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).
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Oct 8, 2026 · Source: ClinicalTrials.gov
The study is underway but is not accepting new participants.
Interventional
Locations may change over time.
Study sponsor
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
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- Key
- 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
- 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/
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: Oct 8, 2026. Always confirm current availability with the study team.