NCT05578326RecruitingPhase 2
Study of Trilaciclib and Lurbinectidin
Study of Trilaciclib and Lurbinectedin in Small Cell Lung Cancer
Source: ClinicalTrials.gov · Last updated 21 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 23 Sept 2022
- Start date
- 12 Oct 2022
- Primary completion date
- 25 Dec 2026
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Diseases
- Lung cancer
- NCT number
- NCT05578326
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 30
- From 12 Oct 2022 to the primary completion date, 25 Dec 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Who the study is looking for
- 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.
Criteria the registry did not label
- In order to participate in this study, a subject must meet all of the eligibility criteria outlined below.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill Coordinator of this site? Confirm its status | Chapel Hill | United States | Recruiting |
| Dartmouth Hitchcock Medical Center Coordinator of this site? Confirm its status | Lebanon | United States | Withdrawn |
This page is information, not medical advice. Discuss any trial with your doctor.