⭐️⭐️⭐️⭐️⭐️ "A total no brainer"

⭐️⭐️⭐️⭐️⭐️ "Love this, so easy."

Spots is the easy way to track your skin, mole and cancer changes.

Spots Global Cancer Trial Database for Trilaciclib vs Placebo in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) Receiving Topotecan

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

Logo

Take Control of Your Skin and Body Changes Today.

Try out Spots for free, set up only takes 2 mins.

spots app storespots app store

Join others from around the world: