Small-cell Lung CancerPhase 3ATLANTISNCT02566993
Clinical Trial of Lurbinectedin (PM01183)/Doxorubicin Versus CAV or Topotecan as Treatment in Patients With Small-Cell Lung Cancer
A Phase 3 study testing Lurbinectedin (PM01183), Doxorubicin (DOX) and Cyclophosphamide (CTX) in people with Small-cell Lung Cancer, run by PharmaMar at 160 sites in 20 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small-cell Lung Cancer
- What is being tested?
- Lurbinectedin (PM01183), Doxorubicin (DOX) and Cyclophosphamide (CTX)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 613 participants
- Where
- 160 sitesin 20 countries
- Study dates
- 30 Aug 2016to 24 Feb 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary written informed consent
- Adult patients ≥ 18 years
- Histologically or cytologically confirmed diagnosis of limited or extensive stage SCLC which failed one prior platinum-containing regimen and with a chemotherapy-free interval (CTFI, time from the last dose of first-line chemotherapy to the occurrence of progressive disease) ≥ 30 days. Small-cell carcinoma of unknown primary site with or without neuroendocrine features confirmed in histology test(s) performed on metastatic lesion(s) are eligible, if Ki-67/MIB-1 is expressed in >50% of tumor cells.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 2.
- Adequate hematological, renal, metabolic and hepatic function within 7-10 days prior to randomization
- At least three weeks since last prior anticancer treatment and adequate recovery from prior treatment toxicity
- Prior radiotherapy (RT): At least four weeks since completion of whole-brain irradiation, at least two weeks since completion of prophylactic cranial irradiation, and to any other site.
- Evidence of non-childbearing status for women of childbearing potential (WOCBP). WOCBP must agree to use a highly effective contraceptive measure up to six weeks after treatment discontinuation. Fertile male patients with WOCBP partners should use condoms during treatment and for four months following the last investigational medicinal product dose.
Who cannot join
- More than one prior chemotherapy-containing line(re-challenge with the same initial regimen is not allowed)
- Patients who never received platinum-containing regimen for Small-cell Lung Cancer (SCLC)
- Prior treatment with PM01183, topotecan or anthracyclines.
- Limited-stage patients who are candidates for local or regional therapy
- Impending need for palliative RT or surgery for pathological fractures and/or for medullary compression within four weeks prior to randomization.
- Symptomatic or progressing or steroid requiring Central Nervous System (CNS) involvement disease at least four weeks prior to randomization
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- Concomitant diseases/conditions:
- Angina, myocardial infarction, congestive heart failure or clinically significant valvular heart disease, arrhythmia, immunodeficiency (including known HIV seropositive), ongoing or treatment-requiring chronic liver disease, active infection, oxygen requirement within two weeks prior to randomization, diffuse interstitial lung disease (ILD) or pulmonary fibrosis, second invasive malignancy treated with chemotherapy and/or radiotherapy, invasive fungal infections requiring systemic treatment within 12 weeks of randomization.
- Pregnant or breast feeding women
Trial locations and contacts
160 sites in 20 countries.
160 sites in 20 countries
United States29 sites
Anne Arundel Medical Center Oncology and Hematology
Annapolis, Maryland, 21401
Alabama Oncology
Birmingham, Alabama, 35243
Boca Raton Regional Hospital Lynn Cancer Institute
Boca Raton, Florida, 33486
Massachusetts General Hospital
Boston, Massachusetts, 02114
Gabrail Cancer Center Research
Canton, Ohio, 44718
Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers
Chandler, Arizona, 85224
Summit Medical Group, P.A.
Florham Park, New Jersey, 07932
Holy Cross Hospital - Michael and Dianne Bienes Comprehensive Cancer Center
Fort Lauderdale, Florida, 33308
The Center for Cancer and Blood Disorders
Fort Worth, Texas, 76104
St Jude Hospital Yorba Linda dba St Joseph Heritage Healthcare
Fullerton, California, 92835
Joliet Oncology-Hematology Associates, Ltd.
