Relapsed Small Cell Lung CancerPhase 3NCT05153239
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)
A Phase 3 study testing Irinotecan, Lurbinectedin and Topotecan in people with Relapsed Small Cell Lung Cancer, run by PharmaMar at 210 sites in 24 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed Small Cell Lung Cancer
- What is being tested?
- Irinotecan, Lurbinectedin and Topotecan
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 705 participants
- Where
- 210 sitesin 24 countries
- Study dates
- 22 Jul 2022to 10 Apr 2026
- Phase
- Phase 3
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 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
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- 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, immune-related hypothyroidism, 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 seven 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.
Who cannot join
- 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.
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- 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 pleural or cardiac effusion rapidly increasing and/or necessitating prompt local treatment within seven days.
- Any other major illness that, in the Investigator's judgment, will substantially increase the risk associated with the patient's participation in this study (e.g.; COVID-19 disease).
- 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 inactivated 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 a highly effective method of contraception
Trial locations and contacts
210 sites in 24 countries.
210 sites in 24 countries
Spain24 sites
Hospital Teresa Herrera C.H.U.A.
A Coruña, A Coruña, 15009
Institut Català d Oncologia (ICO) - Hospital Germans Trias i Pujol
Badalona, Barcelona, 08916
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona, 08035
Hospital Universitario Reina Sofía
Córdoba, Córdoba, 14004
Institut Catala d'Oncologia (ICO) - Hospital Duran i Reynals
L'Hospitalet de Llobregat, Barcelona, 08908
Complejo Hospitalario Materno-Insular de Gran Canaria
Las Palmas de Gran Canaria, Gran Canaria, 35016
Hospital Universitario Lucus Augusti
Lugo, Lugo, 27003
Hospital Universitario La Paz
Madrid, Madrid, 28006
Hospital General Universitario Gregorio Marañón
Madrid, Madrid, 28007
Clínica Universidad de Navarra
Madrid, Madrid, 28027
MD Anderson Cancer Center
Madrid, Madrid, 28033
Hospital Universitario Ramón y Cajal
Madrid, Madrid, 28034
Hospital Clínico San Carlos
Madrid, Madrid, 28040
Hospital Universitario Fundación Jimenez Díaz
Madrid, Madrid, 28040
Hospital Universitario 12 de Octubre
Madrid, Madrid, 28041
Hospital Universitario HM Sanchinarro
Madrid, Madrid, 28050
Hospital Regional Universitario Málaga Hospital Civil
Málaga, Málaga, 29010
Clínica Universidad de Navarra
Pamplona, Navarre, 31008
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008
Hospital Universitario Virgen del Rocío
Seville, Sevilla, 41013
Hospital Universitari i Politècnic La Fe
Valencia, Valencia, 46026
Hospital Clínico Universitario de Valladolid
Valladolid, Valladolid, 47003
Complexo Hospitalario Universitario De Vigo (CHUVI) - Hospital Xeral
Vigo, Pontevedra, 36312
Hospital Clínico Universitario Lozano Bleza
Zaragoza, Zaragoza, 50009
Italy19 sites
A.O. SS. Antonio e Biagio e Cesare Arrigo di Alessandria
Alessandria, 15121
Azienda Ospedaliero Universitaria delle Marche
Ancona, 60126
IRCCS Centro di Riferimento Oncologico
Aviano, 33081
IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola Malpighi Oncologia medica
Bologna, 40138
Azienda Ospedaliera Univ. Policlinico G Rodolico San Marco
Catania, 95125
A.O. Santa Croce e Carle, Ospedale Carle
Cuneo, 12100
AOU Careggi
Florence, 50134
ASL 3 Genovese Oncologia Medica Villa Scassi
Genova, 16149
IRCCS Istituto Clinico Humanitas - Cancer Center
Milan, 20089
Universita degli Studi della Campania Luigi Vanvitelli
Naples, 80138
Ospedale Maggiore di Novara
Novara, 28100
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Orbassano, 10043
Oncologia Medica II Istituto Oncologico Veneto IRCCS
Padova, 35128
Azienda USL di Piacenza
Piacenza, 29121
Irccs-Crob
Rionero in Vulture, 85028
Fondazione Policlinico Universitario Campus Bio-Medico
Roma, 00128
IFO Regina Elena
Roma, 00128
ASST Valtellina e Alto Lario Ospedale di Sondrio
Sondrio, 23100
ASST Sette Laghi
Varese, 21100
Germany17 sites
Zentralklinik Bad Berka GmbH
Bad Berka, 99437
Evangelische Lungenklinik Berlin
Berlin, 13125
Klinikum Bremen Ost
Bremen, 28325
Helios St. Johannes Klinikum
Duisburg, 74166
Klinikum Esslingen GmbH
Esslingen am Neckar, 73730
Universittsklinikum Freiburg
Freiburg im Breisgau, 79106
Asklepios Fachklinik München-Gauting
Gauting, 82131
LungenClinic Grosshansdorf
Großhansdorf, Schleswig-Holstein, 22927
Krankenhaus Martha-Maria Halle gGmbH
Halle, 06120
Universitaetsklinikum Halle Saale
Halle, 06120
Thoraxclinic Heidelberg GmbH
Heidelberg, 69126
Vincentius-Diakonissen-Kliniken gAG Karlsruhe
Karlsruhe, 76137
Klinikum Kassel - Medizinische Klinik IV
Kassel, 34125
Klinik Loewenstein gGmbH
Löwenstein, 74245
Universitaetsmedizin Mannheim
Mannheim, 68167
Staedtisches Klinikum München - Bogenhausen
München, 81925
Sana Klinikum Offenbach
Offenbach, 63069
United States15 sites
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Ironwood Cancer & Research Centers
Chandler, Arizona, 85224
Florida Cancer Specialists - South
Fort Myers, Florida, 33901
Oncology Hematology West, PC (Grand Island)
Grand Island, Nebraska, 68803
Genesis Cancer and Blood
Hot Springs, Arkansas, 71913
Duly Health and Care
Joliet, Illinois, 60435
Norton Cancer Institue, Downtown
Louisville, Kentucky, 40202
Froedtert Hospital/Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Oncology Hematology West, PC dba Nebraska Cancer Specialists
Omaha, Nebraska, 68130
FirstHealth Outpatient Cancer Center
Pinehurst, North Carolina, 28374
Utah Cancer Specialists
Salt Lake City, Utah, 84106
Florida Cancer Specialists - North
St. Petersburg, Florida, 33705
MultiCare Regional Cancer Center - Tacoma
Tacoma, Washington, 98405
Florida Cancer Specialists - Panhandle
Tallahassee, Florida, 32308
Florida Cancer Specialists - East
West Palm Beach, Florida, 33401
Japan14 sites
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Bunkyō-Ku, Tokyo
Kyushu University Hospital
Fukuoka, Fukuoka, 812-8582
Osaka Habikino Medical Center
Habikino, Osaka
Kansai Medical University Hospital
Hirakata-shi, Osaka, 573-1191
Hirosaki University Hospital
Hirosaki, Aomori, 036-8563
Izumi City General Hospital
Izumi, Osaka, 594-0073
Kanagawa Cancer Center
Izumi, Osaka, 594-0073
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, 920-8641
Kishiwada City Hospital
Kishiwada, Osaka, 596-8501
Kobe City Medical Center General Hospital
Kobe, Hyōgo, 650-0047
The Cancer Institute Hospital Of JFCR
Koto-Ku, Tokyo, 135-8550
Ohara HealthCare Foundation Kurashiki Central Hospital
Kurashiki, Okayama-ken, 710-8602
Sendai Kousei Hospital
Sendai, Miyagi, 980-0873
Center Hospital of the National Center for Global Health and Medicine
Shinjuku-Ku, Tokyo, 162-8655
France13 sites
Hopital Jean Minjoz
Besançon, 25030
AssAP-HP - Hopital Ambroise-Pare
Boulogne-Billancourt, 92100
Hopital Morvan CHU de Brest
Brest, 29200
Centre François Baclesse
Caen, 14000
CHU de Caen - Hopital Cote de Nacre
Caen, 14033
Centre Hospitalier Intercommunal de Creteil (CHIC)
Créteil, 94000
Centre Hospitalier Universitaire CHU De Limoges
Limoges, 87000
CHU de Nantes
Nantes, Cedex 01 44093
Bichat-Claude Bernard Hospital
Paris, 75018
CHU Reims - Hpital Maison Blanche
Reims, 51092
Hopital Civil / Nouvel Hopital Civil
Strasbourg, 67091
Hospital Foch
Suresnes, 92150
Gustave Roussy
Villejuif, 94805
South Korea9 sites
Chungbuk National University Hospital
Cheongju-si, 28644
CHA Bundang Medical Center, CHA University
Gyeonggi-do, 13496
The Catholic University of Korea, St.Vincents Hospital
Gyeonggi-do, 16247
Gachon University Gil Medical Center
Incheon, 21565
Inha University Hospital
Incheon, 22332
Kangbuk Samsung Hospital
Seoul, 03181
Asan Medical Center
Seoul, 05505
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 06591
Seoul Metropolitan Government-Seoul National University Boramae Medical Center
Seoul, 07061
Australia8 sites
BRICC - Ballarat Health Services
Ballarat Central, Victoria, 3350
Box Hill Hospital Eastern Health Clinical School
Box Hill, Victoria, 3128
The Chris Obrien Lifehouse
Camperdown, New South Wales, 2050
Northern Beaches Hospital
Frenchs Forest, NSW 2086
Gosford Hospital GH - Central Coast Cancer Centre
Gosford, 2250
Austin Hospital- Medical Oncology Unit
Heidelberg, VIC 3084
St John of God Murdoch Hospital
Murdoch, WA 6150
Cancer Care Wollongong
Wollongong, NSW 2500
Belgium8 sites
Algemeen Ziekenhuis AZ Klina - Borstkliniek
Brasschaat, 2930
Grand Hopital de Charleroi GHdC - Hopital Saint Joseph
Charleroi, 6000
Antwerp University Hospital
Edegem, Antwerp, 2650
Centre Hospitalier Chretien CHC - MontLegia
Liège, 4000
CHR de la Citadelle
Liège, 4000
CHU Liege
Liège, 4000
Az Sint Maarten Mechelen
Mechelen, 2800
Centre Hospitalier Universitaire (CHU) Ambroise Pare
Mons, 7000
Brazil8 sites
Fundacao Pio XII - Hospital de Cancer de Barretos - Hospital de Amor
Barretos, SP 14784-400
Oncocentro-Centro de Oncologia do Parana
Curitiba, Paraná, 82305-100
ONCOSITE - Centro de Pesquisa Clinica em Oncologia Ltda
Ijuí, 98700-00
Nucleo de Oncologia da Bahia - NOB
Ondina, Salvador, BA 40170-110
Irmandade daSanta Casa de Misericordia de Porto Alegre
Porto Alegre, Porto Alegre, 90050-170
Hospital Sao Lucas da PUCRS
Porto Alegre, Porto Alegre, 90610-000
Instituto Nacional de Cancer - Ministrio da Sade
Rio de Janeiro, 20231-050
UPCO - Hospital de Clinicas de Porto Alegre
Santa Cecília, Porto Alegre, RS 90035-903
Chile7 sites
Centro de Estudios Clínicos SAGA
Santiago
Clinica Alemana de Santiago
Santiago
Clínica Santa María
Santiago
Fundación Arturo López Pérez
Santiago
Hospital Clinico Universidad de Chile
Santiago
James Lind Centro de Investigación del Cáncer
Temuco, Araucania, 4780000
Clinical Research Chile SpA
Valdivia, Los Ríos Region, 5090000
Poland7 sites
II Klinika Chorob Pluc i Gruzlicy
Bialystok, 15-569
Szpitale Pomorskie Sp. z o.o., Oddzial Onkologii K
Gdynia, 81-519
Wojewódzkie Wielospecjalistyczne Centrum Onkologii
Lodz, 93-513
Specjalistyczna Praktyka Lekarska Slawomir Mandziuka
Lublin, 20-093
Szpital Specjalistyczny w Prabutach Sp. z o.o
Prabuty, 82-550
Mrukmed. Lekarz Beata Madej-Mruk i Partner. Sp.p
Rzeszów, 35-021
Specjalistyczny Szpital Onkologiczny NU-MED sp. Z
Tomaszów Mazowiecki, 97-200
Switzerland7 sites
University Hospital Basel
Basel, 4031
Istituto Oncologico della Svizzera Italiana
Bellinzona, 6500
Spital Thurgau - Kantonspital Frauenfeld
Frauenfeld, 8501
Centre Hospitalier Universitaire Vaudois
Lausanne, 1011
Kantonsspital Baselland
Liestal, 4410
