Study of Trilaciclib and Lurbinectidin

Launched by UNC LINEBERGER COMPREHENSIVE CANCER CENTER · Oct 12, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effects of two medications, Trilaciclib and Lurbinectedin, in patients with small cell lung cancer (SCLC) that has not responded to initial treatment. SCLC is a serious form of lung cancer, and while there are treatments available, they often don’t work for long. The goal of this study is to see if adding Trilaciclib can help reduce side effects related to blood cell production (called myelosuppression) when patients are treated with Lurbinectedin. This combination treatment could potentially improve the overall effectiveness of therapy for those with advanced stages of SCLC.

To participate in the trial, individuals must be at least 18 years old and have measurable disease that has not improved after prior treatments with certain cancer drugs. They should also be in relatively good health, as indicated by specific performance criteria. Participants will be monitored closely throughout the study to assess the effects of the treatment and to ensure their safety. It’s important to note that individuals with active infections, those who are pregnant or breastfeeding, and those taking certain other medications may not be eligible to join. This trial represents an opportunity to explore a new combination therapy that could offer hope for patients facing challenging cancer outcomes.

Gender

ALL

Eligibility criteria

• • 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.