Joliet, Illinois, 60435
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169
Dartmouth-Hitchcock Medical Center/Mary Hitchcock Memorial Hospital
Lebanon, New Hampshire, 03756
Loma Linda University Medica! Center
Loma Linda, California, 92354
Norton Cancer Institute
Louisville, Kentucky, 40202
East Jefferson Hematology-Oncology Metairie Physicians Services, Inc
Metairie, Louisiana, 70006
Froedtert Hospital & the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Montgomery Cancer Center
Mount Sterling, Kentucky, 40353
FirstHealth Outpatient Cancer Center
Pinehurst, North Carolina, 28374
QUEST Research Institute
Royal Oak, Michigan, 48073
Medical Oncology Associates PS (dba Summit Cancer Centers)
Spokane, Washington, 99208
MultiCare Institute for Research & Innovation
Tacoma, Washington, 98405
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612
Healthcare Research Network III, LLC
Tinley Park, Illinois, 60487
Oklahoma Cancer Specialists and Research Institute, LLC
Tulsa, Oklahoma, 74146
Tyler Hematology-Oncology PA
Tyler, Texas, 75701
Associates in Hematology and Oncology, P.C.
Upland, Pennsylvania, 19013
Carle Cancer Center
Urbana, Illinois, 61801
Innovative Clinical Research Institute (ICRI)
Whittier, California, 90603
Germany20 sites
Central Clinic of Bad Berka
Bad Berka, 99437
Vivantes Klinikum am Urban, Hämatologie und Onkologie
Berlin, 10967
Evangelische Lungenklinik Berlin
Berlin, 13125
Uniklinik Freiburg, Hämatologie, Onkologie & Stammzellransplantation
Freiburg im Breisgau, 79106
Asklepios-Fachkliniken München Gauting
Gauting, 82131
Center for Pneumology and Thoracic Surgery
Gerlingen, 70839
Thoraxklinik Heidelberg GmbH
Heidelberg, 69126
Lungenklinik Hemer
Hemer, 58675
VIDIA Christliche Kliniken Karlsruhe
Karlsruhe, 76137
Katholisches Klinikum Koblenz-Montabaur, Marienhof Koblenz
Koblenz, 56073
Onkologische Schwerpunktpraxis Leer-Emden
Leer, 26789
Klinik Löwenstein gGmbH, Med. Klinik II Onkologie
Löwenstein, 74245
Uniklinikum Mannheim, TTZ, Medizinische Fakultät Mannheim
Mannheim, 68167
Johannes Wesling Klinikum Minden, Klinik für Hämatologie, Onkologie und Palliativmedizin
Minden, 32429
University of Munich LMU, Dpt. of Medicine V
München, 80336
Städtisches Krankenhaus München Neuperlach
München, 81737
Klinikum Bogenhausen, Städt. Klinikum München GmbH, Klinik für Pneumologie und Pneumologische Onkologie
München, 81925
Klinikum Nürnberg Nord - Pneumologische Onkologie
Nuremberg, 90419
Universitätsklinikum Ulm - Klinik für Innere Medizin II, Pneumologie
Ulm, 89081
Medizinische Klinik I
Wuppertal, 42283
Spain15 sites
Hospital Universitari Germans Trias i Pujol ICO
Badalona, Barcelona, 08916
Hospital Universitari Vall d' Hebron
Barcelona, 08035
Hospital Universitario Reina Sofia
Córdoba, 14004
MD Anderson Cancer Center Madrid
Madrid, 28033
Hospital Universitario Ramón y Cajal
Madrid, 28034
Hospital Universitario Clínico San Carlos
Madrid, 28040
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, 28222
Hospital Regional Universitario de Malaga
Málaga, 29010
Corporació Sanitaria Parc Taulí-Hospital de Sabadell
Sabadell, Barcelona, 08208
Complejo hospitalario regional virgen rocío
Seville, 41013
Hospital General Universitario de Valencia
Valencia, 46014
Hospital Universitario La Fe de Valencia
Valencia, 46026
Hospital Universitario Miguel Servet
Zaragoza, 50009
Brazil10 sites
Fundação PlO XII - Hospital de Câncer de Barretos
Barretos, São Paulo, 14784-400
