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Study of Trilaciclib and Lurbinectidin

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 9 of 13 entries
  2. Primary completion date: Dec 25, 2025 to Dec 25, 2026
    • Study completion date: Dec 25, 2027 to Dec 25, 2028
    v7
  3. Re-verified, no change to tracked fieldsv6
  4. Primary completion date: Jul 25, 2024 to Dec 25, 2025
    • Study completion date: Jul 25, 2026 to Dec 25, 2027
    v5
  5. Re-verified, no change to tracked fieldsv4
Show 2 earlier versionsHide 2 earlier versions
  1. Study sites: 1 to 2v3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Oct 25, 2022 to Oct 12, 2022
    • Site details revised
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05578326
Lead Sponsor UNC Lineberger Comprehensive Cancer Center
Collaborators: G1 Therapeutics, Inc.
Conditions
(from sponsor)		 Lung Cancer, Small-cell Lung Cancer
Related terms Lung Neoplasms, Neutropenia, Small Cell Lung Carcinoma
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov