RECRUITING

Study of Trilaciclib and Lurbinectidin

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Study of Trilaciclib and Lurbinectedin in Small Cell Lung Cancer

Quick Facts

Study Start:2022-10-12
Study Completion:2027-12-25
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05578326

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
  2. * Age ≥ 18 years at the time of consent.
  3. * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
  4. * Measurable disease according to RECIST v1.1 within 28 days prior to start of treatment.
  5. * Previous treatment with a platinum agent, PD1 or PDL1 agent.
  1. * Active infection requiring systemic therapy.
  2. * Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
  3. * Treatment with any investigational drug within 4 weeks prior to start of treatment.
  4. * A known allergy or sensitivity to either study drug or its excipients.
  5. * Subject is receiving prohibited medications or treatments as listed in the protocol.

Contacts and Locations

Study Contact

Shamina Williams
CONTACT
919-966-4432
shamina_williams@med.unc.edu
Lauren Higgins
CONTACT
919-966-4432
Lauren_Higgins@med.unc.edu

Principal Investigator

Jared Weiss, MD
PRINCIPAL_INVESTIGATOR
UNC Lineberger Comprehensive Cancer Center

Study Locations (Sites)

Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
United States
Lineberger Comprehensive Cancer Center at University of North Carolina Chapel Hill
Chapel Hill, North Carolina, 27599
United States

Collaborators and Investigators

Sponsor: UNC Lineberger Comprehensive Cancer Center

  • Jared Weiss, MD, PRINCIPAL_INVESTIGATOR, UNC Lineberger Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-12
Study Completion Date2027-12-25

Study Record Updates

Study Start Date2022-10-12
Study Completion Date2027-12-25

Terms related to this study

Keywords Provided by Researchers

  • Lurbinectedin
  • Trilaciclib
  • myelosuppression
  • neutropenia

Additional Relevant MeSH Terms

  • Lung Cancer
  • Small-cell Lung Cancer