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Active Not Recruiting NCT05445843

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.

Conditions: Locally Advanced or Metastatic KRAS G12C-mutated NSCLC With a PD-L1 Expression <1% or a PD-L1 Expression ≥ 1% and an STK11 Co-mutation

Sex: All
Ages: 18 Years – 100 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 95
Sponsor: Novartis Pharmaceuticals

Location: The Brown University Oncology Group Providence Rhode Island

Summary

This study aims to evaluate 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 have a PD-L1 expression \< 1% (cohort A) or a PD-L1 expression ≥ 1% and an STK11 co-mutation (cohort B).

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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05445843). StuddyBuddy aggregates publicly available trial information.