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Monoclonal Antibodies
Trastuzumab Deruxtecan for Non-Small Cell Lung Cancer
Phase 3
Recruiting
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Protocol-defined adequate organ function including cardiac, renal, hepatic function
Treatment-naïve for palliative intent systemic therapy for locally advanced or metastatic disease
Must not have
Any clinically active brain metastases; previously treated brain metastases allowed
History of non-infectious pneumonitis/ILD, current or suspected ILD
Timeline
Screening 3 weeks
Treatment Varies
Follow Up until death, assessed up to approximately 28 months.
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial will compare the effectiveness and safety of Trastuzumab Deruxtecan to the current standard of care for treating non-small cell lung cancer with HER2 Exon 19 or 20 mutations.
Who is the study for?
Adults with a specific type of advanced lung cancer (non-squamous NSCLC) that has certain HER2 mutations and hasn't been treated yet. They must have good heart, kidney, liver function, an ECOG performance status of 0-1, and measurable disease. Not eligible if they've had a recent heart attack or conditions like active brain metastases or autoimmune diseases.
What is being tested?
The trial is testing Trastuzumab Deruxtecan against standard treatments for this lung cancer type. Standard options include Cisplatin or Carboplatin combined with Pembrolizumab and Pemetrexed to see which is more effective as the first treatment.
What are the potential side effects?
Trastuzumab Deruxtecan can cause side effects such as nausea, hair loss, low blood cell counts increasing infection risk, potential heart damage, fatigue and possible allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My heart, kidneys, and liver are functioning well.
Select...
I have not received any treatment for my advanced or spread cancer.
Select...
I am 18 years old or older.
Select...
My cancer cannot be cured with surgery or radiation and may have spread.
Select...
My non-small cell lung cancer has a specific HER2 mutation.
Select...
I have tumor tissue available for testing.
Select...
I am fully active and can carry on all my pre-disease activities without restriction.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have brain metastases, but they are currently treated and not active.
Select...
I have or might have a lung condition not caused by an infection.
Select...
My tumor has a specific change in genes like EGFR or ALK that can be treated with targeted therapy.
Select...
I cannot receive platinum-based chemotherapy or pembrolizumab due to health reasons.
Select...
I had a heart attack in the last 6 months.
Select...
I have a severe lung illness that affects my daily life.
Select...
I have an active autoimmune or inflammatory condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ until death, assessed up to approximately 28 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~until death, assessed up to approximately 28 months.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Progression Free Survival (PFS) by Blinded Independent Central Review (BICR)
Secondary study objectives
Central Nervous System (CNS) - Progression Free Survival (PFS)
Duration of Response (DoR)
Immunogenicity of T-DXd
+12 moreSide effects data
From 2024 Phase 2 trial • 95 Patients • NCT0498981677%
Anaemia
73%
White blood cell count decreased
61%
Neutrophil count decreased
53%
Platelet count decreased
43%
Nausea
40%
Decreased appetite
39%
Hypoalbuminaemia
32%
Aspartate aminotransferase increased
32%
Vomiting
28%
Weight decreased
26%
Hypokalaemia
25%
Asthenia
25%
Alanine aminotransferase increased
24%
Hypocalcaemia
22%
Hyponatraemia
19%
Constipation
19%
Fatigue
17%
Lymphocyte count decreased
15%
Diarrhoea
13%
Covid-19
12%
Gamma-glutamyltransferase increased
12%
Blood alkaline phosphatase increased
12%
Blood bilirubin increased
9%
Hyperuricaemia
9%
Dizziness
9%
Pyrexia
8%
Hyperglycaemia
8%
Abdominal distension
7%
Oedema peripheral
7%
Insomnia
6%
Bilirubin conjugated increased
6%
Thrombocytopenia
6%
Blood creatinine increased
6%
White blood cell count increased
6%
Hypoaesthesia
6%
Hypochloraemia
6%
Abdominal pain
6%
Dyspepsia
5%
Productive cough
5%
Amylase increased
5%
Back pain
5%
Hepatic function abnormal
5%
Blood lactate dehydrogenase increased
5%
Ejection fraction decreased
5%
Interstitial lung disease
5%
Pneumonia
5%
Cough
5%
Mouth ulceration
5%
Coronavirus infection
5%
Hypoproteinaemia
4%
Covid-19 pneumonia
3%
Gastrointestinal haemorrhage
2%
Death
2%
Febrile neutropenia
1%
Jaundice cholestatic
1%
Malnutrition
1%
Dysphagia
1%
Gastrointestinal infection
1%
Myelosuppression
1%
Arrhythmia
1%
Mental disorder
1%
Haemorrhage intracranial
1%
Haematuria
1%
Renal failure
1%
Pulmonary embolism
1%
Deep vein thrombosis
1%
Cerebral infarction
1%
Sepsis
1%
Upper gastrointestinal haemorrhage
100%
80%
60%
40%
20%
0%
Study treatment Arm
T-DXd
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm 1Experimental Treatment1 Intervention
Trastuzumab Deruxtecan (T-DXd)
Group II: Arm 2Active Control4 Interventions
Standard of Care Treatment (platinum, pemetrexed and pembrolizumab)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab Deruxtecan
2021
Completed Phase 2
~100
Find a Location
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,427 Previous Clinical Trials
289,164,002 Total Patients Enrolled
Daiichi SankyoIndustry Sponsor
423 Previous Clinical Trials
469,013 Total Patients Enrolled
Daiichi Sankyo, Inc.Industry Sponsor
389 Previous Clinical Trials
422,470 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have brain metastases, but they are currently treated and not active.My heart, kidneys, and liver are functioning well.I have or might have a lung condition not caused by an infection.I have not received any treatment for my advanced or spread cancer.My tumor has a specific change in genes like EGFR or ALK that can be treated with targeted therapy.I am 18 years old or older.My cancer cannot be cured with surgery or radiation and may have spread.My non-small cell lung cancer has a specific HER2 mutation.I cannot receive platinum-based chemotherapy or pembrolizumab due to health reasons.I have tumor tissue available for testing.I had a heart attack in the last 6 months.Your heart's pumping function is normal.I have a severe lung illness that affects my daily life.I am fully active and can carry on all my pre-disease activities without restriction.Your doctor can measure your disease using a specific set of guidelines called RECIST 1.1.I have an active autoimmune or inflammatory condition.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 2
- Group 2: Arm 1
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.