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.

Korábbi kezelés

• Previous use of a KRAS G12C inhibitor or previous systemic treatment for metastatic NSCLC.
• 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

Más betegség

• A medical condition that results in increased photosensitivity (i.e., solar urticaria, lupus erythematosus, etc.).

Laborértékek

• 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

Egyéb

• Known active central nervous system (CNS) metastases and/or carcinomatous meningitis

• 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.