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    Association details:
    Biomarker:KRAS G12C
    Cancer:Gastrointestinal Cancer
    Drug:Lumakras (sotorasib) (KRAS G12C inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: C1 - Off-label
      (Approved for Non Small Cell Lung Cancer)
    New
    Title:

    LUMAKRAS® (SOTORASIB) RECEIVES APPROVAL IN JAPAN FOR PATIENTS WITH KRAS G12C-MUTATED ADVANCED NON-SMALL CELL LUNG CANCER

    Excerpt:
    Amgen...announced that LUMAKRAS® (sotorasib) has been approved in Japan for the treatment of KRAS G12C-mutated positive, unresectable, advanced and/or recurrent non-small cell lung cancer (NSCLC) that has progressed after systemic anticancer therapy.
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)

    Excerpt:
    ...- Pathologically documented, locally-advanced or metastatic malignancy with, KRAS p.G12C mutation identified through molecular testing performed according to in-country requirements....
    Trial ID:
    CodeBreak101
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Study of Sotorasib Combined With Chemotherapy for Second Line Treatment of Pancreas Cancer

    Excerpt:
    ...patients must have KRAS p.G12C molecularly confirmed previously or have archived tissue sent for testing and/or undergo biopsy confirming KRAS p.G12C mutation prior to enrollment....
    Trial ID:
    NCT05251038
    More C2 evidence
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    Clinical study to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of AMG 510

    Excerpt:
    ...For all parts except 2e: Pathologically documented, locally-advanced or metastatic malignancy with, KRAS p.G12C mutation identified through molecular testing. ...
    Trial ID:
    2018-001400-11
    Less C2 evidence
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    ESMO-GI 2020
    Title:

    SO-24 AMG 510, a novel small molecule inhibitor of KRAS G12C, for patients with advanced gastrointestinal cancers: Results from the CodeBreak 100 phase 1 trial

    Published date:
    07/08/2020
    Excerpt:
    In patients with heavily pretreated KRAS p.G12C mutant GI cancers, AMG 510 monotherapy was well tolerated, with the majority of patients achieving disease control.
    DOI:
    https://doi.org/10.1016/j.annonc.2020.04.039
    Trial ID:
    CodeBreak 100