Clinical trial NCT02566993: Clinical Trial of Lurbinectedin (PM01183)/Doxorubicin Versus CAV or Topotecan as Treatment in Patients With Small-Cell Lung Cancer
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Small-cell Lung Cancer
Lead sponsor: PharmaMar
Sponsor class: INDUSTRY
First posted: 2015-10-02
Enrollment: 613
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: Every three months up to death or study termination, a period of approximately 3.5 years
Secondary outcomes:
measure: 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
timeFrame: At 12 months
measure: Difference in Overall Survival Between Lurbinectedin/DOX and CAV in Patients With CAV as Best Investigator's Choice: Overall Survival Rate at 18 Months
timeFrame: At 18 months
measure: Difference in Overall Survival Between Lurbinectedin/DOX and CAV in Patients With CAV as Best Investigator's Choice: Overall Survival Rate at 24 Months
timeFrame: At 24 months
measure: Progression-free Survival (PFS) by Independent Review Committee
timeFrame: Every six weeks up to progression disease, a period of approximately 3.5 years
measure: Progression-free Survival Rate at 6 Months by Independent Review Committee
timeFrame: At 6 months
measure: Progression-free Survival Rate at 12 Months by Independent Review Committee
timeFrame: at 12 months
measure: Best Antitumor Response by Independent Review Committee
timeFrame: Every three months up to death or study termination, a period of approximately 3.5 years
measure: Overall Response Rate by Independent Review Committee
timeFrame: Every three months up to death or study termination, a period of approximately 3.5 years
measure: Duration of Response by Independent Review Committee
timeFrame: Every three months up to death or study termination, a period of approximately 3.5 years
measure: Overall Survival in Patients With Chemotherapy-free Interval ≥ 90 Days
timeFrame: Every three months up to death or study termination, a period of approximately 3.5 years
measure: Progression-free Survival in Patients With Chemotherapy-free Interval ≥90 Days
timeFrame: Every six weeks up to progression disease, a period of approximately 3.5 years
measure: Best Antitumor Response in Patients With Chemotherapy-free Interval ≥ 90 Days
timeFrame: Every three months up to death or study termination, a period of approximately 3.5 years
measure: Overall Response Rate in Patients With Chemotherapy-free Interval ≥ 90 Days
timeFrame: Every three months up to death or study termination, a period of approximately 3.5 years
measure: Duration of Response in Patients With Chemotherapy-free Interval ≥ 90 Days
timeFrame: Every three months up to death or study termination, a period of approximately 3.5 years
measure: Overall Survival in Patients With Chemotherapy-free Interval < 90 Days
timeFrame: Every three months up to death or study termination, a period of approximately 3.5 years
measure: Progression-free Survival in Patients With Chemotherapy-free Interval <90 Days
timeFrame: Every six weeks up to progression disease, a period of approximately 3.5 years
measure: Best Antitumor Response in Patients With Chemotherapy-free Interval <90 Days
timeFrame: Every three months up to death or study termination, a period of approximately 3.5 years
measure: Overall Response Rate in Patients With Chemotherapy-free Interval <90 Days
timeFrame: Every three months up to death or study termination, a period of approximately 3.5 years
measure: Duration of Response in Patients With Chemotherapy-free Interval <90 Days
timeFrame: Every three months up to death or study termination, a period of approximately 3.5 years
measure: Overall Survival in Patients Without Central Nervous System Involvement at Baseline
timeFrame: Every three months up to death or study termination, a period of approximately 3.5 years
measure: Progression-free Survival in Patients Without Central Nervous System Involvement at Baseline
timeFrame: Every six weeks up to progression disease, a period of approximately 3.5 years
measure: Best Antitumor Response in Patients Without Central Nervous System Involvement at Baseline
timeFrame: Every three months up to death or study termination, a period of approximately 3.5 years
measure: Overall Response Rate in Patients Without Central Nervous System Involvement at Baseline
timeFrame: Every three months up to death or study termination, a period of approximately 3.5 years
measure: Duration of Response in Patients Without Central Nervous System Involvement at Baseline
timeFrame: Every three months up to death or study termination, a period of approximately 3.5 years
measure: Overall Survival in Patients With Central Nervous System Involvement at Baseline
timeFrame: Every three months up to death or study termination, a period of approximately 3.5 years
measure: Progression-free Survival in Patients With Central Nervous System Involvement at Baseline
timeFrame: Every six weeks up to progression disease, a period of approximately 3.5 years
measure: Best Antitumor Response in Patients With Central Nervous System Involvement at Baseline
timeFrame: Every three months up to death or study termination, a period of approximately 3.5 years
measure: Overall Response Rate in Patients With Central Nervous System Involvement at Baseline
timeFrame: Every three months up to death or study termination, a period of approximately 3.5 years
measure: Duration of Response in Patients With Central Nervous System Involvement at Baseline
timeFrame: Every three months up to death or study termination, a period of approximately 3.5 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Oncology
state: Alabama
city: Chandler
country: United States
facility: Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers
state: Arizona
city: Fullerton
country: United States
facility: St Jude Hospital Yorba Linda dba St Joseph Heritage Healthcare
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Medica! Center
state: California
city: Whittier
country: United States
facility: Innovative Clinical Research Institute (ICRI)
state: California
city: Boca Raton
country: United States
facility: Boca Raton Regional Hospital Lynn Cancer Institute
state: Florida
city: Fort Lauderdale
country: United States
facility: Holy Cross Hospital - Michael and Dianne Bienes Comprehensive Cancer Center
state: Florida
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center & Research Institute
state: Florida
city: Joliet
country: United States
facility: Joliet Oncology-Hematology Associates, Ltd.
state: Illinois
city: Tinley Park
country: United States
facility: Healthcare Research Network III, LLC
state: Illinois
city: Urbana
country: United States
facility: Carle Cancer Center
state: Illinois
city: Louisville
country: United States
facility: Norton Cancer Institute
state: Kentucky
city: Mount Sterling
country: United States
facility: Montgomery Cancer Center
state: Kentucky
city: Metairie
country: United States
facility: East Jefferson Hematology-Oncology Metairie Physicians Services, Inc
state: Louisiana
city: Annapolis
country: United States
facility: Anne Arundel Medical Center Oncology and Hematology
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Royal Oak
country: United States
facility: QUEST Research Institute
state: Michigan
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center/Mary Hitchcock Memorial Hospital
state: New Hampshire
city: Florham Park
country: United States
facility: Summit Medical Group, P.A.
state: New Jersey
city: Pinehurst
country: United States
facility: FirstHealth Outpatient Cancer Center
state: North Carolina
city: Canton
country: United States
facility: Gabrail Cancer Center Research
state: Ohio
city: Tulsa
country: United States
facility: Oklahoma Cancer Specialists and Research Institute, LLC
state: Oklahoma
city: Upland
country: United States
facility: Associates in Hematology and Oncology, P.C.
state: Pennsylvania
city: Fort Worth
country: United States
facility: The Center for Cancer and Blood Disorders
state: Texas
city: Tyler
country: United States
facility: Tyler Hematology-Oncology PA
state: Texas
city: Spokane
country: United States
facility: Medical Oncology Associates PS (dba Summit Cancer Centers)
state: Washington
city: Tacoma
country: United States
facility: MultiCare Institute for Research & Innovation
state: Washington
city: Milwaukee
country: United States
facility: Froedtert Hospital & the Medical College of Wisconsin
state: Wisconsin
city: C.a.b.a.
country: Argentina
facility: Instituto Médico Especializado Alexander Fleming
state: Buenos Aires
city: San Miguel de Tucumán
country: Argentina
facility: Centro para la Atención Integral del Paciente Oncológico (CAIPO)
state: Tucumán
city: Córdoba
country: Argentina
facility: Instituto Oncológico de Córdoba (IONC)
city: La Rioja
country: Argentina
facility: CORI - Centro Oncológico Riojano Integral
city: Santa Fe
country: Argentina
facility: ISIS Centro Especializado de Luce S.A.
city: Salzburg
country: Austria
facility: Universitätsklinik für Innere Medizin III der PMU
city: Wien
country: Austria
facility: Medizinische Universität Wien / AKH Wien, Universitätsklinik für Innere Medizin I, Abteilung für klinische Onkologie
city: Gent
country: Belgium
facility: AZ Maria Middelares
city: Herstal
country: Belgium
facility: Clinique André Renard
city: Liege
country: Belgium
facility: CHR de la citadelle
city: Liege
country: Belgium
facility: CHU de Liege - Sart Tilman
city: Mons
country: Belgium
facility: CHU Ambroise Paré
city: Roeselare
country: Belgium
facility: AZ Delta Campus Wilgenstraat
city: Salvador
country: Brazil
facility: Nucleo de Oncologia da Bahia
state: BA
city: Curitiba
country: Brazil
facility: lOP- Instituto de oncologia do paraná
state: Paraná
city: Rio de Janeiro
country: Brazil
facility: Coordenação de Pesquisa Clínica / Instituto Nacional de Câncer
state: RJ
city: Rio de Janeiro
country: Brazil
facility: Instituto COl de Pesquisa, Educação e Gestão
state: RJ
city: Ijui
country: Brazil
facility: Associação Hospital de Caridade de Ijuí
state: RS
city: Porto Alegre
country: Brazil
facility: lrmandade da Santa Casa de Misericórdia de Porto Alegre
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital São Lucas da PUCRS
state: RS
city: Pôrto Alegre
country: Brazil
facility: Hospital de clínicas de Porto alegre
state: RS
city: Barretos
country: Brazil
facility: Fundação PlO XII - Hospital de Câncer de Barretos
state: São Paulo
city: Sao Paulo
country: Brazil
facility: lnstituto de Ensino e Pesquisa Säo Lucas - IEP Säo Lucas
state: São Paulo
city: Panagyurishte
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment - Uni Hospital, Panagyurishte
city: Sofia
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment of Women Health - "Nadezhda", Sofia; Clinic of Medical Oncology
city: Sofia
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment "Sv. Ivan Rilski", Sofia
city: Sofia
country: Bulgaria
facility: Acibadem City Clinic University Multiprofile Hospital for Active Treatment. EOOD, Sofia; Clinic of Medical Oncology
city: Newmarket
country: Canada
facility: Southlake Regional Health Centre - Stronach Regional Cancer Centre
state: Ontario
city: Oshawa
country: Canada
facility: R.S. Mc Laughlin Durham Regional Cancer Centre, Lakeridge Health
state: Ontario
city: Greenfield Park
country: Canada
facility: Centre intégré de santé et de services sociaux de la Montérégie Centre
state: Quebec
city: Mont-Royal
country: Canada
facility: Biron (Clinique René Laennec)
state: Quebec
city: Montreal
country: Canada
facility: Montreal Oncology Research Inc.
state: Quebec
city: Montréal
country: Canada
facility: McGill University Health Centre
state: Quebec
city: Ostrava
country: Czechia
facility: Vitkovicka nemocnice, a.s., Plicni oddeleni
city: Usti nad Labem
country: Czechia
facility: Krajska zdravotni a.s. Masarykova nemocnice o.z.
city: Bordeaux
country: France
facility: Institut Bergonié
city: Caen
country: France
facility: Centre François Baclesse
city: Creteil
country: France
facility: Centre Hospitalier Intercommunal de Créteil
city: Lyon
country: France
facility: Centre Hospitalier Lyon Sud - Service de Pneumologie
city: Marseille
country: France
facility: Hôpital Nord - Service Oncologie Multidisciplinaire et Innovations Thérapeutiques
city: Nice Cedex 2
country: France
facility: Centre Antoine Lacassagne
city: Rennes
country: France
facility: CHU de Rennes Hôpital Pontchaillou
city: Bad Berka
country: Germany
facility: Central Clinic of Bad Berka
city: Berlin
country: Germany
facility: Vivantes Klinikum am Urban, Hämatologie und Onkologie
city: Berlin
country: Germany
facility: Evangelische Lungenklinik Berlin
city: Freiburg
country: Germany
facility: Uniklinik Freiburg, Hämatologie, Onkologie & Stammzellransplantation
city: Gauting
country: Germany
facility: Asklepios-Fachkliniken München Gauting
city: Gerlingen
country: Germany
facility: Center for Pneumology and Thoracic Surgery
city: Heidelberg
country: Germany
facility: Thoraxklinik Heidelberg GmbH
city: Hemer
country: Germany
facility: Lungenklinik Hemer
city: Karlsruhe
country: Germany
facility: VIDIA Christliche Kliniken Karlsruhe
city: Koblenz
country: Germany
facility: Katholisches Klinikum Koblenz-Montabaur, Marienhof Koblenz
city: Leer
country: Germany
facility: Onkologische Schwerpunktpraxis Leer-Emden
city: Löwenstein
country: Germany
facility: Klinik Löwenstein gGmbH, Med. Klinik II Onkologie
city: Mannheim
country: Germany
facility: Uniklinikum Mannheim, TTZ, Medizinische Fakultät Mannheim
city: Minden
country: Germany
facility: Johannes Wesling Klinikum Minden, Klinik für Hämatologie, Onkologie und Palliativmedizin
city: Munchen
country: Germany
facility: University of Munich LMU, Dpt. of Medicine V
city: Munchen
country: Germany
facility: Städtisches Krankenhaus München Neuperlach
city: Munchen
country: Germany
facility: Klinikum Bogenhausen, Städt. Klinikum München GmbH, Klinik für Pneumologie und Pneumologische Onkologie
city: Nuremberg
country: Germany
facility: Klinikum Nürnberg Nord - Pneumologische Onkologie
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm - Klinik für Innere Medizin II, Pneumologie
city: Wuppertal
country: Germany
facility: Medizinische Klinik I
city: Heraklion
country: Greece
facility: University General Hospital of Heraklion - General Hospital "Venizeleio"
state: Crete
city: Athens
country: Greece
facility: General Hospital of Chest Diseases of Athens "Sotiria"
city: Athens
country: Greece
facility: General Oncology Hospital of Kifissia "Agioi Anargiroi", 2nd Internal Medicine-Oncology Clinic
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloniki "G. Papanikolaou", Pulmonary Clinic, Aristotle University of Thessaloniki
city: Budapest
country: Hungary
facility: Országos Korányi TBC és Pulmonológiai Intézet, 6. Pulmonológia és Bronchologia
city: Budapest
country: Hungary
facility: Országos Korányi TBC és Pulmonológiai lntézet, 14. Pulmonológia
city: Farkasgyepu
country: Hungary
facility: Veszprém Megyei Tüdögyógyintézet, 3. Pulmonológiai Osztály
city: Matrahaza
country: Hungary
facility: Mátrai Gyógyintézet, Bronchológia
city: Miskolc
country: Hungary
facility: Miskolci Semmelweis Kórház és Egyetemi Oktatókórház, Pulmonológiai Osztály
city: Szekesfehervar
country: Hungary
facility: Fejér Megyei Szent György Egyetemi Oktató Kórház, I. Pulmonológiai Osztály
city: Szombathely
country: Hungary
facility: Markusovszky Egyetemi Oktatókórház, Pulmonológiai Osztály
city: Tatabanya
country: Hungary
facility: Szent Borbála Kórház, Pulmonológiai osztály
city: Zalaegerszeg
country: Hungary
facility: Zala Megyei Kórház, Pulmonologia
city: Milano
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda
state: MI
city: Rionero in Vulture
country: Italy
facility: IRCCS CROB (Istituto di Ricovero e Cura a Carattere Scientifico)
state: PZ
city: Aviano
country: Italy
facility: Centro di Riferimento Oncologico di Aviano
city: Catania
country: Italy
facility: Azienda Ospedaliero - Universitaria "Policlinico - Vittorio Emanuele" - Presidio G. Rodolico
city: Novara
country: Italy
facility: AOU Maggiore della Carità - SC Oncologia
city: Padova
country: Italy
facility: Istituto Oncologico Veneto
city: Reggio Emilia
country: Italy
facility: lRCCS-Arcispedale Santa Maria Nuova
city: Roma
country: Italy
facility: Policlinico Universitario Campus Bio-Medico
city: Sondrio
country: Italy
facility: ASST della Valtellina e dell' Alto Lario P.O. Di Sondrio
city: Ain Wazein
country: Lebanon
facility: Ain Wazein Hospital
state: El Chouf
city: Beirut
country: Lebanon
facility: American University of Beirut Medical Center
city: Beirut
country: Lebanon
facility: Hotel Dieu de France
city: Biblos
country: Lebanon
facility: Centre Hospitalier Universitaire Notre Dame de Secours
city: Sidon
country: Lebanon
facility: Hammoud Hospital University Medical Center
city: Amsterdam
country: Netherlands
facility: The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
city: Hoofddorp
country: Netherlands
facility: Spaarne Gasthuis
city: Maastricht
country: Netherlands
facility: MUMC
city: Veldhoven
country: Netherlands
facility: Maxima Medisch Centrum
city: Białystok
country: Poland
facility: Bialostockie Centrum Onkologii im. Marii Sklodowskiej-Curie; Oddzial Onkologii Klinicznej im. dr Ewy Pileckiej z pododdzialem
city: Gdynia
country: Poland
facility: Szpitale Pomorskie Sp. z o.o., Oddzial Onkologii Klinicznej, Oddzial Onkologii i Radioterapii
city: Otwock
country: Poland
facility: Mazowieckie Centrum Leczenia Chorób Pluc i Gruźlicy Oddzial III Chorób Pluc z Pododdzialem Onkologicznym
city: Poznań
country: Poland
facility: Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. K.Marcinkowskiego w Poznaniu, Oddzial Chemioterapii
city: Lisboa
country: Portugal
facility: Centro Clínico Champalimaud - Fundação Champalimaud
city: Lisboa
country: Portugal
facility: Centro Hospitalar Lisboa Norte, EPE- Hospital Pulido Valente
city: Porto
country: Portugal
facility: Centro Hospitalar do Porto, EPE - Hospital de Santo António
city: Porto
country: Portugal
facility: Hospital CUF Porto
city: Porto
country: Portugal
facility: Instituto Português de Oncologia do Porto Francisco Gentil, EPE
city: Porto
country: Portugal
facility: Centro Hospitalar de São João, EPE
city: Craiova
country: Romania
facility: SC Centrul de Oncologie Sf. Nectarie SRL, Departament Oncologie Medícala
state: Dolj
city: Constanta
country: Romania
facility: Spitalul Clinic Judetean de Urgenta "Sf. Apostol Andrei"
state: Judet Constanta
city: Craiova
country: Romania
facility: SC Oncolab SRL
state: Judet Dolj
city: Baia Mare
country: Romania
facility: Spitalul Judetean de Urgenta "Dr. Constantin Opris", Sectia Oncologie Medicala
state: Maramures
city: Cluj
country: Romania
facility: Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca, Departament Oncologie Medicala
city: Cluj
country: Romania
facility: Institutul Oncologic "Prof. Dr. lon Chiricuta" Cluj-Napoca, Dcpartamentul Oncologie Medicala
city: Cluj
country: Romania
facility: Institutul Oncologic "Prof. Dr. lon Chiricuta" Cluj-Napoca, Sectia Oncologic Medicala
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol ICO
state: Barcelona
city: Sabadell
country: Spain
facility: Corporació Sanitaria Parc Taulí-Hospital de Sabadell
state: Barcelona
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
state: Madrid
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d' Hebron
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia
city: Madrid
country: Spain
facility: MD Anderson Cancer Center Madrid
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Malaga
country: Spain
facility: Hospital Regional Universitario de Malaga
city: Sevilla
country: Spain
facility: Complejo hospitalario regional virgen rocío
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Universitario La Fe de Valencia
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
city: Manchester
country: United Kingdom
facility: The Christie NHS Fundation Trust
state: Greater Manchester
city: Bebington
country: United Kingdom
facility: The Clatterbridge Cancer Centre NHS Foundation Trust
state: Wirral
city: Bristol
country: United Kingdom
facility: Bristol Cancer Institute, UHB NHS Foundation Trust
city: London
country: United Kingdom
facility: University College London Hospitals NHS Foundation Trust
city: London
country: United Kingdom
facility: Sarah Cannon Research Institute UK
city: Worcester
country: United Kingdom
facility: Worcestershire Acute Hospitals NHS Trust
Study officials:
References:
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.