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-muta

• Status: Not yet recruiting
• Trial end date: 2027-11-30
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to assess the antitumor activity and safety of JDQ443 single-agent as first-line treatment for participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors harbor a KRAS G12C mutation and a PD-L1 expression < 1% regardless of STK11 mutation status (cohort A), or a PD-L1 expression ≥ 1% and an STK11 co-mutation (cohort B).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

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