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    Association details:
    Biomarker:ALK positive
    Cancer:Non Small Cell Lung Cancer
    Drug:Anluoqing (envonalkib) (ALK inhibitor, ROS1 inhibitor, c-MET inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    Signal Transduct Target Ther
    Title:

    Envonalkib versus crizotinib for treatment-naive ALK-positive non-small cell lung cancer: a randomized, multicenter, open-label, phase III trial

    Published date:
    08/14/2023
    Excerpt:
    ...duration of response was longer (median, 25.79 [95% CI, 16.53-29.47] vs. 11.14 [95% CI, 9.23-16.59] months, p = 0.0003) in the envonalkib group compared with the crizotinib group….Envonalkib significantly improved PFS and delayed brain metastasis progression in advanced ALK-positive NSCLC.
    DOI:
    https://doi.org/10.1038/s41392-023-01538-w
    Trial ID:
    NCT04009317
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    ESMO Asia 2022
    Title:

    320MO - Envonalkib vs crizotinib in treatment-naïve advanced ALK-positive NSCLC: A randomized, multicenter, phase III trial

    Published date:
    11/28/2022
    Excerpt:
    Confirmed ORR was 81.68% in Env and 69.92% in Cri. Treatment with Env was associated with more durable response (mDoR: NE vs 12.68 m, p=0.0014) than Cri….Compared with Cri, Env significantly prolonged PFS in advanced ALK-positive NSCLC pts who had not received a prior ALK inhibitor, and showed greater advantages in controlling BMs.
    Trial ID:
    NCT04009317
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Study of TQ-B3139 in Subjects With Anaplastic Lymphoma Kinase (ALK) Positive Non-Small Cell Lung Cancer (NSCLC) Previously Treated With Crizotinib

    Excerpt:
    ...Histologically or cytologically confirmed diagnosis of advanced or metastatic NSCLC that is ALK-positive....
    Trial ID:
    NCT04056572
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Go to data
    Source:
    clinicaltrials.gov
    Title:

    Study of TQ-B3139 Versus Crizotinib in the First Line Treatment of Subjects With Anaplastic Lymphoma Kinase (ALK) Positive Non-Small Cell Lung Cancer (NSCLC)

    Excerpt:
    ...Histologically or cytologically confirmed advanced or metastatic NSCLC with ALK-positive....
    Trial ID:
    NCT04009317
    Less C2 evidence
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    ASCO 2020
    Title:

    A phase I, dose-escalation and expansion study of TQ-B3139, a novel ALK TKI, in Chinese ALK or ROS1 positive advanced non-small cell lung cancer (NSCLC).

    Published date:
    05/13/2020
    Excerpt:
    TQ-B3139 was administered orally from 50mg~100mg qd and 200, 300, 400, 500, 600 and 800mg bid, using a PK-guided modified...totally 63 patients (59 ALK+, 4 ROS1+) were enrolled….Overall ORR was 73.0% (2 CR, 44 PR); DCR was 85.7% (8 SD)….Objective response was observed from dose level 200mg bid cohort, ORR and DCR at ≥200mg bid was 78.0% and 89.8%....TQ-B3139 was well tolerated in Chinese NSCLC patients with high antitumor activity.
    DOI:
    10.1200/JCO.2020.38.15_suppl.9585