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Monoclonal Antibodies
Trastuzumab Deruxtecan for Non-Small Cell Lung Cancer (DESTINY-LUNG02 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
Willing and able to provide an archival tumor tissue sample. A fresh biopsy is required if an archival tumor tissue sample cannot be supplied. Resection and core needle biopsy are acceptable. Fine needle aspirates or cell block are not acceptable.
Eastern Cooperative Oncology Group performance status 0 to 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 months after the last participant is randomized or later to data cut off, up to approximately 35 months
Awards & highlights
DESTINY-LUNG02 Trial Summary
This trial looks at whether a new drug, trastuzumab deruxtecan, is safe and effective for people with HER2-mutated metastatic non-small cell lung cancer who have had their disease come back or get worse after treatment with at least one other cancer drug regimen that contained a platinum-based chemotherapy drug.
Who is the study for?
This trial is for adults with HER2-mutated metastatic non-small cell lung cancer who have already tried a platinum-based chemotherapy and it didn't work or caused bad side effects. They need to be in good enough health, not planning to have kids soon, and able to provide a tumor sample. People with certain heart conditions, other cancers within the last 3 years, severe allergies, active hepatitis B or C, uncontrolled infections or those who are pregnant can't join.Check my eligibility
What is being tested?
The study tests Trastuzumab deruxtecan's safety and effectiveness on patients whose lung cancer has worsened after treatment. It's given to people who've had at least one previous therapy that included platinum-based chemo. The goal is to see if this drug helps when standard treatments fail.See study design
What are the potential side effects?
Trastuzumab deruxtecan might cause allergic reactions, potential heart issues like reduced heart function or irregular heartbeat (QT prolongation), lung problems such as interstitial lung disease/pneumonitis which could require steroids if severe enough, liver issues from hepatitis B/C reactivation and general side effects like fatigue.
DESTINY-LUNG02 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can provide a past or new tissue sample, but not just fluid or cells.
Select...
I can carry out all my usual activities without help.
Select...
My advanced lung cancer has a confirmed HER2 mutation, not just from a blood test.
Select...
I have at least one tumor that can be measured for its size.
DESTINY-LUNG02 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 9 months after the last participant is randomized or later to data cut off, up to approximately 35 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 months after the last participant is randomized or later to data cut off, up to approximately 35 months
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 Confirmed Objective Response Rate by Blinded Independent Central Review Following Intravenous Administration of Trastuzumab Deruxtecan in Participants With Metastatic Non-small Cell Lung Cancer
Secondary outcome measures
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30) and EORTC Quality of Life Questionnaire for Lung Cancer Trials (QLQ-LC13) Scores
Disease Control Rate Following Intravenous Administration of Trastuzumab Deruxtecan in Participants With Metastatic Non-small Cell Lung Cancer
Duration of Response Following Intravenous Administration of Trastuzumab Deruxtecan in Participants With Metastatic Non-small Cell Lung Cancer
+9 moreSide effects data
From 2024 Phase 2 trial • 79 Patients • NCT0401407565%
Nausea
44%
Vomiting
42%
Fatigue
38%
Anaemia
37%
Diarrhoea
35%
Weight Decreased
33%
Decreased Appetite
29%
Constipation
24%
Alopecia
18%
Platelet Count Decreased
16%
Neutrophil Count Decreased
16%
Aspartate Aminotransferase Increased
16%
Hypokalaemia
15%
Asthenia
14%
Abdominal Pain
11%
Pyrexia
11%
Cough
11%
White Blood Cell Count Decreased
11%
Blood Alkaline Phosphatase Increased
10%
Neutropenia
10%
Hypoalbuminaemia
10%
Epistaxis
10%
Gastrooesophageal Reflux Disease
10%
Alanine Aminotransferase Increased
9%
Back Pain
9%
Dyspnoea
9%
Headache
8%
Hyponatraemia
8%
Hypotension
8%
Dizziness
6%
Urinary Retention
6%
Ascites
6%
Pneumonitis
6%
Abdominal Pain Upper
6%
Dysphagia
6%
Covid-19
6%
Insomnia
6%
Thrombocytopenia
6%
Weight Increased
6%
Blood Bilirubin Increased
5%
Acute Kidney Injury
5%
Interstitial Lung Disease
5%
Device Related Infection
5%
Hypophosphataemia
5%
Depression
5%
Flatulence
5%
Mucosal Inflammation
5%
Blood Creatinine Increased
5%
Urinary Tract Infection
5%
Oedema Peripheral
3%
Pneumonia
3%
Disease Progression
3%
Malignant Neoplasm Progression
1%
Colitis
1%
Wound Infection
1%
Covid-19 Pneumonia
1%
Hyperpyrexia
1%
Staphylococcal Infection
1%
Haematemesis
1%
Bacterial Sepsis
1%
Intestinal Obstruction
1%
Animal Bite
1%
Enteritis
1%
Basal Ganglia Infarction
1%
Cerebrovascular Accident
1%
Generalised Tonic-Clonic Seizure
1%
Pulmonary Embolism
1%
Lymphangiosis Carcinomatosa
1%
Tumour Haemorrhage
1%
Bile Duct Stenosis
1%
Hepatotoxicity
1%
Hydronephrosis
1%
Urinary Tract Obstruction
1%
Exposure To Communicable Disease
1%
Device Occlusion
1%
Catheter Site Infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab Deruxtecan
DESTINY-LUNG02 Trial Design
2Treatment groups
Experimental Treatment
Group I: Trastuzumab deruxtecan 6.4 mg/kgExperimental Treatment1 Intervention
Participants will be randomized to receive trastuzumab deruxtecan 6.4 mg/kg administered by intravenous infusion every 3 weeks (Q3W).
