^
    5d
    FALCO: Neoadjuvant Treatment of Fulzerasib Plus Cetuximab N01 in KRAS G12C Mutated Locally Advanced Colorectal Cancer With or Without Resectable Metastases (clinicaltrials.gov)
    P2, N=40, Recruiting, Zhejiang University
    New P2 trial
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    KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog)
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    KRAS mutation • KRAS G12C • BRAF mutation • NRAS mutation • BRAF wild-type • KRAS G12 • NRAS wild-type • NRAS G12
    |
    Erbitux (cetuximab) • Dupert (fulzerasib) • Datalai (cetuximab biosimilar)
    5d
    The Efficacy and Safety of IBI351, Cetuximab β Combined With FOLFIRI as First-line /IBI351, Cetuximab β as Second-line in the Treatment of KRAS G12C-mutated Metastatic Colorectal Cancer (clinicaltrials.gov)
    P2, N=50, Enrolling by invitation, Second Affiliated Hospital, School of Medicine, Zhejiang University | Not yet recruiting --> Enrolling by invitation | Trial completion date: Nov 2027 --> Dec 2028 | Trial primary completion date: Nov 2027 --> May 2027
    Enrollment open • Trial completion date • Trial primary completion date
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12C • KRAS G12
    |
    Erbitux (cetuximab) • 5-fluorouracil • irinotecan • leucovorin calcium • Dupert (fulzerasib)
    1m
    Fulzerasib plus cetuximab in first-line KRASG12C-mutated non-small-cell lung cancer (KROCUS): a single-arm, multicentre, phase 1b/2 trial. (PubMed, Lancet Oncol)
    In treatment-naive KRASG12C-mutated NSCLC, fulzerasib plus cetuximab showed encouraging activity with a favourable safety profile. The combination is currently being planned for investigation in a phase 3 study.
    P1/2 data • Journal
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12C • KRAS G12
    |
    Erbitux (cetuximab) • Dupert (fulzerasib)
    2ms
    K-NADIR: Fulzerasib Sequential Sintilimab Plus Platinum-Doublet Neoadjuvant Therapy for Resectable KRAS G12C-Mutant NSCLC (clinicaltrials.gov)
    P2, N=30, Recruiting, Jianxing He
    New P2 trial
    |
    KRAS (KRAS proto-oncogene GTPase) • ALK (Anaplastic lymphoma kinase)
    |
    KRAS mutation • KRAS G12C • KRAS G12
    |
    carboplatin • Tyvyt (sintilimab) • albumin-bound paclitaxel • Dupert (fulzerasib)
    2ms
    Tunlametinib Combination Therapy in KRAS-Mutated Unresectable Locally Advanced or Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=55, Not yet recruiting, Sun Yat-sen University
    New P2 trial
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12C • KRAS G12
    |
    Erbitux (cetuximab) • Kolupin (tunlametinib) • Dupert (fulzerasib)
    2ms
    IBI351 Plus Cetuximab β in Untreated Advanced Non-small Cell Lung Cancer With KRAS G12C Mutation (clinicaltrials.gov)
    P2, N=48, Recruiting, Guangdong Association of Clinical Trials | Not yet recruiting --> Recruiting
    Enrollment open
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12C • KRAS G12
    |
    Erbitux (cetuximab) • Dupert (fulzerasib)
    2ms
    Cetuximab co-treatment with KRAS G12C inhibitors fulzerasib and sotorasib in human KRAS G12C non-small cell lung cancer cells. (PubMed, Cell Death Discov)
    Notably, the cotreatment response of H358 cells mirrors clinical trials with KRAS G12C colorectal cancer and NSCLC patients, where the combination of cetuximab with KRAS G12C inhibitors resulted in increased response and progression-free survival. Our findings provide insight into further tailoring EGFR inhibitor cotreatment in KRAS G12C NSCLC patients.
    Journal
    |
    KRAS (KRAS proto-oncogene GTPase) • AKT1 (V-akt murine thymoma viral oncogene homolog 1) • YAP1 (Yes associated protein 1) • ASS1 (Argininosuccinate synthase 1) • ERRFI1 (ERBB Receptor Feedback Inhibitor 1)
    |
    Erbitux (cetuximab) • Lumakras (sotorasib) • Dupert (fulzerasib)
    6ms
    GFH925X1101: A Study of GFH925 in Patients With Advanced Solid Tumors With KRAS G12C Mutations (clinicaltrials.gov)
    P1/2, N=334, Completed, Innovent Biologics (Suzhou) Co. Ltd. | Recruiting --> Completed | Trial completion date: Apr 2024 --> Dec 2024
    Trial completion • Trial completion date
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    Dupert (fulzerasib)
    7ms
    Efficacy and Safety Evaluation of Fulzerasib in the Treatment of Advanced NSCLC with KRAS G12C Mutation: A Multicenter, Non-Interventional, Observational Study (IBI351-RWS-001) (ChiCTR2500110467)
    P=N/A, N=200, Not yet recruiting, Cancer Hospital Chinese Academy of Medical Sciences; Cancer Hospital Chinese Academy of Medical Sciences
    New trial
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12C • KRAS G12
    |
    Dupert (fulzerasib)
    7ms
    Advances in Diagnosis and Targeted Therapy of KRASG12C Mutant Non-small Cell Lung Cancer (PubMed, Zhongguo Fei Ai Za Zhi)
    In targeted therapies, KRASG12C targeted drugs, including Sotorasib, Adagrasib, Fulzerasib, Garsorasib, and Glecirasib, have demonstrated certain therapeutic efficacies in clinical trials and have obtained marketing approval. To tackle drug resistance and enhance patient's prognoses, combination therapeutic strategies that integrate targeted agents with chemotherapy, immune checkpoint inhibitors, Src homology region 2 domain-containing phosphatase 2 (SHP2) inhibitors, and epidermal growth factor receptor (EGFR) monoclonal antibodies have emerged. This paper systematically reviews the advancements in the diagnosis and targeted therapy of NSCLC with KRASG12C mutation, aiming to offer a reference for the selection of clinical treatment regimens and subsequent research..
    Review • Journal • IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12C • KRAS G12
    |
    Lumakras (sotorasib) • Krazati (adagrasib) • Anfangning (garsorasib) • Airuikai (glecirasib) • Dupert (fulzerasib)
    8ms
    A Real-World Study of IBI351 for KRAS G12C+ NSCLC in China (clinicaltrials.gov)
    P=N/A, N=600, Not yet recruiting, Guangdong Association of Clinical Trials
    New trial • Real-world evidence
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    Dupert (fulzerasib)
    8ms
    IBI351 Plus Cetuximab β in Untreated Advanced Non-small Cell Lung Cancer With KRAS G12C Mutation (clinicaltrials.gov)
    P2, N=48, Not yet recruiting, Guangdong Association of Clinical Trials
    New P2 trial
    |
    Erbitux (cetuximab) • Dupert (fulzerasib)