Trial Title:
DZD9008 in Pretreated Lung Cancer Patients With EGFR Exon20 Insertion Mutation
NCT ID:
NCT05712902
Condition:
Non-Small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
DZD9008
Description:
Daily dose of DZD9008
Arm group label:
Daily dose of DZD9008
Summary:
This is a Phase II, single-arm, multi-center clinical study to evaluate the anti-tumor
efficacy, safety, tolerability and pharmacokinetics of DZD9008 in participants with
locally advanced or metastatic NSCLC carrying EGFR exon 20 insertion mutations whose
disease has progressed on prior platinum-based chemotherapy
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patients must be able to understand the nature of the trial and provide a signed and
dated, written informed consent form.
2. Aged at least 18 years old.
3. Histological or cytological confirmed locally advanced or metastatic NSCLC
4. Tumor tissue EGFR exon 20 insertion mutations confirmed by qualified local
laboratories or sponsor-designated central laboratories.
5. Participants must exhibit Eastern Cooperative Oncology Group (ECOG) performance
status 0 - 1 at ICF signature with no deterioration over the past 2 weeks.
6. Predicted life expectancy ≥ 12 weeks.
7. Patient must have measurable disease according to RECIST 1.1.
8. Patients with brain metastasis (BM) can only be enrolled under the condition that BM
is previously treated and stable.
9. Adequate organ system functions.
10. Patients should receive at least one line but no more than three lines of prior
systemic therapy (at least one line must contain platinum-based therapy).
Exclusion Criteria:
1. Prior malignancy within 2 years requires active treatment, except for adequately
treated basal cell skin carcinoma, in situ cervical carcinoma, or other cancer types
(to be discussed with Dizal's Study Physician) who has been disease free for > 2
years with life expectancy >2 years.
2. Any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time
of starting DZD9008 with the exception of alopecia and grade 2 prior
platinum-therapy related neuropathy.
3. Spinal cord compression or leptomeningeal metastasis.
4. History of stroke or intracranial hemorrhage within 6 months before first
administration of DZD9008.
5. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled
hypertension and active bleeding diatheses.
6. Active infection including hepatitis B, hepatitis C, human immunodeficiency virus
(HIV) and COVID-19.
7. Any of the following cardiac criteria:
- Mean resting corrected QT interval (QTc) > 470 msec obtained from 3
electrocardiograms (ECGs).
- Any clinically significant abnormalities in rhythm, conduction or morphology of
resting ECG, e.g., complete left bundle branch block, third degree heart block,
and second-degree heart block, PR interval > 250 msec.
- Any factors that increase the risk of QTc prolongation, such as heart failure,
hypokalemia, congenital long QT syndrome, family history of long QT syndrome or
unexplained sudden death under 40 years of age in first degree relatives or any
concomitant medication known to prolong the QT interval .
- Prior history of atrial fibrillation within 6 months of first administration of
DZD9008, except prior drug treatment related and recovered.
8. Participants with hemorrhagic diseases such as von Willebrand disease.
9. Past medical history of interstitial lung disease, drug-induced interstitial lung
disease, radiation pneumonitis which required steroid treatment, or any evidence of
clinically active interstitial lung disease or immunotherapy induced immune
pneumonia.
10. Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to
swallow the formulated product or previous significant bowel resection that would
preclude adequate absorption of DZD9008.
11. Prior/concomitant therapy
1. Patients who have received prior Poziotinib, TAK-788, CLN-081 or BDTX-189,
furmonertinib or any other EGFR/HER2 exon20ins small molecule inhibitors
treatment should be excluded.
2. Other EGFR TKIs, such as gefitinib, erlotinib, osimertinib, afatinib,
dacomitinb are not considered EGFR or HER2 Exon20ins small molecule inhibitors,
and thus prior treatment with these drugs is allowed unless the patient had an
objective response and subsequent progression as assessed by the investigator
or treating physician during treatment with that prior TKI.
3. Treatment with antibodies within 4 weeks before first administration of
DZD9008.
4. Any cytotoxic chemotherapy, investigational agents or other anticancer drugs
from a previous treatment regimen or clinical study within 14 days before first
administration of DZD9008.