lOP- Instituto de oncologia do paraná
Curitiba, Paraná, 80530-010
Associação Hospital de Caridade de Ijuí
Ijuí, Rio Grande do Sul, 98700-000
lrmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90020-090
Hospital São Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, 90610-000
Hospital de clínicas de Porto alegre
Pôrto Alegre, Rio Grande do Sul, 90.035-903
Coordenação de Pesquisa Clínica / Instituto Nacional de Câncer
Rio de Janeiro, Rio de Janeiro, 20231-092
Instituto COl de Pesquisa, Educação e Gestão
Rio de Janeiro, Rio de Janeiro, 22793-080
Nucleo de Oncologia da Bahia
Salvador, Estado de Bahia, 40170-110
lnstituto de Ensino e Pesquisa Säo Lucas - IEP Säo Lucas
São Paulo, São Paulo, 01236-030
Hungary9 sites
Országos Korányi TBC és Pulmonológiai Intézet, 6. Pulmonológia és Bronchologia
Budapest, 1121
Országos Korányi TBC és Pulmonológiai lntézet, 14. Pulmonológia
Budapest, 1121
Veszprém Megyei Tüdögyógyintézet, 3. Pulmonológiai Osztály
Farkasgyepű, 8582
Mátrai Gyógyintézet, Bronchológia
Mátraháza, 3233
Miskolci Semmelweis Kórház és Egyetemi Oktatókórház, Pulmonológiai Osztály
Miskolc, 3529
Fejér Megyei Szent György Egyetemi Oktató Kórház, I. Pulmonológiai Osztály
Székesfehérvár, 8000
Markusovszky Egyetemi Oktatókórház, Pulmonológiai Osztály
Szombathely, 9700
Szent Borbála Kórház, Pulmonológiai osztály
Tatabánya, 2800
Zala Megyei Kórház, Pulmonologia
Zalaegerszeg, 8900
Italy9 sites
Centro di Riferimento Oncologico di Aviano
Aviano, 33081
Azienda Ospedaliero - Universitaria "Policlinico - Vittorio Emanuele" - Presidio G. Rodolico
Catania, 95123
ASST Grande Ospedale Metropolitano Niguarda
Milan, MI, 20162
AOU Maggiore della Carità - SC Oncologia
Novara, 28100
Istituto Oncologico Veneto
Padova, 35128
lRCCS-Arcispedale Santa Maria Nuova
Reggio Emilia, 42123
IRCCS CROB (Istituto di Ricovero e Cura a Carattere Scientifico)
Rionero in Vulture, PZ, 85028
Policlinico Universitario Campus Bio-Medico
Roma, 00128
ASST della Valtellina e dell' Alto Lario P.O. Di Sondrio
Sondrio, 23100
France7 sites
Institut Bergonié
Bordeaux, 33076
Centre François Baclesse
Caen, 14076
Centre Hospitalier Intercommunal de Créteil
Créteil, 94010
Centre Hospitalier Lyon Sud - Service de Pneumologie
Lyon, 69310
Hôpital Nord - Service Oncologie Multidisciplinaire et Innovations Thérapeutiques
Marseille, 13915
Centre Antoine Lacassagne
Nice, 06189
CHU de Rennes Hôpital Pontchaillou
Rennes, 35033
Romania7 sites
Spitalul Judetean de Urgenta "Dr. Constantin Opris", Sectia Oncologie Medicala
Baia Mare, Maramureş, 430031
Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca, Departament Oncologie Medicala
Cluj-Napoca, 400015
Institutul Oncologic "Prof. Dr. lon Chiricuta" Cluj-Napoca, Dcpartamentul Oncologie Medicala
Cluj-Napoca, 400015
Institutul Oncologic "Prof. Dr. lon Chiricuta" Cluj-Napoca, Sectia Oncologic Medicala
Cluj-Napoca, 400015
Spitalul Clinic Judetean de Urgenta "Sf. Apostol Andrei"
Constanța, Judet Constanta, 900591
SC Centrul de Oncologie Sf. Nectarie SRL, Departament Oncologie Medícala
Craiova, Dolj, 200347
SC Oncolab SRL
Craiova, Judet Dolj, 200385
Belgium6 sites
AZ Maria Middelares
Ghent, 9000
Clinique André Renard
Herstal, 4040
CHR de la citadelle
Liège, 4000
CHU de Liege - Sart Tilman
Liège, 4000
CHU Ambroise Paré
Mons, 7000
AZ Delta Campus Wilgenstraat
Roeselare, 8800
Canada6 sites
Centre intégré de santé et de services sociaux de la Montérégie Centre
Greenfield Park, Quebec, J4V 2H1
Montreal Oncology Research Inc.
