Trastuzumab Deruxtecan for Carcinoma, Non-Small-Cell Lung

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Carcinoma, Non-Small-Cell Lung+2 More
Trastuzumab Deruxtecan - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Carcinoma, Non-Small-Cell Lung
  • Malignant Neoplasms

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 15 Secondary · Reporting Duration: Until death, assessed up to approximately 28 months.

Month 12
Landmark analysis of PFS (PFS12)
Month 20
Time to second progression or death (PFS2)
Month 24
Landmark analysis of OS (OS24)
Month 12
Central Nervous System (CNS) - Progression Free Survival (PFS)
Month 28
Overall Survival (OS)
Month 12
Progression Free Survival (PFS) by Blinded Independent Central Review (BICR)
Month 28
Safety and tolerability of T-DXd versus Standard of Care treatment
Month 12
Duration of Response (DoR)
Objective Response Rate (ORR)
Progression Free Survival (PFS) by investigator assessment
Month 13
Immunogenicity of T-DXd
Patient-reported pulmonary symptoms associated with Non-Small Cell Lung Cancer
Patient-reported tolerability of T-DXd described using overall side-effect bother
Patient-reported tolerability of T-DXd described using physical function
Patient-reported tolerability of T-DXd described using symptomatic AEs
Week 12
Pharmacokinetics (PK) of T-DXd, total anti-HER2 antibody and DXd in serum

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Arm 2
1 of 2
Arm 1
1 of 2

Active Control

Experimental Treatment

264 Total Participants · 2 Treatment Groups

Primary Treatment: Trastuzumab Deruxtecan · No Placebo Group · Phase 3

Arm 1
Drug
Experimental Group · 1 Intervention: Trastuzumab Deruxtecan · Intervention Types: Drug
Arm 2ActiveComparator Group · 4 Interventions: Cisplatin, Pembrolizumab, Pemetrexed, Carboplatin · Intervention Types: Drug, Drug, Drug, Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: until death, assessed up to approximately 28 months.

Who is running the clinical trial?

AstraZenecaLead Sponsor
3,960 Previous Clinical Trials
91,809,919 Total Patients Enrolled
263 Trials studying Carcinoma, Non-Small-Cell Lung
91,971 Patients Enrolled for Carcinoma, Non-Small-Cell Lung
Daiichi Sankyo, Inc.Industry Sponsor
356 Previous Clinical Trials
341,290 Total Patients Enrolled
27 Trials studying Carcinoma, Non-Small-Cell Lung
7,746 Patients Enrolled for Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The disease is too advanced to be cured, or it has spread to other parts of the body.
Non-squamous NSCLC with a mutation in the HER2 gene in either exon 19 or 20, as detected by tissue NGS or ctDNA analysis.
and hemoglobin level The text says that the patient's organ function must be adequate according to a specific protocol, including cardiac, renal, and hepatic function, and hemoglobin levels.
The disease is assessed by the Investigator to be measurable, based on the RECIST 1.1 guidelines.
You are at least 18 years of age.
People who have not received any treatment yet for their advanced cancer that is not responding to local therapies or has spread to other parts of their body may be treated with systemic therapy meant to improve their quality of life.
You have a left ventricular ejection fraction (LVEF) of 50% or more.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: November 13th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.