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RecruitingInterventionalPhase 2

Study of Trilaciclib and Lurbinectedin in Small Cell Lung Cancer

NCT ID: NCT05578326Sponsor: UNC Lineberger Comprehensive Cancer CenterLast updated: 2026-03-30

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.

Arms & interventions

  • DrugTrilaciclib

    240 mg/m2 intravenous, over 30 minutes at day 1 of each cycle

  • DrugLurbinectedin

    3.2 mg/m2, over 60 minutes at day 1 of each cycle

Outcome measures

Primary

  • 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 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.

    Time frame: Up to 21 days

Secondary

  • The mean duration of grade 4 neutropenia

    Time frame: Up to 21 days

  • The number of grade 3/4 anemia, grade 3/4 thrombocytopenia, and febrile neutropenia

    Time frame: Up to 8 months

  • Use of secondary/reactive supportive measures

    Time frame: Up to 8 months

  • Dose Intensity of Chemotherapy/ Number of chemotherapy dose reductions

    Time frame: Up to 8 months

  • Dose Intensity of Chemotherapy/ Number of chemotherapy cycles

    Time frame: Up to 8 months

  • Dose Intensity of Chemotherapy/ Number of chemotherapy delays

    Time frame: Up to 8 months

  • Dose Intensity of Chemotherapy/ the total chemotherapy dose

    Time frame: Up to 8 months

  • Overall Response Rate (ORR)

    Time frame: Up to 5 years

  • Progression-free survival (PFS)

    Time frame: Up to 5 years

  • Overall survival (OS)

    Time frame: Up to 5 years

  • The kinetics of response

    Time frame: Up to 5 years

  • QOL assessments FACT-L

    Time frame: Up to 5 years

  • QOL assessments FACT-An

    Time frame: Up to 5 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (2)

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756

Withdrawn

Lineberger Comprehensive Cancer Center at University of North Carolina Chapel Hill

Chapel Hill, North Carolina, 27599

Recruiting
Jared Weiss, MD · Contact
919-843-7718jared_weiss@med.unc.edu
Lauren Higgins · Contact
lqhiggin@ad.unc.edu
Jared Weiss, MD · Principal Investigator
Study of Trilaciclib and Lurbinectidin | Cancerify