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DZD9008 in Pretreated Lung Cancer Patients With EGFR Exon20 Insertion Mutation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05712902
Recruitment Status : Active, not recruiting
First Posted : February 6, 2023
Last Update Posted : February 6, 2023
Sponsor:
Information provided by (Responsible Party):
Dizal Pharmaceuticals

Study Description
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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
Non-Small Cell Lung Cancer Drug: DZD9008 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : July 19, 2021
Actual Primary Completion Date : October 17, 2022
Estimated Study Completion Date : May 6, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Daily dose of DZD9008 Drug: DZD9008
Daily dose of DZD9008


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

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05712902


Locations
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Sponsors and Collaborators
Dizal Pharmaceuticals
Investigators
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Principal Investigator: Mengzhao Wang Peking Union Medical College Hospital
More Information
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Responsible Party: Dizal Pharmaceuticals
ClinicalTrials.gov Identifier: NCT05712902    
Other Study ID Numbers: DZ2020E0001
First Posted: February 6, 2023    Key Record Dates
Last Update Posted: February 6, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms