- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05246514
A Single Arm Phase 2 Study to Evaluate Efficacy and Safety of Trastuzumab Deruxtecan for Patients With HER2 Mutant NSCLC (DL-05)
April 9, 2024 updated by: AstraZeneca
An Open-label, Single-arm, Phase 2 Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd) for Patients With HER2-mutant Metastatic NSCLC Who Have Disease Progression on or After at Least One-line of Treatment (DESTINY-Lung05)
The purpose of this study is to evaluate the efficacy and safety of T-DXd in participants with HER2 mutant metastatic non-squamous NSCLC.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
72
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Baoding, China, 071000
- Research Site
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Beijing, China, 100142
- Research Site
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Beijing, China, 100191
- Research Site
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Changchun, China, 130000
- Research Site
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Changsha, China, 410013
- Research Site
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Changsha, China, 410008
- Research Site
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Chengdu, China, 610041
- Research Site
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Chongqing, China, 400030
- Research Site
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Guangzhou, China, 510080
- Research Site
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Guangzhou, China, 510515
- Research Site
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Hangzhou, China, 310022
- Research Site
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Hangzhou, China, 310020
- Research Site
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Harbin, China, 150081
- Research Site
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Hefei, China, 230601
- Research Site
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Hefei, China, 133500
- Research Site
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Linyi, China, 276000
- Research Site
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Nanjing, China, 210029
- Research Site
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Shandong, China
- Research Site
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Shanghai, China, 200032
- Research Site
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Shanghai, China, 200025
- Research Site
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ShenZhen, China, 518020
- Research Site
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Shenyang, China, 110042
- Research Site
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Wuhan, China, 430022
- Research Site
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Wuhan, China, 430060
- Research Site
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Xi'an, China, 710061
- Research Site
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Xiamen, China, 361003
- Research Site
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Yangzhou, China, 225001
- Research Site
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Zhengzhou City, China, 450000
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Pathologically documented metastatic non-squamous NSCLC.
- Has relapsed from or is refractory to at least one-line of anticancer treatment.
- Documented HER2 exon 19 or 20 mutation from central FFPE tumour tissue testing.
- WHO or ECOG performance status of 0 or 1.
- Presence of at least one measurable lesion assessed by the investigator based on RECIST 1.1.
- LVEF ≥ 50% within 28 days before enrolment.
Exclusion Criteria:
- Mixed small cell lung cancer, squamous histology NSCLC, and sarcomatoid histology variant NSCLC.
- Corrected QT interval (QTcF) prolongation to > 470 ms (females) or > 450 ms (males), based on average of the screening triplicate 12-lead ECG.
- History of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
- Has unresolved toxicities from previous anticancer therapy, defined as toxicities (excluding alopecia) not yet resolved to Grade ≤1 or baseline. Participants with clinically stable chronic Grade 2 toxicity not reasonably expected to be exacerbated by study intervention may be included only after consultation with the AstraZeneca study physician or designee.
- Has been previously treated with HER2-targeted therapies, except for pan-HER class TKIs or has received prior treatment with an ADC which consists of an exatecan derivative that is a topoisomerase I inhibitor.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: T-DXd arm
Participants will receive T-DXd as an IV infusion Q3W, on Day 1 of each 3-week cycle.
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administered as an IV infusion
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ICR-assessed ORR (objective response rate)
Time Frame: At an average of approximately 14 months
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Confirmed ORR, defined as the proportion of participants with confirmed complete response or partial response, as assessed by independent central review(ICR) based on RECIST 1.1.
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At an average of approximately 14 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Investigator-assessed ORR (objective response rate)
Time Frame: An average of approximately 14 months
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Confirmed ORR is defined as the proportion of participants who have a confirmed CR or confirmed PR, as determined by the investigator at local site per RECIST 1.1
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An average of approximately 14 months
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ICR-assessed and investigator-assessed DoR (duration of response)
Time Frame: At an average of approximately 14 months
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DoR is time from the initial confirmed response (CR or PR) until documented tumour progression or death from any cause.
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At an average of approximately 14 months
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ICR-assessed and investigator-assessed DCR (disease control rate)
Time Frame: Approximately 6 weeks
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DCR is the proportion of participants who achieved confirmed CR, PR, or SD during study intervention.
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Approximately 6 weeks
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ICR-assessed and investigator-assessed PFS (progression-free survival)
Time Frame: An average of approximately 14 months
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PFS is the time from date of enrolment until first objective radiographic tumour progression or death from any cause.
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An average of approximately 14 months
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OS (overall survival)
Time Frame: An average of approximately 22 months
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OS is the time from date of enrolment until death from any cause.
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An average of approximately 22 months
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ICR-assessed CNS-PFS (central nervous system progression-free survival)
Time Frame: An average of approximately 14 months
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CNS-PFS is the time from date of enrolment until CNS tumour progression per RECIST 1.1 as assessed by ICR due to any cause in the absence of CNS progression.
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An average of approximately 14 months
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Serum concentrations of T-DXd
Time Frame: An average of approximately 14 months
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Individual patient data and descriptive statistics will be provided for serum concentration data at each time point for T-DXd.
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An average of approximately 14 months
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Serum concentrations of total anti-HER2 antibody
Time Frame: An average of approximately 14 months
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Individual patient data and descriptive statistics will be provided for serum concentration data at each time point for total anti-HER2 antibody.
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An average of approximately 14 months
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Serum concentrations of DXd
Time Frame: An average of approximately 14 months
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Individual patient data and descriptive statistics will be provided for serum concentration data at each time point for DXd.
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An average of approximately 14 months
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Immunogenicity
Time Frame: An average of approximately 14 months
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Presence of ADAs against T-DXd in serum during treatment and at follow-up.
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An average of approximately 14 months
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Frequency of AEs, SAEs and AESIs
Time Frame: An average of approximately 16 months
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Occurrence of AEs and SAEs graded according to NCI CTCAE v5.0.
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An average of approximately 16 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 13, 2022
Primary Completion (Actual)
September 23, 2023
Study Completion (Estimated)
June 24, 2024
Study Registration Dates
First Submitted
February 11, 2022
First Submitted That Met QC Criteria
February 11, 2022
First Posted (Actual)
February 18, 2022
Study Record Updates
Last Update Posted (Actual)
April 10, 2024
Last Update Submitted That Met QC Criteria
April 9, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Physiological Effects of Drugs
- Antineoplastic Agents
- Immunologic Factors
- Antineoplastic Agents, Immunological
- Immunoconjugates
- Trastuzumab
- Trastuzumab deruxtecan
Other Study ID Numbers
- D7811C00001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.
All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
IPD Sharing Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles.
For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD Sharing Access Criteria
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool.
Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access.
For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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