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    Association details:
    Biomarker:ALK positive
    Cancer:Lung Cancer
    Drug:Lorbrena (lorlatinib) (ALK inhibitor, ROS1 inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: C1 - Off-label
      (Approved for Non Small Cell Lung Cancer)
    New
    Title:

    European Commission Approves LORVIQUA® (lorlatinib) as a First-Line Treatment for ALK-Positive Advanced Lung Cancer

    Excerpt:
    Pfizer Inc. (NYSE: PFE) announced today that the European Commission (EC) granted marketing authorization for LORVIQUA® (lorlatinib, available in the U.S. under the brand name LORBRENA®) as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)- positive advanced non-small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor.
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Study of Lorlatinib in ALK Inhibitor-Treated ALK-Positive NSCLC in China

    Excerpt:
    ...Evidence of histologically or cytologically confirmed diagnosis of locally advanced or metastatic ALK positive NSCLC where ALK status has been previously established by the Ventana ALK (D5F3) CDx Assay (Roche Diagnostics), the Vysis ALK Break Apart FISH Probe Kit (Abbott Molecular), or the EML4 ALK Fusion Gene Detection Kit (AmoyDx)....
    Trial ID:
    NCT03909971
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Lorlatinib as the First-line Treatment in China Advanced ALK+ NSCLC

    Excerpt:
    ...Diagnosed as ALK-positive NSCLC as in CC cohort, but...
    Trial ID:
    NCT06092086
    More C2 evidence
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Expanded Access For Lorlatinib For Patients With Non Small Cell Lung Cancer ALK Positive or ROS1 Positive

    Excerpt:
    ...For ALK positive patients:...
    Trial ID:
    NCT03178071
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Study Of PF-06463922 An ALK/ROS1 Inhibitor In Patients With Advanced Non Small Cell Lung Cancer With Specific Molecular Alterations

    Excerpt:
    ...All patients (ALK positive and ROS1 positive) must have archival tissue sample available and collected prior to enrollment....
    Trial ID:
    NCT01970865
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Post Marketing Surveillance(PMS) Study of Lorviqua in Korea

    Excerpt:
    ...Use in the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) 2....
    Trial ID:
    NCT05599412
    Less C2 evidence
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    JCO Precis Oncol
    Title:

    Phase II Study of Lorlatinib in Patients With Anaplastic Lymphoma Kinase-Positive Lung Cancer and CNS-Specific Relapse

    Published date:
    05/18/2022
    Excerpt:
    Patients with ALK+ lung cancer who had intracranial progression on ≥ 1 ALK inhibitor without measurable extracranial disease received lorlatinib 100 mg once daily….The intracranial objective response rate was 59% with six complete and seven partial responses. The median intracranial progression-free survival was 24.6 months (95% CI, 20.2 to not reached).
    DOI:
    10.1200/PO.21.00522