Spital Thurgau - Kantonsspital Muensterlingen
Münsterlingen, 8596
HFR Freiburg Kantonsspital
Villars-sur-Glâne, 1752
United Kingdom7 sites
Belfast Health and Social Care Trust
Belfast, BT9 7AB
The Princess Alexandra Hospital
Harlow, CM20 1QX
Guys and St Thomas NHS Foundation Trust
London, SE1 9RT
The Christie NHS Foundation Trust
Manchester, M20 4BX
Clatterbridge Hospital
Metropolitan Borough of Wirral, CH63 4JY
Nottingham University Hospitals NHS Trust
Nottingham, NG5 1PB
The Royal Wolverhampton NHS Trust
Wolverhampton, WV10 0QP
Canada6 sites
Hamilton Health Sciences -Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2
Hôpital de la Cité-de-la- Santé
Laval, Quebec, H7M 3L9
CISSS de la Montérégie-Centre - Hôpital Charles LeMoyne
Longueuil, Quebec, J4V 2H1
McGill University Health Centre (MUHC)
Montreal, H4A 3J1
Southlake Regional Health Centre
Newmarket, Ontario, L3Y 2P9
University Health Network - Princess Margaret Hospital
Toronto, ON M5G 2C1
Georgia6 sites
High Technology Hospital Medcenter
Batumi, 6000
Todua Clinic
Tbilisi, 112
New Hospitals
Tbilisi, 114
Institute Of Clinical Oncology
Tbilisi, 156
JSC Evex Hospitals "Caraps Medline"
Tbilisi, 179
LTD Cancer Research Centre
Tbilisi, 186
Romania6 sites
Sc Oncopremium Team Srl
Baia Mare, 020945
Medisprof srl
Cluj-Napoca, 400641
Oncolab SRL
Craiova, 200385
Centrul de Oncologie Sfantu Nectarie
Craiova, 200746
Ovidius Clinical Hospital
Ovidiu, 9005900
Oncocenter Oncologie clinica S.R.L
Timișoara, 300166
Hungary5 sites
Debreceni Egyetem - Klinikai Kozpont
Debrecen, 4032
Veszprem Megyei Tudogyogyintezet Farkasgyepu
Farkasgyepű, 8582
Bacs-Kiskun County Hospital
Kecskemét, 6000
Hetenyi G Korhaz, Onkologiai Kozpont
Szolnok, 5004
Pulmonology Hospital Torokbalint
Törökbálint, 2045
Israel5 sites
Rambam Health Care Campu
Haifa, 3109601
Shaare Zedek Medical Center
Jerusalem, 9103102
Rabin Medical Center
Petah Tikva, 49100
The Chaim Sheba Medical Center
Ramat Gan
Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906
Turkey (Türkiye)5 sites
Bagcilar Medipol Mega University Hospital
Bağcılar, Istanbul, 34214
Liv Hospital Ankara
Çankaya, Ankara, 06680
Kocaeli University Hospital
İzmit, Kocaeli, 41380
Goztepe Prof. Dr. Suleyman Yalcin City Hospital
Kadıköy, Istanbul, 34722
Medicalpark Seyhan Hospital
Seyhan, Adana, 01140
Bulgaria4 sites
Multiprofile Hospital for Active Treatment - Uni Hospital OOD Department of Medical Oncology
Panagyurishte, Panagyurishte, 4500
Complex Oncology Center - Plovdiv EOOD, First Department of Medical Oncology and Oncological Diseases in Gastroenterology
Plovdiv, 4000
Specialized hospital for active treatment of oncological diseases
Sofia, 1303
Multiprofile Hospital for Active Treatment Serdika EOOD Second Department of Medical Oncology
Sofia, 1632
Denmark4 sites
Aalborg University Hospital
Aalborg, 9000
Sjællands Universitetshospital
Næstved, 4700
Sønderborg Sygehus
Sønderborg, 6400
Vejle Hospital
Vejle, 7100
Taiwan4 sites
Changhua Christian Hospital
Chang-hua, Chang Hua, 500
Buddhist Dalin Tzu Chi Hospital
Dalin, Chiayi, 622401
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Kaohsiung, 83301
National Taiwan University Cancer Center
Taipei, 106
Austria2 sites
University Hospital Salzburg
Salzburg, A-5020
Medizinische Universitaet Wien
Vienna, A-1090
About this study
Official title: A Randomized, Multicenter, Open-label, Phase III Study of Lurbinectedin Single-Agent or Lurbinectedin in Combination With Irinotecan Versus Investigator's Choice (Topotecan or Irinotecan) in Relapsed Small Cell Lung Cancer Patients (LAGOON Trial)
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.
