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Antibody-drug conjugate

Patritumab Deruxtecan for Non-Small Cell Lung Cancer

Phase 3
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
Has histologically or cytologically documented metastatic or locally advanced non-squamous NSCLC not amenable to curative surgery or radiation.
Is willing to have a tumor biopsy or provide recently obtained tumor tissue
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to approximately 49 months
Awards & highlights

Study Summary

This trial is testing a new drug to see if it's effective and safe for patients with a certain type of lung cancer.

Who is the study for?
Adults with advanced non-squamous non-small cell lung cancer (NSCLC) that has an EGFR mutation and worsened after EGFR TKI therapy. They should not have had other systemic treatments in the metastatic setting, must be able to perform daily activities with minimal assistance (ECOG PS of 0 or 1), and have adequate organ function.Check my eligibility
What is being tested?
The trial is testing Patritumab Deruxtecan against standard platinum-based chemotherapy in patients whose NSCLC has progressed despite previous treatment with EGFR TKI drugs. The goal is to find a more effective and tolerable treatment for these patients.See study design
What are the potential side effects?
Potential side effects include reactions related to drug infusion, issues affecting blood cells, liver enzymes changes, kidney function alterations, possible lung problems like interstitial lung disease, and general symptoms such as fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My non-squamous NSCLC cannot be cured with surgery or radiation.
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I am willing to undergo a tumor biopsy or provide recent tumor samples.
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My advanced lung cancer cannot be cured with surgery or radiation.
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My cancer progressed despite treatment with a specific lung cancer medication.
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My cancer has a specific EGFR mutation.
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I haven't had any treatments like chemotherapy or immunotherapy for my advanced cancer.
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My blood counts and organ functions are within the required ranges.
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My cancer has a specific EGFR mutation.
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I've had 1 or 2 treatments with specific lung cancer drugs, including a newer type.
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I haven't had any treatments like chemotherapy or immunotherapy for my advanced cancer.
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I am 18 years old or older.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I've had 1 or 2 treatments with specific lung cancer drugs, including a newer type.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to approximately 49 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to approximately 49 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) as Assessed by Blinded Independent Central Review (BICR) Based on RECIST v1.1
Secondary outcome measures
Clinical Benefit Rate (CBR) as Assessed by BICR and Investigator Review Based on RECIST v1.1
Disease Control Rate (DCR) as Assessed by BICR and Investigator Review Based on RECIST v1.1
Duration of Response (DoR) as Assessed by BICR and Investigator Review Based on RECIST v1.1
+14 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Patritumab deruxtecanExperimental Treatment1 Intervention
Participants who will be randomized to receive patritumab deruxtecan (HER3-DXd) 5.6 mg/kg q3W.
Group II: Platinum-based chemotherapyActive Control1 Intervention
Participants who will be randomized to receive platinum-based chemotherapy for 4 cycles: pemetrexed plus either cisplatin or carboplatin. Participants without disease progression after 4 cycles of platinum plus pemetrexed therapy may continue treatment with maintenance pemetrexed with no restriction on the number of cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Patritumab Deruxtecan
2016
Completed Phase 2
~190

Find a Location

Who is running the clinical trial?

Daiichi SankyoLead Sponsor
392 Previous Clinical Trials
410,779 Total Patients Enrolled
Daiichi Sankyo, Inc.Lead Sponsor
389 Previous Clinical Trials
414,711 Total Patients Enrolled
Global Clinical LeaderStudy DirectorDaiichi Sankyo
162 Previous Clinical Trials
78,552 Total Patients Enrolled

Media Library

Patritumab Deruxtecan (Antibody-drug conjugate) Clinical Trial Eligibility Overview. Trial Name: NCT05338970 — Phase 3
Epidermal Growth Factor Receptor Deletion Research Study Groups: Platinum-based chemotherapy, Patritumab deruxtecan
Epidermal Growth Factor Receptor Deletion Clinical Trial 2023: Patritumab Deruxtecan Highlights & Side Effects. Trial Name: NCT05338970 — Phase 3
Patritumab Deruxtecan (Antibody-drug conjugate) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05338970 — Phase 3

Frequently Asked Questions

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

Does Patritumab Deruxtecan have any dangerous side effects for human patients?

"Patritumab Deruxtecan is a Phase 3 medication, so it has some evidence of efficacy and multiple rounds of safety data. Our team at Power gave it a score of 3 for safety."

Answered by AI

How many total participants are needed for this research project?

"In order to start the clinical trial, 560 eligible participants are needed. These people must meet the specific inclusion criteria for the study and can come from locations like American Oncology Partners of Maryland in Bethesda or Innovative Clinical Research Institute in Whittier."

Answered by AI

How many sites are running this clinical trial?

"There are 24 sites conducting this clinical trial, with locations in Bethesda, Whittier and Vallejo among others. If you enroll in the study, it is recommended that you choose a clinic nearest to your location to cut down on travel time."

Answered by AI

Are investigators currently looking for new participants in this trial?

"Yes, the information on clinicaltrials.gov indicates that this trial is actively recruiting patients. The trial was first posted on May 10th, 2022 and was last updated on November 16th, 2022. The study is looking for 560 patients across 24 sites."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
University of Texas Southwestern Medical Center
Innovative Clinical Research Institute
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Recent research and studies
clinicaltrials.govStudy
HERTHENA-Lung02: A Study of Patritumab Deruxtecan Versus Platinum-based Chemotherapy in Metastatic or Locally Advanced EGFRm NSCLC After Failure of EGFR TKI Therapy
2022. "HERTHENA-Lung02: A Study of Patritumab Deruxtecan Versus Platinum-based Chemotherapy in Metastatic or Locally Advanced EGFRm NSCLC After Failure of EGFR TKI Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05338970.
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