A Single Arm Phase 2 Study to Evaluate Efficacy and Safety of Trastuzumab Deruxtecan for Patients With HER2 Mutant NSCLC
DL-05
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)
1 other identifier
interventional
72
1 country
28
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of T-DXd in participants with HER2 mutant metastatic non-squamous NSCLC.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2022
Typical duration for phase_2
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 11, 2022
CompletedFirst Posted
Study publicly available on registry
February 18, 2022
CompletedStudy Start
First participant enrolled
July 13, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 4, 2024
CompletedResults Posted
Study results publicly available
December 4, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
ExpectedMay 12, 2026
April 1, 2026
2.3 years
February 11, 2022
September 4, 2024
April 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
ICR-assessed ORR (Objective Response Rate)
Confirmed ORR, defined as the percentage of participants with confirmed complete response or partial response, as assessed by independent central review(ICR) based on RECIST 1.1.
Tumour assessments (per RECIST 1.1) every 6 weeks for the first 48 weeks relative to the date of enrolment and then every 9 weeks thereafter. Assessed up to 28 months. (from date of enrolment to final analysis data cut-off)
Secondary Outcomes (10)
Investigator-assessed ORR (Objective Response Rate)
Tumour assessments (per RECIST 1.1) every 6 weeks for the first 48 weeks relative to the date of enrolment and then every 9 weeks thereafter. Assessed up to 28 months. (from date of enrolment to final analysis data cut-off)
ICR-assessed DoR (Duration of Response)
Tumour assessments (per RECIST 1.1) every 6 weeks for the first 48 weeks relative to the date of enrolment and then every 9 weeks thereafter. Assessed up to 28 months.
Investigator-assessed DoR (Duration of Response)
Tumour assessments (per RECIST 1.1) every 6 weeks for the first 48 weeks relative to the date of enrolment and then every 9 weeks thereafter. Assessed up to 28 months.
ICR-assessed and Investigator-assessed DCR (Disease Control Rate)
Tumour assessments (per RECIST 1.1) every 6 weeks for the first 48 weeks relative to the date of enrolment and then every 9 weeks thereafter. Assessed up to 28 months.
ICR-assessed and Investigator-assessed PFS (Progression-free Survival)
Tumour assessments every 6 weeks after enrolment for the first 48 weeks and then every 9 weeks thereafter until date of RECIST 1.1 defined radiological progressive disease or death. Assessed up to 28 months.
- +5 more secondary outcomes
Study Arms (1)
T-DXd arm
EXPERIMENTALParticipants will receive T-DXd as an IV infusion Q3W, on Day 1 of each 3-week cycle.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Daiichi Sankyocollaborator
Study Sites (28)
Research Site
Baoding, 071000, China
Research Site
Beijing, 100142, China
Research Site
Beijing, 100191, China
Research Site
Changchun, 130000, China
Research Site
Changsha, 410008, China
Research Site
Changsha, 410013, China
Research Site
Chengdu, 610041, China
Research Site
Chongqing, 400030, China
Research Site
Guangzhou, 510080, China
Research Site
Guangzhou, 510515, China
Research Site
Hangzhou, 310020, China
Research Site
Hangzhou, 310022, China
Research Site
Harbin, 150081, China
Research Site
Hefei, 133500, China
Research Site
Hefei, 230601, China
Research Site
Linyi, 276000, China
Research Site
Nanjing, 210029, China
Research Site
Shandong, China
Research Site
Shanghai, 200025, China
Research Site
Shanghai, 200032, China
Research Site
Shenyang, 110042, China
Research Site
Shenzhen, 518020, China
Research Site
Wuhan, 430022, China
Research Site
Wuhan, 430060, China
Research Site
Xi'an, 710061, China
Research Site
Xiamen, 361003, China
Research Site
Yangzhou, 225001, China
Research Site
Zhengzhou, 450000, China
Related Links
MeSH Terms
Interventions
Results Point of Contact
- Title
- Global Clinical Lead
- Organization
- AstraZeneca Clinical Study Information Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 11, 2022
First Posted
February 18, 2022
Study Start
July 13, 2022
Primary Completion
November 4, 2024
Study Completion (Estimated)
June 30, 2026
Last Updated
May 12, 2026
Results First Posted
December 4, 2024
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- 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.
- 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.
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.