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

• ClinicalTrials.gov Identifier: NCT02566993
• Recruitment Status: Completed
• First Posted: October 2, 2015
• Results First Posted: October 28, 2021
• Last Update Posted: October 28, 2021
• Sponsor: PharmaMar
• Information provided by (Responsible Party): PharmaMar

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.

Condition or disease	Intervention/treatment	Phase
Small-cell Lung Cancer	Drug: Lurbinectedin (PM01183); Drug: Doxorubicin (DOX); Drug: Cyclophosphamide (CTX); Drug: Vincristine (VCR); Drug: Topotecan	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 613 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: August 30, 2016
• Actual Primary Completion Date: February 24, 2020
• Actual Study Completion Date: February 24, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Overall Survival (OS) [ Time Frame: Every three months up to death or study termination, a period of approximately 3.5 years ]
   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 :

1. 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 [ Time Frame: 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).
2. Difference in Overall Survival Between Lurbinectedin/DOX and CAV in Patients With CAV as Best Investigator's Choice: Overall Survival Rate at 18 Months [ Time Frame: 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).
3. Difference in Overall Survival Between Lurbinectedin/DOX and CAV in Patients With CAV as Best Investigator's Choice: Overall Survival Rate at 24 Months [ Time Frame: 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).
4. Progression-free Survival (PFS) by Independent Review Committee [ Time Frame: Every six weeks up to progression disease, a period of approximately 3.5 years ]
   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.
5. Progression-free Survival Rate at 6 Months by Independent Review Committee [ Time Frame: At 6 months ]
   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.
6. Progression-free Survival Rate at 12 Months by Independent Review Committee [ Time Frame: at 12 months ]
   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.
7. Best Antitumor Response by Independent Review Committee [ Time Frame: Every three months up to death or study termination, a period of approximately 3.5 years ]

   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

8. Overall Response Rate by Independent Review Committee [ Time Frame: Every three months up to death or study termination, a period of approximately 3.5 years ]

   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

9. Duration of Response by Independent Review Committee [ Time Frame: Every three months up to death or study termination, a period of approximately 3.5 years ]

   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

10. Overall Survival in Patients With Chemotherapy-free Interval ≥ 90 Days [ Time Frame: Every three months up to death or study termination, a period of approximately 3.5 years ]
    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).
11. Progression-free Survival in Patients With Chemotherapy-free Interval ≥90 Days [ Time Frame: Every six weeks up to progression disease, a period of approximately 3.5 years ]
    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.
12. Best Antitumor Response in Patients With Chemotherapy-free Interval ≥ 90 Days [ Time Frame: Every three months up to death or study termination, a period of approximately 3.5 years ]

    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

13. Overall Response Rate in Patients With Chemotherapy-free Interval ≥ 90 Days [ Time Frame: Every three months up to death or study termination, a period of approximately 3.5 years ]

    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

14. Duration of Response in Patients With Chemotherapy-free Interval ≥ 90 Days [ Time Frame: Every three months up to death or study termination, a period of approximately 3.5 years ]

    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

15. Overall Survival in Patients With Chemotherapy-free Interval < 90 Days [ Time Frame: Every three months up to death or study termination, a period of approximately 3.5 years ]
    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).
16. Progression-free Survival in Patients With Chemotherapy-free Interval <90 Days [ Time Frame: Every six weeks up to progression disease, a period of approximately 3.5 years ]
    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.
17. Best Antitumor Response in Patients With Chemotherapy-free Interval <90 Days [ Time Frame: Every three months up to death or study termination, a period of approximately 3.5 years ]

    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

18. Overall Response Rate in Patients With Chemotherapy-free Interval <90 Days [ Time Frame: Every three months up to death or study termination, a period of approximately 3.5 years ]

    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

19. Duration of Response in Patients With Chemotherapy-free Interval <90 Days [ Time Frame: Every three months up to death or study termination, a period of approximately 3.5 years ]

    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

20. Overall Survival in Patients Without Central Nervous System Involvement at Baseline [ Time Frame: Every three months up to death or study termination, a period of approximately 3.5 years ]
    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).
21. Progression-free Survival in Patients Without Central Nervous System Involvement at Baseline [ Time Frame: Every six weeks up to progression disease, a period of approximately 3.5 years ]
    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.
22. Best Antitumor Response in Patients Without Central Nervous System Involvement at Baseline [ Time Frame: Every three months up to death or study termination, a period of approximately 3.5 years ]

    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

23. Overall Response Rate in Patients Without Central Nervous System Involvement at Baseline [ Time Frame: Every three months up to death or study termination, a period of approximately 3.5 years ]

    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

24. Duration of Response in Patients Without Central Nervous System Involvement at Baseline [ Time Frame: Every three months up to death or study termination, a period of approximately 3.5 years ]

    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

25. Overall Survival in Patients With Central Nervous System Involvement at Baseline [ Time Frame: Every three months up to death or study termination, a period of approximately 3.5 years ]
    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).
26. Progression-free Survival in Patients With Central Nervous System Involvement at Baseline [ Time Frame: Every six weeks up to progression disease, a period of approximately 3.5 years ]
    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.
27. Best Antitumor Response in Patients With Central Nervous System Involvement at Baseline [ Time Frame: Every three months up to death or study termination, a period of approximately 3.5 years ]

    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

28. Overall Response Rate in Patients With Central Nervous System Involvement at Baseline [ Time Frame: Every three months up to death or study termination, a period of approximately 3.5 years ]

    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

29. Duration of Response in Patients With Central Nervous System Involvement at Baseline [ Time Frame: Every three months up to death or study termination, a period of approximately 3.5 years ]

    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

Eligibility Criteria

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

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

Contacts and Locations

Locations

United States, Alabama

Alabama Oncology

Birmingham, Alabama, United States, 35243

United States, Arizona

Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers

Chandler, Arizona, United States, 85224

United States, California

St Jude Hospital Yorba Linda dba St Joseph Heritage Healthcare

Fullerton, California, United States, 92835

Loma Linda University Medica! Center

Loma Linda, California, United States, 92354

Innovative Clinical Research Institute (ICRI)

Whittier, California, United States, 90603

United States, Florida

Boca Raton Regional Hospital Lynn Cancer Institute

Boca Raton, Florida, United States, 33486

Holy Cross Hospital - Michael and Dianne Bienes Comprehensive Cancer Center

Fort Lauderdale, Florida, United States, 33308

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, United States, 33612

United States, Illinois

Joliet Oncology-Hematology Associates, Ltd.

Joliet, Illinois, United States, 60435

Healthcare Research Network III, LLC

Tinley Park, Illinois, United States, 60487

Carle Cancer Center

Urbana, Illinois, United States, 61801

United States, Kentucky

Norton Cancer Institute

Louisville, Kentucky, United States, 40202

Montgomery Cancer Center

Mount Sterling, Kentucky, United States, 40353

United States, Louisiana

East Jefferson Hematology-Oncology Metairie Physicians Services, Inc

Metairie, Louisiana, United States, 70006

United States, Maryland

Anne Arundel Medical Center Oncology and Hematology

Annapolis, Maryland, United States, 21401

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

United States, Michigan

QUEST Research Institute

Royal Oak, Michigan, United States, 48073

United States, Nevada

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States, 89169

United States, New Hampshire

Dartmouth-Hitchcock Medical Center/Mary Hitchcock Memorial Hospital

Lebanon, New Hampshire, United States, 03756

United States, New Jersey

Summit Medical Group, P.A.

Florham Park, New Jersey, United States, 07932

United States, North Carolina

FirstHealth Outpatient Cancer Center

Pinehurst, North Carolina, United States, 28374

United States, Ohio

Gabrail Cancer Center Research

Canton, Ohio, United States, 44718

United States, Oklahoma

Oklahoma Cancer Specialists and Research Institute, LLC

Tulsa, Oklahoma, United States, 74146

United States, Pennsylvania

Associates in Hematology and Oncology, P.C.

Upland, Pennsylvania, United States, 19013

United States, Texas

The Center for Cancer and Blood Disorders

Fort Worth, Texas, United States, 76104

Tyler Hematology-Oncology PA

Tyler, Texas, United States, 75701

United States, Washington

Medical Oncology Associates PS (dba Summit Cancer Centers)

Spokane, Washington, United States, 99208

MultiCare Institute for Research & Innovation

Tacoma, Washington, United States, 98405

United States, Wisconsin

Froedtert Hospital & the Medical College of Wisconsin

Milwaukee, Wisconsin, United States, 53226

Argentina

Instituto Médico Especializado Alexander Fleming

C.a.b.a., Buenos Aires, Argentina, C1426ANZ

Centro para la Atención Integral del Paciente Oncológico (CAIPO)

San Miguel de Tucumán, Tucumán, Argentina, T4000GTB

Instituto Oncológico de Córdoba (IONC)

Córdoba, Argentina, X5000HLX

CORI - Centro Oncológico Riojano Integral

La Rioja, Argentina, F5300COE

ISIS Centro Especializado de Luce S.A.

Santa Fe, Argentina, S3000FFU

Austria

Universitätsklinik für Innere Medizin III der PMU

Salzburg, Austria, 5020

Medizinische Universität Wien / AKH Wien, Universitätsklinik für Innere Medizin I, Abteilung für klinische Onkologie

Wien, Austria, 1090

Belgium

AZ Maria Middelares

Gent, Belgium, 9000

Clinique André Renard

Herstal, Belgium, 4040

CHR de la citadelle

Liege, Belgium, 4000

CHU de Liege - Sart Tilman

Liege, Belgium, 4000

CHU Ambroise Paré

Mons, Belgium, 7000

AZ Delta Campus Wilgenstraat

Roeselare, Belgium, 8800

Brazil

Nucleo de Oncologia da Bahia

Salvador, BA, Brazil, 40170-110

lOP- Instituto de oncologia do paraná

Curitiba, Paraná, Brazil, 80530-010

Coordenação de Pesquisa Clínica / Instituto Nacional de Câncer

Rio de Janeiro, RJ, Brazil, 20231-092

Instituto COl de Pesquisa, Educação e Gestão

Rio de Janeiro, RJ, Brazil, 22793-080

Associação Hospital de Caridade de Ijuí

Ijui, RS, Brazil, 98700-000

lrmandade da Santa Casa de Misericórdia de Porto Alegre

Porto Alegre, RS, Brazil, 90020-090

Hospital São Lucas da PUCRS

Porto Alegre, RS, Brazil, 90610-000

Hospital de clínicas de Porto alegre

Pôrto Alegre, RS, Brazil, 90.035-903

Fundação PlO XII - Hospital de Câncer de Barretos

Barretos, São Paulo, Brazil, 14784-400

lnstituto de Ensino e Pesquisa Säo Lucas - IEP Säo Lucas

Sao Paulo, São Paulo, Brazil, 01236-030

Bulgaria

Multiprofile Hospital for Active Treatment - Uni Hospital, Panagyurishte

Panagyurishte, Bulgaria, 4500

Multiprofile Hospital for Active Treatment of Women Health - "Nadezhda", Sofia; Clinic of Medical Oncology

Sofia, Bulgaria, 1330

University Multiprofile Hospital for Active Treatment "Sv. Ivan Rilski", Sofia

Sofia, Bulgaria, 1431

Acibadem City Clinic University Multiprofile Hospital for Active Treatment. EOOD, Sofia; Clinic of Medical Oncology

Sofia, Bulgaria, 1784

Canada, Ontario

Southlake Regional Health Centre - Stronach Regional Cancer Centre

Newmarket, Ontario, Canada, L3Y 2P9

R.S. Mc Laughlin Durham Regional Cancer Centre, Lakeridge Health

Oshawa, Ontario, Canada, L1G 2B9

Canada, Quebec

Centre intégré de santé et de services sociaux de la Montérégie Centre

Greenfield Park, Quebec, Canada, J4V 2H1

Biron (Clinique René Laennec)

Mont-Royal, Quebec, Canada, H3P 3H5

Montreal Oncology Research Inc.

Montreal, Quebec, Canada, H1M 1B1

McGill University Health Centre

Montréal, Quebec, Canada, H4A 3J1

Czechia

Vitkovicka nemocnice, a.s., Plicni oddeleni

Ostrava, Czechia, 703 84

Krajska zdravotni a.s. Masarykova nemocnice o.z.

Usti nad Labem, Czechia, 401 13

France

Institut Bergonié

Bordeaux, France, 33076

Centre François Baclesse

Caen, France, 14076

Centre Hospitalier Intercommunal de Créteil

Creteil, France, 94010

Centre Hospitalier Lyon Sud - Service de Pneumologie

Lyon, France, 69310

Hôpital Nord - Service Oncologie Multidisciplinaire et Innovations Thérapeutiques

Marseille, France, 13915

Centre Antoine Lacassagne

Nice Cedex 2, France, 06189

CHU de Rennes Hôpital Pontchaillou

Rennes, France, 35033

Germany

Central Clinic of Bad Berka

Bad Berka, Germany, 99437

Vivantes Klinikum am Urban, Hämatologie und Onkologie

Berlin, Germany, 10967

Evangelische Lungenklinik Berlin

Berlin, Germany, 13125

Uniklinik Freiburg, Hämatologie, Onkologie & Stammzellransplantation

Freiburg, Germany, 79106

Asklepios-Fachkliniken München Gauting

Gauting, Germany, 82131

Center for Pneumology and Thoracic Surgery

Gerlingen, Germany, 70839

Thoraxklinik Heidelberg GmbH

Heidelberg, Germany, 69126

Lungenklinik Hemer

Hemer, Germany, 58675

VIDIA Christliche Kliniken Karlsruhe

Karlsruhe, Germany, 76137

Katholisches Klinikum Koblenz-Montabaur, Marienhof Koblenz

Koblenz, Germany, 56073

Onkologische Schwerpunktpraxis Leer-Emden

Leer, Germany, 26789

Klinik Löwenstein gGmbH, Med. Klinik II Onkologie

Löwenstein, Germany, 74245

Uniklinikum Mannheim, TTZ, Medizinische Fakultät Mannheim

Mannheim, Germany, 68167

Johannes Wesling Klinikum Minden, Klinik für Hämatologie, Onkologie und Palliativmedizin

Minden, Germany, 32429

University of Munich LMU, Dpt. of Medicine V

Munchen, Germany, 80336

Städtisches Krankenhaus München Neuperlach

Munchen, Germany, 81737

Klinikum Bogenhausen, Städt. Klinikum München GmbH, Klinik für Pneumologie und Pneumologische Onkologie

Munchen, Germany, 81925

Klinikum Nürnberg Nord - Pneumologische Onkologie

Nuremberg, Germany, 90419

Universitätsklinikum Ulm - Klinik für Innere Medizin II, Pneumologie

Ulm, Germany, 89081

Medizinische Klinik I

Wuppertal, Germany, 42283

Greece

University General Hospital of Heraklion - General Hospital "Venizeleio"

Heraklion, Crete, Greece, 71110

General Hospital of Chest Diseases of Athens "Sotiria"

Athens, Greece, 11527

General Oncology Hospital of Kifissia "Agioi Anargiroi", 2nd Internal Medicine-Oncology Clinic

Athens, Greece, 14564

General Hospital of Thessaloniki "G. Papanikolaou", Pulmonary Clinic, Aristotle University of Thessaloniki

Thessaloniki, Greece, 57010

Hungary

Országos Korányi TBC és Pulmonológiai Intézet, 6. Pulmonológia és Bronchologia

Budapest, Hungary, 1121

Országos Korányi TBC és Pulmonológiai lntézet, 14. Pulmonológia

Budapest, Hungary, 1121

Veszprém Megyei Tüdögyógyintézet, 3. Pulmonológiai Osztály

Farkasgyepu, Hungary, 8582

Mátrai Gyógyintézet, Bronchológia

Matrahaza, Hungary, 3233

Miskolci Semmelweis Kórház és Egyetemi Oktatókórház, Pulmonológiai Osztály

Miskolc, Hungary, 3529

Fejér Megyei Szent György Egyetemi Oktató Kórház, I. Pulmonológiai Osztály

Szekesfehervar, Hungary, 8000

Markusovszky Egyetemi Oktatókórház, Pulmonológiai Osztály

Szombathely, Hungary, 9700

Szent Borbála Kórház, Pulmonológiai osztály

Tatabanya, Hungary, 2800

Zala Megyei Kórház, Pulmonologia

Zalaegerszeg, Hungary, 8900

Italy

ASST Grande Ospedale Metropolitano Niguarda

Milano, MI, Italy, 20162

IRCCS CROB (Istituto di Ricovero e Cura a Carattere Scientifico)

Rionero in Vulture, PZ, Italy, 85028

Centro di Riferimento Oncologico di Aviano

Aviano, Italy, 33081

Azienda Ospedaliero - Universitaria "Policlinico - Vittorio Emanuele" - Presidio G. Rodolico

Catania, Italy, 95123

AOU Maggiore della Carità - SC Oncologia

Novara, Italy, 28100

Istituto Oncologico Veneto

Padova, Italy, 35128

lRCCS-Arcispedale Santa Maria Nuova

Reggio Emilia, Italy, 42123

Policlinico Universitario Campus Bio-Medico

Roma, Italy, 00128

ASST della Valtellina e dell' Alto Lario P.O. Di Sondrio

Sondrio, Italy, 23100

Lebanon

Ain Wazein Hospital

Ain Wazein, El Chouf, Lebanon

American University of Beirut Medical Center

Beirut, Lebanon

Hotel Dieu de France

Beirut, Lebanon

Centre Hospitalier Universitaire Notre Dame de Secours

Biblos, Lebanon

Hammoud Hospital University Medical Center

Sidon, Lebanon

Netherlands

The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

Amsterdam, Netherlands, 1066 CX

Spaarne Gasthuis

Hoofddorp, Netherlands, 2134 TM

MUMC

Maastricht, Netherlands, 6229 HX

Maxima Medisch Centrum

Veldhoven, Netherlands, 5504 DB

Poland

Bialostockie Centrum Onkologii im. Marii Sklodowskiej-Curie; Oddzial Onkologii Klinicznej im. dr Ewy Pileckiej z pododdzialem