Group II: Trastuzumab deruxtecan 5.4 mg/kgExperimental Treatment1 Intervention
Participants will be randomized to receive trastuzumab deruxtecan 5.4 mg/kg administered by intravenous infusion every 3 weeks (Q3W).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab deruxtecan
2022
Completed Phase 2
~400
Find a Location
Who is running the clinical trial?
Daiichi SankyoLead Sponsor
392 Previous Clinical Trials
411,213 Total Patients Enrolled
Daiichi Sankyo, Inc.Lead Sponsor
389 Previous Clinical Trials
415,145 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,262 Previous Clinical Trials
288,595,090 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had serious allergic reactions to other types of antibodies.I haven't had any cancer except for non-melanoma skin cancer, in-situ disease, or other solid tumors that were completely removed or treated.I do not have active brain metastases needing steroids or seizure meds.I haven't had a heart attack or severe heart failure in the last 6 months.I have had surgery to remove one entire lung.I do not have active liver disease like hepatitis B or C.I am 18 years old or older, or meet the legal age for study participation in my area.I still have side effects from cancer treatment, except for hair loss, that haven't improved.I will not donate sperm or eggs during and up to 4 months (for males) or 7 months (for females) after the study.I can provide a past or new tissue sample, but not just fluid or cells.I've had platinum therapy for advanced cancer and can't have surgery or radiation due to progression or side effects.I can carry out all my usual activities without help.You are expected to live for at least 3 more months.Your heart's electrical activity is measured and if it takes too long, you cannot participate—470 milliseconds for females and 450 milliseconds for males.My advanced lung cancer has a confirmed HER2 mutation, not just from a blood test.I have waited the required time after my last treatment before joining this trial.My heart pumps well and my organs are functioning properly.My cancer has a specific genetic change in EGFR, BRAF, MET, ALK, ROS1, RET, or NTRK.I have or had lung inflammation that needed steroids, or it might be present but not confirmed.I have at least one tumor that can be measured for its size.I do not have an infection needing IV drugs.I have an autoimmune or inflammatory condition that affects my lungs.I am HIV positive.You have had strong allergic reactions to the drug or its inactive ingredients in the past.I do not have severe lung conditions like severe asthma or COPD.I have been treated with a drug targeting topoisomerase I.
Research Study Groups:
This trial has the following groups:- Group 1: Trastuzumab deruxtecan 6.4 mg/kg
- Group 2: Trastuzumab deruxtecan 5.4 mg/kg
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are we currently able to sign up for this clinical trial?
"Unfortunately, this study is no longer recruiting new patients. The listing was first posted on March 19th, 2021 and updated for the final time on October 10th, 2022. However, there are 2098 other trials currently looking for patients with non-small cell lung carcinoma (nsclc) and 37 studies involving Trastuzumab deruxtecan that are actively recruiting participants."
Answered by AI
Is this research on Trastuzumab deruxtecan new?
"The first clinical trial for trastuzumab deruxtecan was conducted in 2015 at UC Health Clinical Trials Office. In the 5 years since, there have been 37 additional trials with many of them still recruiting patients presently. These studies are primarily based out of Boston, Massachusetts."
Answered by AI
Do patients often experience negative side effects from Trastuzumab deruxtecan?
"Trastuzumab deruxtecan is rated as a 2 in terms of safety. This means that while there is some evidence to support its safety, there is no data suggesting that it is an effective treatment option."
Answered by AI
What are the unique aspects of this research?
"Since 2015, Trastuzumab deruxtecan has undergone extensive clinical trials. In 2015, the first trial was completed by Daiichi Sankyo, Inc.. There are now 37 live trials in progress across 487 cities and 44 countries."
Answered by AI
Are there other locations in state where this research project is taking place?
"There are 15 sites that patients can enroll at, these include the Dana-Farber Cancer Institute in Boston and Sarah Cannon Research Institute in Nashville. There are also 13 other locations across the country."
Answered by AI
How many people are currently involved in this experiment?
"Presently, this trial is not looking for new candidates. The date when this study was first posted was March 19th, 2021 and the most recent update to the listing occurred on October 10th, 2022. There are presently 2098 trials actively enrolling participants with non-small cell lung carcinoma (nsclc) and 37 trials for Trastuzumab deruxtecan admitting participants."
Answered by AI
Who else is applying?
What state do they live in?
Colorado
How old are they?
65+
What site did they apply to?
UC San Diego Moores Cancer
What portion of applicants met pre-screening criteria?
Met criteria
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