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Trial Title:
Study of Trilaciclib and Lurbinectidin
NCT ID:
NCT05578326
Condition:
Lung Cancer
Small-cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Conditions: Keywords:
Lurbinectedin
Trilaciclib
myelosuppression
neutropenia
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Trilaciclib
Description:
240 mg/m2 intravenous, over 30 minutes at day 1 of each cycle
Arm group label:
Trilaciclib and Lurbinectedin
Intervention type:
Drug
Intervention name:
Lurbinectedin
Description:
3.2 mg/m2, over 60 minutes at day 1 of each cycle
Arm group label:
Trilaciclib and Lurbinectedin
Summary:
Lung cancer is by far the leading cause of cancer death among both men and women
worldwide and the second most common cancer in terms of new cases. Small cell lung cancer
(SCLC) is the deadliest form of lung cancer. The standard first-line treatment is the
combination of carboplatin, etoposide, and atezolizumab. While response rates for this
regimen are high (roughly 60%), the duration of response is short, typically 4 months.
Following progression after the 1st line treatment of SCLC, there is no consensus
regarding subsequent therapy. Lurbinectedin is FDA approved and is increasingly preferred
in clinical practice. Toxicity was significant, but appeared favorable compared to
historic results with topotecan, leading to the adoption of this therapy for second-line
SCLC. The toxicity profile was dominated by myelosuppression.
This study investigates the effect of Trilaciclib on myelosuppression rate in subjects
with platinum refractory extensive stage (ES)- SCLC receiving Lurbinectedin as well as
the clinical synergy of Trilaciclib and Lurbinectedin combination.
Criteria for eligibility:
Criteria:
In order to participate in this study, a subject must meet all of the eligibility
criteria outlined below.
Inclusion Criteria:
- Written informed consent obtained to participate in the study and HIPAA
authorization for release of personal health information.
- Age ≥ 18 years at the time of consent.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
- Measurable disease according to RECIST v1.1 within 28 days prior to start of
treatment.
- Previous treatment with a platinum agent, PD1 or PDL1 agent.
Exclusion Criteria:
- Active infection requiring systemic therapy.
- Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use
while the mother is being treated on study).
- Treatment with any investigational drug within 4 weeks prior to start of
treatment.
- A known allergy or sensitivity to either study drug or its excipients.
- Subject is receiving prohibited medications or treatments as listed in the
protocol.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Dartmouth Hitchcock Medical Center
Address:
City:
Lebanon
Zip:
03756
Country:
United States
Status:
Withdrawn
Facility:
Name:
Lineberger Comprehensive Cancer Center at University of North Carolina Chapel Hill
Address:
City:
Chapel Hill
Zip:
27599
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jared Weiss, MD
Phone:
919-843-7718
Email:
jared_weiss@med.unc.edu
Contact backup:
Last name:
Lauren Higgins
Email:
lqhiggin@ad.unc.edu
Investigator:
Last name:
Jared Weiss, MD
Email:
Principal Investigator
Start date:
October 12, 2022
Completion date:
December 25, 2027
Lead sponsor:
Agency:
UNC Lineberger Comprehensive Cancer Center
Agency class:
Other
Collaborator:
Agency:
G1 Therapeutics, Inc.
Agency class:
Industry
Source:
UNC Lineberger Comprehensive Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05578326
http://unclineberger.org/patientcare/clinical-trials/clinical-trials
