Study of Trilaciclib and Lurbinectidin

Part of paid clinical trials in Lebanon, New Hampshire.

Sponsor
UNC Lineberger Comprehensive Cancer Center
Study ID
NCT05578326
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Trilaciclib — DRUG
    240 mg/m2 intravenous, over 30 minutes at day 1 of each cycle
  • Lurbinectedin — DRUG
    3.2 mg/m2, over 60 minutes at day 1 of each cycle

Study Details

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.

Key Dates

Start date
Oct 12, 2022
Status verified
Mar 2026
Primary completion
Dec 25, 2026
Completion
Dec 25, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Trilaciclib and Lurbinectedin
    Subjects with platinum refractory extensive stage small cell lung cancer receiving laciclib and Lurbinectedin

Primary Outcome Measure

The proportion of grade 4 neutropenia [ Time Frame: Up to 21 days ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Dartmouth Hitchcock Medical CenterLebanonNew Hampshire03756-
Lineberger Comprehensive Cancer Center at University of North Carolina Chapel HillChapel HillNorth Carolina27599
Jared Weiss, MD
[email protected]
919-843-7718
Lauren Higgins
[email protected]
Jared Weiss, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Lebanon, NH

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Dartmouth Hitchcock Medical Center· Lebanon, NHLineberger Comprehensive Cancer Center at University of North Carolina Chapel Hill· Chapel Hill, NC

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