Clinical trial NCT05874401: 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 type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Extensive-stage Small-cell Lung Cancer
Keywords: myelosuppression
ES-SCLC
chemotherapy-induced myelosuppression
chemotherapy-induced neutropenia
chemotherapy-induced anemia
myeloprotection
Lead sponsor: G1 Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2023-05-24
Enrollment: 302
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Overall survival (OS)
timeFrame: From date of randomization until date of death due to any cause for those who died; or date of last contact known as alive for those who survived in the study (censored cases), assessed up to 52 months
Secondary outcomes:
measure: Anti-tumor efficacy
timeFrame: From date of randomization until date of documented radiologic disease progression per RECIST v1.1 or death due to any cause, whichever comes first, assessed up to 52 months
measure: Anti-tumor efficacy
timeFrame: From date of randomization until the occurrence of progressive disease, withdrawal of consent, or initiation of subsequent anti-cancer therapy, assessed up to 52 months
measure: Anti-tumor efficacy
timeFrame: From date of first objective response of complete response (CR) or partial response (PR) and the first date that progressive disease is objectively documented or death, whichever comes first, assessed up to 52 months
measure: Neutrophil-related myeloprotection efficacy
timeFrame: From date of randomization until end of cycle 1 (each cycle is 21 days)
measure: Neutrophil-related myeloprotection efficacy
timeFrame: From date of randomization until end of treatment, assessed up to 52 months
measure: Neutrophil-related myeloprotection efficacy
timeFrame: From date of randomization until end of treatment, assessed up to 52 months
measure: RBC related myeloprotection efficacy
timeFrame: From date of randomization until end of treatment, assessed up to 52 months
measure: RBC related myeloprotection efficacy
timeFrame: From date of randomization until end of Week 5
measure: RBC related myeloprotection efficacy
timeFrame: From date of randomization until end of Week 5
measure: Platelet related myeloprotection efficacy
timeFrame: From date of randomization until end of treatment, assessed up to 52 months
measure: Platelet related myeloprotection efficacy
timeFrame: From date of randomization until end of treatment, assessed up to 52 months
measure: Myeloprotection efficacy
timeFrame: From date of randomization until end of treatment, assessed up to 52 months
measure: Myeloprotection efficacy
timeFrame: From date of randomization until end of treatment, assessed up to 52 months
measure: Chemotherapy dosing
timeFrame: From the date of randomization until end of treatment, assessed up to 52 months
measure: Chemotherapy dosing
timeFrame: From the date of randomization until end of treatment, assessed up to 52 months
measure: Incidence of Treatment-Emergent Adverse Events as Assessed by CTCAE
timeFrame: From the date of randomization until end of treatment, assessed up to 52 months
Other outcomes:
Locations:
city: Klagenfurt am Worthersee
country: Austria
facility: Klinikum Klagenfurt am Wörthersee
city: Vienna
country: Austria
facility: Klinik Hietzing
city: Wien
country: Austria
facility: Wiener Gesundheitsverband Klinik Penzing
city: Libramont
country: Belgium
facility: Centre Hospitalier de l'Ardenne
city: Liege
country: Belgium
facility: CHU de Liège
city: Liège
country: Belgium
facility: C. H. R. de la Citadelle
city: Pleven
country: Bulgaria
facility: Multiprofile Hospital for ActiveTreatment "Heart and Brain"
city: Plovdiv
country: Bulgaria
facility: Complex Oncological Center - Plovdiv, EOOD
city: Plovdiv
country: Bulgaria
facility: MHAT Park Hospital EOOD
city: Sofia
country: Bulgaria
facility: UMHAT "SofiaMed", OOD
city: Batumi
country: Georgia
facility: High Technology Hospital Medcentre LLC
city: Kutaisi
country: Georgia
facility: JSC Vian
city: Tbilisi
country: Georgia
facility: Institute of Clinical Oncology LTD
city: Tbilisi
country: Georgia
facility: LLC Todua Clinic
city: Tbilisi
country: Georgia
facility: Multiprofile Clinic Consilium Medulla LLC
city: Tbilisi
country: Georgia
facility: New Hospitals LLC
city: Tbilisi
country: Georgia
facility: Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic, LLC
city: Augsburg
country: Germany
facility: Hämatologie-Onkologie im Zentrum Augsburg MVZ GmbH
city: Frankfurt
country: Germany
facility: Universitaetsklinikum Frankfurt Goethe-Universitaet
city: Halle
country: Germany
facility: MVZ Martha-Maria Halle-Doelau
city: Hamburg
country: Germany
facility: Asklepios Klinik Harburg
city: Luebeck
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
city: Athens
country: Greece
facility: General Hospital of Athens "Alexandra"
city: Athens
country: Greece
facility: General Hospital of Athens of Chest Diseases "SOTIRIA"
city: Neo Faliro
country: Greece
facility: Metropolitan Hospital
city: Neo Faliro
country: Greece
facility: Metropolitan Hospital
city: Thessaloniki
country: Greece
facility: Bioclinic Thessaloniki
city: Thessaloníki
country: Greece
facility: St Luke's Hospital
city: Budapest
country: Hungary
facility: Orszagos Koranyi Pulmonologiai Intezet
city: Gyula
country: Hungary
facility: Bekes Varmegyei Kozponti Korhaz
city: Kecskemet
country: Hungary
facility: Bacs-Kiskun Varmegyei Oktatokorhaz
city: Székesfehérvár
country: Hungary
facility: Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz
city: Tatabanya
country: Hungary
facility: Komarom-Esztergom Varmegyei Szent Borbala Korhaz
city: Törökbálint
country: Hungary
facility: Torokbalinti Tudogyogyintezet
city: Zalaegerszeg
country: Hungary
facility: Zala Varmegyei Szent Rafael Korhaz
city: Biała Podlaska
country: Poland
facility: Wojewodzki Szpital Specjalistyczny w Bialej Podlaskiej
city: Kraków
country: Poland
facility: Krakowskie Centrum Medyczne
city: Lodz
country: Poland
facility: FutureMeds Lodz
city: Olsztyn
country: Poland
facility: Warminsko Mazurskie Centrum Chorob Pluc
city: Otwock
country: Poland
facility: Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy
city: Szklarska Poręba
country: Poland
facility: Izerskie Centrum Pulmonologii i Chemioterapii "IZER-MED" Spolka z o.o.
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofia
city: Mataro
country: Spain
facility: Hospital de Mataro
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
city: San Cristobal de La laguna
country: Spain
facility: Hospital Universitario de Canarias
city: Sevilla
country: Spain
facility: Hospital Universitario Nuestra Señora de Valme
city: Valencia
country: Spain
facility: Instituto Valenciano de Oncologia IVO
city: Adana
country: Turkey
facility: Medical Park Seyhan Hospital
city: Ankara
country: Turkey
facility: Ankara City Hospital
city: Ankara
country: Turkey
facility: Ankara Liv Hospital
city: Edirne
country: Turkey
facility: Trakya University Medical Faculty
city: Istanbul
country: Turkey
facility: Goztepe Prof. Dr. Suleyman Yalcin City Hospital
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty
city: Istanbul
country: Turkey
facility: Marmara University Pendik Research and Training Hospital
city: Istanbul
country: Turkey
facility: Medipol University Medical Faculty
city: İzmir
country: Turkey
facility: Izmir Medicalpark Hospital
city: Malatya
country: Turkey
facility: Inonu Uni. Med. Fac.
Study officials:
References: