Phase 2 Study of Carboplatin, Etoposide, and Atezolizumab With or Without Trilaciclib in Patients With Untreated Extensive-Stage Small Cell Lung Cancer (SCLC)

Who is this study for? Patients with Small Cell Lung Carcinoma
What treatments are being studied? Trilaciclib
Status: Terminated
Location: See all (45) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This was a study to investigate the potential clinical benefit of trilaciclib (G1T28) in preserving the bone marrow and the immune system, and enhancing antitumor efficacy when administered with carboplatin, etoposide, and atezolizumab (E/P/A) therapy in first line treatment for patients with newly diagnosed extensive-stage SCLC. The study was a randomized, double-blinded, placebo-controlled design. Approximately, 100 patients were randomized to trilaciclib + E/P/A or placebo + E/P/A in the study.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Male or female subjects aged ≥18 years

• Unequivocally confirmed diagnosis of SCLC by histology or cytology, preferably including the presence of neuroendocrine features by immunohistochemistry

• Extensive-stage SCLC

• At least 1 target lesion that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

• Adequate organ function

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2

• Predicted life expectancy of ≥3 months

• Able to understand and sign an informed consent

Locations
United States
California
Beverly Hills Cancer Center
Beverly Hills
St. Jude Heritage Healthcare
Fullerton
Loma Linda University
Loma Linda
UCLA Medical Center - Santa Monica Hematology And Oncology
Santa Monica
Redwood Regional Medical Group (RRMG) - Fountain Grove
Santa Rosa
Singing River Health System
Whittier
Georgia
Northside Hospital - Georgia Cancer Specialists
Atlanta
Piedmont Cancer Institute
Atlanta
Illinois
Joliet Oncology-Hematology Associates
Joliet
Indiana
Horizon Oncology Center
Lafayette
Louisiana
Ochsner Clinic Foundation
New Orleans
Missouri
St. Louis Cancer Care, LLP, North County
Bridgeton
The Alvin J. Siteman Cancer Center - Center for Advanced Med
Saint Louis
North Dakota
Trinity Health - Trinity CancerCare Center
Minot
New Jersey
Summit Medical Group, P.A.
Morristown
New York
Northern Westchester Hospital
Mount Kisco
Oklahoma
Oklahoma University - Peggy and Charles Stephenson Cancer Center
Oklahoma City
South Carolina
Gibbs Cancer Center
Spartanburg
Texas
Valley Cancer Associates
Harlingen
Millennium Oncology
Houston
Virginia
Virginia Cancer Specialists
Arlington
Blue Ridge Cancer Care
Blacksburg
Fort Belvoir Community Hospital
Fort Belvoir
Other Locations
Bulgaria
Complex Oncology Center - Burgas
Burgas
Multiprofile Hospital for Active Treatment Serdika
Sofia
Multiprofile Hospital for Active Treatment Serdika, Sofia
Sofia
Estonia
East Tallinn Central Hospital Ltd., Clinic of Internal Medicine, Center for Oncology
Tallinn
France
CHU Caen De La Côte De Nacre
Caen
Centre Oscar Lambret
Lille
Latvia
Daugavpils Regional Hospital, Department of Oncology
Daugavpils
Pauls Stradiņš Clinical University Hospital, Oncology Clinic
Riga
Spain
Hospital Teresa Herrera
A Coruña
H.U. Quirón Dexeus, Hospital Universitario
Barcelona
Hospital Clinic de Barcelona- Servicio de Oncología Médica
Barcelona
Hospital 12 de Octubre
Madrid
Hospital Universitario Ramón y Cajal
Madrid
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda
Hospital Universitario Son Espases
Palma
Hospital Clínico
San Carlos
H. Donostia, Hospital Donostia- Servicio de Oncología
San Sebastián
Hospital Universitario Ntra. Sra. de Valme
Sevilla
Hospital Arnau de Vilanova
Valencia
Ukraine
Chernivtsi Regional Clinical Oncology Center
Chernivtsi
Dnipropetrovsk City Multispecialty Clinical Hospital #4
Dnipro
Lviv State Regional Treatment and Diagnostics Oncology Center
Lviv
Time Frame
Start Date: 2017-06-29
Completion Date: 2020-10-29
Participants
Target number of participants: 107
Treatments
Experimental: trilaciclib+etoposide/carboplatin/atezolizumab
Induction: Patients received trilaciclib 240 mg/m² administered intravenously (IV) once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target area under the concentration-time curve (AUC) = 5 milligrams per milliliter per minute (mg/mL/min) to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.~Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity or discontinuation by the patient or investigator.
Experimental: placebo+etoposide/carboplatin/atezolizumab
Induction: Patients received placebo administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was be administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.~Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity or discontinuation by the patient or investigator.
Sponsors
Collaborators: Roche-Genentech
Leads: G1 Therapeutics, Inc.

This content was sourced from clinicaltrials.gov