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    Home > Active Ingredient News > Antitumor Therapy > J Thorac Oncol: Phase 3 clinical trial results of niraparib as the first-line maintenance treatment for platinum-sensitive patients with extensive-stage small cell lung cancer in China

    J Thorac Oncol: Phase 3 clinical trial results of niraparib as the first-line maintenance treatment for platinum-sensitive patients with extensive-stage small cell lung cancer in China

    • Last Update: 2021-05-20
    • Source: Internet
    • Author: User
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    The latest epidemiological analysis shows that lung cancer is the cancer with the second highest age-standardized incidence rate (35.


    ZL-2306-005 is a randomized, double-blind, multicenter phase 3 study to evaluate the use of the PARP inhibitor niraparib as a platinum-sensitive extensive-stage small cell lung cancer (ES-SCLC) patient in China The effectiveness and safety of the first-line maintenance treatment.


    The study randomly divided patients with standardized, platinum-based, complete/partial remission (CR/PR) after first-line chemotherapy into two groups (2:1) and received niraparib or placebo (300 mg [baseline weight ≥77 kg, platelet count ≥150000/μL] or 200 mg), once a day until the disease progresses or unacceptable toxicity occurs.


    Due to changes in the ES-SCLC treatment environment, the ZL-2306-005 trial was terminated early (data cut-off time: March 20, 2020).


    Screening

    Primary endpoint PFS (A) and OS (B)

    Primary endpoint PFS (A) and OS (B)

    The median PFS of the niraparib group and the placebo group were 1.


    Manila Palley group and median PFS in the placebo group was 1.


    Adverse events

    Adverse events

    The incidence of adverse events ≥ grade 3 in the niraparib group and placebo group was 34.


    In summary, ZL-2306-005 did not reach the main end point.


    Nirapari as a maintenance therapy, moderately improved the PFS of platinum-sensitive ES-SCLC patients, and it was well tolerated, and there is no new safety signal.


    Original source:

    Ai Xinghao,Pan Yueyin,Shi Jianhua et al.


    org/10.
    1016/j.
    jtho.
    2021.
    04.
    001" target="_blank" rel="noopener">Efficacy and Safety of Niraparib as Maintenance Treatment in Patients with Extensive-Stage Small Cell Lung Cancer after First-Line Chemotherapy: A Randomized, Double-Blind, Phase 3 Study

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