months up to death or study termination, a period of approximately 3.5 years
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	Every three months up to death or study termination, a period of approximately 3.5 years
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).	Every three months up to death or study termination, a period of approximately 3.5 years
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.	Every six weeks up to progression disease, a period of approximately 3.5 years
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	Every three months up to death or study termination, a period of approximately 3.5 years
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	Every three months up to death or study termination, a period of approximately 3.5 years
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	Every three months up to death or study termination, a period of approximately 3.5 years
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).	Every three months up to death or study termination, a period of approximately 3.5 years
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.	Every six weeks up to progression disease, a period of approximately 3.5 years
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	Every three months up to death or study termination, a period of approximately 3.5 years
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	Every three months up to death or study termination, a period of approximately 3.5 years
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	Every three months up to death or study termination, a period of approximately 3.5 years
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).	Every three months up to death or study termination, a period of approximately 3.5 years
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.	Every six weeks up to progression disease, a period of approximately 3.5 years
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	Every three months up to death or study termination, a period of approximately 3.5 years
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	Every three months up to death or study termination, a period of approximately 3.5 years
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	Every three months up to death or study termination, a period of approximately 3.5 years
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).	Every three months up to death or study termination, a period of approximately 3.5 years
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.	Every six weeks up to progression disease, a period of approximately 3.5 years
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	Every three months up to death or study termination, a period of approximately 3.5 years
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	Every three months up to death or study termination, a period of approximately 3.5 years
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	Every three months up to death or study termination, a period of approximately 3.5 years

Collaborators and Investigators

• Sponsor: PharmaMar

Publications and helpful links

General Publications

• 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. 2022 Oct 14:S2213-2600(22)00309-5. doi: 10.1016/S2213-2600(22)00309-5. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2016
• Primary Completion (Actual): February 24, 2020
• Study Completion (Actual): February 24, 2020

Study Registration Dates

• First Submitted: September 24, 2015
• First Submitted That Met QC Criteria: October 1, 2015
• First Posted (Estimate): October 2, 2015

Study Record Updates

• Last Update Posted (Actual): October 28, 2021
• Last Update Submitted That Met QC Criteria: September 29, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antibiotics, Antineoplastic; Topoisomerase I Inhibitors; Cyclophosphamide; Doxorubicin; Vincristine; Topotecan
• Other Study ID Numbers: PM1183-C-003-14