12. Women who are pregnant or breast feeding.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Country:
China
Facility:
Name:
Beijing Chest Hospital，Capital Medical University
Address:
City:
Beijing
Country:
China
Facility:
Name:
Peking Union Medical College Hospital
Address:
City:
Beijing
Country:
China
Facility:
Name:
Peking University Third Hospital
Address:
City:
Beijing
Country:
China
Facility:
Name:
Jilin Cancer Hospital
Address:
City:
Chang chun
Country:
China
Facility:
Name:
Hunan Cancer Hospital(The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University
Address:
City:
Changsha
Country:
China
Facility:
Name:
West China Hospital of Sichuan University
Address:
City:
Chengdu
Country:
China
Facility:
Name:
Army Medical Center of PLA
Address:
City:
Chongqing
Country:
China
Facility:
Name:
Chongqing University Cancer Hospital(Chongqing Cancer Hospital)
Address:
City:
Chongqing
Country:
China
Facility:
Name:
The First Affiliated Hospital of Guangzhou Medical University
Address:
City:
Guangzhou
Country:
China
Facility:
Name:
The First Affiliated Hospital, Sun Yat-sen University
Address:
City:
Guangzhou
Country:
China
Facility:
Name:
Hainan General Hospital
Address:
City:
Haikou
Country:
China
Facility:
Name:
The First Affiliated Hospital Zhejiang University School of Medicine
Address:
City:
Hangzhou
Country:
China
Facility:
Name:
The Second Affiliated Hospital Zhejiang University School of Medicine
Address:
City:
Hangzhou
Country:
China
Facility:
Name:
Zhejiang Cancer Hospital (Cancer Hospital of the University of Chinese Academy of Sciences)
Address:
City:
Hangzhou
Country:
China
Facility:
Name:
Harbin Medical University Cancer Hospital
Address:
City:
Harbin
Country:
China
Facility:
Name:
The Second Hospital of Anhui Medical University
Address:
City:
Hefei
Country:
China
Facility:
Name:
The Affiliated Hospital of Inner Mongolia Medical University
Address:
City:
Hohhot
Country:
China
Facility:
Name:
Jinan Central Hospital (Central Hospital Affiliated to Shandong First Medical University)
Address:
City:
Jinan
Country:
China
Facility:
Name:
Yunnan Cancer Hospital
Address:
City:
Kunming
Country:
China
Facility:
Name:
The First Affiliated Hospital of Nanchang University
Address:
City:
Nanchang
Country:
China
Facility:
Name:
The Second Affiliated Hospital of Nanchang University
Address:
City:
Nanchang
Country:
China
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Country:
China
Facility:
Name:
The First Hospital of China Medical University
Address:
City:
Shenyang
Country:
China
Facility:
Name:
The Fourth Hospital of Hebei Medical University
Address:
City:
Shijiazhuang
Country:
China
Facility:
Name:
The First Affiliated Hospital of Soochow University
Address:
City:
Suzhou
Country:
China
Facility:
Name:
Shanxi Provincial Cancer Hospital
Address:
City:
Taiyuan
Country:
China
Facility:
Name:
Tianjin Medical University Cancer Institute & Hospital
Address:
City:
Tianjin
Country:
China
Facility:
Name:
Hubei Cancer Hospital
Address:
City:
Wuhan
Country:
China
Facility:
Name:
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Address:
City:
Wuhan
Country:
China
Facility:
Name:
The First Affiliated Hospital of Xi'an Jiaotong University
Address:
City:
Xi'an
Country:
China
Facility:
Name:
Affiliated Cancer Hospital of Zhengzhou University(Henan Cancer Hospital)
Address:
City:
Zhengzhou
Country:
China
Facility:
Name:
The Affiliated Cancer Hospital of Xinjiang Medical University
Address:
City:
Ürümqi
Country:
China
Start date:
July 19, 2021
Completion date:
May 6, 2024
Lead sponsor:
Agency:
Dizal Pharmaceuticals
Agency class:
Industry
Source:
Dizal Pharmaceuticals
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05712902
