Study of Trilaciclib and Lurbinectedin in Small Cell Lung Cancer

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
North Carolina
Lineberger Comprehensive Cancer Center at University of North Carolina Chapel Hill
RECRUITING
Chapel Hill
New Hampshire
Dartmouth Hitchcock Medical Center
WITHDRAWN
Lebanon
Contact Information
Primary
Shamina Williams
shamina_williams@med.unc.edu
919-966-4432
Backup
Lauren Higgins
Lauren_Higgins@med.unc.edu
919-966-4432
Time Frame
Start Date: 2022-10-12
Estimated Completion Date: 2027-12-25
Participants
Target number of participants: 30
Treatments
Experimental: Trilaciclib and Lurbinectedin
Subjects with platinum refractory extensive stage small cell lung cancer receiving laciclib and Lurbinectedin
Sponsors
Leads: UNC Lineberger Comprehensive Cancer Center
Collaborators: G1 Therapeutics, Inc.

This content was sourced from clinicaltrials.gov

Similar Clinical Trials