Białystok, Poland, 15-027

Szpitale Pomorskie Sp. z o.o., Oddzial Onkologii Klinicznej, Oddzial Onkologii i Radioterapii

Gdynia, Poland, 81-519

Mazowieckie Centrum Leczenia Chorób Pluc i Gruźlicy Oddzial III Chorób Pluc z Pododdzialem Onkologicznym

Otwock, Poland, 05-400

Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. K.Marcinkowskiego w Poznaniu, Oddzial Chemioterapii

Poznań, Poland, 60-569

Portugal

Centro Clínico Champalimaud - Fundação Champalimaud

Lisboa, Portugal, 1400-038

Centro Hospitalar Lisboa Norte, EPE- Hospital Pulido Valente

Lisboa, Portugal, 1769-001

Centro Hospitalar do Porto, EPE - Hospital de Santo António

Porto, Portugal, 4099-001

Hospital CUF Porto

Porto, Portugal, 4100-180

Instituto Português de Oncologia do Porto Francisco Gentil, EPE

Porto, Portugal, 4200-072

Centro Hospitalar de São João, EPE

Porto, Portugal, 4200-319

Romania

SC Centrul de Oncologie Sf. Nectarie SRL, Departament Oncologie Medícala

Craiova, Dolj, Romania, 200347

Spitalul Clinic Judetean de Urgenta "Sf. Apostol Andrei"

Constanta, Judet Constanta, Romania, 900591

SC Oncolab SRL

Craiova, Judet Dolj, Romania, 200385

Spitalul Judetean de Urgenta "Dr. Constantin Opris", Sectia Oncologie Medicala

Baia Mare, Maramures, Romania, 430031

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

Cluj, Romania, 400015

Spain

Hospital Universitari Germans Trias i Pujol ICO

Badalona, Barcelona, Spain, 08916

Corporació Sanitaria Parc Taulí-Hospital de Sabadell

Sabadell, Barcelona, Spain, 08208

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Madrid, Spain, 28222

Hospital Universitari Vall d' Hebron

Barcelona, Spain, 08035

Hospital Universitario Reina Sofia

Cordoba, Spain, 14004

MD Anderson Cancer Center Madrid

Madrid, Spain, 28033

Hospital Universitario Ramón y Cajal

Madrid, Spain, 28034

Hospital Universitario Clínico San Carlos

Madrid, Spain, 28040

Hospital Universitario Fundación Jiménez Díaz

Madrid, Spain, 28040

Hospital Universitario 12 de Octubre

Madrid, Spain, 28041

Hospital Regional Universitario de Malaga

Malaga, Spain, 29010

Complejo hospitalario regional virgen rocío

Sevilla, Spain, 41013

Hospital General Universitario de Valencia

Valencia, Spain, 46014

Hospital Universitario La Fe de Valencia

Valencia, Spain, 46026

Hospital Universitario Miguel Servet

Zaragoza, Spain, 50009

United Kingdom

The Christie NHS Fundation Trust

Manchester, Greater Manchester, United Kingdom, M20 4BX

The Clatterbridge Cancer Centre NHS Foundation Trust

Bebington, Wirral, United Kingdom, CH63 4JY

Bristol Cancer Institute, UHB NHS Foundation Trust

Bristol, United Kingdom, BS2 8ED

University College London Hospitals NHS Foundation Trust

London, United Kingdom, NW1 2PG

Sarah Cannon Research Institute UK

London, United Kingdom, W1G 6AD

Worcestershire Acute Hospitals NHS Trust

Worcester, United Kingdom, WR5 1DO

Sponsors and Collaborators

PharmaMar

  Study Documents (Full-Text)

Documents provided by PharmaMar:

Study Protocol  [PDF] May 3, 2018

Statistical Analysis Plan  [PDF] September 4, 2020

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: PharmaMar
• ClinicalTrials.gov Identifier: NCT02566993
• Other Study ID Numbers: PM1183-C-003-14
• First Posted: October 2, 2015
• Results First Posted: October 28, 2021
• Last Update Posted: October 28, 2021
• Last Verified: August 2021

Additional relevant MeSH terms:

Lung Neoplasms; Small Cell Lung Carcinoma; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Cyclophosphamide; Doxorubicin; Vincristine; Topotecan; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Antirheumatic Agents; Antineoplastic Agents, Alkylating; Alkylating Agents; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Myeloablative Agonists; Antibiotics, Antineoplastic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Enzyme Inhibitors; Antineoplastic Agents, Phytogenic; Tubulin Modulators; Antimitotic Agents