Lung Cancer Clinical Trial

Clinical Trial of Lurbinectedin as Single-agent or in Combination With Irinotecan Versus Topotecan or Irinotecan in Patients With Relapsed Small-cell Lung Cancer (LAGOON)

Summary

Multicenter, open-label, randomized, controlled phase III clinical trial to evaluate and compare the activity and safety of two experimental arms consisting of lurbinectedin as single agent (Group A) or the combination of lurbinectedin with irinotecan (Group B) versus Investigator's Choice (topotecan or irinotecan) as control arm (Group C), in Small-cell Lung Cancer (SCLC) patients who failed one prior platinum-containing line.

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Full Description

Approximately 705 Adult SCLC patients with Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2 who have failed one prior platinum-containing line with CTFI ≥ 30 days and controlled asymptomatic Central Nervous System metastases will be enrolled and assigned to each treatment arm.

Central randomization will be implemented; patients will be assigned to each treatment arm at a 1:1:1 ratio.

An Independent Data Monitoring Committee (IDMC) will oversee the conduct of the study. The IDMC should have access to unblinded efficacy and safety data throughout the trial to enable timely and informed judgments about risks and benefits.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Voluntary written informed consent of the patient obtained before any study-specific procedure
Age≥18 years
Histologically or cytologically confirmed diagnosis of SCLC.
One prior line of platinum-containing chemotherapy with/without anti-PD-1 or anti-PD-L1 (Note: at least 70% of patients included in the study have to be pretreated with anti-PD-1 or anti-PD-L1)
Chemotherapy-free interval (CTFI, time from the last dose of first-line platinum-containing chemotherapy to the occurrence of progressive disease) ≥ 30 days (independent of the immunotherapy maintenance, if applicable)
Patients with history of Central Nervous System (CNS) metastases can participate provided they are pretreated and radiologically stable (i.e., without evidence of progression) for at least 4 weeks by repeated imaging (note: repeated imaging should be performed during study screening), asymptomatic, and without requirement of steroid treatment for at least 7 days before the first dose of study treatment
Eastern Cooperative Oncology Group (ECOG) PS ≤ 2

Adequate hematological, renal, metabolic and hepatic function:

Hemoglobin ≥ 9.0 g/dL [patients may have received prior red blood cell (RBC) transfusion, if clinically indicated]; absolute neutrophil count (ANC) ≥ 2.0 x 10^9/L, and platelet count ≥ 100 x 10^9/L.
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 x upper limit of normal (ULN).
Total bilirubin ≤ 1.5 x ULN or direct bilirubin ≤ ULN.
Albumin ≥ 3.0 g/dL.
Calculated creatinine clearance (CrCL) ≥ 30 mL/min (using Cockcroft and Gault's formula).
At least three weeks since last prior antineoplastic treatment and recovery to grade ≤ 1 from any adverse event (AE) related to previous anticancer treatment (excluding sensory neuropathy, anemia, asthenia and alopecia, all grade ≤ 2) according to the National Cancer InstituteCommon Terminology Criteria for Adverse Events (NCICTCAE) v.5.
Prior radiotherapy (RT): At least two weeks since completion of prophylactic cranial irradiation (PCI), and to any other site not previously specified.
Evidence of non-childbearing status for women of childbearing potential (WOCBP). WOCBP must agree to use a highly effective contraceptive measure up to six months after treatment discontinuation. Fertile male patients with WOCBP partners should use condoms during treatment and for four months following the last investigational medicinal product (IMP) dose.

Exclusion Criteria:

Platinum-naïve patients or patients pretreated with more than one prior chemotherapy regimen (including patients re-challenged with same initial regimen).
Prior treatment with lurbinectedin, trabectedin, PM14, or topoisomerase I inhibitors (irinotecan, topotecan, etc.).
Active or untreated CNS metastases and/or carcinomatous meningitis.
Patients with limited-stage disease who are candidates for local or regional therapy, including PCI, thoracic RT or both, must have been offered that option and completed treatment or refused it prior to randomization.

Concomitant diseases/conditions:

History or presence of unstable angina, myocardial infarction, congestive heart failure, or clinically significant valvular heart disease within last year.
Symptomatic arrhythmia or any uncontrolled arrhythmia requiring ongoing treatment.
Ongoing chronic alcohol consumption or cirrhosis with Child-Pugh score B or C.
Known Gilbert's disease.
Active uncontrolled infection. Serious non-healing wound, ulcer or bone fracture. Presence of external drainages.
Ongoing, treatment-requiring, non-neoplastic chronic liver disease of any origin. For Hepatitis B, this includes positive tests for both Hepatitis B surface antigen (HBsAg) and quantitative Hepatitis B polymerase chain reaction (PCR). For Hepatitis C, this includes positive tests for both Hepatitis C antibody and quantitative Hepatitis C PCR. Subjects taking hepatitis related antiviral therapy within six months prior to the first dose of study drugs will also be excluded.
Intermittent or continuous oxygen requirement within two weeks prior to randomization. Patients with confirmed or suspected diagnosis of diffuse interstitial lung disease or pulmonary fibrosis.
Patients with a second invasive malignancy treated with chemotherapy and/or RT. Patients with a previous malignancy that was completely resected with curative intention three or more years prior to randomization, except treated in situ carcinoma of the cervix, basal or squamous cell skin carcinoma, and in situ transitional cell bladder carcinoma and who has been continuously in remission since then will be permitted.
Limitation of the patient's ability to comply with the treatment or to follow the protocol.
Documented or suspected invasive fungal infections requiring systemic treatment within 12 weeks of randomization.
Known human immunodeficiency virus (HIV) infection.
Any past or present chronic inflammatory colon and/or liver disease, past intestinal obstruction, pseudo or subocclusion or paralysis.
Evident symptomatic pulmonary fibrosis or interstitial pneumonitis, pleural or cardiac effusion rapidly increasing and/or necessitating prompt local treatment within seven days.
Active COVID-19 disease (this includes positive test for SARS-CoV-2 in nasopharyngeal/oropharyngeal swabs or nasal swabs by PCR).
Any other major illness that, in the Investigator's judgment, will substantially increase the risk associated with the patient's participation in this study.
RT in more than 35% of the bone marrow.
History of previous bone marrow and/or stem cell transplantation and allogenic transplant.
Patient has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
Impending need for RT (e.g., painful bone metastasis and/or risk of spinal cord compression).
History of allergy or hypersensitivity to any of the study drugs or any of their excipients.
Women who are pregnant or breast feeding and fertile patients (men and women) who are not able to use an effective method of contraception

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

705

Study ID:

NCT05153239

Recruitment Status:

Recruiting

Sponsor:

PharmaMar

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There are 127 Locations for this study

See Locations Near You

Duly Health and Care
Joliet Illinois, 60435, United States
Norton Cancer Institue, Downtown
Louisville Kentucky, 40202, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States
FirstHealth Outpatient Cancer Center
Pinehurst North Carolina, 28374, United States
The Chris Obrien Lifehouse
Camperdown New South Wales, 2050, Australia
BRICC - Ballarat Health Services
Ballarat Central Victoria, 3350, Australia
Box Hill Hospital Eastern Health Clinical School
Box Hill Victoria, 3128, Australia
Northern Beaches Hospital
Frenchs Forest , NSW 2, Australia
Gosford Hospital GH - Central Coast Cancer Centre
Gosford , 2250, Australia
Austin Hospital- Medical Oncology Unit
Heidelberg , VIC 3, Australia
St John of God Murdoch Hospital
Murdoch , WA 61, Australia
Southern Medical Day Care Centre
Wollongong , NSW 2, Australia
Antwerp University Hospital
Edegem Antwerp, 2650, Belgium
Algemeen Ziekenhuis AZ Klina - Borstkliniek
Brasschaat , 2930, Belgium
Grand Hopital de Charleroi GHdC - Hopital Saint Joseph
Charleroi , 6000, Belgium
Centre Hospitalier Chretien CHC - MontLegia
Liège , 4000, Belgium
CHR de la Citadelle
Liège , 4000, Belgium
CHU Liege
Liège , 4000, Belgium
Az Sint Maarten Mechelen
Mechelen , 2800, Belgium
Centre Hospitalier Universitaire (CHU) Ambroise Pare
Mons , 7000, Belgium
Oncocentro-Centro de Oncologia do Parana
Curitiba Parana, 82305, Brazil
UPCO - Hospital de Clinicas de Porto Alegre
Santa Cecília Porto Alegre, RS 90, Brazil
Nucleo de Oncologia da Bahia - NOB
Ondina Salvador, BA 40, Brazil
Fundacao Pio XII - Hospital de Cancer de Barretos - Hospital de Amor
Barretos , SP 14, Brazil
ONCOSITE - Centro de Pesquisa Clinica em Oncologia Ltda
Ijuí , 98700, Brazil
Santa Casa de Misericordia de Porto Alegre
Porto Alegre , 90050, Brazil
Hospital Sao Lucas da PUCR
Porto Alegre , 90610, Brazil
Instituto Nacional de Cancer - Ministrio da Sade
Rio De Janeiro , 20231, Brazil
Multiprofile Hospital for Active Treatment - Uni Hospital OOD Department of Medical Oncology
Sofia Dianabad, 1797 , Bulgaria
Complex Oncology Center - Plovdiv EOOD, First Department of Medical Oncology and Oncological Diseases in Gastroenterology
Plovdiv , 4000, Bulgaria
Specialized hospital for active treatment of oncological diseases
Sofia , 1233, Bulgaria
Multiprofile Hospital for Active Treatment Serdika EOOD Second Department of Medical Oncology
Sofia , 1303, Bulgaria
McGill University Health Centre (MUHC)
Montréal , H4A 3, Canada
University Health Network - Princess Margaret Hospital
Toronto , ON M5, Canada
Hopital Jean Minjoz
Besancon , 25030, France
AssAP-HP - Hopital Ambroise-Pare
Boulogne-Billancourt , 92100, France
Hopital Morvan CHU de Brest
Brest , 29200, France
Centre François Baclesse
Caen , 14000, France
CHU de Caen - Hopital Cote de Nacre
Caen , 14033, France
Centre Hospitalier Intercommunal de Creteil (CHIC)
Créteil , 94000, France
Centre Hospitalier Universitaire CHU De Limoges
Limoges , 87000, France
APHM - Hopital Nord
Marseille , 13015, France
CHU de Nantes
Nantes , Cedex, France
Bichat-Claude Bernard Hospital
Paris , 75018, France
CHU Reims - Hpital Maison Blanche
Reims , 51092, France
Hopital Civil / Nouvel Hopital Civil
Strasbourg , 67091, France
Hospital Foch
Suresnes , 92150, France
Gustave Roussy
Villejuif , 94805, France
High Technology Hospital Medcenter
Batumi , 6000, Georgia
Todua Clinic
Tbilisi , 112, Georgia
New Hospitals
Tbilisi , 114, Georgia
Institute Of Clinical Oncology
Tbilisi , 156, Georgia
JSC Evex Hospitals "Caraps Medline"
Tbilisi , 179, Georgia
LTD Cancer Research Centre
Tbilisi , 186, Georgia
LungenClinic Grosshansdorf
Großhansdorf Schleswig Holstein, 22927, Germany
Charite - Universitaetsmedizin Berlin
Berlin , 13353, Germany
Klinikum Bremen Ost
Bremen , 28325, Germany
Asklepios Fachklinik München-Gauting
Gauting , 82131, Germany
Krankenhaus Martha-Maria Halle gGmbH
Halle (saale) , 06120, Germany
Thoraxclinic Heidelberg GmbH
Heidelberg , 69126, Germany
Klinikum Kassel - Medizinische Klinik IV
Kassel , 34125, Germany
Universitaetsmedizin Mannheim
Mannheim , 68167, Germany
Staedtisches Klinikum München - Bogenhausen
München , 81925, Germany
Debreceni Egyetem - Klinikai Kozpont
Debrecen , 4032, Hungary
Veszprem Megyei Tudogyogyintezet Farkasgyepu
Farkasgyepű , 8582, Hungary
Bacs-Kiskun County Hospital
Kecskemét , 6000, Hungary
Fejer County St. Gyorgy Hospital
Székesfehérvár , 8000, Hungary
Pulmonology Hospital Torokbalint
Törökbálint , 2045, Hungary
Zala Megyei Szent Rafael Korhaz
Zalaegerszeg , 8900, Hungary
A.O. SS. Antonio e Biagio e Cesare Arrigo di Alessandria
Alessandria , 15121, Italy
Clinica Oncologica
Ancona , 60126, Italy
IRCCS Centro di Riferimento Oncologico
Aviano , 33081, Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola Malpighi Oncologia medica
Bologna , 40138, Italy
Azienda Ospedaliera Univ. Policlinico G Rodolico San Marco
Catania , 95125, Italy
A.O. Santa Croce e Carle, Ospedale Carle
Cuneo , 12100, Italy
AOU Careggi
Florence , 50134, Italy
ASL 3 Genovese Oncologia Medica Villa Scassi
Genova , 16149, Italy
Universita degli Studi della Campania Luigi Vanvitelli
Napoli , 80138, Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Orbassano , 10043, Italy
Oncologia Medica II Istituto Oncologico Veneto IRCCS
Padova , 35128, Italy
Azienda USL di Piacenza
Piacenza , 29121, Italy
Irccs-Crob
Rionero In Vulture , 85028, Italy
IFO Regina Elena
Roma , 00128, Italy
Policlinico Uni. Campus Bio-Medico
Roma , 00128, Italy
Azienda Ospedaliera Univ. Senese Policlinico Le Scotte
Siena , 53100, Italy
ASST Valtellina e Alto Lario Ospedale di Sondrio ASST Valtellina e Alto Lario - UOC Oncologia Medica Ospedale di Sondrio
Sondrio , 23100, Italy
ASST Sette Laghi
Varese , 21100, Italy
II Klinika Chorob Pluc i Gruzlicy
Białystok , 15-56, Poland
Szpitale Pomorskie Sp. z o.o., Oddzial Onkologii K
Gdynia , 81-51, Poland
Specjalistyczna Praktyka Lekarska Slawomir Mandziuka
Lublin , 20-09, Poland
Szpital Specjalistyczny w Prabutach Sp. z o.o
Prabuty , 82-55, Poland
Mrukmed. Lekarz Beata Madej-Mruk i Partner. Sp.p
Rzeszów , 35-02, Poland
Specjalistyczny Szpital Onkologiczny NU-MED sp. Z
Tomaszów Mazowiecki , 97-20, Poland
Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu
Toruń , 87-10, Poland
Wojewódzkie Wielospecjalistyczne Centrum Onkologii
Łódź , 93-51, Poland
Dr. Constantin Opriş County Hospital
Baia Mare , 43003, Romania
Medisprof srl
Cluj-Napoca , 40064, Romania
Spitalul Judeteande Urgenta Constanta
Constanţa , 90059, Romania
Oncolab SRL
Craiova , 20038, Romania
Centrul de Oncologie Sfantu Nectarie
Craiova , , Romania
Oncocenter Oncologie clinica S.R.L
Timişoara , 30016, Romania
Institut Català d Oncologia (ICO) - Hospital Germans Trias i Pujol
Badalona Barcelona, 08916, Spain
Institut Catala d'Oncologia (ICO) - Hospital Duran i Reynals
L'Hospitalet De Llobregat Barcelona, 08908, Spain
Hospital Universitario Marqués de Valdecilla
Santander Cantabria, 39008, Spain
Complejo Hospitalario Materno-Insular de Gran Canaria
Las Palmas De Gran Canaria Gran Canaria, 35016, Spain
Complexo Hospitalario Universitario De Vigo (CHUVI) - Hospital Xeral
Vigo Pontevedra, 36312, Spain
Hospital Teresa Herrera C.H.U.A.
A Coruña , 15009, Spain
Hospital HM Nou Delfos
Barcelona , 08023, Spain
Hospital Universitari Vall d'Hebron
Barcelona , 08035, Spain
Hospital Universitario Reina Sofía
Córdoba , 14004, Spain
Hospital Universitario Lucus Augusti
Lugo , 27003, Spain
Hospital Universitario La Paz
Madrid , 28006, Spain
Hospital General Universitario Gregorio Marañón
Madrid , 28007, Spain
Clínica Universidad de Navarra
Madrid , 28027, Spain
MD Anderson Cancer Center
Madrid , 28033, Spain
Hospital Universitario Ramón y Cajal
Madrid , 28034, Spain
Hospital Clínico San Carlos
Madrid , 28040, Spain
Hospital Universitario Fundación Jimenez Díaz
Madrid , 28040, Spain
Hospital Universitario 12 de Octubre
Madrid , 28041, Spain
Hospital Universitario HM Sanchinarro
Madrid , 28050, Spain
Hospital Regional Universitario Málaga Hospital Civil
Málaga , 29010, Spain
Hospital Universitario Virgen del Rocío
Sevilla , 41013, Spain
Hospital Universitari i Politècnic La Fe
Valencia , 46026, Spain
Hospital Clínico Universitario de Valladolid
Valladolid , 47003, Spain
Hospital Clínico Universitario Lozano Bleza
Zaragoza , 50009, Spain
University Hospital Basel
Basel , 4031, Switzerland
Istituto Oncologico della Svizzera Italiana
Bellinzona , 6500, Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne , 1011, Switzerland
Kantonsspital Baselland
Liestal , 4410, Switzerland
Spital Thurgau - Kantonsspital Muensterlingen
Münsterlingen , 8596, Switzerland
HFR Freiburg Kantonsspital
Villars-sur-Glâne , 1752, Switzerland
Belfast Health and Social Care Trust
Belfast , BT9 7, United Kingdom
The Princess Alexandra Hospital
Harlow , CM20 , United Kingdom
University Hospitals of Leicester NHS Trust
Leicester , LE1 5, United Kingdom
Guys and St Thomas NHS Foundation Trust
London , SE1 9, United Kingdom
The Christie NHS Foundation Trust
Manchester , M20 4, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

705

Study ID:

NCT05153239

Recruitment Status:

Recruiting

Sponsor:


PharmaMar

How clear is this clinincal trial information?

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