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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: 19 Jul 2024

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At a glance

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

    • Most Recent Events

    • 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.
    • 27 Dec 2023 According to a Simcere Pharmaceutical Group media release, COSELA has obtained the approval notice of Supplementary Application of Drugs issued by the National Medical Products Administration of China (the NMPA). Pursuant to which, the transfer of COSELAs production technology from G1 Therapeutics Inc. to Hainan Simcere Pharmaceutical Co., Ltd. has been approved in China

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