Lung Cancer Clinical Trial

Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Combination With Etoposide and Carboplatin in Extensive Stage Small Cell Lung Cancer (SCLC)

Summary

This is a study to investigate the potential clinical benefit of trilaciclib (G1T28) in preserving the bone marrow and the immune system, and enhancing chemotherapy antitumor efficacy when administered prior to carboplatin and etoposide in first line treatment for patients with newly diagnosed extensive-stage SCLC.

The study consists of 2 parts: a limited open-label, dose-finding portion (Part 1), and a randomized double-blind portion (Part 2). Both parts include 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. The Treatment Phase begins on the day of first dose with study treatment and completes at the Post-Treatment Visit. Approximately, 90 patients will be enrolled in the study; 20 patients in the Part 1 and 70 patients in the Part 2 portion.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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
At least 1 target lesion that is unirradiated and measurable by RECIST, Version 1.1
Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2
Adequate organ function

Exclusion Criteria:

Prior chemotherapy for extensive-stage SCLC
Presence of symptomatic brain metastases requiring immediate treatment with radiation therapy or steroids.
Uncontrolled ischemic heart disease or uncontrolled symptomatic congestive heart failure
Known history of stroke or cerebrovascular accident within 6 months prior to enrollment
Other uncontrolled serious chronic disease or conditions that in the investigator's opinion could affect compliance or follow-up in the protocol
Concurrent radiotherapy to any site or radiotherapy within 2 weeks prior to enrollment or previous radiotherapy to the target lesion sites (the sites that are to be followed for determination of a response)
Receipt of any investigational medication within 4 weeks prior to enrollment

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

122

Study ID:

NCT02499770

Recruitment Status:

Completed

Sponsor:

G1 Therapeutics, Inc.

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There are 40 Locations for this study

See Locations Near You

Genesis Cancer Center
Hot Springs Arkansas, 71913, United States
Highlands Oncology Group
Rogers Arkansas, 72758, United States
The Oncology Institute of Hope and Innovation
Whittier California, 90603, United States
Memorial Hospital - Univ. of Colorado Health
Colorado Springs Colorado, 80909, United States
University of Colorado Health, Oncology Clinical Research Northern Region
Fort Collins Colorado, 80528, United States
Boca Raton Regional Hospital - Lynn Cancer Institute
Boca Raton Florida, 33486, United States
Florida Cancer Specialists - South
Fort Myers Florida, 33916, United States
Florida Cancer Specialists - North
Tavares Florida, 32778, United States
Florida Cancer Specialists - East
West Palm Beach Florida, 33401, United States
University Cancer and Blood Center, LLC
Athens Georgia, 30607, United States
Emory University
Atlanta Georgia, 30322, United States
Norton Cancer Institute
Louisville Kentucky, 40202, United States
Center For Cancer and Blood Disorders
Bethesda Maryland, 20817, United States
Norris Cotton Cancer Center
Lebanon New Hampshire, 03756, United States
University of New Mexico Comprehensive Cancer Center
Albuquerque New Mexico, 87106, United States
Roswell Park
Buffalo New York, 14263, United States
UNC - Lineberger Comprehensive Cancer Center
Chapel Hill North Carolina, 27514, United States
Oklahoma University - Peggy and Charles Stephenson Cancer Center
Oklahoma City Oklahoma, 73117, United States
Thomas Jefferson University
Philadelphia Pennsylvania, 19107, United States
Guthrie Medical Group, PC
Sayre Pennsylvania, 18840, United States
Greenville Health System
Greenville South Carolina, 29605, United States
Gibbs Cancer Center
Spartanburg South Carolina, 29203, United States
Tennessee Cancer Specialists
Knoxville Tennessee, 37909, United States
Hanna Cancer Associates - University of Tennessee
Knoxville Tennessee, 37920, United States
Texas Oncology
Tyler Texas, 75702, United States
Northwest Cancer Specialists, P.C.
Vancouver Washington, 98684, United States
CHU de Rennes Hopital Pontchaillou
Rennes , 35033, France
ARENSIA Exploratory Medicine LLC
Tbilisi , 0112, Georgia
Veszprem Megyei Tudogyogyintezet
Farkasgyepu Veszprem, 8582, Hungary
Orszagos Koranyi Tbc es Pulmonologiai Intezet, XI. Tudobelosztaly
Budapest , 1121, Hungary
Hetenyi Geza Korhaz
Szolnok , 5000, Hungary
ARENSIA Exploratory Medicine Phase I Unit, The Institute of Oncology
Chisinau , 2025, Moldova, Republic of
Samodzielny Publiczny ZespAA GruAicy i ChorAb PA¿uc
Olsztyn , 10-35, Poland
Wojewodzki Szpital Zespolony im. L. Rydygiera
Torun , 87-10, Poland
Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie
Warszawa , 02-78, Poland
Hospital Regional Universitario HRU Carlos Haya Malaga
Malaga Andalucia, 29010, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona , 08041, Spain
Consorcio Hospitalario Provincial
Castillón , 12002, Spain
Hgu Gregorio Maranon
Madrid , 28009, Spain
Fundacion Jimenez Diaz
Madrid , 28040, Spain

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

122

Study ID:

NCT02499770

Recruitment Status:

Completed

Sponsor:


G1 Therapeutics, Inc.

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