Trial Title:
Trilaciclib vs Placebo in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) Receiving Topotecan
NCT ID:
NCT05874401
Condition:
Extensive-stage Small-cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Topotecan
Conditions: Keywords:
myelosuppression
ES-SCLC
chemotherapy-induced myelosuppression
chemotherapy-induced neutropenia
chemotherapy-induced anemia
myeloprotection
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Drug
Intervention name:
Trilaciclib
Description:
Participants will receive intravenous trilaciclib infusion
Arm group label:
Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m²
Other name:
G1T28
Other name:
CDK 4/6 inhibitor
Other name:
cyclin-dependent kinase 4/6 inhibitor
Intervention type:
Drug
Intervention name:
Placebo
Description:
Participants will receive intravenous placebo infusion
Arm group label:
Placebo + Topotecan 1.5 mg/m²
Intervention type:
Drug
Intervention name:
Topotecan
Description:
Participants will receive intravenous topotecan infusion
Arm group label:
Placebo + Topotecan 1.5 mg/m²
Arm group label:
Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m²
Other name:
Hycamtin
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.
Criteria for eligibility:
Criteria:
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-line
regimen must have been a platinum-containing combination.
3. Measurable or evaluable disease as defined by RECIST v1.1
Exclusion Criteria:
1. History of topotecan (or other topoisomerase I inhibitor) or trilaciclib treatment
for SCLC
2. 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
3. Presence of brain metastases/leptomeningeal disease requiring immediate treatment
with 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 no
evidence of disease for ≥ 2 years or other NCS cancers
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Klinikum Klagenfurt am Wörthersee
Address:
City:
Klagenfurt am Worthersee
Country:
Austria
Status:
Not yet recruiting
Contact:
Last name:
Markus Rauter, MD
Facility:
Name:
Klinik Hietzing
Address:
City:
Vienna
Country:
Austria
Status:
Not yet recruiting
Contact:
Last name:
Robab Breyer Kohansal, MD
Facility:
Name:
Wiener Gesundheitsverband Klinik Penzing
Address:
City:
Wien
Country:
Austria
Status:
Not yet recruiting
Contact:
Last name:
Marie Kathrin Breyer, MD
Facility:
Name:
Centre Hospitalier de l'Ardenne
Address:
City:
Libramont
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Frederic Forget, MD
Facility:
Name:
CHU de Liège
Address:
City:
Liege
Country:
Belgium
Status:
Not yet recruiting
Contact:
Last name:
Marie Lecocq, MD
Facility:
Name:
C. H. R. de la Citadelle
Address:
City:
Liège
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Frédérique Bustin, MD
Facility:
Name:
Multiprofile Hospital for ActiveTreatment "Heart and Brain"
Address:
City:
Pleven
Country:
Bulgaria
Status:
Not yet recruiting
Contact:
Last name:
Nataliya Chilingirova, MD
Facility:
Name:
Complex Oncological Center - Plovdiv, EOOD
Address:
City:
Plovdiv
Country:
Bulgaria
Status:
Recruiting
Contact:
Last name:
Ivan Tonev, MD
Facility:
Name:
MHAT Park Hospital EOOD
Address:
City:
Plovdiv
Country:
Bulgaria
Status:
Recruiting
Contact:
Last name:
Vladimir Kanarev, MD
Facility:
Name:
UMHAT "SofiaMed", OOD
Address:
City:
Sofia
Country:
Bulgaria
Status:
Recruiting
Contact:
Last name:
Velko Minchev, MD
Facility:
Name:
High Technology Hospital Medcentre LLC
Address:
City:
Batumi
Country:
Georgia
Status:
Recruiting
Contact:
Last name:
Tamta Makharadze, MD
Facility:
Name:
JSC Vian
Address:
City:
Kutaisi
Country:
Georgia
Status:
Recruiting
Contact:
Last name:
Khatuna Bibichadze, MD
Facility:
Name:
Institute of Clinical Oncology LTD
Address:
City:
Tbilisi
Country:
Georgia
Status:
Recruiting
Contact:
Last name:
Vladimer Kuchava, MD
Facility:
Name:
LLC Todua Clinic
Address:
City:
Tbilisi
Country:
Georgia
Status:
Recruiting
Contact:
Last name:
Tamar Melkadze, MD
Facility:
Name:
Multiprofile Clinic Consilium Medulla LLC
Address:
City:
Tbilisi
Country:
Georgia
Status:
Recruiting
Contact:
Last name:
Tsira Kortua, MD
Facility:
Name:
New Hospitals LLC
Address:
City:
Tbilisi
Country:
Georgia
Status:
Recruiting
Contact:
Last name:
David Giorgadze, MD
Facility:
Name:
Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic, LLC
Address:
City:
Tbilisi
Country:
Georgia
Status:
Not yet recruiting
Contact:
Last name:
Miranda Gogishvili, MD
Facility:
Name:
Hämatologie-Onkologie im Zentrum Augsburg MVZ GmbH
Address:
City:
Augsburg
Country:
Germany
Status:
Not yet recruiting
Contact:
Last name:
Bernhard Heinrich, MD
Facility:
Name:
Universitaetsklinikum Frankfurt Goethe-Universitaet
Address:
City:
Frankfurt
Country:
Germany
Status:
Not yet recruiting
Contact:
Last name:
Wolfgang Gleiber, MD
Facility:
Name:
MVZ Martha-Maria Halle-Doelau
Address:
City:
Halle
Country:
Germany
Status:
Not yet recruiting
Contact:
Last name:
Wolfgang Schuette, MD
Facility:
Name:
Asklepios Klinik Harburg
Address:
City:
Hamburg
Country:
Germany
Status:
Not yet recruiting
Contact:
Last name:
Claas Wesseler, MD
Facility:
Name:
Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
Address:
City:
Luebeck
Country:
Germany
Status:
Not yet recruiting
Contact:
Last name:
Sabine Bohnet, MD
Facility:
Name:
General Hospital of Athens "Alexandra"
Address:
City:
Athens
Country:
Greece
Status:
Not yet recruiting
Contact:
Last name:
Flora Zagouri, MD
Facility:
Name:
General Hospital of Athens of Chest Diseases "SOTIRIA"
Address:
City:
Athens
Country:
Greece
Status:
Not yet recruiting
Contact:
Last name:
Konstantinos Syrigos, MD
Facility:
Name:
Metropolitan Hospital
Address:
City:
Neo Faliro
Country:
Greece
Status:
Not yet recruiting
Contact:
Last name:
Eleni Linardou, MD
Facility:
Name:
Metropolitan Hospital
Address:
City:
Neo Faliro
Country:
Greece
Status:
Not yet recruiting
Contact:
Last name:
Dimitrios Bafaloukos, MD
Facility:
Name:
Bioclinic Thessaloniki
Address:
City:
Thessaloniki
Country:
Greece
Status:
Not yet recruiting
Contact:
Last name:
Ioannis Boukovinas, MD
Facility:
Name:
St Luke's Hospital
Address:
City:
Thessaloníki
Country:
Greece
Status:
Not yet recruiting
Contact:
Last name:
Elena Fountzila, MD
Facility:
Name:
Orszagos Koranyi Pulmonologiai Intezet
Address:
City:
Budapest
Country:
Hungary
Status:
Not yet recruiting
Contact:
Last name:
Andrea Fulop, MD
Facility:
Name:
Bekes Varmegyei Kozponti Korhaz
Address:
City:
Gyula
Country:
Hungary
Status:
Not yet recruiting
Contact:
Last name:
Ibolya Laczo, MD
Facility:
Name:
Bacs-Kiskun Varmegyei Oktatokorhaz
Address:
City:
Kecskemet
Country:
Hungary
Status:
Not yet recruiting
Contact:
Last name:
Zsolt Horvath, MD
Facility:
Name:
Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz
Address:
City:
Székesfehérvár
Country:
Hungary
Status:
Not yet recruiting
Contact:
Last name:
Zsolt Papai-Szekely
Facility:
Name:
Komarom-Esztergom Varmegyei Szent Borbala Korhaz
Address:
City:
Tatabanya
Country:
Hungary
Status:
Not yet recruiting
Contact:
Last name:
Renata Bocskei, MD
Facility:
Name:
Torokbalinti Tudogyogyintezet
Address:
City:
Törökbálint
Country:
Hungary
Status:
Not yet recruiting
Contact:
Last name:
Gabriella Galffy, MD
Facility:
Name:
Zala Varmegyei Szent Rafael Korhaz
Address:
City:
Zalaegerszeg
Country:
Hungary
Status:
Not yet recruiting
Contact:
Last name:
Sandor Tehenes, MD
Facility:
Name:
Wojewodzki Szpital Specjalistyczny w Bialej Podlaskiej
Address:
City:
Biała Podlaska
Country:
Poland
Status:
Not yet recruiting
Contact:
Last name:
Maria Pawlowicz, MD
Facility:
Name:
Krakowskie Centrum Medyczne
Address:
City:
Kraków
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Michal Parkitny, MD
Facility:
Name:
FutureMeds Lodz
Address:
City:
Lodz
Country:
Poland
Status:
Not yet recruiting
Contact:
Last name:
Lukasz Matczak, MD
Facility:
Name:
Warminsko Mazurskie Centrum Chorob Pluc
Address:
City:
Olsztyn
Country:
Poland
Status:
Not yet recruiting
Contact:
Last name:
Jaroslaw Kolb-Sielecki, MD
Facility:
Name:
Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy
Address:
City:
Otwock
Country:
Poland
Status:
Not yet recruiting
Contact:
Last name:
Aleksandra Szczesna, MD
Facility:
Name:
Izerskie Centrum Pulmonologii i Chemioterapii "IZER-MED" Spolka z o.o.
Address:
City:
Szklarska Poręba
Country:
Poland
Status:
Not yet recruiting
Contact:
Last name:
Justyna Kaj, MD
Facility:
Name:
Hospital Universitario Reina Sofia
Address:
City:
Córdoba
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Isidoro Carlos Barneto Aranda, MD
Facility:
Name:
Hospital de Mataro
Address:
City:
Mataro
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Carlos Rivas Corredor, MD
Facility:
Name:
Hospital Universitario Central de Asturias
Address:
City:
Oviedo
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Emilio Esteban Gonzalez, MD
Facility:
Name:
Hospital Universitario de Canarias
Address:
City:
San Cristobal de La laguna
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Juana Oramas, MD
Facility:
Name:
Hospital Universitario Nuestra Señora de Valme
Address:
City:
Sevilla
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Jose Fuentes Pradera, MD
Facility:
Name:
Instituto Valenciano de Oncologia IVO
Address:
City:
Valencia
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Ignacio Gil Bazo, MD
Facility:
Name:
Medical Park Seyhan Hospital
Address:
City:
Adana
Country:
Turkey
Status:
Not yet recruiting
Contact:
Last name:
Ahmet Sezer, MD
Facility:
Name:
Ankara City Hospital
Address:
City:
Ankara
Country:
Turkey
Status:
Not yet recruiting
Contact:
Last name:
Mehmet Ali Sendur, MD
Facility:
Name:
Ankara Liv Hospital
Address:
City:
Ankara
Country:
Turkey
Status:
Not yet recruiting
Contact:
Last name:
Saadettin Kilickap, MD
Facility:
Name:
Trakya University Medical Faculty
Address:
City:
Edirne
Country:
Turkey
Status:
Not yet recruiting
Contact:
Last name:
Irfan Cicin, MD
Facility:
Name:
Goztepe Prof. Dr. Suleyman Yalcin City Hospital
Address:
City:
Istanbul
Country:
Turkey
Status:
Not yet recruiting
Contact:
Last name:
Mahmut Gumus, MD
Facility:
Name:
Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty
Address:
City:
Istanbul
Country:
Turkey
Status:
Not yet recruiting
Contact:
Last name:
Mustafa Ozguroglu, MD
Facility:
Name:
Marmara University Pendik Research and Training Hospital
Address:
City:
Istanbul
Country:
Turkey
Status:
Not yet recruiting
Contact:
Last name:
Osman Kostek, MD
Facility:
Name:
Medipol University Medical Faculty
Address:
City:
Istanbul
Country:
Turkey
Status:
Not yet recruiting
Contact:
Last name:
Ahmet Bilici, MD
Facility:
Name:
Izmir Medicalpark Hospital
Address:
City:
İzmir
Country:
Turkey
Status:
Not yet recruiting
Contact:
Last name:
Cagatay Arslan, MD
Facility:
Name:
Inonu Uni. Med. Fac.
Address:
City:
Malatya
Country:
Turkey
Status:
Not yet recruiting
Contact:
Last name:
Hakan Harputluoglu, MD
Start date:
October 18, 2023
Completion date:
July 30, 2027
Lead sponsor:
Agency:
G1 Therapeutics, Inc.
Agency class:
Industry
Source:
G1 Therapeutics, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05874401
