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Trastuzumab Deruxtecan for Non-Small Cell Lung Cancer (DESTINY-Lung01 Trial)
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.
DESTINY-Lung01 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowDESTINY-Lung01 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.DESTINY-Lung01 Trial Design
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Who is running the clinical trial?
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- I have or had lung inflammation that needed steroids, or it's suspected but not confirmed.Your heart takes longer than normal to recharge between beats.My cancer has a known HER2 mutation.I have a history of serious lung disease.I have at least one tumor that can be measured.My cancer is HER2-positive, confirmed by a certified lab test.My HER2 mutation was confirmed by a tissue test, not a liquid biopsy.I can provide a sample of my tumor for testing.I am willing to have a tissue biopsy after my latest treatment.I have been treated with HER2-targeted therapies, but not with pan-HER inhibitors.I am at least 20 years old in Japan or 18 in other countries.My lung cancer cannot be removed by surgery and is not squamous type.My condition did not improve with standard treatment or there is no standard treatment for it.You may have other specific diseases that can be seen on screening images.I have a history of serious heart conditions.I am fully active or restricted in physically strenuous activity but can do light work.
- Group 1: Cohort 1: HER2 Overexpressing
- Group 2: Cohort 1a: HER2 Overexpressing
- Group 3: Cohort 2: HER2 Mutated
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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