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    Association details:
    Biomarker:KRAS G12C
    Cancer:Lung Non-Squamous Non-Small Cell 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:

    A Phase II Study of Neoadjuvant Sotorasib in Combination With Cisplatin or Carboplatin and Pemetrexed for Surgically Resectable Stage IIA-IIIB Non-Squamous Non-Small Cell Lung Cancer With a KRAS p.G12C Mutation

    Excerpt:
    ...Identification of a KRAS p.G12C mutation in tumor tissue or plasma by an approved diagnostic device for detection of KRAS p.G12C in NSCLC or through any nucleic acid-based diagnostic testing method [including droplet-digital PCR, real-time PCR based methods such as the Idylla KRAS Mutation Assay (Biocartis), tissue and circulating tumor DNA -based next generation sequencing, Sanger-sequencing etc] performed in a Clinical Laboratory Improvement Amendments (CLIA)-certified or equivalently accredited laboratory....
    Trial ID:
    NCT05118854
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Sotorasib in KRAS G12C Mutated, Resectable, Stage Ib-IIIA NSCLC

    Excerpt:
    ...Patients must have non-squamous NSCLC with KRAS G12C mutation identified through molecular testing (local assessment), AJCC 8 stages Ib, IIa, IIb, IIIa (single nodal station) and assessment by a thoracic surgeon that the patient is potentially resectable and physiologically operable....
    Trial ID:
    NCT05400577
    More C2 evidence
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Testing the Use of Targeted Treatment (AMG 510) for KRAS G12C Mutated Advanced Non-squamous Non-small Cell Lung Cancer (A Lung-MAP Treatment Trial)

    Excerpt:
    ...Biomarker eligibility for S1900E is based on the identification of a KRAS^G12C mutation...
    Trial ID:
    ECOG-ACRIN LUNG-MAP SUB-STUDY
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    SHERLOCK: Phase 2 trial of sotorasib in combination with carboplatin-pemetrexed and bevacizumab-biosimilar as first line treatment for advanced non-squamous non-small cell lung cancernwith KRAS G12C mutationn

    Excerpt:
    ...Presence of KRAS G12C mutation in tumour tissue ...
    Trial ID:
    ACTRN12622000973718
    Less C2 evidence
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    ASCO 2023
    Title:

    The primary endpoint analysis of SCARLET study: A single-arm, phase II study of sotorasib plus carboplatin-pemetrexed in patients with advanced non-squamous, non-small cell lung cancer with KRAS G12C mutation (WJOG14821L).

    Published date:
    05/25/2023
    Excerpt:
    In this single-arm, phase 2 study, chemotherapy-naïve, advanced non-Sq, NSCLC patients with KRAS G12C mutation were enrolled….The primary endpoint, ORR by independent review was 88.9% (80%CI 78.5-94.8%)....Sotorasib in combination with CBDCA/PEM demonstrated favorable ORR and tolerability in advanced non-Sq, NSCLC patients with KRAS G12C mutation.
    Secondary therapy:
    carboplatin + pemetrexed
    DOI:
    10.1200/JCO.2023.41.16_suppl.9006