A Study of DZD9008 Versus Platinum-Based Doublet Chemotherapy in Local Advanced or Metastatic Non-small Cell Lung Cancer (WU-KONG28)

Running, not enrolling · Phase 3

Conditions studied: Non-small Cell Lung Cancer

In brief

This is a phase 3, open-label, randomized, multi-center study assessing the efficacy and safety of DZD9008 versus platinum-based doublet chemotherapy in participants with locally advanced or metastatic NSCLC with EGFR Exon20ins mutation, who are newly diagnosed or have not received prior systemic therapy in advanced stage. Primary objective of this study is to assess the efficacy of DZD9008 versus platinum-based doublet chemotherapy using by BICR-assessed PFS per RECIST 1.1 as primary endpoint. Approximately 320 participants are estimated to be randomized into the study. Participants enrolled will be randomized to DZD9008 or platinum-based doublet chemotherapy in a 1:1 manner, stratified by baseline brain metastasis (with/without).

Key facts

Study ID

NCT05668988

Run by

Dizal Pharmaceuticals

People needed

324

Starts

2022-12-13

Expected to finish

2027-10-31

Last updated by the study team

2026-05-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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).

Where it is running

• Ordensklinikum Linz GmbH Elisabethinen — Linz, Austria
• Yantai Yuhuangding Hospital — Yantai, China
• Henan Cancer Hospital — Zhengzhou, China
• Hospital Universitario La Paz — Madrid, Spain
• OPN Healthcare, Inc. — Glendale, California, United States
• Kaiser Permanente Medical Center — Vallejo, California, United States
• University of Colorado Hospital - Anschutz Cancer Pavilion — Aurora, Colorado, United States
• D&H Cancer Research Center LLC — Margate, Florida, United States
• BRCR Medical Center Inc. — Plantation, Florida, United States
• NYU Laura & Issac Perlmutter Cancer Center at NYU Langone Health — New York, New York, United States
• Columbia University Medical Center — New York, New York, United States
• Gabrail Cancer Center Research — Canton, Ohio, United States
• OSU Brain & Spine Hospital — Columbus, Ohio, United States
• Providence Portland Institute Franz — Portland, Oregon, United States
• Texas Oncology - Baylor Charles A. Sammons Cancer Center — Dallas, Texas, United States
• The University of Texas MD Anderson cancer center — Houston, Texas, United States
• exas Oncology--McAllen — Weslaco, Texas, United States
• University of Virginia Comprehensive Cancer Center — Charlottesville, Virginia, United States
• Centro de Educación Médica e Investigaciones Clínicas, CEMIC — Buenos Aires, Argentina
• Centro Diabaid — Buenos Aires, Argentina
• Centro Medico Austral — Buenos Aires, Argentina
• Consultorios Medicos Dr. Doreski - Fundacion Respirar — Buenos Aires, Argentina
• Fundacion Cenit Para El Estudio De Neurociencias — Buenos Aires, Argentina
• Hospital Italiano de Buenos Aires (HIBA) — Buenos Aires, Argentina
• Prince of Wales Hospital — Randwick, Australia

Full record on ClinicalTrials.gov

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