Clinical trial NCT05578326: Study of Trilaciclib and Lurbinectidin
Official title: Study of Trilaciclib and Lurbinectedin in Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Lung Cancer
Small-cell Lung Cancer
Keywords: Lurbinectedin
Trilaciclib
myelosuppression
neutropenia
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: G1 Therapeutics, Inc.
First posted: 2022-10-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


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.

Primary outcomes:
measure: The proportion of grade 4 neutropenia
timeFrame: Up to 21 days
measure: The duration of grade 4 neutropenia
timeFrame: Up to 21 days
Secondary outcomes:
measure: The mean duration of grade 4 neutropenia
timeFrame: Up to 21 days
measure: The number of grade 3/4 anemia, grade 3/4 thrombocytopenia, and febrile neutropenia
timeFrame: Up to 8 months
measure: Use of secondary/reactive supportive measures
timeFrame: Up to 8 months
measure: Dose Intensity of Chemotherapy/ Number of chemotherapy dose reductions
timeFrame: Up to 8 months
measure: Dose Intensity of Chemotherapy/ Number of chemotherapy cycles
timeFrame: Up to 8 months
measure: Dose Intensity of Chemotherapy/ Number of chemotherapy delays
timeFrame: Up to 8 months
measure: Dose Intensity of Chemotherapy/ the total chemotherapy dose
timeFrame: Up to 8 months
measure: Overall Response Rate (ORR)
timeFrame: Up to 5 years
measure: Progression-free survival (PFS)
timeFrame: Up to 5 years
measure: Overall survival (OS)
timeFrame: Up to 5 years
measure: The kinetics of response
timeFrame: Up to 5 years
measure: QOL assessments FACT-L
timeFrame: Up to 5 years
measure: QOL assessments FACT-An
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Chapel Hill
country: United States
facility: Lineberger Comprehensive Cancer Center at University of North Carolina Chapel Hill
state: North Carolina
Study officials:
affiliation: UNC Lineberger Comprehensive Cancer Center
name: Jared Weiss, MD
role: PRINCIPAL_INVESTIGATOR
References: