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Active, not recruiting Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT05668988

Public ClinicalTrials.gov record NCT05668988. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 3, 2026, 1:27 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3, Open-Label, Randomized, Multi-Center Study of DZD9008 Versus Platinum-Based Doublet Chemotherapy as First-Line Treatment for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring Epidermal Growth Factor Receptor Exon 20 Insertion Mutation

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID
NCT05668988
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Dizal Pharmaceuticals
Industry
Enrollment
324 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 12, 2022
Primary completion
Jan 15, 2026
Completion
Oct 30, 2027
Last update posted
May 25, 2026

2022 – 2027

United States locations

U.S. sites
14
U.S. states
8
U.S. cities
13
Facility City State ZIP Site status
OPN Healthcare, Inc. Glendale California 91203
Kaiser Permanente Medical Center Vallejo California 94589
University of Colorado Hospital - Anschutz Cancer Pavilion Aurora Colorado 80045
D&H Cancer Research Center LLC Margate Florida 33054
BRCR Medical Center Inc. Plantation Florida 33324
NYU Laura & Issac Perlmutter Cancer Center at NYU Langone Health New York New York 10016
Columbia University Medical Center New York New York 10032
Gabrail Cancer Center Research Canton Ohio 44718
OSU Brain & Spine Hospital Columbus Ohio 43210
Providence Portland Institute Franz Portland Oregon 97213
Texas Oncology - Baylor Charles A. Sammons Cancer Center Dallas Texas 75246
The University of Texas MD Anderson cancer center Houston Texas 77030
exas Oncology--McAllen Weslaco Texas 78596
University of Virginia Comprehensive Cancer Center Charlottesville Virginia 22908

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 144 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05668988, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 25, 2026 · Synced Sep 3, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05668988 live on ClinicalTrials.gov.

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