Last updated 30 days ago

Study of JDQ443 in Comparison With Docetaxel in Participants With Locally Advanced or Metastatic KRAS G12C Mutant Non-small Cell Lung Cancer

95 patients around the world
Available in Argentina
The study has been designed as a Phase III trial and consists of 2 parts: - Randomized part will evaluate the efficacy and safety of JDQ443 as monotherapy in comparison with docetaxel. Participants randomized to docetaxel arm will have the opportunity to cross-over to JDQ443 at disease progression per RECIST 1.1 confirmed by BIRC. - Extension part will be open after final progression-free survival (PFS) analysis (if the primary endpoint has met statistical significance) to allow participants randomized to docetaxel treatment to crossover to receive JDQ443 treatment regardless of progression on docetaxel. The study population will include adult participants with locally advanced or metastatic (stage IIIB/IIIC or IV) KRAS G12C mutant non-small cell lung cancer (by tissue or plasma as determined by a Novartis-designated central laboratory or accepted local tests) who have received prior platinum-based chemotherapy and prior immune checkpoint inhibitor therapy administered either in sequence or as combination therapy. Approximately 360 participants will be randomized to JDQ443 or docetaxel in a 1:1 ratio stratified by prior line of therapy and ECOG performance status.
Novartis Pharmaceuticals
4Research sites
95Patients around the world
This study is for people with
Lung cancer
Non-small cell lung carcinoma
Requirements for the patient
From 18 Years
All Gender
Medical requirements
Sites
CEMIC - Hospital Universitario Sede Saavedra - CABA, Buenos Aires
CEMIC - Hospital Universitario Sede Saavedra - CABA, Buenos Aires
Recruiting
Av. Galvan 4102, CABA, Buenos Aires
Hospital Universitario Austral - Pilar
Recruiting
Av. Juan Domingo Perón 1500, Pilar, Buenos Aires
Sanatorio Allende (Nueva Córdoba)
Recruiting
Hipolito Yrigoyen 384, Córdoba
Centro Médico Fleischer
Recruiting
CABA, C1414
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