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.

Running, not enrolling · Phase 2

Conditions studied: 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

In brief

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).

Key facts

Study ID

NCT05445843

Run by

Novartis Pharmaceuticals

People needed

95

Starts

2022-12-06

Expected to finish

2026-12-31

Last updated by the study team

2026-07-02

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

Where it is running

• The Brown University Oncology Group — Providence, Rhode Island, United States
• Novartis Investigative Site — Pilar, Buenos Aires, Argentina
• Novartis Investigative Site — Córdoba, Córdoba Province, Argentina
• Novartis Investigative Site — Buenos Aires, Argentina
• Novartis Investigative Site — Córdoba, Argentina
• Novartis Investigative Site — Feldkirch, Austria
• Novartis Investigative Site — Wels, Austria
• Novartis Investigative Site — Sint-Niklaas, Oost Vlaanderen, Belgium
• Novartis Investigative Site — Roeselare, West-Vlaanderen, Belgium
• Novartis Investigative Site — Salvador, Estado de Bahia, Brazil
• Novartis Investigative Site — Belo Horizonte, Brazil
• Novartis Investigative Site — Rio de Janeiro, Brazil
• Novartis Investigative Site — Wuhan, Hubei, China
• Novartis Investigative Site — Changsha, Hunan, China
• Novartis Investigative Site — Beijing, China
• Novartis Investigative Site — Marseille, Bouches Du Rhone, France
• Novartis Investigative Site — Bron, France
• Novartis Investigative Site — Montpellier, France
• Novartis Investigative Site — Saint-Herblain, France
• Novartis Investigative Site — Strasbourg, France
• Novartis Investigative Site — Kempten (Allgäu), Bavaria, Germany
• Novartis Investigative Site — Halle, Saxony-Anhalt, Germany
• Novartis Investigative Site — Hamburg, Germany
• Novartis Investigative Site — Oldenburg, Germany
• Novartis Investigative Site — Tübingen, Germany

Full record on ClinicalTrials.gov

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