Read the detailed 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 and pretreated 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.
- Conditions
- Relapsed Small Cell Lung Cancer
- Being tested
- Irinotecan, Lurbinectedin, Topotecan
- Keywords
- Relapsed Small Cell Lung Cancer, PharmaMar, Lurbinectedin, Irinotecan, 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.
IrinotecanDrug
Irinotecan 75 mg/m² intravenously Days 1 \& 8 q3wk
LurbinectedinDrug
Also called PM01183
Lurbinectedin 3.2 mg/m² will be administered intravenously on Day 1 q3wk
IrinotecanDrug
For patients aged <70 years: irinotecan 350 mg/m² intravenously Day 1 q3wk For patients aged ≥70 years: irinotecan 300 mg/m² intravenously Day 1 q3wk
TopotecanDrug
Topotecan 2.3 mg/m² oral or 1.5 mg/m² intravenously Days 1-5 q3wk
LurbinectedinDrug
Also called PM01183
Lurbinectedin 2.0 mg/m² will be administered intravenously on Day 1 q3wk
| Study group | Role | What they receive |
|---|---|---|
| Lurbinectedin | Experimental | Patients will consecutively receive lurbinectedin on Day 1 q3wk (every three weeks = one treatment cycle) Receives: Drug: Lurbinectedin |
| Lurbinectedin plus Irinotecan | Experimental | Patients will consecutively receive the following q3wk (every three weeks = one treatment cycle):
* Irinotecan (Day 1 and Day 8)
* Lurbinectedin (Day 1) Receives: Drug: Irinotecan; Drug: Lurbinectedin |
| Control arm | Active comparator | Best Investigator's choice prior to randomization between:
* Irinotecan on Day 1 q3wk
* Topotecan on Days 1-5 q3wk Receives: Drug: Irinotecan; Drug: Topotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Overall survival (OS) will be calculated from the date of randomization to the date of death or last contact (in this case, survival will be censored on that date).
Measured: From the date of randomization to the date of death or last contact, up to 39 months
Secondary outcomes (13)
Progression-free survival by IRC (Independent Review Committee)
Progression-free survival (PFS) will be calculated from the date of randomization to the date of documented progression per RECIST v.1.1 (Progressive disease is declared when there is an increase in sum of target disease ≥ 20%) or death (regardless of the cause of death). If the patient receives further antitumor therapy, withdraws from the study, or is lost to follow-up before progressive disease (PD), PFS will be censored at the date of last evaluable tumor assessment before the date of subsequent antitumor therapy.
Measured: From the date of randomization to the date of progressive disease, death or last tumor assessment or further anticancer treatment, up to 39 months
Progression-free survival by IA (Investigator Assessment)
Progression-free survival (PFS) will be calculated from the date of randomization to the date of documented progression per RECIST v.1.1 (Progressive disease is declared when there is an increase in sum of target disease ≥ 20%) or death (regardless of the cause of death). If the patient receives further antitumor therapy, withdraws from the study, or is lost to follow-up before progressive disease (PD), PFS will be censored at the date of last evaluable tumor assessment before the date of subsequent antitumor therapy.
Measured: From the date of randomization to the date of progressive disease, death or last tumor assessment or further anticancer treatment, up to 39 months
Overall response rate by IRC
Overall response rate (ORR) will be the percentage of patients with complete or partial response as the best response obtained in any evaluation according to RECIST v.1.1. Progressive disease is declared when there is an increase in sum of target disease ≥ 20%, stable disease when the change is > -30% and ≤ 20%, partial response when there is a decrease in sum of target disease ≥ 30%, and complete response when all lesions have disappeared or all lesions have disappeared and all nodal disease is < 10 mm each.
Measured: From the date of randomization to the date of death or last contact, up to 39 months
Overall response rate by IA
Overall response rate (ORR) will be the percentage of patients with complete or partial response as the best response obtained in any evaluation according to RECIST v.1.1. Progressive disease is declared when there is an increase in sum of target disease ≥ 20%, stable disease when the change is > -30% and ≤ 20%, partial response when there is a decrease in sum of target disease ≥ 30%, and complete response when all lesions have disappeared or all lesions have disappeared and all nodal disease is < 10 mm each.
Measured: From the date of randomization to the date of death or last contact, up to 39 months
Overall survival rate at 12 months
Overall survival rate at 12 months is defined as the percentage of people who are still alive at 12 months after randomization.
Measured: At 12 months
Overall survival rate at 24 months
Overall survival rate at 24 months is defined as the percentage of people who are still alive at 24 months after randomization.
Measured: At 24 months
Progression-free survival rate at 6 months by IRC
Progression-free survival rate at 6 months is defined as the percentage of people who remain free from progression at 6 months after randomization
Measured: At 6 months
Progression-free survival rate at 6 months by IA
Progression-free survival rate at 6 months is defined as the percentage of people who remain free from progression at 6 months after randomization
Measured: At 6 months
Progression-free survival rate at 12 months by IRC
Progression-free survival rate at 12 months is defined as the percentage of people who remain free from progression at 12 months after randomization
Measured: At 12 months
Progression-free survival rate at 12 months by IA
Progression-free survival rate at 12 months is defined as the percentage of people who remain free from progression at 12 months after randomization
Measured: At 12 months
Duration of response by IRC
Duration of response (DoR) will be calculated from the date of first documentation of response per RECIST v.1.1 (complete or partial response, whichever occurs first) to the date of documented PD or death. Progressive disease is declared when there is an increase in sum of target disease ≥ 20%, stable disease when the change is > -30% and ≤ 20%, partial response when there is a decrease in sum of target disease ≥ 30%, and complete response when all lesions have disappeared or all lesions have disappeared and all nodal disease is < 10 mm each.
Measured: From the date of first documentation of complete or partial response to the date of documented progression disease, death or last contact, up to 39 months
Duration of response by IA
Duration of response (DoR) will be calculated from the date of first documentation of response per RECIST v.1.1 (complete or partial response, whichever occurs first) to the date of documented PD or death. Progressive disease is declared when there is an increase in sum of target disease ≥ 20%, stable disease when the change is > -30% and ≤ 20%, partial response when there is a decrease in sum of target disease ≥ 30%, and complete response when all lesions have disappeared or all lesions have disappeared and all nodal disease is < 10 mm each.
Measured: From the date of first documentation of complete or partial response to the date of documented progression disease, death or last contact, up to 39 months
Patient-reported outcomes
To measure the quality of life of patients, the Lung Cancer Symptom Scale (LCSS) questionnaire will be analyzed.
Measured: At baseline and every six weeks (± one week) until end of treatment, up to 39 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2021
- Study start22 Jul 2022
- Primary completion10 Apr 2026
- Study completion10 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Relapsed 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
- Model description
- Multicenter, open-label, randomized, controlled
- Masking
- None (open label)
- Enrolment
- 705 participants (actual)
Sponsor and investigators
- Lead sponsor
- PharmaMar
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05153239
- Sponsor's protocol ID
- PM1183-C-008-21
- Status last verified
- Oct 2026
- First submitted
- 29 Nov 2021
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Falcon A, Ponce S, Cote GM, Gil A, Lin JJ, Bockorny B, Martinez J, Kahatt C, Martinez S, Zubiaur P, Siguero M, Cullell-Young M, Jimenez J, Zugazagoitia J, Paz-Ares L. Phase I results on the efficacy, safety and pharmacokinetics of lurbinectedin and irinotecan in advanced solid tumors. Invest New Drugs. 2025 Aug;43(4):955-967. doi: 10.1007/s10637-025-01583-y. Epub 2025 Sep 18.
PubMed 40963055