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    Association details:
    Biomarker:ROS1 rearrangement
    Cancer:Non Small Cell Lung Cancer
    Drug:Zykadia (ceritinib) (ALK inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A2 - Guideline
    Source:
    NCCN
    Published date:
    02/16/2021
    Excerpt:
    Non-Small Cell Lung cancer: Targeted therapy or immunotherapy for advanced or metastatic disease...ROS1 rearrangement positive…ceritinib
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Ceritinib and Everolimus in Treating Patients With Locally Advanced or Metastatic Solid Tumors or Stage IIIB-IV Non-small Cell Lung Cancer

    Excerpt:
    ...patients with stage IIIB or IV ALK + NSCLC who have failed at least one line of therapy and are progressing on an ALK inhibitor; for dose expansion, patients who have ROS1 rearrangement testing by either next generation sequencing (NGS) or fluorescence in situ hybridization (FISH) will be eligible...
    Trial ID:
    NCT02321501
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Study of LDK378 in Patients With Non-small Cell Lung Cancer Harboring ROS1 Rearrangement

    Excerpt:
    ...- histologically or cytologically confirmed, stage IV or recurrent NSCLC that carries a ROS1 rearrangement, as per anchored multiplex PCR...
    Trial ID:
    NCT03399487
    More C2 evidence
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    An Open-label, Multicenter, Phase II Study of LDK378 in Patients With Non-small Cell Lung Cancer Harboring ROS1 Rearrangement

    Excerpt:
    ...- Subjects with histologically or cytologically confirmed, unresectable NSCLC that carries a ROS1 rearrangement, as per FISH assay (Abbott Molecular Inc.)...
    Trial ID:
    NCT01964157
    Less C2 evidence
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    Medicine (Baltimore)
    Title:

    Activity of ceritinib in crizotinib-resistant ROS1-rearranged non-small-cell lung cancer patients

    Published date:
    07/21/2023
    Excerpt:
    From December 2015 to October 2021, a total of 246 patients with ROS1-rearranged NSCLC were screened, 12 (4.9%) of whom were treated with ceritinib after the development of crizotinib resistance....The objective response rate, disease control rate and median progression-free survival of all patients were 25% (95% confidence interval [CI]: −3.7% to 53.7%; 3 of 12 patients), 50% (95% CI: 16.8% to 83.2%; 6 of 12 patients), and 10.5 months (95% CI, 5.7 to 15.3 months), respectively.
    DOI:
    10.1097/MD.0000000000033543
    Evidence Level:
    Sensitive: C4 – Case Studies
    New
    Source:
    Proc Natl Acad Sci U S A
    Title:

    Clinical activity of ceritinib in ROS1-rearranged non-small cell lung cancer: Bench to bedside report

    Excerpt:
    The patient was next enrolled on the “Signature Trial,” a modular phase II study to link targeted therapy to patients with pathway activated tumors; in this study patients whose tumors have aberrations in ALK or ROS1 are treated with ceritinib (LDK378) at 750 mg orally daily...Restaging scans after two cycles and confirmed after four cycles showed a partial response (56% decrease) per RECIST1.1 (Fig. 1 A and B). Moreover, MRI showed that his brain metastases decreased as well (Fig. 1 C and D).
    DOI:
    10.1073/pnas.1522052113