Study on JDQ443 as First-line Treatment for Advanced KRAS G12C-Mutated Non-small Cell Lung Cancer

Sponsor: Novartis Pharmaceuticals

Sponsor score: 60

ClinicalTrials ID:NCT05445843

Provider View

This clinical trial is testing the effectiveness and safety of JDQ443 as a first treatment option for patients with advanced non-small cell lung cancer (NSCLC) that has a specific KRAS G12C mutation. The study includes patients with different levels of PD-L1 expression and genetic mutations.

Patient Parameters

Program Overview

The purpose of this study is to evaluate how well JDQ443 works and how safe it is for treating patients with advanced non-small cell lung cancer (NSCLC) that has a KRAS G12C mutation. The study focuses on two groups of patients: those with low PD-L1 expression and those with higher PD-L1 expression and an additional STK11 mutation.

Description

This study is designed to test JDQ443 as a single treatment for patients with advanced non-small cell lung cancer (NSCLC) that has a specific genetic change called KRAS G12C mutation. The study is open-label, meaning both the doctors and participants know what treatment is being given, and it takes place at multiple centers.

There are two groups in the study:

  • Cohort A: Patients whose cancer has a KRAS G12C mutation and low PD-L1 expression (less than 1%), regardless of other mutations.
  • Cohort B: Patients whose cancer has a KRAS G12C mutation, higher PD-L1 expression (1% or more), and an additional STK11 mutation.

Participants will start treatment on the first day of the first cycle, which lasts about 21 days. The study will continue until the last participant completes their final visit, withdraws, or if the study is stopped early. If another study becomes available that offers JDQ443, participants may be transferred to continue their treatment there.

Eligibility Criteria

Key Inclusion criteria

  • Histologically confirmed locally advanced (stage IIIb/IIIc not eligible for definitive chemoradiation or surgical resection with curative intent) or metastatic (stage IV) NSCLC without previous systemic treatment for metastatic disease. Prior (neo)adjuvant treatment with chemotherapy and/or immunotherapy, or prior radiotherapy administered sequentially or concomitantly with chemotherapy and/or immunotherapy for localized or locally advanced disease are accepted if the time between therapy completion and enrollment is > 12 months.

  • Presence of a KRAS G12C mutation (all participants) and:

    • Cohort A: PD-L1 expression < 1%, regardless of STK11 mutation status
    • Cohort B: PD-L1 expression ≥ 1% and an STK11 co-mutation

  • At least one measurable lesion per RECIST 1.1.

  • ECOG performance status ≤ 1.

  • Participants capable of swallowing study medication.

Key Exclusion criteria

  • Participants whose tumors harbor an EGFR-sensitizing mutation and/or ALK rearrangement by local laboratory testing. Participants with other known druggable alterations will be excluded, if required by local guidelines
  • Previous use of a KRAS G12C inhibitor or previous systemic treatment for metastatic NSCLC.
  • A medical condition that results in increased photosensitivity (i.e., solar urticaria, lupus erythematosus, etc.).
  • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Participants who are taking a prohibited medication (strong CYP3A inducers) that cannot be discontinued at least seven days prior to the first dose of study treatment and for the duration of the study.

Other inclusion/exclusion criteria may apply

Locations

FACILITYZIPCITYSTATE
The Brown University Oncology Group02903ProvidenceRhode Island

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