Montreal, Quebec, H1M 1B1
McGill University Health Centre
Montreal, Quebec, H4A 3J1
Biron (Clinique René Laennec)
Mount Royal, Quebec, H3P 3H5
Southlake Regional Health Centre - Stronach Regional Cancer Centre
Newmarket, Ontario, L3Y 2P9
R.S. Mc Laughlin Durham Regional Cancer Centre, Lakeridge Health
Oshawa, Ontario, L1G 2B9
Portugal6 sites
Centro Clínico Champalimaud - Fundação Champalimaud
Lisbon, 1400-038
Centro Hospitalar Lisboa Norte, EPE- Hospital Pulido Valente
Lisbon, 1769-001
Centro Hospitalar do Porto, EPE - Hospital de Santo António
Porto, 4099-001
Hospital CUF Porto
Porto, 4100-180
Instituto Português de Oncologia do Porto Francisco Gentil, EPE
Porto, 4200-072
Centro Hospitalar de São João, EPE
Porto, 4200-319
United Kingdom6 sites
The Clatterbridge Cancer Centre NHS Foundation Trust
Bebington, Wirral, CH63 4JY
Bristol Cancer Institute, UHB NHS Foundation Trust
Bristol, BS2 8ED
University College London Hospitals NHS Foundation Trust
London, NW1 2PG
Sarah Cannon Research Institute UK
London, W1G 6AD
The Christie NHS Fundation Trust
Manchester, Greater Manchester, M20 4BX
Worcestershire Acute Hospitals NHS Trust
Worcester, WR5 1DO
Argentina5 sites
Instituto Médico Especializado Alexander Fleming
C.a.b.a., Buenos Aires, C1426ANZ
Instituto Oncológico de Córdoba (IONC)
Córdoba, X5000HLX
CORI - Centro Oncológico Riojano Integral
La Rioja, F5300COE
Centro para la Atención Integral del Paciente Oncológico (CAIPO)
San Miguel de Tucumán, Tucumán Province, T4000GTB
ISIS Centro Especializado de Luce S.A.
Santa Fe, S3000FFU
Lebanon5 sites
Ain Wazein Hospital
Ain Wazein, El Chouf
American University of Beirut Medical Center
Beirut
Hotel Dieu de France
Beirut
Centre Hospitalier Universitaire Notre Dame de Secours
Byblos
Hammoud Hospital University Medical Center
Sidon
Bulgaria4 sites
Multiprofile Hospital for Active Treatment - Uni Hospital, Panagyurishte
Panagyurishte, 4500
Multiprofile Hospital for Active Treatment of Women Health - "Nadezhda", Sofia; Clinic of Medical Oncology
Sofia, 1330
University Multiprofile Hospital for Active Treatment "Sv. Ivan Rilski", Sofia
Sofia, 1431
Acibadem City Clinic University Multiprofile Hospital for Active Treatment. EOOD, Sofia; Clinic of Medical Oncology
Sofia, 1784
Greece4 sites
General Hospital of Chest Diseases of Athens "Sotiria"
Athens, 11527
General Oncology Hospital of Kifissia "Agioi Anargiroi", 2nd Internal Medicine-Oncology Clinic
Athens, 14564
University General Hospital of Heraklion - General Hospital "Venizeleio"
Heraklion, Crete, 71110
General Hospital of Thessaloniki "G. Papanikolaou", Pulmonary Clinic, Aristotle University of Thessaloniki
Thessaloniki, 57010
Netherlands4 sites
The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Amsterdam, 1066 CX
Spaarne Gasthuis
Hoofddorp, 2134 TM
MUMC
Maastricht, 6229 HX
Maxima Medisch Centrum
Veldhoven, 5504 DB
Poland4 sites
Bialostockie Centrum Onkologii im. Marii Sklodowskiej-Curie; Oddzial Onkologii Klinicznej im. dr Ewy Pileckiej z pododdzialem
Bialystok, 15-027
Szpitale Pomorskie Sp. z o.o., Oddzial Onkologii Klinicznej, Oddzial Onkologii i Radioterapii
Gdynia, 81-519
Mazowieckie Centrum Leczenia Chorób Pluc i Gruźlicy Oddzial III Chorób Pluc z Pododdzialem Onkologicznym
Otwock, 05-400
Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. K.Marcinkowskiego w Poznaniu, Oddzial Chemioterapii
Poznan, 60-569
Austria2 sites
Universitätsklinik für Innere Medizin III der PMU
Salzburg, 5020
Medizinische Universität Wien / AKH Wien, Universitätsklinik für Innere Medizin I, Abteilung für klinische Onkologie
Vienna, 1090
Czechia2 sites
Vitkovicka nemocnice, a.s., Plicni oddeleni
Ostrava, 703 84
Krajska zdravotni a.s. Masarykova nemocnice o.z.
Ústí nad Labem, 401 13
About this study
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)
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.
Read the 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.
