^
    2ms
    KontRASt-03: Platform Study of JDQ443 in Combinations in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation (clinicaltrials.gov)
    P1/2, N=74, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: Dec 2025 --> May 2026 | Trial primary completion date: Nov 2025 --> Apr 2026
    Trial completion date • Trial primary completion date
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    Erbitux (cetuximab) • Mekinist (trametinib) • Kisqali (ribociclib) • opnurasib (JDQ443)
    4ms
    A Phase 1 Study to Evaluate the Pharmacokinetics of JDQ443 in Participants With Hepatic Impairment Compared to Matched Healthy Control Participants. (clinicaltrials.gov)
    P1, N=33, Completed, Novartis Pharmaceuticals | Terminated --> Completed
    Trial completion
    |
    opnurasib (JDQ443)
    4ms
    Profiling opnurasib (JDQ-443) for the treatment of non-small cell lung cancer (NSCLC). (PubMed, Expert Opin Pharmacother)
    Oral small molecule inhibitors, including sotorasib and adagrasib, have demonstrated moderate efficacy in targeting KRAS G12C in NSCLC. In the face of an expanding market, development of JDQ-443 has been halted despite promising safety and efficacy outcomes and ongoing innovative trials, highlighting critical challenges in the drug development process. The existing body of work characterizing JDQ-443 remains extremely informative.
    Review • Journal
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12C
    |
    Lumakras (sotorasib) • Krazati (adagrasib) • opnurasib (JDQ443)
    7ms
    KontRASt-02: Study of JDQ443 in Comparison With Docetaxel in Participants With Locally Advanced or Metastatic KRAS G12C Mutant Non-small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=96, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: Oct 2025 --> Mar 2026 | Trial primary completion date: Oct 2025 --> Feb 2026
    Trial completion date • Trial primary completion date
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12C • KRAS G12
    |
    docetaxel • opnurasib (JDQ443)
    9ms
    KontRASt-01: Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation (clinicaltrials.gov)
    P1/2, N=344, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: Apr 2026 --> Aug 2026 | Trial primary completion date: Apr 2026 --> Aug 2026
    Trial completion date • Trial primary completion date
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    Tevimbra (tislelizumab-jsgr) • batoprotafib (TNO155) • opnurasib (JDQ443)
    10ms
    KontRASt-02: Study of JDQ443 in Comparison With Docetaxel in Participants With Locally Advanced or Metastatic KRAS G12C Mutant Non-small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=96, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: May 2025 --> Oct 2025 | Trial primary completion date: May 2025 --> Oct 2025
    Trial completion date • Trial primary completion date
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12C • KRAS G12
    |
    docetaxel • opnurasib (JDQ443)
    11ms
    Neoadjuvant Platform Trial in Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=4, Active, not recruiting, Canadian Cancer Trials Group | Recruiting --> Active, not recruiting | N=27 --> 4
    Enrollment closed • Enrollment change
    |
    opnurasib (JDQ443)
    12ms
    KontRASt-01: Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation (clinicaltrials.gov)
    P1/2, N=344, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: Aug 2025 --> Apr 2026 | Trial primary completion date: Aug 2025 --> Apr 2026
    Trial completion date • Trial primary completion date • Metastases
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    Tevimbra (tislelizumab-jsgr) • batoprotafib (TNO155) • opnurasib (JDQ443)
    12ms
    KontRASt-01: Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation (clinicaltrials.gov)
    P1/2, N=344, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: Mar 2026 --> Aug 2025 | Trial primary completion date: Mar 2026 --> Aug 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    Tevimbra (tislelizumab-jsgr) • batoprotafib (TNO155) • opnurasib (JDQ443)
    1year
    Study of Efficacy and Safety of JDQ443 Single-agent as First-line Treatment for Patients With Locally Advanced or Metastatic KRAS G12C- Mutated Non-small Cell Lung Cancer With a PD-L1 Expression < 1% or a PD-L1 Expression ≥ 1% and an STK11 Co-mutation. (clinicaltrials.gov)
    P2, N=96, Active, not recruiting, Novartis Pharmaceuticals | Trial primary completion date: Nov 2026 --> Nov 2024
    Trial primary completion date • IO biomarker • Metastases
    |
    PD-L1 (Programmed death ligand 1) • KRAS (KRAS proto-oncogene GTPase) • STK11 (Serine/threonine kinase 11)
    |
    PD-L1 expression • KRAS mutation • KRAS G12C • STK11 mutation • KRAS G12 • KRAS G12C + PD-L1 expression
    |
    opnurasib (JDQ443)
    1year
    KontRASt-03: Platform Study of JDQ443 in Combinations in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation (clinicaltrials.gov)
    P1/2, N=74, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: Jun 2025 --> Dec 2025 | Trial primary completion date: Apr 2025 --> Nov 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    Erbitux (cetuximab) • Mekinist (trametinib) • Kisqali (ribociclib) • opnurasib (JDQ443)
    1year
    KontRASt-02: Study of JDQ443 in Comparison With Docetaxel in Participants With Locally Advanced or Metastatic KRAS G12C Mutant Non-small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=95, Active, not recruiting, Novartis Pharmaceuticals | Trial primary completion date: Sep 2024 --> May 2025
    Trial primary completion date • Metastases
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12C • KRAS G12
    |
    docetaxel • opnurasib (JDQ443)