Trilaciclib vs Placebo in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) Receiving Topotecan

StatusActive, Not Recruiting
PhasePhase 4
Started

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Trial flagged as At Risk
Primary completion moved at least 3 months later Oct 30, 2027 → Feb 5, 2028
See other at-risk trials from Pharmacosmos A/S

Record History

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  1. Lead sponsor: Pharmacosmos A/S to Pharmacosmos A/S Show 5 more changesShow less
    • Enrollment closed, study ongoing
    • Primary and study completion pushed from Oct 30, 2027 to Feb 5, 2028
    • Start date: Oct 18, 2023 to Oct 13, 2023
    • Eligibility criteria expanded, about 9 words
    • Site details revised
  2. Lead sponsor: G1 Therapeutics, Inc. to Pharmacosmos A/S
    • Study sites: 57 to 1
    • Primary and study completion dates: Jul 30, 2027 to Oct 30, 2027
    v6
  3. Site details revised at 8 of 57 sitesv5
  4. Start date changed from estimate of Nov 30, 2023 to Oct 18, 2023
    • Site details revised at 2 of 57 sites
    v4
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 57
    v3
  6. Start date: Jun 30, 2023 to Nov 30, 2023v2
  7. Study First Submitted
  • 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.
This is a multicenter, randomized, double-blind, placebo-controlled study to assess whether trilaciclib administered prior to topotecan is non-inferior to placebo administered prior to topotecan with regard to overall survival.
Trial Details
NCT Number NCT05874401
Lead Sponsor Pharmacosmos A/S
Conditions
(from sponsor)		 Extensive-stage Small-cell Lung Cancer
Related terms Small Cell Lung Carcinoma
Enrollment 302 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov