Study Details

Open

Phase II Study of Trilaciclib and Lurbinectidin

People with SCLC are usually treated with a combination of drugs that are approved by the Food and Drug Administration (FDA). However, these drugs may no longer be working in controlling your cancer or may not be a good treatment option for you. This study uses an investigational combination of drugs, trilaciclib and lurbinectedin. The purpose of this study is to test whether trilaciclib helps minimize the side effects of lurbinectedin and therefore improve the safety of lurbinectedin for the treatment of small cell lung cancer (SCLC).

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)
Visits can be combined with regular clinical appointments

Location

North Carolina (Statewide)

What will be asked of you

This study aims to treat your cancer and closely resembles routine care that would be received regardless of participating on a research study. To participate on the study, you will frequently meet with a member of the study team in addition to your oncology care team. The study requires you to have 2 fresh tissue biopsies. The study involves blood collection for research purposes in addition to routine blood work, diagnostic imaging scans, and every 3 week intravenous dosing of trilaciclib and lurbinectedin.

Incentives

In-person visits:
12

Phone or online visits:
10

Total length of participation:
Approximately 15 months on treatment and 5 years of follow-up

Looking for Specific Volunteers

Able to participate:

You have been diagnosed with extensive stage small cell lung cancer (ES-SCLC)
You have had previous treatment with a platinum agent, PD1 or PDL1 agent
Your last chemotherapy treatment was less than 90 days ago

Not eligible if:

You are receiving systemic treatment for active infections
You have active central nervous system (CNS) metastases
You have received treatment with any investigational drug within 4 weeks prior to start of treatment
You have a known allergy or sensitivity to either study drug or its excipients
If you are pregnant or breastfeeding

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Lineberger Clinical Trials Office
cancerclinicaltrials@med.unc.edu
(919) 966-4432

Primary Visit Location

Lineberger Comprehensive Cancer Center
NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Jared Weiss
Medicine- Oncology

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Lung)
Lungs and Breathing

IRB Number

22-1098

ClinicalTrials.gov

NCT05578326