DZD9008 in Pretreated Lung Cancer Patients With EGFR Exon20 Insertion Mutation
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ClinicalTrials.gov Identifier: NCT05712902 |
Recruitment Status :
Active, not recruiting
First Posted : February 6, 2023
Last Update Posted : February 6, 2023
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Sponsor:
Dizal Pharmaceuticals
Information provided by (Responsible Party):
Dizal Pharmaceuticals
Tracking Information | |||||
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First Submitted Date ICMJE | January 12, 2023 | ||||
First Posted Date ICMJE | February 6, 2023 | ||||
Last Update Posted Date | February 6, 2023 | ||||
Actual Study Start Date ICMJE | July 19, 2021 | ||||
Actual Primary Completion Date | October 17, 2022 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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 ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | DZD9008 in Pretreated Lung Cancer Patients With EGFR Exon20 Insertion Mutation | ||||
Official Title ICMJE | 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 | ||||
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 | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Non-Small Cell Lung Cancer | ||||
Intervention ICMJE | Drug: DZD9008
Daily dose of DZD9008
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Study Arms ICMJE | Experimental: Daily dose of DZD9008
Intervention: Drug: DZD9008
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Actual Enrollment ICMJE |
104 | ||||
Original Actual Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | May 6, 2024 | ||||
Actual Primary Completion Date | October 17, 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | China | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT05712902 | ||||
Other Study ID Numbers ICMJE | DZ2020E0001 | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Dizal Pharmaceuticals | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Dizal Pharmaceuticals | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Dizal Pharmaceuticals | ||||
Verification Date | January 2023 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |