Study of Trilaciclib and Lurbinectidin

Study of Trilaciclib and Lurbinectedin in Small Cell Lung Cancer

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer; Small-cell Lung Cancer
• Intervention / Treatment: Drug: Trilaciclib; Drug: Lurbinectedin

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Shamina Williams; Phone Number: 919-966-4432; Email: Shamina_Williams@med.unc.edu
• Study Contact Backup: Name: Lauren Higgins; Phone Number: 919-966-4432; Email: Lauren_Higgins@med.unc.edu

Study Locations

• United States
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Withdrawn
      • Dartmouth Hitchcock Medical Center
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Recruiting
      • Lineberger Comprehensive Cancer Center at University of North Carolina Chapel Hill
      • Principal Investigator: Jared Weiss, MD
      • Contact: Lauren Higgins; Email: lqhiggin@ad.unc.edu
      • Contact: Jared Weiss, MD; Phone Number: 919-843-7718; Email: jared_weiss@med.unc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Trilaciclib and Lurbinectedin; Subjects with platinum refractory extensive stage small cell lung cancer receiving laciclib and Lurbinectedin	Drug: Trilaciclib; 240 mg/m2 intravenous, over 30 minutes at day 1 of each cycle; Drug: Lurbinectedin; 3.2 mg/m2, over 60 minutes at day 1 of each cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 21 days
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.	Up to 21 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 21 days
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).	Up to 8 months
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.	Up to 8 months
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.	Up to 8 months
Dose Intensity of Chemotherapy/ Number of chemotherapy cycles	The dose Intensity of Chemotherapy/ Number of chemotherapy cycles will be defined as the median number of chemotherapy cycles among the subject who received study treatment.	Up to 8 months
Dose Intensity of Chemotherapy/ Number of chemotherapy delays	The dose Intensity of Chemotherapy/ Number of chemotherapy delays will be defined as the median number of chemotherapy cycle delays dates among the subject who received study treatment.	Up to 8 months
Dose Intensity of Chemotherapy/ the total chemotherapy dose	The dose Intensity of Chemotherapy/ the total chemotherapy dose will be defined as the median chemotherapy dose among the subject who received study treatment.	Up to 8 months
Overall Response Rate (ORR)	To estimate the ORR, the proportion of subjects that respond (CR + PR) will be measured according to RESIST 1.1 will be calculated. RECIST: Radiographic response will be measured by RECIST, Response Evaluation Criteria In Solid Tumors Criteria, indicating if the subject experienced a Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), no response or less response than Partial or Progressive; or Progressive Disease (PD), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.	Up to 5 years
Progression-free survival (PFS)	PFS will be measured from the initiation of study therapy until progression per RECIST 1.1 or death of any cause or at last date of disease assessment if no progression is observed during the study period.	Up to 5 years
Overall survival (OS)	OS will be measured from the initiation of therapy until death of any cause or censored at the last time known to be alive.	Up to 5 years
The kinetics of response	The kinetics of response will be reported as tumor size over time for all patients, including the pace of progression from prior therapy.	Up to 5 years
QOL assessments FACT-L	Scores from QOL assessments FACT-L version 4, from prior to study therapy through cycle 12 will be obtained, as described in the protocol. The FACT-L is a lung cancer specific subscale given at baseline, after each cycle and at end of treatment. Items are rated by patients on a Likert scale from 0 to 4. Higher scores represent better QOL.	Up to 5 years
QOL assessments FACT-An	Scores from QOL assessments FACT-An version 4, from prior to study therapy through cycle 12 will be obtained, as described in the protocol. The FACT-An is an anemia specific subscale given at baseline, after each cycle and at end of treatment. Items are rated by patients on a Likert scale from 0 to 4. Higher scores represent better QOL.	Up to 5 years

Collaborators and Investigators

• Sponsor: UNC Lineberger Comprehensive Cancer Center
• Collaborators: G1 Therapeutics, Inc.
• Investigators: Principal Investigator: Jared Weiss, MD, UNC Lineberger Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2022
• Primary Completion (Estimated): December 25, 2026
• Study Completion (Estimated): December 25, 2028

Study Registration Dates

• First Submitted: September 23, 2022
• First Submitted That Met QC Criteria: October 12, 2022
• First Posted (Actual): October 13, 2022

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: neutropenia; Lurbinectedin; Trilaciclib; myelosuppression
• Additional Relevant MeSH Terms: Cytopenia; Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Leukocyte Disorders; Hematologic Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Leukopenia; Agranulocytosis; Hemic and Lymphatic Diseases; Lung Neoplasms; Small Cell Lung Carcinoma; Neutropenia; PM 01183; trilaciclib
• Other Study ID Numbers: LCCC2117

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes