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Brief Title: Trilaciclib vs Placebo in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) Receiving Topotecan
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study of Trilaciclib vs Placebo in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) Receiving Topotecan Chemotherapy
Study ID: NCT05874401
Brief Summary: This is a multicenter, randomized, double-blind, placebo-controlled study to assess whether trilaciclib administered prior to topotecan is non-inferior to placebo administered prior to topotecan with regard to overall survival.
Detailed Description: The study will include 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. Patients randomized in this study will receive trilaciclib/placebo + topotecan 1.5 mg/m2 until disease progression, unacceptable toxicity, withdrawal of consent, Investigator decision to discontinue treatment, or the end of the trial, whichever comes first. Trilaciclib was approved by the United States (US) Food and Drug Administration (FDA) as a treatment to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for ES-SCLC. As a post-marketing requirement, the FDA asked the Sponsor to conduct a study in patients with ES-SCLC undergoing chemotherapy to evaluate survival and disease progression following trilaciclib administration in patients treated with a platinum/etoposide-containing regimen or topotecan-containing regimen with at least 2 years of follow-up. This study is designed to fulfill this requirement.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Klinikum Klagenfurt am Wörthersee, Klagenfurt am Worthersee, , Austria
Klinik Hietzing, Vienna, , Austria
Wiener Gesundheitsverband Klinik Penzing, Wien, , Austria
Centre Hospitalier de l'Ardenne, Libramont, , Belgium
CHU de Liège, Liege, , Belgium
C. H. R. de la Citadelle, Liège, , Belgium
Multiprofile Hospital for ActiveTreatment "Heart and Brain", Pleven, , Bulgaria
Complex Oncological Center - Plovdiv, EOOD, Plovdiv, , Bulgaria
MHAT Park Hospital EOOD, Plovdiv, , Bulgaria
UMHAT "SofiaMed", OOD, Sofia, , Bulgaria
High Technology Hospital Medcentre LLC, Batumi, , Georgia
JSC Vian, Kutaisi, , Georgia
Institute of Clinical Oncology LTD, Tbilisi, , Georgia
LLC Todua Clinic, Tbilisi, , Georgia
Multiprofile Clinic Consilium Medulla LLC, Tbilisi, , Georgia
New Hospitals LLC, Tbilisi, , Georgia
Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic, LLC, Tbilisi, , Georgia
Hämatologie-Onkologie im Zentrum Augsburg MVZ GmbH, Augsburg, , Germany
Universitaetsklinikum Frankfurt Goethe-Universitaet, Frankfurt, , Germany
MVZ Martha-Maria Halle-Doelau, Halle, , Germany
Asklepios Klinik Harburg, Hamburg, , Germany
Universitaetsklinikum Schleswig-Holstein - Campus Luebeck, Luebeck, , Germany
General Hospital of Athens "Alexandra", Athens, , Greece
General Hospital of Athens of Chest Diseases "SOTIRIA", Athens, , Greece
Metropolitan Hospital, Neo Faliro, , Greece
Metropolitan Hospital, Neo Faliro, , Greece
Bioclinic Thessaloniki, Thessaloniki, , Greece
St Luke's Hospital, Thessaloníki, , Greece
Orszagos Koranyi Pulmonologiai Intezet, Budapest, , Hungary
Bekes Varmegyei Kozponti Korhaz, Gyula, , Hungary
Bacs-Kiskun Varmegyei Oktatokorhaz, Kecskemet, , Hungary
Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz, Székesfehérvár, , Hungary
Komarom-Esztergom Varmegyei Szent Borbala Korhaz, Tatabanya, , Hungary
Torokbalinti Tudogyogyintezet, Törökbálint, , Hungary
Zala Varmegyei Szent Rafael Korhaz, Zalaegerszeg, , Hungary
Wojewodzki Szpital Specjalistyczny w Bialej Podlaskiej, Biała Podlaska, , Poland
Krakowskie Centrum Medyczne, Kraków, , Poland
FutureMeds Lodz, Lodz, , Poland
Warminsko Mazurskie Centrum Chorob Pluc, Olsztyn, , Poland
Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy, Otwock, , Poland
Izerskie Centrum Pulmonologii i Chemioterapii "IZER-MED" Spolka z o.o., Szklarska Poręba, , Poland
Hospital Universitario Reina Sofia, Córdoba, , Spain
Hospital de Mataro, Mataro, , Spain
Hospital Universitario Central de Asturias, Oviedo, , Spain
Hospital Universitario de Canarias, San Cristobal de La laguna, , Spain
Hospital Universitario Nuestra Señora de Valme, Sevilla, , Spain
Instituto Valenciano de Oncologia IVO, Valencia, , Spain
Medical Park Seyhan Hospital, Adana, , Turkey
Ankara City Hospital, Ankara, , Turkey
Ankara Liv Hospital, Ankara, , Turkey
Trakya University Medical Faculty, Edirne, , Turkey
Goztepe Prof. Dr. Suleyman Yalcin City Hospital, Istanbul, , Turkey
Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty, Istanbul, , Turkey
Marmara University Pendik Research and Training Hospital, Istanbul, , Turkey
Medipol University Medical Faculty, Istanbul, , Turkey
Izmir Medicalpark Hospital, İzmir, , Turkey
Inonu Uni. Med. Fac., Malatya, , Turkey