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    Association details:
    Biomarker:ALK rearrangement
    Cancer:Solid Tumor
    Drug:Alecensa (alectinib) (ALK inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrialsregister.eu
    Title:

    Standard dose alectinib versus Therapeutic Drug Monitoring guided alectinib dosing

    Excerpt:
    ...Documented ALK rearrangement based on an EMA approved test6. ...
    Trial ID:
    2020-001737-13
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Delayed or Upfront Brain RAdiotherapy in Treatment naïve Lung Cancer Patients With Asymptomatic or Minimally Symptomatic Brain Metastases and ALK rEarrangements

    Excerpt:
    ...Confirmation of positive ALK rearrangement per local standard of care testing....
    Trial ID:
    DURABLE
    More C2 evidence
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Alectinib Followed by Concomitant Consolidation Radiation Therapy in Advanced NSCLC With ALK-rearrangement (A-SAB)

    Excerpt:
    ...ALK-rearrangement 3....
    Trial ID:
    A-SAB
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Comparison of Standard Dose Alectinib to Alectinib in Adjusted Dose Based on Alectinib Bloodlevels

    Excerpt:
    ...- Documented ALK rearrangement based on an EMA approved test...
    Trial ID:
    ADAPT ALEC
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    A Study of Alectinib in RET-rearranged Non-small Cell Lung Cancer or RET-mutated Thyroid Cancer

    Excerpt:
    ...- Phase 1: Subjects must have a histologically or cytologically confirmed diagnosis of metastatic (AJCC Stage IV) NSCLC that carries an ALK rearrangement with CNS metastases, as determined by FISH, RT-PCR, immunohistochemistry (IHC), or NGS via a CLIA-certified LDT....
    Trial ID:
    NCT03131206
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    A Study of the Efficacy and Safety of Alectinib in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer

    Excerpt:
    ...- Having contributive biopsy performed on fresh tissue (FFPE blocks required) taken after progression on previous therapy showing presence of anaplastic lymphoma kinase (ALK) rearrangement, assessed by immunohistochemistry (IHC) and confirmed by fluorescence in situ hybridization (FISH)...
    Trial ID:
    ATALK
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    A Study of Alectinib (RO5424802) in Participants With Non-Small Cell Lung Cancer Who Have Anaplastic Lymphoma Kinase (ALK) Mutation and Failed Crizotinib Treatment

    Excerpt:
    ...- Documented ALK rearrangement based on Food and Drug Administration (FDA)-approved test...
    Trial ID:
    NCT01801111
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    A Study of Alectinib (CH5424802/RO5424802) in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (NSCLC)

    Excerpt:
    ...- ALK-rearrangement confirmed by the Food and Drug Administration (FDA) approved test...
    Trial ID:
    NCT01871805
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Expanded Access Study of Alectinib for Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (NSCLC) After Disease Progression on or Intolerance to Prior ALK Tyrosine Kinase Inhibitor Therapy

    Excerpt:
    ...- Documented ALK rearrangement as assessed by approved fluorescence in situ hybridization (FISH) test, using the Vysis ALK Break Apart FISH Probe Kit or the Ventana immunohistochemistry (IHC) test...
    Trial ID:
    NCT02271139
    Less C2 evidence
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    JCO Precis Oncol
    Title:

    Impact of ALK Inhibitors in Patients With ALK-Rearranged Nonlung Solid Tumors

    Published date:
    05/03/2021
    Excerpt:
    ...the potential benefit of ALK-TKIs, especially alectinib, in patients with ALK-rearranged nonlung solid tumors.
    DOI:
    10.1200/PO.20.00383