A Study of DZD9008 Versus Platinum-Based Doublet Chemotherapy in Local Advanced or Metastatic Non-small Cell Lung Cancer (WU-KONG28)
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).
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated May 26, 2026 · Source: ClinicalTrials.gov
The study is underway but is not accepting new participants.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 3
- Sponsor
- Dizal Pharmaceuticals
- Interventions being studied
- Drug: sunvozertinib; Drug: Pemetrexed+carboplatin
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
1. Aged at least 18 years old (or per local regulatory/IRB requirement). 2. 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. 3. Adequate tumor tissue available, for central laboratory confirmation of EGFR exon 20 insertion mutation 4. At least 1 measurable lesion per RECIST Version 1.1 5. Life expectancy ≥ 12 weeks 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 7. Adequate organ and hematologic function
1. Prior treatment with any systemic anti-cancer therapy for locally advanced or metastatic NSCLC. 2. Spinal cord compression or leptomeningeal metastasis. 3. Concurrent EGFR mutations: exon 19 deletion, L858R, T790M, G719X, S768I, or L861Q. 4. History of stroke or intracranial hemorrhage within 6 months before randomization. 5. 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).
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- OPN Healthcare, Inc.Glendale, California
- Kaiser Permanente Medical CenterVallejo, California
- University of Colorado Hospital - Anschutz Cancer PavilionAurora, Colorado
- D&H Cancer Research Center LLCMargate, Florida
- BRCR Medical Center Inc.Plantation, Florida
- NYU Laura & Issac Perlmutter Cancer Center at NYU Langone HealthNew York, New York
- Columbia University Medical CenterNew York, New York
- Gabrail Cancer Center ResearchCanton, Ohio
- OSU Brain & Spine HospitalColumbus, Ohio
- Providence Portland Institute FranzPortland, Oregon
- Texas Oncology - Baylor Charles A. Sammons Cancer CenterDallas, Texas
- The University of Texas MD Anderson cancer centerHouston, Texas
Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 26, 2026. Always confirm current availability with the study team.