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+carboplatinDrug: DZD9008
- 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 β₯ 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 Platinum-based Chemotherapy Pemetrexed+carboplatin - DZD9008 DZD9008 -
- 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 (46)
WK28 Investigative Site
πΉπ·Konya, Turkey
MD Anderson cancer center
πΊπΈHouston, Texas, United States
Antwerpen University Hospital (UZA)
π§πͺEdegem, Antwerp, Belgium
University Hospital Gent- Drug Research Unit Ghent (D.R.U.G.)
π§πͺGhent, Flanders, Belgium
Grand Hopital de Charleroi (GHdC) - Hopital Notre Dame
π§πͺCharleroi, Hainaut, Belgium
Beijing Cancer Hospital
π¨π³Beijing, China
Beijing Chest Hospital, Capital Medical University
π¨π³Beijing, China
Cancer Hospital of the Chinese Academy of Medical Sciences
π¨π³Beijing, China
Peking Union Medical College Hospital
π¨π³Beijing, China
Hunan Cancer Hospital
π¨π³Changsha, China
Chongqing Cancer Hospital
π¨π³Chongqing, China
West China Hospital of Sichuan University
π¨π³Chengdu, China
Army Medical Center of PLA
π¨π³Chongqing, China
Fujian Medical University Union Hospital
π¨π³Fuzhou, China
The First Affiliated Hospital Zhejiang University School of Medicine
π¨π³Hangzhou, China
Zhejiang Cancer Hospital
π¨π³Hangzhou, China
Anhui Provincial Hospital
π¨π³Hefei, China
The Affiliated Hospital of Inner Mongolia Medical University
π¨π³Hohhot, China
Shandong Cancer Hospital & Institution
π¨π³Jinan, China
The Second Affiliated Hospital of Nanchang University
π¨π³Nanchang, China
Guangxi Medical University Cancer Hospital
π¨π³Nanning, China
Shanghai Chest Hospital
π¨π³Shanghai, China
Shanghai Pulmonary Hospital
π¨π³Shanghai, China
ZhongShan Hospital Fudan University
π¨π³Shanghai, China
Taizhou Hospital of Zhejiang Province
π¨π³Taizhou, China
Tianjin Medical University Cancer Institute & Hospital
π¨π³Tianjin, China
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
π¨π³Wuhan, China
The First Affiliated Hospital of Xi 'an Jiaotong University
π¨π³Xi'an, China
The First Affiliated Hospital of Zhengzhou University
π¨π³Zhengzhou, China
Henan Cancer Hospital
π¨π³Zhengzhou, China
Fujian Cancer Hospital
π¨π³Fuzhou, China
Peking University Third Hospital
π¨π³Beijing, China
The First Affiliated Hospital of Guangzhou Medical University
π¨π³Guangzhou, China
The First Affiliated Hospital of Sun Yat-sen University
π¨π³Guangzhou, China
Harbin Medical University Cancer Hospital
π¨π³Ha'erbin, China
The First Affiliated Hospital of Anhui Medical University
π¨π³Hefei, China
Jilin Cancer Hospital
π¨π³Jilin, China
Central Hospital Affiliated to Shandong First Medical University
π¨π³Jinan, China
Yunnan Cancer Hospital
π¨π³Kunming, China
The First Hospital of China Medical University
π¨π³Shenyang, China
The Fourth Hospital of Hebei Medical University
π¨π³Shijiazhuang, China
Shanxi Provincial Cancer Hospital
π¨π³Taiyuan, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
π¨π³Wuhan, China
Yantai Yuhuangding Hospital
π¨π³Yantai, China
Jiangsu Cancer Hospital
π¨π³Nanjing, China
Jiangsu Provincial Hospital
π¨π³Nanjing, China
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