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

Phase 3

Recruiting

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: sunvozertinib; Drug: Pemetrexed+carboplatin

• Registration Number: NCT05668988
• Lead Sponsor: Dizal Pharmaceuticals

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-13
• Study First Submitted: 2022-12-20
• Study First Submitted QC: 2022-12-20
• Study First Posted: 2022-12-30
• Status Verified: 2025-02
• Last Update Submitted: 2025-05-08
• Last Update Posted: 2025-05-09
• Primary Completion: 2026-02-28
• Study Completion: 2027-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

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

Exclusion Criteria

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sunvozertinib	sunvozertinib	-
Platinum-based Chemotherapy	Pemetrexed+carboplatin	-

Primary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS) as assessed by Blinded Independent Central Review (BICR) per RECIST 1.1	Up to approximately 34 months after the first participant is randomized

Secondary Outcome Measures

Name	Time	Method
Overall Survival	Up to approximately 34 months after the first participant is randomized

Trial Locations

Locations (160)

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; 🇺🇸 Margate, Florida, United States

Brcr Global; 🇺🇸 Plantation, Florida, United States

H. Lee Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States

NYU Laura & Issac Perlmutter Cancer Center; 🇺🇸 New York, New York, United States

Columbia University Medical Center; 🇺🇸 New York, New York, United States

Gabrail Cancer Center Research; 🇺🇸 Canton, Ohio, United States

The Ohio State University; 🇺🇸 Columbus, Ohio, United States

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