Trilaciclib vs Placebo in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) Receiving Topotecan

Last updated: August 27, 2025
Sponsor: Pharmacosmos A/S
Overall Status: Active - Recruiting

Phase

4

Condition

Small Cell Lung Cancer

Treatment

Placebo

Trilaciclib

Topotecan

Clinical Study ID

NCT05874401
G1T28-211
2022-502357-34-00
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. ES-SCLC with confirmed diagnosis of SCLC by histology or cytology

  2. Progression during or after prior first or second line chemotherapy. First-lineregimen must have been a platinum-containing combination.

  3. Measurable or evaluable disease as defined by RECIST v1.1

Exclusion

Exclusion Criteria:

  1. History of topotecan (or other topoisomerase I inhibitor) or trilaciclib treatmentfor SCLC

  2. Any chemotherapy, immunotherapy, biologic, investigational, or hormonal therapy forcancer treatment within 3 weeks, except for adjuvant hormonal therapy for breastcancer and prostate cancer

  3. Presence of brain metastases/leptomeningeal disease requiring immediate treatmentwith radiation therapy or steroids

  4. Radiotherapy within 2 weeks

  5. History of ILD/pneumonitis

  6. History of other malignancies, except for curatively treated solid tumors with noevidence of disease for ≥ 2 years or other NCS cancers

Study Design

Total Participants: 302
Treatment Group(s): 3
Primary Treatment: Placebo
Phase: 4
Study Start date:
October 18, 2023
Estimated Completion Date:
October 30, 2027

Study 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.

Connect with a study center

  • Klinikum Klagenfurt am Wörthersee

    Klagenfurt am Worthersee,
    Austria

    Site Not Available

  • Klinik Hietzing

    Vienna,
    Austria

    Site Not Available

  • Wiener Gesundheitsverband Klinik Penzing

    Wien,
    Austria

    Site Not Available

  • Centre Hospitalier de l'Ardenne

    Libramont,
    Belgium

    Site Not Available

  • CHU de Liège

    Liege,
    Belgium

    Site Not Available

  • C. H. R. de la Citadelle

    Liège,
    Belgium

    Site Not Available

  • Multiprofile Hospital for ActiveTreatment "Heart and Brain"

    Pleven,
    Bulgaria

    Site Not Available

  • Complex Oncological Center - Plovdiv, EOOD

    Plovdiv,
    Bulgaria

    Active - Recruiting

  • MHAT Park Hospital EOOD

    Plovdiv,
    Bulgaria

    Site Not Available

  • UMHAT "SofiaMed", OOD

    Sofia,
    Bulgaria

    Site Not Available

  • High Technology Hospital Medcentre LLC

    Batumi,
    Georgia

    Site Not Available

  • JSC Vian

    Kutaisi,
    Georgia

    Site Not Available

  • Institute of Clinical Oncology LTD

    Tbilisi,
    Georgia

    Active - Recruiting

  • LLC Todua Clinic

    Tbilisi,
    Georgia

    Site Not Available

  • Multiprofile Clinic Consilium Medulla LLC

    Tbilisi,
    Georgia

    Active - Recruiting

  • New Hospitals LLC

    Tbilisi,
    Georgia

    Active - Recruiting

  • Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic, LLC

    Tbilisi,
    Georgia

    Site Not Available

  • Hämatologie-Onkologie im Zentrum Augsburg MVZ GmbH

    Augsburg,
    Germany

    Site Not Available

  • Universitaetsklinikum Frankfurt Goethe-Universitaet

    Frankfurt,
    Germany

    Site Not Available

  • MVZ Martha-Maria Halle-Doelau

    Halle,
    Germany

    Site Not Available

  • Asklepios Klinik Harburg

    Hamburg,
    Germany

    Site Not Available

  • Universitaetsklinikum Schleswig-Holstein - Campus Luebeck

    Luebeck,
    Germany

    Site Not Available

  • General Hospital of Athens "Alexandra"

    Athens,
    Greece

    Site Not Available

  • General Hospital of Athens of Chest Diseases "SOTIRIA"

    Athens,
    Greece

    Site Not Available

  • Metropolitan Hospital

    Neo Faliro,
    Greece

    Site Not Available

  • Bioclinic Thessaloniki

    Thessaloniki,
    Greece

    Site Not Available

  • St Luke's Hospital

    Thessaloníki,
    Greece

    Site Not Available

  • Orszagos Koranyi Pulmonologiai Intezet

    Budapest,
    Hungary

    Site Not Available

  • Bekes Varmegyei Kozponti Korhaz

    Gyula,
    Hungary

    Site Not Available

  • Bacs-Kiskun Varmegyei Oktatokorhaz

    Kecskemet,
    Hungary

    Site Not Available

  • Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz

    Székesfehérvár,
    Hungary

    Site Not Available

  • Komarom-Esztergom Varmegyei Szent Borbala Korhaz

    Tatabanya,
    Hungary

    Site Not Available

  • Torokbalinti Tudogyogyintezet

    Törökbálint,
    Hungary

    Site Not Available

  • Zala Varmegyei Szent Rafael Korhaz

    Zalaegerszeg,
    Hungary

    Site Not Available

  • Wojewodzki Szpital Specjalistyczny w Bialej Podlaskiej

    Biała Podlaska,
    Poland

    Site Not Available

  • Krakowskie Centrum Medyczne

    Kraków,
    Poland

    Site Not Available

  • FutureMeds Lodz

    Lodz,
    Poland

    Site Not Available

  • Warminsko Mazurskie Centrum Chorob Pluc

    Olsztyn,
    Poland

    Site Not Available

  • Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy

    Otwock,
    Poland

    Site Not Available

  • Izerskie Centrum Pulmonologii i Chemioterapii "IZER-MED" Spolka z o.o.

    Szklarska Poręba,
    Poland

    Site Not Available

  • Hospital Universitario Reina Sofia

    Córdoba,
    Spain

    Site Not Available

  • Hospital de Mataro

    Mataro,
    Spain

    Site Not Available

  • Hospital Universitario Central de Asturias

    Oviedo,
    Spain

    Site Not Available

  • Hospital Universitario de Canarias

    San Cristobal de La laguna,
    Spain

    Site Not Available

  • Hospital Universitario Nuestra Señora de Valme

    Sevilla,
    Spain

    Site Not Available

  • Hospital

    Seville 2510911,
    Spain

    Active - Recruiting

  • Instituto Valenciano de Oncologia IVO

    Valencia,
    Spain

    Site Not Available

  • Medical Park Seyhan Hospital

    Adana,
    Turkey

    Site Not Available

  • Ankara City Hospital

    Ankara,
    Turkey

    Site Not Available

  • Ankara Liv Hospital

    Ankara,
    Turkey

    Site Not Available

  • Trakya University Medical Faculty

    Edirne,
    Turkey

    Site Not Available

  • Goztepe Prof. Dr. Suleyman Yalcin City Hospital

    Istanbul,
    Turkey

    Site Not Available

  • Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty

    Istanbul,
    Turkey

    Site Not Available

  • Marmara University Pendik Research and Training Hospital

    Istanbul,
    Turkey

    Site Not Available

  • Medipol University Medical Faculty

    Istanbul,
    Turkey

    Site Not Available

  • Inonu Uni. Med. Fac.

    Malatya,
    Turkey

    Site Not Available

  • Izmir Medicalpark Hospital

    İzmir,
    Turkey

    Site Not Available

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