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.
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).
Checked against the public recordLast updated Jul 2, 2026 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Novartis Pharmaceuticals
- Interventions being studied
- Drug: JDQ443
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- The Brown University Oncology GroupProvidence, Rhode Island
- Novartis Investigative SitePilar, Buenos Aires
- Novartis Investigative SiteCórdoba, Córdoba Province
- Novartis Investigative SiteBuenos Aires
- Novartis Investigative SiteCórdoba
- Novartis Investigative SiteFeldkirch
- Novartis Investigative SiteWels
- Novartis Investigative SiteSint-Niklaas, Oost Vlaanderen
- Novartis Investigative SiteRoeselare, West-Vlaanderen
- Novartis Investigative SiteSalvador, Estado de Bahia
- Novartis Investigative SiteBelo Horizonte
- Novartis Investigative SiteRio de Janeiro
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 2, 2026. Always confirm current availability with the study team.