A Study of DZD9008 Versus Platinum-Based Doublet Chemotherapy in Local Advanced or Metastatic Non-small Cell Lung Cancer (WU-KONG28)
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 320
- 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).
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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