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

Primary Purpose

Non-small Cell Lung Cancer

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
DZD9008
Pemetrexed+carboplatin
Sponsored by
Dizal Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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).

Sites / Locations

  • Beijing Cancer Hospital
  • Beijing Chest Hospital, Capital Medical University
  • Cancer Hospital of the Chinese Academy of Medical Sciences
  • Peking Union Medical College Hospital
  • Peking University Third Hospital
  • Hunan Cancer Hospital
  • West China Hospital of Sichuan University
  • Army Medical Center of PLA
  • Chongqing Cancer Hospital
  • Fujian Cancer Hospital
  • Fujian Medical University Union Hospital
  • The First Affiliated Hospital of Guangzhou Medical University
  • The First Affiliated Hospital of Sun Yat-sen University
  • Harbin Medical University Cancer Hospital
  • The First Affiliated Hospital Zhejiang University School of Medicine
  • Zhejiang Cancer Hospital
  • Anhui Provincial Hospital
  • The First Affiliated Hospital of Anhui Medical University
  • The Affiliated Hospital of Inner Mongolia Medical University
  • Jilin Cancer Hospital
  • Central Hospital Affiliated to Shandong First Medical University
  • Shandong Cancer Hospital & Institution
  • Yunnan Cancer Hospital
  • The Second Affiliated Hospital of Nanchang University
  • Jiangsu Cancer Hospital
  • Jiangsu Provincial Hospital
  • Guangxi Medical University Cancer Hospital
  • Shanghai Chest Hospital
  • Shanghai Pulmonary HospitalRecruiting
  • ZhongShan Hospital Fudan University
  • The First Hospital of China Medical University
  • The Fourth Hospital of Hebei Medical University
  • Shanxi Provincial Cancer Hospital
  • Taizhou Hospital of Zhejiang Province
  • Tianjin Medical University Cancer Institute & Hospital
  • Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • The First Affiliated Hospital of Xi 'an Jiaotong University
  • Yantai Yuhuangding Hospital
  • Henan Cancer Hospital
  • The First Affiliated Hospital of Zhengzhou University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DZD9008

Platinum-based Chemotherapy

Arm Description

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS) as assessed by Blinded Independent Central Review (BICR) per RECIST 1.1

Secondary Outcome Measures

Overall Survival

Full Information

First Posted
December 20, 2022
Last Updated
September 20, 2023
Sponsor
Dizal Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT05668988
Brief Title
A Study of DZD9008 Versus Platinum-Based Doublet Chemotherapy in Local Advanced or Metastatic Non-small Cell Lung Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 13, 2022 (Actual)
Primary Completion Date
February 28, 2026 (Anticipated)
Study Completion Date
October 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dizal Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
320 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DZD9008
Arm Type
Experimental
Arm Title
Platinum-based Chemotherapy
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
DZD9008
Intervention Description
orally, 300 mg, once daily until a treatment discontinuation criterion is met.
Intervention Type
Drug
Intervention Name(s)
Pemetrexed+carboplatin
Intervention Description
Participants randomized into chemotherapy arm can receive up to 6 cycles of pemetrexed + carboplatin (pemetrexed 500 mg/m2 + carboplatin area under the plasma concentration-time curve 5 mg/ml per minute (AUC5), IV infusion, every 3 weeks) as the initial treatment. Participants whose disease has not progressed after 4 cycles of first-line platinum-based doublet chemotherapy may receive pemetrexed maintenance monotherapy until a treatment discontinuation criterion is met.
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS) as assessed by Blinded Independent Central Review (BICR) per RECIST 1.1
Time Frame
Up to approximately 34 months after the first participant is randomized
Secondary Outcome Measure Information:
Title
Overall Survival
Time Frame
Up to approximately 34 months after the first participant is randomized

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cyrus Cai, M.D.
Phone
+86 21 6109 5805
Email
cyrus.cai@dizalpharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caicun Zhou
Organizational Affiliation
Shanghai Pulmonary Hospital, Shanghai, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Cancer Hospital
City
Beijing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fang
Facility Name
Beijing Chest Hospital, Capital Medical University
City
Beijing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hu
Facility Name
Cancer Hospital of the Chinese Academy of Medical Sciences
City
Beijing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li
Facility Name
Peking Union Medical College Hospital
City
Beijing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wang
Facility Name
Peking University Third Hospital
City
Beijing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liang
Facility Name
Hunan Cancer Hospital
City
Changsha
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wu
Facility Name
West China Hospital of Sichuan University
City
Chengdu
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wang
Facility Name
Army Medical Center of PLA
City
Chongqing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
He
Facility Name
Chongqing Cancer Hospital
City
Chongqing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wang
Facility Name
Fujian Cancer Hospital
City
Fuzhou
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lin
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chen
Facility Name
The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhou
Facility Name
The First Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tang
Facility Name
Harbin Medical University Cancer Hospital
City
Ha'erbin
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu
Facility Name
The First Affiliated Hospital Zhejiang University School of Medicine
City
Hangzhou
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhou
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fan
Facility Name
Anhui Provincial Hospital
City
Hefei
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhang
Facility Name
The First Affiliated Hospital of Anhui Medical University
City
Hefei
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Du
Facility Name
The Affiliated Hospital of Inner Mongolia Medical University
City
Hohhot
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gao
Facility Name
Jilin Cancer Hospital
City
Jilin
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cheng
Facility Name
Central Hospital Affiliated to Shandong First Medical University
City
Jinan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sun
Facility Name
Shandong Cancer Hospital & Institution
City
Jinan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xing
Facility Name
Yunnan Cancer Hospital
City
Kunming
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yang
Facility Name
The Second Affiliated Hospital of Nanchang University
City
Nanchang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liu
Facility Name
Jiangsu Cancer Hospital
City
Nanjing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Feng
Facility Name
Jiangsu Provincial Hospital
City
Nanjing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guo
Facility Name
Guangxi Medical University Cancer Hospital
City
Nanning
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zeng
Facility Name
Shanghai Chest Hospital
City
Shanghai
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhong
Facility Name
Shanghai Pulmonary Hospital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhou
Facility Name
ZhongShan Hospital Fudan University
City
Shanghai
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong
Facility Name
The First Hospital of China Medical University
City
Shenyang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin
Facility Name
The Fourth Hospital of Hebei Medical University
City
Shijiazhuang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wang
First Name & Middle Initial & Last Name & Degree
Ding
Facility Name
Shanxi Provincial Cancer Hospital
City
Taiyuan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Song
Facility Name
Taizhou Hospital of Zhejiang Province
City
Taizhou
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lv
Facility Name
Tianjin Medical University Cancer Institute & Hospital
City
Tianjin
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huang
Facility Name
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
City
Wuhan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chu
Facility Name
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dong
Facility Name
The First Affiliated Hospital of Xi 'an Jiaotong University
City
Xi'an
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yao
Facility Name
Yantai Yuhuangding Hospital
City
Yantai
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sun
Facility Name
Henan Cancer Hospital
City
Zhengzhou
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhao
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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