Study of Trilaciclib and Lurbinectidin

NCT05578326 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: LCCC2117
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Lung Cancer; Small-cell Lung Cancer

Keywords

Lurbinectedin; Trilaciclib; myelosuppression; neutropenia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (13)

• The mean duration of grade 4 neutropenia

  Up to 21 days

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

  Up to 8 months

• Use of secondary/reactive supportive measures

  Up to 8 months

• Dose Intensity of Chemotherapy/ Number of chemotherapy dose reductions

  Up to 8 months

• Dose Intensity of Chemotherapy/ Number of chemotherapy cycles

  Up to 8 months

Study Arms (1)

Trilaciclib and Lurbinectedin

EXPERIMENTAL

Subjects with platinum refractory extensive stage small cell lung cancer receiving laciclib and Lurbinectedin

Drug: Trilaciclib; Drug: Lurbinectedin

Interventions

Trilaciclib DRUG

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

Trilaciclib and Lurbinectedin

Lurbinectedin DRUG

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

Trilaciclib and Lurbinectedin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• G1 Therapeutics, Inc.: collaborator

Study Sites (2)

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

WITHDRAWN

Lineberger Comprehensive Cancer Center at University of North Carolina Chapel Hill

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Related Links

• University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

MeSH Terms

Conditions

Lung Neoplasms; Small Cell Lung Carcinoma; Neutropenia

Interventions

trilaciclib; PM 01183

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Study Officials

• Jared Weiss, MD

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shamina Williams

CONTACT

919-966-4432; shamina_williams@med.unc.edu

Lauren Higgins

CONTACT

919-966-4432; Lauren_Higgins@med.unc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2022
• First Posted: October 13, 2022
• Study Start: October 12, 2022
• Primary Completion (Estimated): December 25, 2026
• Study Completion (Estimated): December 25, 2028
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

US (2)