Last updated 8 months ago
A Study of DZD9008 Versus Platinum-Based Doublet Chemotherapy in Local Advanced or Metastatic Non-small Cell Lung Cancer (WU-KONG28)
320 patients around the world
Available in Spain, Brazil, Argentina, United States
Dizal Pharmaceuticals
6Research sites
320Patients 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
- Aged at least 18 years old (or per local regulatory/IRB requirement).Histologically or cytologically confirmed diagnosis of non-squamous NSCLC, locally advanced (Stage IIIB and IIIC according to the 8th edition of the AJCC TNM staging criteria) or metastatic (Stage IV), not suitable for curative therapy.Adequate tumor tissue available, for central laboratory confirmation of EGFR exon 20 insertion mutation.At least 1 measurable lesion per RECIST Version 1.1.Life expectancy ≥ 12 weeks.Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.Adequate organ and hematologic function.
- Prior treatment with any systemic anti-cancer therapy for locally advanced or metastatic NSCLC.Spinal cord compression or leptomeningeal metastasis.Concurrent EGFR mutations: exon 19 deletion, L858R, T790M, G719X, S768I, or L861Q.History of stroke or intracranial hemorrhage within 6 months before randomization.As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses (i.e., hemophilia and Von Willebrand disease).
Sites
Instituto Argentino de Diagnóstico y Tratamiento - IADT
Recruiting
Fundación CENIT para la Investigación en Neurociencias
Recruiting
Fundación Ars Médica - San Salvador de Jujuy
Recruiting
Instituto Médico de la Fundación Estudios Clínicos - Rosario
Recruiting
Centro Médico Austral OMI - CABA
Recruiting
Consultorios Médicos Dr. Doreski
Recruiting
SponsorDizal Pharmaceuticals
Conditions
Non-small cell lung carcinomaLung cancer
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05668988
