Combining Trilaciclib with Lurbinectedin for Small-cell Lung Cancer
Study of Trilaciclib and Lurbinectedin in Small Cell Lung Cancer
This study is testing if adding Trilaciclib can help reduce side effects from Lurbinectedin in patients with advanced small-cell lung cancer who have already tried other treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | UNC Lineberger Comprehensive Cancer Center Academic / other |
| Drugs / interventions | atezolizumab |
| Locations | 2 sites (Lebanon, New Hampshire and 1 other locations) |
| Trial ID | NCT05578326 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of Trilaciclib on reducing myelosuppression in patients with extensive stage small-cell lung cancer (SCLC) who are receiving Lurbinectedin after failing platinum-based chemotherapy. The trial aims to improve the safety and tolerability of Lurbinectedin by mitigating its side effects, particularly myelosuppression, which is a common and serious complication. Participants will be closely monitored for their response to treatment and any adverse effects. The study is designed for patients who have previously been treated with platinum agents and PD1 or PDL1 inhibitors.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with extensive stage small-cell lung cancer who have previously received platinum-based chemotherapy.
Not a fit: Patients with active infections requiring systemic therapy or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the treatment outcomes for patients with small-cell lung cancer by reducing harmful side effects associated with current therapies.
How similar studies have performed: While the combination of Trilaciclib and Lurbinectedin is a novel approach, previous studies have shown promising results with Lurbinectedin in treating small-cell lung cancer, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Lebanon, New Hampshire and 1 other locations
- Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States (Withdrawn)
- Lineberger Comprehensive Cancer Center at University of North Carolina Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Jared Weiss, MD — UNC Lineberger Comprehensive Cancer Center
- Study coordinator: Shamina Williams
- Email: shamina_williams@med.unc.edu
- Phone: 919-966-4432
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.