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DZD9008 in Pretreated Lung Cancer Patients With EGFR Exon20 Insertion Mutation

Sponsor
Dizal Pharmaceuticals (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT05712902
Collaborator
(none)
104
Enrollment
33
Locations
1
Arm
33.6
Anticipated Duration (Months)
3.2
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
104 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II, Single Arm, Multicenter Study to Evaluate Anti-tumor Activity, Safety, Tolerability and Pharmacokinetics of DZD9008 in Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With EGFR Exon 20 Insertion Mutation
Actual Study Start Date :
Jul 19, 2021
Actual Primary Completion Date :
Oct 17, 2022
Anticipated Study Completion Date :
May 6, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Daily dose of DZD9008

Drug: DZD9008
Daily dose of DZD9008

Outcome Measures

Primary Outcome Measures

  1. Objective Response Rate (ORR) according to RECIST 1.1 by an Independent Review Committee (IRC) [From first dosing until disease progression or intolerable adverse events]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

  1. Participants with hemorrhagic diseases such as von Willebrand disease.

  2. 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.

  3. 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.

  4. Prior/concomitant therapy

  5. 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.

  6. 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.

  7. Treatment with antibodies within 4 weeks before first administration of DZD9008.

  8. 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.

  9. Women who are pregnant or breast feeding.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beijing Cancer Hospital Beijing China
2 Beijing Chest Hospital，Capital Medical University Beijing China
3 Peking Union Medical College Hospital Beijing China
4 Peking University Third Hospital Beijing China
5 Jilin Cancer Hospital Chang chun China
6 Hunan Cancer Hospital(The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University Changsha China
7 West China Hospital of Sichuan University Chengdu China
8 Army Medical Center of PLA Chongqing China
9 Chongqing University Cancer Hospital(Chongqing Cancer Hospital) Chongqing China
10 The First Affiliated Hospital of Guangzhou Medical University Guangzhou China
11 The First Affiliated Hospital, Sun Yat-sen University Guangzhou China
12 Hainan General Hospital Haikou China
13 The First Affiliated Hospital Zhejiang University School of Medicine Hangzhou China
14 The Second Affiliated Hospital Zhejiang University School of Medicine Hangzhou China
15 Zhejiang Cancer Hospital (Cancer Hospital of the University of Chinese Academy of Sciences) Hangzhou China
16 Harbin Medical University Cancer Hospital Harbin China
17 The Second Hospital of Anhui Medical University Hefei China
18 The Affiliated Hospital of Inner Mongolia Medical University Hohhot China
19 Jinan Central Hospital (Central Hospital Affiliated to Shandong First Medical University) Jinan China
20 Yunnan Cancer Hospital Kunming China
21 The First Affiliated Hospital of Nanchang University Nanchang China
22 The Second Affiliated Hospital of Nanchang University Nanchang China
23 Fudan University Shanghai Cancer Center Shanghai China
24 The First Hospital of China Medical University Shenyang China
25 The Fourth Hospital of Hebei Medical University Shijiazhuang China
26 The First Affiliated Hospital of Soochow University Suzhou China
27 Shanxi Provincial Cancer Hospital Taiyuan China
28 Tianjin Medical University Cancer Institute & Hospital Tianjin China
29 Hubei Cancer Hospital Wuhan China
30 Union Hospital Tongji Medical College Huazhong University of Science and Technology Wuhan China
31 The First Affiliated Hospital of Xi'an Jiaotong University Xi'an China
32 Affiliated Cancer Hospital of Zhengzhou University(Henan Cancer Hospital) Zhengzhou China
33 The Affiliated Cancer Hospital of Xinjiang Medical University Ürümqi China

Sponsors and Collaborators

  • Dizal Pharmaceuticals

Investigators

  • Principal Investigator: Mengzhao Wang, Peking Union Medical College Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dizal Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT05712902
Other Study ID Numbers:
  • DZ2020E0001
First Posted:
Feb 6, 2023
Last Update Posted:
Feb 6, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of Feb 6, 2023