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Monoclonal Antibodies

Trastuzumab Deruxtecan for Non-Small Cell Lung Cancer (DESTINY-Lung01 Trial)

Phase 2
Waitlist Available
Research Sponsored by Daiichi Sankyo
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Presence of at least 1 measurable lesion assessed by the investigator and based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
For Cohort 1 and Cohort 1a: HER2-overexpression (IHC 2+ or 3+) status must be assessed and confirmed by Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory or equivalent, from an archival tumor tissue sample
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 months (data cut-off)
Awards & highlights

DESTINY-Lung01 Trial Summary

This trial is testing a new drug for people with advanced lung cancer who have too much HER2 protein or a HER2 mutation.

Who is the study for?
This trial is for adults with advanced non-squamous Non-Small Cell Lung Cancer (NSCLC) that's HER2-overexpressing or mutated. Participants must have at least one measurable lesion, be willing to undergo a biopsy, and have an ECOG Performance Status of 0-1. Those previously treated with certain HER2-targeted therapies or with significant lung disease are excluded.Check my eligibility
What is being tested?
The trial tests the effectiveness of trastuzumab deruxtecan in patients with advanced NSCLC who overexpress HER2 or have a HER2 mutation. It aims to see how well this treatment works on tumors by measuring their response according to standard criteria.See study design
What are the potential side effects?
Trastuzumab deruxtecan may cause side effects such as lung problems like interstitial lung disease/pneumonitis, heart issues including congestive heart failure and arrhythmias, and potential QT interval prolongation which affects heart rhythm.

DESTINY-Lung01 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have at least one tumor that can be measured.
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My cancer is HER2-positive, confirmed by a certified lab test.
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My HER2 mutation was confirmed by a tissue test, not a liquid biopsy.
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I can provide a sample of my tumor for testing.
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I am willing to have a tissue biopsy after my latest treatment.
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I am at least 20 years old in Japan or 18 in other countries.
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My lung cancer cannot be removed by surgery and is not squamous type.
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My condition did not improve with standard treatment or there is no standard treatment for it.
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I am fully active or restricted in physically strenuous activity but can do light work.

DESTINY-Lung01 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 months (data cut-off)
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 months (data cut-off) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants With Objective Response Rate (ORR) Based on Independent Central Review Following Treatment With DS8201a in Participants With HER2-Over-Expressing or -Mutated Non-Small-Cell Lung Cancer (NSCLC)
Secondary outcome measures
Malignant Neoplasms
Malignant Neoplasms
Malignant Neoplasms
+2 more

DESTINY-Lung01 Trial Design

3Treatment groups
Experimental Treatment
Group I: Cohort 2: HER2 MutatedExperimental Treatment1 Intervention
Participants with HER2-mutated, unresectable and/or metastatic NSCLC who received 6.4 mg/kg trastuzumab deruxtecan (DS-8201a).
Group II: Cohort 1a: HER2 OverexpressingExperimental Treatment1 Intervention
Participants with HER2-overexpressing (immunohistochemistry [IHC] 3+ or IHC 2+), unresectable and/or metastatic NSCLC adenocarcinoma who received 5.4 mg/kg trastuzumab deruxtecan (DS-8201a).
Group III: Cohort 1: HER2 OverexpressingExperimental Treatment1 Intervention
Participants with HER2-overexpressing(immunohistochemistry [IHC] 3+ or IHC 2+), unresectable and/or metastatic NSCLC adenocarcinoma who received 6.4 mg/kg trastuzumab deruxtecan (DS-8201a).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab deruxtecan
FDA approved

Find a Location

Who is running the clinical trial?

Daiichi SankyoLead Sponsor
388 Previous Clinical Trials
409,330 Total Patients Enrolled
Daiichi Sankyo, Inc.Lead Sponsor
389 Previous Clinical Trials
414,928 Total Patients Enrolled
Daiichi Sankyo Co., Ltd.Industry Sponsor
115 Previous Clinical Trials
49,048 Total Patients Enrolled

Media Library

Trastuzumab deruxtecan (DS-8201a) (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03505710 — Phase 2
Non-Small Cell Lung Cancer Research Study Groups: Cohort 1: HER2 Overexpressing, Cohort 1a: HER2 Overexpressing, Cohort 2: HER2 Mutated
Non-Small Cell Lung Cancer Clinical Trial 2023: Trastuzumab deruxtecan (DS-8201a) Highlights & Side Effects. Trial Name: NCT03505710 — Phase 2
Trastuzumab deruxtecan (DS-8201a) (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03505710 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

DS-8201a is an antibody-drug conjugate (ADC) that has been studied in other clinical trials. Could you please provide more information about these previous investigations?

"UC Health Clinical Trials Office first began investigating trastuzumab deruxtecan (DS-8201a) in 2015. To date, there have been 5 completed clinical trials with 37 more currently underway. A large number of these active studies are based in Tampa, Florida."

Answered by AI

Are there any current vacancies for participants in this research?

"The clinical trial in question is not accepting patients at this time, as indicated by its listing on clinicaltrials.gov. This study was first posted on May 21st, 2018 and was last updated on April 25th, 2022. There are over 2000 other trials that are actively recruiting participants."

Answered by AI

Have these types of treatments been done before?

"First researched in 2015, trastuzumab deruxtecan (DS-8201a) has undergone 37 clinical trials across 44 countries and 487 cities since its Phase 1 drug approval."

Answered by AI

Is this research being conducted at multiple facilities within the state?

"Notably, this trial is open to patients at Moffitt Cancer Center in Tampa, Florida, Dana-Farber Cancer Institute in Boston, Massachusetts, as well as University of California San Diego (UCSD) which is situated in La Jolla, California. There are 9 other locations listed on the clinicaltrials.gov website."

Answered by AI

When might the FDA give its stamp of approval to Trastuzumab deruxtecan (DS-8201a)?

"Trastuzumab deruxtecan (DS-8201a) is a medication that, while having some clinical data supporting its safety, has not yet been proven effective. Therefore, it received a score of 2."

Answered by AI
~26 spots leftby Mar 2025