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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.
Sponsor: Novartis Pharmaceuticals
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).
Official title: KontRASt-06: An Open-label Phase II Trial Evaluating the Activity 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.
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
95
Start Date
2022-12-06
Completion Date
2026-12-31
Last Updated
2026-02-13
Healthy Volunteers
No
Interventions
JDQ443
JDQ443 per os (PO) 200 mg twice a day continuously
Locations (45)
The Brown University Oncology Group
Providence, Rhode Island, United States
Novartis Investigative Site
Pilar, Buenos Aires, Argentina
Novartis Investigative Site
Buenos Aires, Argentina
Novartis Investigative Site
Córdoba, 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
Novartis Investigative Site
Athens, Greece
Novartis Investigative Site
Mátraháza, Hungary
Novartis Investigative Site
Thellakom Kottayam, Kerala, India
Novartis Investigative Site
Varanasi, Uttar Pradesh, India
Novartis Investigative Site
Bari, BA, Italy
Novartis Investigative Site
Rozzano, MI, Italy
Novartis Investigative Site
Roma, RM, Italy
Novartis Investigative Site
Orbassano, TO, Italy
Novartis Investigative Site
George Town, Pulau Pinang, Malaysia
Novartis Investigative Site
Kuching, Sarawak, Malaysia
Novartis Investigative Site
Breda, North Brabant, Netherlands
Novartis Investigative Site
Leeuwarden, Provincie Friesland, Netherlands
Novartis Investigative Site
Porto, Portugal
Novartis Investigative Site
Barcelona, Spain
Novartis Investigative Site
Madrid, Spain
Novartis Investigative Site
Bangkok, Thailand
Novartis Investigative Site
Istanbul, Bagcilar, Turkey (Türkiye)
Novartis Investigative Site
Diyarbakır, Sur, Turkey (Türkiye)
Novartis Investigative Site
Ankara, Yenimahalle, Turkey (Türkiye)
Novartis Investigative Site
Torquay, United Kingdom