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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

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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My heart, kidneys, and liver are functioning well.

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I have not received any treatment for my advanced or spread cancer.

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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 tumor tissue available for testing.

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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:

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I have brain metastases, but they are currently treated and not active.

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I have or might have a lung condition not caused by an infection.

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My tumor has a specific change in genes like EGFR or ALK that can be treated with targeted therapy.

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I cannot receive platinum-based chemotherapy or pembrolizumab due to health reasons.

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I had a heart attack in the last 6 months.

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I have a severe lung illness that affects my daily life.

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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.

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

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

~610

0 / 14Eligibility criteria met

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor

4,302 Previous Clinical Trials

288,624,149 Total Patients Enrolled

Daiichi SankyoIndustry Sponsor

396 Previous Clinical Trials

419,538 Total Patients Enrolled

Daiichi Sankyo, Inc.Industry Sponsor

389 Previous Clinical Trials

421,015 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 2, Arm 1

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

~112 spots leftby Jun 2025

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