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

Extensive-stage Small-cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05874401
• Other study ID #: G1T28-211
• Secondary ID: 2022-502357-34-0
• Status: Recruiting
• Phase: Phase 4
• Start date: October 18, 2023
• Est. completion date: July 30, 2027

Study information

• Verified date: November 2023
• Source: G1 Therapeutics, Inc.
• Contact: G1 Therapeutics
• Phone: 919-213-9835
• Email: clinicalinfo[@]g1therapeutics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 302
• Est. completion date: July 30, 2027
• Est. primary completion date: July 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Extensive-stage Small-cell Lung Cancer
• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

Drug:
• Trilaciclib
Participants will receive intravenous trilaciclib infusion
• Placebo
Participants will receive intravenous placebo infusion
• Topotecan
Participants will receive intravenous topotecan infusion

Locations

Country	Name	City	State
Austria	Klinikum Klagenfurt am Wörthersee	Klagenfurt am Worthersee
Austria	Klinik Hietzing	Vienna
Austria	Wiener Gesundheitsverband Klinik Penzing	Wien
Belgium	Centre Hospitalier de l'Ardenne	Libramont
Belgium	CHU de Liège	Liege
Belgium	C. H. R. de la Citadelle	Liège
Bulgaria	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
Georgia	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
Germany	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
Greece	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
Hungary	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
Poland	Wojewodzki Szpital Specjalistyczny w Bialej Podlaskiej	Biala 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 Poreba
Spain	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
Turkey	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	Izmir
Turkey	Inonu Uni. Med. Fac.	Malatya

Sponsors (1)

Lead Sponsor	Collaborator
G1 Therapeutics, Inc.

Countries where clinical trial is conducted

Austria,  Belgium,  Bulgaria,  Georgia,  Germany,  Greece,  Hungary,  Poland,  Spain,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival (OS)	To assess the effect of trilaciclib on OS compared with placebo in patients receiving topotecan	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	Anti-tumor efficacy	To assess the effect of trilaciclib on Progression Free Survival (PFS) compared with placebo in patients receiving Topotecan	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
Secondary	Anti-tumor efficacy	To assess the effect of trilaciclib on objective response rate (ORR) compared with placebo in patients receiving Topotecan	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
Secondary	Anti-tumor efficacy	To assess the effect of trilaciclib on duration of response (DOR) compared with placebo in patients receiving Topotecan	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
Secondary	Neutrophil-related myeloprotection efficacy	Duration of severe (CTCAE Grade 4) neutropenia in Cycle 1	From date of randomization until end of cycle 1 (each cycle is 21 days)
Secondary	Neutrophil-related myeloprotection efficacy	Occurrence of severe (CTCAE Grade 4) neutropenia and febrile neutropenia AEs	From date of randomization until end of treatment, assessed up to 52 months
Secondary	Neutrophil-related myeloprotection efficacy	Occurrence of G-CSF administration	From date of randomization until end of treatment, assessed up to 52 months
Secondary	RBC related myeloprotection efficacy	Occurrence of CTCAE Grade 3 or 4 decreased hemoglobin laboratory values and ESA administration	From date of randomization until end of treatment, assessed up to 52 months
Secondary	RBC related myeloprotection efficacy	RBC transfusions on or after Week 5 (occurrence)	From date of randomization until end of Week 5
Secondary	RBC related myeloprotection efficacy	RBC transfusions on or after Week 5 (number of transfusions)	From date of randomization until end of Week 5
Secondary	Platelet related myeloprotection efficacy	Occurrence of CTCAE Grade 3 or 4 decreased platelet count laboratory values and Platelet transfusions (occurrence)	From date of randomization until end of treatment, assessed up to 52 months
Secondary	Platelet related myeloprotection efficacy	Occurrence of CTCAE Grade 3 or 4 decreased platelet count laboratory values and Platelet transfusions (number of transfusions)	From date of randomization until end of treatment, assessed up to 52 months
Secondary	Myeloprotection efficacy	Occurrence of hospitalizations due to chemotherapy-induced myelosuppression	From date of randomization until end of treatment, assessed up to 52 months
Secondary	Myeloprotection efficacy	Number of hospitalizations due to chemotherapy-induced myelosuppression	From date of randomization until end of treatment, assessed up to 52 months
Secondary	Chemotherapy dosing	To assess the effects of trilaciclib on chemotherapy dosing (delays) compared with placebo when administered prior to topotecan.	From the date of randomization until end of treatment, assessed up to 52 months
Secondary	Chemotherapy dosing	To assess the effects of trilaciclib on chemotherapy dosing (reductions) compared with placebo when administered prior to topotecan.	From the date of randomization until end of treatment, assessed up to 52 months
Secondary	Incidence of Treatment-Emergent Adverse Events as Assessed by CTCAE	To assess the effects of trilaciclib administered prior to topotecan compared with placebo administered prior to topotecan on occurrence and severity of adverse events by CTCAE, study treatment discontinuation due to adverse events, and trilaciclib adverse events of special interest	From the date of randomization until end of treatment, assessed up to 52 months