Study of Trilaciclib and Lurbinectidin
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUNC Lineberger Comprehensive Cancer Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Trilaciclib
Drug240 mg/m2 intravenous, over 30 minutes at day 1 of each cycle
Lurbinectedin
Drug3.2 mg/m2, over 60 minutes at day 1 of each cycle
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Trilaciclib and LurbinectedinExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
The proportion of grade 4 neutropenia
The proportion of subjects that experience grade 4 neutropenia as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0 will be determined. CTCAE is descriptive terminology that can be used for Adverse Event (AE) grading and reporting. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.
Time frame
Up to 21 days2
The duration of grade 4 neutropenia
The median duration of subjects that experience grade 4 neutropenia as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0 will be reported.
Time frame
Up to 21 daysSecondary outcomes
1
The mean duration of grade 4 neutropenia
The mean duration of grade 4 neutropenia in cycle 1 will be defined as the start of grade 4 neutropenia to the time of decreased grade as measured in days or censored at the time of death if a subject dies with Grade 4 neutropenia in Cycle 1.
Time frame
Up to 21 days2
The number of grade 3/4 anemia, grade 3/4 thrombocytopenia, and febrile neutropenia
Toxicity will be evaluated, as the number of grade 3/4 anemia, grade 3/4 thrombocytopenia, and febrile neutropenia based on the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0 criteria, in any cycle (including cycle 1).
Time frame
Up to 8 months3
Use of secondary/reactive supportive measures
To characterize use of secondary/reactive supportive measures any supportive measures such as Granulocyte colony-stimulating factor ( G-CSF) and erythropoietin stimulating agents (ESA) administration, red blood cell and platelet transfusion will be recorded.
Time frame
Up to 8 months4
Dose Intensity of Chemotherapy/ Number of chemotherapy dose reductions
The dose Intensity of Chemotherapy/ Number of chemotherapy dose reductions will be defined as the ratio of the subjects who required chemotherapy dose reductions to all subjects who received study treatment.
Time frame
Up to 8 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
UNC Lineberger Comprehensive Cancer Center
Lead sponsor
G1 Therapeutics, Inc.
Collaborator
Source ClinicalTrials.gov