Trilaciclib vs Placebo in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) Receiving Topotecan
Extensive-stage Small-cell Lung Cancer
About this trial
This is an interventional treatment trial for Extensive-stage Small-cell Lung Cancer focused on measuring myelosuppression, ES-SCLC, chemotherapy-induced myelosuppression, chemotherapy-induced neutropenia, chemotherapy-induced anemia, myeloprotection
Eligibility Criteria
Inclusion Criteria: ES-SCLC with confirmed diagnosis of SCLC by histology or cytology Progression during or after prior first or second line chemotherapy. First-line regimen must have been a platinum-containing combination. Measurable or evaluable disease as defined by RECIST v1.1 Exclusion Criteria: History of topotecan (or other topoisomerase I inhibitor) or trilaciclib treatment for SCLC Any chemotherapy, immunotherapy, biologic, investigational, or hormonal therapy for cancer treatment within 3 weeks, except for adjuvant hormonal therapy for breast cancer and prostate cancer Presence of brain metastases/leptomeningeal disease requiring immediate treatment with radiation therapy or steroids Radiotherapy within 2 weeks History of ILD/pneumonitis History of other malignancies, except for curatively treated solid tumors with no evidence of disease for ≥ 2 years or other NCS cancers
Sites / Locations
- Klinikum Klagenfurt am Wörthersee
- Klinik Hietzing
- Wiener Gesundheitsverband Klinik Penzing
- Centre Hospitalier de l'ArdenneRecruiting
- CHU de Liège
- C. H. R. de la CitadelleRecruiting
- Multiprofile Hospital for ActiveTreatment "Heart and Brain"
- Complex Oncological Center - Plovdiv, EOODRecruiting
- MHAT Park Hospital EOODRecruiting
- UMHAT "SofiaMed", OOD
- High Technology Hospital Medcentre LLC
- JSC Vian
- Institute of Clinical Oncology LTD
- LLC Todua Clinic
- Multiprofile Clinic Consilium Medulla LLC
- New Hospitals LLC
- Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic, LLC
- Hämatologie-Onkologie im Zentrum Augsburg MVZ GmbH
- Universitaetsklinikum Frankfurt Goethe-Universitaet
- MVZ Martha-Maria Halle-Doelau
- Asklepios Klinik Harburg
- Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
- General Hospital of Athens "Alexandra"
- General Hospital of Athens of Chest Diseases "SOTIRIA"
- Metropolitan Hospital
- Metropolitan Hospital
- Bioclinic Thessaloniki
- St Luke's Hospital
- Orszagos Koranyi Pulmonologiai Intezet
- Bekes Varmegyei Kozponti Korhaz
- Bacs-Kiskun Varmegyei Oktatokorhaz
- Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz
- Komarom-Esztergom Varmegyei Szent Borbala Korhaz
- Torokbalinti Tudogyogyintezet
- Zala Varmegyei Szent Rafael Korhaz
- Wojewodzki Szpital Specjalistyczny w Bialej Podlaskiej
- Krakowskie Centrum Medyczne
- FutureMeds Lodz
- Warminsko Mazurskie Centrum Chorob Pluc
- Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy
- Izerskie Centrum Pulmonologii i Chemioterapii "IZER-MED" Spolka z o.o.
- Hospital Universitario Reina Sofia
- Hospital de Mataro
- Hospital Universitario Central de Asturias
- Hospital Universitario de CanariasRecruiting
- Hospital Universitario Nuestra Señora de Valme
- Instituto Valenciano de Oncologia IVORecruiting
- Medical Park Seyhan Hospital
- Ankara City Hospital
- Ankara Liv Hospital
- Trakya University Medical Faculty
- Goztepe Prof. Dr. Suleyman Yalcin City Hospital
- Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty
- Marmara University Pendik Research and Training Hospital
- Medipol University Medical Faculty
- Izmir Medicalpark Hospital
- Inonu Uni. Med. Fac.
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m²
Placebo + Topotecan 1.5 mg/m²
Patients randomized 1:1 to trilaciclib. Patients receive trilaciclib (240 mg/m²) administered once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients receive topotecan (1.5 mg/m²)
Patients are randomized 1:1 to placebo. Patients receive placebo administered once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of placebo on Days 1 to 5, patients receive topotecan (1.5 mg/m²).