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A Randomized, Double-blind, Placebo-controlled, Multi-center Phase 3 Study Evaluating Efficacy, Safety and Pharmacokinetics of Trilaciclib In Extensive-Stage Small Cell Lung Cancer Patients Receiving Carboplatin Combined With Etoposide or Topotecan

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Trial Profile

A Randomized, Double-blind, Placebo-controlled, Multi-center Phase 3 Study Evaluating Efficacy, Safety and Pharmacokinetics of Trilaciclib In Extensive-Stage Small Cell Lung Cancer Patients Receiving Carboplatin Combined With Etoposide or Topotecan

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 11 Oct 2024

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At a glance

  • Drugs Trilaciclib (Primary) ; Carboplatin; Etoposide; Topotecan
  • Indications Myelosuppression; Small cell lung cancer
  • Focus Adverse reactions; Pharmacokinetics; Registrational
  • Acronyms TRACE; TRACES
  • Sponsors Jiangsu Simcere Pharmaceutical

    • Most Recent Events

    • 01 Oct 2024 Results of pooled analysis analyzing potential ethnic disparities in the dose exposure response relationships of trilaciclib ((studies G1T2802 (NCT02499770), G1T2803 (NCT02514447), and G1T2805 (NCT03041311) and B02B00801 TRILA301 (NCT04902885)) , published in the Acta Pharmacologica Sinica
    • 28 Apr 2024 According to a Simcere Pharmaceutical Group media release, the Chinese Society of Clinical Oncology (CSCO) has included COSELA (Trilaciclib hydrochloride for injection) in the 2024 CSCO guidelines for the diagnosis and treatment of Small Cell Lung Cancer (SCLC) with an enhanced recommendation.
    • 01 Feb 2024 Results assessing the safety, efficacy and pharmacokinetics (PK) of trilaciclib before chemotherapy in Chinese patients with ES-SCLC, published in the Lung Cancer.

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