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

Primary Purpose

Extensive-stage Small-cell Lung Cancer

Status
Recruiting
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Trilaciclib
Placebo
Topotecan
Sponsored by
G1 Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Placebo Comparator

Arm Label

Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m²

Placebo + Topotecan 1.5 mg/m²

Arm Description

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).

Outcomes

Primary Outcome Measures

Overall survival (OS)
To assess the effect of trilaciclib on OS compared with placebo in patients receiving topotecan

Secondary Outcome Measures

Anti-tumor efficacy
To assess the effect of trilaciclib on Progression Free Survival (PFS) compared with placebo in patients receiving Topotecan
Anti-tumor efficacy
To assess the effect of trilaciclib on objective response rate (ORR) compared with placebo in patients receiving Topotecan
Anti-tumor efficacy
To assess the effect of trilaciclib on duration of response (DOR) compared with placebo in patients receiving Topotecan
Neutrophil-related myeloprotection efficacy
Duration of severe (CTCAE Grade 4) neutropenia in Cycle 1
Neutrophil-related myeloprotection efficacy
Occurrence of severe (CTCAE Grade 4) neutropenia and febrile neutropenia AEs
Neutrophil-related myeloprotection efficacy
Occurrence of G-CSF administration
RBC related myeloprotection efficacy
Occurrence of CTCAE Grade 3 or 4 decreased hemoglobin laboratory values and ESA administration
RBC related myeloprotection efficacy
RBC transfusions on or after Week 5 (occurrence)
RBC related myeloprotection efficacy
RBC transfusions on or after Week 5 (number of transfusions)
Platelet related myeloprotection efficacy
Occurrence of CTCAE Grade 3 or 4 decreased platelet count laboratory values and Platelet transfusions (occurrence)
Platelet related myeloprotection efficacy
Occurrence of CTCAE Grade 3 or 4 decreased platelet count laboratory values and Platelet transfusions (number of transfusions)
Myeloprotection efficacy
Occurrence of hospitalizations due to chemotherapy-induced myelosuppression
Myeloprotection efficacy
Number of hospitalizations due to chemotherapy-induced myelosuppression
Chemotherapy dosing
To assess the effects of trilaciclib on chemotherapy dosing (delays) compared with placebo when administered prior to topotecan.
Chemotherapy dosing
To assess the effects of trilaciclib on chemotherapy dosing (reductions) compared with placebo when administered prior to topotecan.
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

Full Information

First Posted
April 12, 2023
Last Updated
October 19, 2023
Sponsor
G1 Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05874401
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 18, 2023 (Actual)
Primary Completion Date
July 30, 2027 (Anticipated)
Study Completion Date
July 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
G1 Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extensive-stage Small-cell Lung Cancer
Keywords
myelosuppression, ES-SCLC, chemotherapy-induced myelosuppression, chemotherapy-induced neutropenia, chemotherapy-induced anemia, myeloprotection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
302 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m²
Arm Type
Experimental
Arm Description
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)
Arm Title
Placebo + Topotecan 1.5 mg/m²
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Trilaciclib
Other Intervention Name(s)
G1T28, CDK 4/6 inhibitor, cyclin-dependent kinase 4/6 inhibitor
Intervention Description
Participants will receive intravenous trilaciclib infusion
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will receive intravenous placebo infusion
Intervention Type
Drug
Intervention Name(s)
Topotecan
Other Intervention Name(s)
Hycamtin
Intervention Description
Participants will receive intravenous topotecan infusion
Primary Outcome Measure Information:
Title
Overall survival (OS)
Description
To assess the effect of trilaciclib on OS compared with placebo in patients receiving topotecan
Time Frame
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 Outcome Measure Information:
Title
Anti-tumor efficacy
Description
To assess the effect of trilaciclib on Progression Free Survival (PFS) compared with placebo in patients receiving Topotecan
Time Frame
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
Title
Anti-tumor efficacy
Description
To assess the effect of trilaciclib on objective response rate (ORR) compared with placebo in patients receiving Topotecan
Time Frame
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
Title
Anti-tumor efficacy
Description
To assess the effect of trilaciclib on duration of response (DOR) compared with placebo in patients receiving Topotecan
Time Frame
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
Title
Neutrophil-related myeloprotection efficacy
Description
Duration of severe (CTCAE Grade 4) neutropenia in Cycle 1
Time Frame
From date of randomization until end of cycle 1 (each cycle is 21 days)
Title
Neutrophil-related myeloprotection efficacy
Description
Occurrence of severe (CTCAE Grade 4) neutropenia and febrile neutropenia AEs
Time Frame
From date of randomization until end of treatment, assessed up to 52 months
Title
Neutrophil-related myeloprotection efficacy
Description
Occurrence of G-CSF administration
Time Frame
From date of randomization until end of treatment, assessed up to 52 months
Title
RBC related myeloprotection efficacy
Description
Occurrence of CTCAE Grade 3 or 4 decreased hemoglobin laboratory values and ESA administration
Time Frame
From date of randomization until end of treatment, assessed up to 52 months
Title
RBC related myeloprotection efficacy
Description
RBC transfusions on or after Week 5 (occurrence)
Time Frame
From date of randomization until end of Week 5
Title
RBC related myeloprotection efficacy
Description
RBC transfusions on or after Week 5 (number of transfusions)
Time Frame
From date of randomization until end of Week 5
Title
Platelet related myeloprotection efficacy
Description
Occurrence of CTCAE Grade 3 or 4 decreased platelet count laboratory values and Platelet transfusions (occurrence)
Time Frame
From date of randomization until end of treatment, assessed up to 52 months
Title
Platelet related myeloprotection efficacy
Description
Occurrence of CTCAE Grade 3 or 4 decreased platelet count laboratory values and Platelet transfusions (number of transfusions)
Time Frame
From date of randomization until end of treatment, assessed up to 52 months
Title
Myeloprotection efficacy
Description
Occurrence of hospitalizations due to chemotherapy-induced myelosuppression
Time Frame
From date of randomization until end of treatment, assessed up to 52 months
Title
Myeloprotection efficacy
Description
Number of hospitalizations due to chemotherapy-induced myelosuppression
Time Frame
From date of randomization until end of treatment, assessed up to 52 months
Title
Chemotherapy dosing
Description
To assess the effects of trilaciclib on chemotherapy dosing (delays) compared with placebo when administered prior to topotecan.
Time Frame
From the date of randomization until end of treatment, assessed up to 52 months
Title
Chemotherapy dosing
Description
To assess the effects of trilaciclib on chemotherapy dosing (reductions) compared with placebo when administered prior to topotecan.
Time Frame
From the date of randomization until end of treatment, assessed up to 52 months
Title
Incidence of Treatment-Emergent Adverse Events as Assessed by CTCAE
Description
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
Time Frame
From the date of randomization until end of treatment, assessed up to 52 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
G1 Therapeutics
Phone
919-213-9835
Email
clinicalinfo@g1therapeutics.com
Facility Information:
Facility Name
Klinikum Klagenfurt am Wörthersee
City
Klagenfurt am Worthersee
Country
Austria
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Markus Rauter, MD
Facility Name
Klinik Hietzing
City
Vienna
Country
Austria
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robab Breyer Kohansal, MD
Facility Name
Wiener Gesundheitsverband Klinik Penzing
City
Wien
Country
Austria
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie Kathrin Breyer, MD
Facility Name
Centre Hospitalier de l'Ardenne
City
Libramont
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frederic Forget, MD
Facility Name
CHU de Liège
City
Liege
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie Lecocq, MD
Facility Name
C. H. R. de la Citadelle
City
Liège
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frédérique Bustin, MD
Facility Name
Multiprofile Hospital for ActiveTreatment "Heart and Brain"
City
Pleven
Country
Bulgaria
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nataliya Chilingirova, MD
Facility Name
Complex Oncological Center - Plovdiv, EOOD
City
Plovdiv
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ivan Tonev, MD
Facility Name
MHAT Park Hospital EOOD
City
Plovdiv
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vladimir Kanarev, MD
Facility Name
UMHAT "SofiaMed", OOD
City
Sofia
Country
Bulgaria
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Velko Minchev, MD
Facility Name
High Technology Hospital Medcentre LLC
City
Batumi
Country
Georgia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tamta Makharadze, MD
Facility Name
JSC Vian
City
Kutaisi
Country
Georgia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Khatuna Bibichadze, MD
Facility Name
Institute of Clinical Oncology LTD
City
Tbilisi
Country
Georgia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vladimer Kuchava, MD
Facility Name
LLC Todua Clinic
City
Tbilisi
Country
Georgia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tamar Melkadze, MD
Facility Name
Multiprofile Clinic Consilium Medulla LLC
City
Tbilisi
Country
Georgia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tsira Kortua, MD
Facility Name
New Hospitals LLC
City
Tbilisi
Country
Georgia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Giorgadze, MD
Facility Name
Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic, LLC
City
Tbilisi
Country
Georgia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miranda Gogishvili, MD
Facility Name
Hämatologie-Onkologie im Zentrum Augsburg MVZ GmbH
City
Augsburg
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bernhard Heinrich, MD
Facility Name
Universitaetsklinikum Frankfurt Goethe-Universitaet
City
Frankfurt
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wolfgang Gleiber, MD
Facility Name
MVZ Martha-Maria Halle-Doelau
City
Halle
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wolfgang Schuette, MD
Facility Name
Asklepios Klinik Harburg
City
Hamburg
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claas Wesseler, MD
Facility Name
Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
City
Luebeck
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Bohnet, MD
Facility Name
General Hospital of Athens "Alexandra"
City
Athens
Country
Greece
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Flora Zagouri, MD
Facility Name
General Hospital of Athens of Chest Diseases "SOTIRIA"
City
Athens
Country
Greece
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Konstantinos Syrigos, MD
Facility Name
Metropolitan Hospital
City
Neo Faliro
Country
Greece
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eleni Linardou, MD
Facility Name
Metropolitan Hospital
City
Neo Faliro
Country
Greece
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dimitrios Bafaloukos, MD
Facility Name
Bioclinic Thessaloniki
City
Thessaloniki
Country
Greece
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ioannis Boukovinas, MD
Facility Name
St Luke's Hospital
City
Thessaloníki
Country
Greece
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elena Fountzila, MD
Facility Name
Orszagos Koranyi Pulmonologiai Intezet
City
Budapest
Country
Hungary
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Fulop, MD
Facility Name
Bekes Varmegyei Kozponti Korhaz
City
Gyula
Country
Hungary
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ibolya Laczo, MD
Facility Name
Bacs-Kiskun Varmegyei Oktatokorhaz
City
Kecskemet
Country
Hungary
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zsolt Horvath, MD
Facility Name
Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz
City
Székesfehérvár
Country
Hungary
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zsolt Papai-Szekely
Facility Name
Komarom-Esztergom Varmegyei Szent Borbala Korhaz
City
Tatabanya
Country
Hungary
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Renata Bocskei, MD
Facility Name
Torokbalinti Tudogyogyintezet
City
Törökbálint
Country
Hungary
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabriella Galffy, MD
Facility Name
Zala Varmegyei Szent Rafael Korhaz
City
Zalaegerszeg
Country
Hungary
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandor Tehenes, MD
Facility Name
Wojewodzki Szpital Specjalistyczny w Bialej Podlaskiej
City
Biała Podlaska
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Pawlowicz, MD
Facility Name
Krakowskie Centrum Medyczne
City
Kraków
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michal Parkitny, MD
Facility Name
FutureMeds Lodz
City
Lodz
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lukasz Matczak, MD
Facility Name
Warminsko Mazurskie Centrum Chorob Pluc
City
Olsztyn
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaroslaw Kolb-Sielecki, MD
Facility Name
Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy
City
Otwock
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aleksandra Szczesna, MD
Facility Name
Izerskie Centrum Pulmonologii i Chemioterapii "IZER-MED" Spolka z o.o.
City
Szklarska Poręba
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Justyna Kaj, MD
Facility Name
Hospital Universitario Reina Sofia
City
Córdoba
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isidoro Carlos Barneto Aranda, MD
Facility Name
Hospital de Mataro
City
Mataro
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos Rivas Corredor, MD
Facility Name
Hospital Universitario Central de Asturias
City
Oviedo
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emilio Esteban Gonzalez, MD
Facility Name
Hospital Universitario de Canarias
City
San Cristobal de La laguna
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juana Oramas, MD
Facility Name
Hospital Universitario Nuestra Señora de Valme
City
Sevilla
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Fuentes Pradera, MD
Facility Name
Instituto Valenciano de Oncologia IVO
City
Valencia
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ignacio Gil Bazo, MD
Facility Name
Medical Park Seyhan Hospital
City
Adana
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmet Sezer, MD
Facility Name
Ankara City Hospital
City
Ankara
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mehmet Ali Sendur, MD
Facility Name
Ankara Liv Hospital
City
Ankara
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Saadettin Kilickap, MD
Facility Name
Trakya University Medical Faculty
City
Edirne
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Irfan Cicin, MD
Facility Name
Goztepe Prof. Dr. Suleyman Yalcin City Hospital
City
Istanbul
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahmut Gumus, MD
Facility Name
Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty
City
Istanbul
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mustafa Ozguroglu, MD
Facility Name
Marmara University Pendik Research and Training Hospital
City
Istanbul
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Osman Kostek, MD
Facility Name
Medipol University Medical Faculty
City
Istanbul
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmet Bilici, MD
Facility Name
Izmir Medicalpark Hospital
City
İzmir
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cagatay Arslan, MD
Facility Name
Inonu Uni. Med. Fac.
City
Malatya
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hakan Harputluoglu, MD

12. IPD Sharing Statement

Learn more about this trial

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

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