- Conditions
- Small-cell Lung Cancer
- Being tested
- Lurbinectedin (PM01183), Doxorubicin (DOX), Cyclophosphamide (CTX), Vincristine (VCR), Topotecan
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lurbinectedin (PM01183)Drug
Doxorubicin (DOX)Drug
Cyclophosphamide (CTX)Drug
Vincristine (VCR)Drug
TopotecanDrug
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | Lurbinectedin (PM01183) / Doxorubicin Receives: Drug: Lurbinectedin (PM01183); Drug: Doxorubicin (DOX) |
| Control Arm 1 | Active comparator | CAV (Cyclophosphamide (CTX), Doxorubicin (DOX) and Vincristine (VCR)) Receives: Drug: Doxorubicin (DOX); Drug: Cyclophosphamide (CTX); Drug: Vincristine (VCR) |
| Control Arm 2 | Active comparator | Topotecan Receives: Drug: Topotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Every three months up to death or study termination, a period of approximately 3.5 years
Secondary outcomes (29)
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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: Every three months up to death or study termination, a period of approximately 3.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2015 (estimated)
- Study start30 Aug 2016
- Primary completion24 Feb 2020
- Study completion24 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Small-cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 613 participants (actual)
Sponsor and investigators
- Lead sponsor
- PharmaMar
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02566993
- Sponsor's protocol ID
- PM1183-C-003-14
- Acronym
- ATLANTIS
- Status last verified
- Aug 2021
- First submitted
- 24 Sep 2015
- Last updated
- 28 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
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. 2023 Jan;11(1):74-86. doi: 10.1016/S2213-2600(22)00309-5. Epub 2022 Oct 14.
PubMed 36252599
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02566993
- Acronym / sponsor ID
- ATLANTIS / PM1183-C-003-14
- Conditions
- Small-cell Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 613 participants (actual)
- Lead sponsor
- PharmaMarIndustry (pharma, biotech, devices)
- Study start
- 30 Aug 2016 (actual)
- Primary completion
- 24 Feb 2020 (actual)
- Study completion
- 24 Feb 2020 (actual)
- First posted
- 2 Oct 2015 (estimated)
- Results
- Posted 28 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Drug: Lurbinectedin (PM01183), Drug: Doxorubicin (DOX)Lurbinectedin (PM01183) / Doxorubicin |
| Control Arm 1 | Active comparator | Drug: Doxorubicin (DOX), Drug: Cyclophosphamide (CTX), Drug: Vincristine (VCR)CAV (Cyclophosphamide (CTX), Doxorubicin (DOX) and Vincristine (VCR)) |
| Control Arm 2 | Active comparator | Drug: TopotecanTopotecan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Voluntary written informed consent
- Adult patients ≥ 18 years
- Histologically or cytologically confirmed diagnosis of limited or extensive stage SCLC which failed one prior platinum-containing regimen and with a chemotherapy-free interval (CTFI, time from the last dose of first-line chemotherapy to the occurrence of progressive disease) ≥ 30 days. Small-cell carcinoma of unknown primary site with or without neuroendocrine features confirmed in histology test(s) performed on metastatic lesion(s) are eligible, if Ki-67/MIB-1 is expressed in >50% of tumor cells.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 2.
- Adequate hematological, renal, metabolic and hepatic function within 7-10 days prior to randomization
Key exclusion criteria (9 listed)
- More than one prior chemotherapy-containing line(re-challenge with the same initial regimen is not allowed)
- Patients who never received platinum-containing regimen for Small-cell Lung Cancer (SCLC)
- Prior treatment with PM01183, topotecan or anthracyclines.
- Limited-stage patients who are candidates for local or regional therapy
- Impending need for palliative RT or surgery for pathological fractures and/or for medullary compression within four weeks prior to randomization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lurbinectedin (PM01183) | Drug | Experimental Arm |
| Doxorubicin (DOX) | Drug | Control Arm 1, Experimental Arm |
| Cyclophosphamide (CTX) | Drug | Control Arm 1 |
| Vincristine (VCR) | Drug | Control Arm 1 |
| Topotecan | Drug | Control Arm 2 |
Primary outcome
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).
29 secondary outcomes
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
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
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
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 Rate at 6 Months by Independent Review Committee
Time frame: At 6 months
Progression-free Survival Rate at 12 Months by Independent Review Committee
Time frame: at 12 months
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36252599Aix 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
160 sites in 20 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lurbinectedin (PM01183), Doxorubicin (DOX) and Cyclophosphamide (CTX) in people with Small-cell Lung Cancer, run by PharmaMar at 160 sites in 20 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 160 sites in United States, Germany, Spain, Brazil, Hungary and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: Every three months up to death or study termination, a period of approximately 3.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02566993, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2021.