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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
Having tumour tissue available for central testing
Participants at least 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up until death, assessed up to approximately 28 months.
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Study 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.Check my eligibility
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.See study design
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 below
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I have tumor tissue available for testing.
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I am 18 years old or older.
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My cancer cannot be cured with surgery or radiation and may have spread.
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My non-small cell lung cancer has a specific HER2 mutation.
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I have not received any treatment for my advanced or spread cancer.
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My heart, kidneys, and liver are functioning well.
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I am fully active and can carry on all my pre-disease activities without restriction.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~until death, assessed up to approximately 28 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and until death, assessed up to approximately 28 months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression Free Survival (PFS) by Blinded Independent Central Review (BICR)
Secondary outcome measures
Central Nervous System (CNS) - Progression Free Survival (PFS)
Duration of Response (DoR)
Immunogenicity of T-DXd
+12 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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 3
~510

Find a Location

Who is running the clinical trial?

Daiichi SankyoIndustry Sponsor
385 Previous Clinical Trials
408,753 Total Patients Enrolled
AstraZenecaLead Sponsor
4,224 Previous Clinical Trials
288,417,835 Total Patients Enrolled
Daiichi Sankyo, Inc.Industry Sponsor
389 Previous Clinical Trials
414,845 Total Patients Enrolled

Media Library

Trastuzumab Deruxtecan (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05048797 — Phase 3
Non-Small Cell Lung Cancer Research Study Groups: Arm 1, Arm 2
Non-Small Cell Lung Cancer Clinical Trial 2023: Trastuzumab Deruxtecan Highlights & Side Effects. Trial Name: NCT05048797 — Phase 3
Trastuzumab Deruxtecan (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05048797 — Phase 3

Frequently Asked Questions

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

Can people who are over twenty participate in this research study?

"In order to enroll in this particular clinical trial, patients must be between the ages of 18-123. There are a total of 3942 studies for people over 65 and 169 for those under 18."

Answered by AI

Might this study be a good fit for you or someone you know?

"To be eligible for this study, patients must have carcinoma, non-small-cell lung and be aged between 18 and 123. In addition, patients must meet the following criteria: Locally advanced not amenable to curative therapy, or metastatic disease, Measurable disease assessed by Investigator based on RECIST 1.1, ECOG 0-1, Participants at least 18 years of age, Treatment-naïve for palliative intent systemic therapy for locally advanced or metastatic disease."

Answered by AI

What is the projected amount of people who will be taking part in this research?

"Yes, this is an active recruitment. According to the information provided on clinicaltrials.gov, the trial was posted on 10/28/2021 and last updated on 11/10/2022. They are looking for 264 subjects from 26 sites in total."

Answered by AI

Is this trial widespread throughout the state?

"There are 26 sites running this clinical trial, with locations in Silver Spring, Basking Ridge and Montvale. It is advisable that patients pick the location closest to them to reduce travel burdens if they enroll in the study."

Answered by AI

Are there any open positions in this clinical trial for new patients?

"That is accurate. According to the listing on clinicaltrials.gov, this trial is still recruiting patients. This research project was initially posted on October 28th 2021 and last updated November 10th 2022. They are looking for a total of 264 people spread out over 26 locations."

Answered by AI

When will Trastuzumab Deruxtecan be available to the public?

"Trastuzumab Deruxtecan was given a safety score of 3. This is because Phase 3 trials have shown some efficacy and there is also multiple rounds of data that supports Trastuzumab Deruxtecan's safety."

Answered by AI

Are there any ongoing or previous investigations on Trastuzumab Deruxtecan?

"Trastuzumab Deruxtecan was first studied in 1997. Since then, there have been a total of 1994 clinical trials completed with 2078 currently underway. A large proportion of these live studies are based out of Silver Spring, Maryland."

Answered by AI

What disease is Trastuzumab Deruxtecan most commonly used as a treatment for?

"Trastuzumab Deruxtecan is most often used as a treatment for cancer. However, it has also been shown to be effective in treating unresectable melanoma, microsatellite instability high, and locally advanced nonsquamous non-small cell lung cancer."

Answered by AI
~69 spots leftby Jan 2025